pda europe conference, exhibition the universe of pre ... · pdf filethe universe of...

The Universe of Pre-filled Syringes & Injection Devices

The Parenteral Drug Association presents:

2017 PDA Europe Conference, Exhibition

7–8 November 2017 Austria Center

Vienna | Austriapda.org/EU-UPS2017

Improving Patient Outcomes with Innovative Drug Delivery

https://pda.org/EU-UPS2017


14th The Universe of Pre-filled Syringes & Injection DevicesThe Parenteral Drug Association warmly invites you to join the 14th edition of The Universe of Pre-filled

Syringes and Injection Devices!

Since its first edition in 2004, the conference has become a fixture in the calendar for the pharmaceutical

industry, and a must-attend event for everyone working in the fields related to parenteral drug and device

development.

For its 14th year, the European event once again returns to Vienna, one of Europe’s most vibrant cities.

The Austrian capital perfectly integrates tradition and innovation, with an overwhelming cultural offer of the

arts and the sciences.

Geographically situated between central and southeastern Europe, with its many neighboring countries,

Vienna holds great potential for interaction, exchange of expertise and networking.

By coming to Vienna, you will become part of this cultural melting pot, with unlimited potential for getting

involved in the vast professional network of PDA members, speakers and special guests.

Another impressive opportunity to gain access to key decision makers from the pharmaceutical industry as

well as government representatives, service providers and manufacturers awaits you!

Join us this fall in Vienna and be part of the world’s largest event on this subject.

2 pda.org/EU-UPS2017


Introduction 4

Activities at a Glance 4

Pre-Conference Workshops 5

Venue 11

Main Event 12

Letter from the Chairs 13

Conference 14

Conference Agenda 14

Exhibition Floor Plan 20

PDA Education Program 23

Training Course Agendas 23

General Information 33

Registration Form 34

VENUEAustria Center ViennaBruno-Kreisky-Platz 11220 Vienna | Austriawww.acv.at

ORGANIZERPDA EuropeAm Borsigturm 6013507 Berlin | GermanyTel: +49(0) 30 43 65 50 80Fax: +49(0) 30 436 55 08 [email protected]

MEDIA PARTNER

International Pharmaceutical Industry Supporting the industry through communication

IN

TERNATIONAL PHA

RM

ACEUTICAL IN

DU

STRY

TABLE OF CONTENTS

3pda.org/EU-UPS2017


ACTIVITIES AT A GLANCE

7:00 – 16:30The Universe of Pre-filled Syringes &

Injection Devices

9:00 – 16:00Exhibition, Live Demos &

Poster Session

CONFERENCE

7:30 – 18:00Registration

9:00 – 18:30The Universe of Pre-filled

Syringes & Injection Devices

9:00 – 18:30Exhibition, Live Demos &Poster Session

18:30 – 21:30Color the NightNetworking Event

Tuesday, 7 November


Wednesday, 8 November

PRE- CONFERENCE WORK SHOPS


10:00 – 18:00Workshop

Innovative Drug Delivery Systems/Combination Products

10:00 – 18:00WorkshopImpact of Pre-filled Syringe

Packaging Components on Biopharmaceuticals

10:00 – 17:30Workshop

Connected Health & Drug Delivery

Monday, 6 November

PDA EUROPE EDUC ATION PROGR A M



9:00 – 17:00Workshop

Drug Delivery Systems: Global

Technical, Regu-latory and Quality

Challenges

9:00 - 16:00Workshop

Drug Delivery Systems: Global

Technical, Regu-latory and Quality

Challenges

9:00 – 18:00Training Course

Best Practices and Points to

Consider in Aseptic

Processing


Container Closure Integrity

Testing


Container Closure Integrity

Testing


Rapid Microbiological

Methods


Development and

Manufacturing of Pre-filled

Syringes


Container Closure Development


Development and

Manufacturing of Pre-filled

Syringes


Rapid Microbiological

Methods


Best Practices and Points to

Consider in Aseptic

Processing

Thursday, 9 November

Friday, 10 November



6 November 2017Innovative Drug Delivery Systems / Combination ProductsOne-Day Workshop

6 November 2017Impact of Pre-filled Syringe Packaging Components on BiopharmaceuticalsOne-Day Workshop

6 November 2017Connected Health & Drug DeliveryOne-Day Workshop

Pre-Conference Workshops


PRE-CONFERENCE WORKSHOP

Innovative Drug Delivery Systems/Combination ProductsFrom Project Initiation to Life Cycle Management

Workshop DescriptionIncreasingly, parenteral products are injected using devices like pen-injectors, auto injectors and wearable pumps. Typically, the primary containers are pre-filled syringes and cartridges. The materials are glass or polymer. Special applications have treated surfaces or coated materials.

Starting with a key note presentation describing the needs of the pharmaceutical and biopharmaceutical industry, this workshop will give an overview of currently used devices. Technical aspects, handling and training, as well as regulations will be highlighted. Device companies will present their products and focus on the most current drug delivery requirements such as:

• Mixing technology for liquid/liquid or lyo/liquid formulation combinations

• Large Volume• High Viscosity• High Precision Dosing

Challenges in development impeding a life cycle approach will be one of the themes of the workshop.

Learn from suppliers’ solutions, and hear guest speakers and facilitators share approval and life-cycle management experiences from developing their drug delivery combination products.

Listen to the latest trends in final assembly during drug product manufacturing and what the benefits of target-focused training for users and health care professionals can be. Learn which activities succeeded and hear about the lessons learned. Interact with other participants and speakers during panel discussions and exchange on all issues vital for ensuring success of your product.

Who Should Attend:The target audience for this workshop is from departments like Device Development, Compliance, Operations, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Business Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Con-trol, Clinical Affairs.

Learning Objectives:Upon participation of this workshop you will be able to:• Use combination products to gain market differentiation• Identify to best possible and innovative drug delivery solution for your drug product• Understand the latest trends in drug delivery technology• Implement world class training solutions to prepare for a smooth market entrance • Understand best in class assembly concepts


7pda.org/EU-UPS2017

WORKSHOP AGENDA

Thomas Schoenknecht, PhD, PDA IG Leader Combination Products, SHL

Thomas Schönknecht is currently Executive Director, Business Development at SHL Group, with responsibility for global Business Development, Key Account Management and new Technology Evaluation within SHL’s Medical division. Thomas has over 20 years of experience in pharmaceutical industry in various leading roles in project management, research & development and business development. He received his Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University Goettingen, Germany and a Master’s

degree in Chemistry from the University Goettingen. He is currently active as PDA interest group leader combination products in Europe. In addition he had been active as member in various DIN ISO committees regarding primary packaging materials and drug delivery devices.

Workshop Chair

2 Nov 2017

Monday, 6 November 2017 10:00 – 18:00

10:00 Welcome and Introduction Thomas Schoenknecht, SHL

10:15 Data-driven Discovery: Knowledge Management for Drug Delivery Technologies

Jeffrey Schacherl, Amgen Christian Marc Schmidt, Schema Design

10:45 Device Companies Presentation Overview of Devices by• Becton Dickinson • Bespak

• BIOCORP • Dali Medical Devices

• Haselmeier• Ypsomed

12:30 Lunch Break

13:30 Device Companies Presentation (cont.)Overview of Devices by• Sensile • SHL • Oval Medical • West

14:30 Panel Discussion:Drivers of Life Cycle Management in Pharmaceutical Companies

15:30 Coffee Break

16:00 A Novel Autoinjector for High Volume, High Viscosity, and Outstanding Usability

Avi Eliahu, Genentech

16:30 Device Training for Patients & Healthcare Providers Joe Reynolds, Noble

17:00 Considerations on Lifecycle Management in Scope of the Changing Regulatory Landscape• Recent changes on standards and regulatory expectations/requirements• Considerations on legacy products in light of changing standards

Rosemary Gonzalez, SHL

17:30 Q&A on Real Cases, Discussion

18:00 End of Pre-Conference Workshop




Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals

Workshop DescriptionParenteral drug delivery using pre-filled syringes and cartridges in combination with devices is of great importance, especially for the application of biopharmaceutical products.

The development of such delivery systems is complex and therefore it is important to consider critical aspects early on in development. This workshop considers the potential influences of primary packaging components on the quality, in particular for biopharmaceuticals. The most relevant aspects are the quality and the chemical and physical interactions of the packaging material with the product. Special considerations are given to the influence of particles, extractables and leachables, silicon oil and handling on the product quality, e.g. aggregation, degradation routes and stability. Experts from academia, the pharmaceutical industry and suppliers of packaging components will share their experiences. There will be plenty of time for discussion, interaction and questions you may have.

Who Should Attend:• Professionals in pharma dealing with development and manufacturing of biopharmaceuticals, con-

tainer and device development, quality and regulatory functions

Workshop Co-Chairs

John Carpenter, University of Colorado

John F. Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado (CU) and Co-Director of the CU Center for Pharmaceutical Biotechnology. His research focuses on mechanisms for protein degradation and stabilization. John has published >270 peer-reviewed papers and holds more than 30 patents. He is an Editor for Journal of Pharmaceutical Sciences and serves on several Editorial Advisory Boards. He has received The Ebert Prize and the American Association of Pharmaceutical Scientists (AAPS) Research Achievement

Award in Biotechnology. He is a Fellow of the American Association for Advancement of Science, the AAPS and the National Academy of Inventors.

William Dierick, Terumo

William Dierick is Fellow - Science & Technology of TERUMO, a global research & development company, offering a wide range of innovative products related to drug delivery devices and injection technology, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems. With extensive experience in the Medical and Pharma sector for more than 40 years, William has held various positions in Terumo, covering quality assurance, manufacturing, product development & engineering, project management, marketing,

corporate planning and business development. He serves as expert of ISO/TC76 and ISO/TC84 and is an active member of Eucomed (MedTech Europe) and volunteer of PDA.


9pda.org/EU-UPS2017

WORKSHOP AGENDA

2 Nov 2017

Monday, 6 November 2017 10:00 – 18:00

10:00 Welcome William Dierick, TERUMO


KEYNOTE PRESENTATIONS

10:10 Aggregates, Particles and Patient Immunogenicity with Biopharmaceuticals


10:40 Factors Affecting Stabilities of Biopharmaceuticals in Pre-filled Syringes

Susumu Uchiyama, Osaka University

11:10 Packaging Components and Biopharmaceuticals: Quality Aspects from Industry Perspective

Hanns-Christian Mahler, Lonza

11:40 Q&A - Discussion

12:00 Lunch Break

Session 1 Aggregation Phenomena

13:00 Protein – Device Compatibility Flora Felsovalyi, Roche

13:30 Characterization of Particles and Practical Implications Linda O. Narhi, Amgen

14:00 Ex-Vivo Risk Assessment of Immunogenicity Mark Fogg, Abzena

14:30 Q&A – Discussion

15:00 Coffee Break

Session 2 Particles

15:30 Particulates in Sterile Drug Products: Testing, Contributions and Mitigation from Packaging Components

Fran DeGrazio, West

16:00 Particles in Packaging Components: Numbers and Chemical Composition Markus Lankers, Rap.ID


Session 3 Extractables & Leachables

16:45 Extractables and Leachables: Impact of Packaging Components on Biopharmaceuticals

Piet Christiaens, Toxikon

Session 4 Functionality

17:15 Needle Clogging of Staked-In-Needle PFS with High Concentration Protein Therapeutics

Monica De Bardi, Roche


17:55 Closing Remarks by Co-Chairs

18:00 End of Workshop




Connected Health & Drug Delivery Improved patient convenience and adherence through new technologies

Workshop DescriptionMeanwhile there are a number of technical solutions for smart devices and connected health. In this workshop we will focus on the patient s perspective. How do patients accept smart devices and what might be challenges for implementation? Patients will talk about their experiences and companies will present approaches they took to get patient s acceptance.

Who Should Attend:

• Professionals from pharmaceutical and supplier companies involved in functions such as clinical, pharmaceutical and container development, as well as business development and marketing, but also people dealing with regulatory issues.

Markus Bauss, Managing Director, SHL Connect

Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up company ConnectMeSmart GmbH in 2013. In 2015, SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their

potential application within each of SHL Group’s companies. From 2004 to 2014, Markus was working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, Markus contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. Markus studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997, prior to moving to the pharmaceutical area.

Workshop Chair


11pda.org/EU-UPS2017

WORKSHOP AGENDA

2 Nov 2017

Monday, 6 November 2017 10:00 – 17:30

10:00 Welcome Markus Bauss, SHL Connect

10:30 The Patient s Perspective• Expectations of the patient about technology - Two diabetes patients

share their experiences

11:00 Products by Patients for Patients • Experiences, key success factors and lessons learned establishing a mo-

bile health platform for diabetes care

Fredrik Debong, mysugr

11:30 Injection Devices – How do YOU do it ? • User centric drug delivery device development • Applying new technology in design process and usability testing to en-

sure patient convenience

Markus Bauss, SHL Connect

Jez Clements, Cambridge Design Partnership

12:00 Discussion

12:30 Lunch Break

TECHNOLOGY & DIGITAL HEALTH PLATFORMS

13:30 The Evolving Perspective of Digital Health Cliff Lee, Flex

14:00 The Internet of Health• Wireless sensors for prevention, cure and care

Chris van Hoof, Imec

14:30 The Move to Connected Devices• Key elements to consider in product design

Chris McKenzie, Batelle

15:00 Why Make Your Existing auto-injector “smart”• Comparison of benefits of different accessory form factors and integra-

tion into a connected health platform

Brian Lynch, West

15:30 Coffee Break

APPLICATIONS IN SPECIFIC THERAPIES

16:00 Connected Health & Rare Diseases • Opportunities through new technology

Sujit Basu, Shire

16:30 Creating a Digital Ecosystem to Support Repatha Patients• The potential to support patients before and after the prescription of

drug products through complementary digital technologies

Shawn Davis, Amgen

17:00 Panel Discussion

17:30 End of Pre-Conference Workshop


PRE-CONFERENCE – EXHIBITION FLOOR PLAN

Workshop Rooms

1

10

9

4

5 876

Teru

mo

IWAT

A

Table Top 2 m x 2,5 m (5 m2)

Buffet/Coffee Station

TO EXHIBIT:PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.995 Euro net. For more information please contact [email protected]



www.terumo-ps.com

C a r e f u l l y C r a f t e d

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• Drug delivery solutions & technologies for injection and infusion

• Expert platforms in pharmaceuticals, polymers, coatings,

precision and miniaturization technologies

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For more information, contact West today. www.westpharma.com

West and the diamond logo is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

© 2017 West Pharmaceutical Services, Inc. 9822 • 0717

World leader in integrated containment and delivery systemsPatient Focus: Sharing our partners’ goals of improving patient health

Quality Driven: Delivering high-quality products that meet industry leading specifications

Global Reach: More than 50 sales, manufacturing and R&D centers around the world

A Trusted Partner: Helping to address the needs of patients and the challenges of our partners for more than 90 years

EXHIBITION HALL

CONFERENCE AREA

ENTRANCE

TRACK A

TRACK B TRACK C

Access to Parking

D

KG

PDA Registration

Smart Phone Loading Stations

Speakers Ready Room(Room 2.31)

DemoBooth 1

DemoBooth 2

DemoBooth 3

DemoBooth 4

DemoBooth 8

DemoBooth 7

DemoBooth 6

DemoBooth 5

WC

WC

POSTER SESSION

E X HIB I T H A L LC AT ER IN G A R E A

EXHIBITION ARE A

Austria Center ViennaLevel -2 (Brown Level)

DETAILED CONFERENCE EXHIBITION FLOOR PLAN ON PAGES 22–23

VENUE



MAIN EVENT

Join our Welcome Party at the Highest Point of Vienna

6 November 2017 19:30 - 22:30Meliá Hotel | BAR 57Donau City Strasse 71220 Vienna

proudly provided by

Included in full Conference and Exhibition Registration Fee. First come first served. See details on Registration Form.

7–8 November 2017

The Universe of Pre-filled Syringes and Injection Devices

7 November 2017

7:30 Registration | Welcome Coffee & Exhibition

8 November 2017

6:45 Registration | Welcome Coffee & Exhibition

Conference



Dear Colleagues,

During the last decade, PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject. We are looking forward to welcoming you to the 14th edition of this event, to be held 7–8 November 2017 at the Austria Center Vienna.

There is a continued process in the pharmaceutical and biopharmaceutical industry to improve the application of injectables. Starting from primary packaging solutions to devices with increased functionalities, new concepts are being developed to better serve the patient needs. Innovations cover a broad range like new materials, new devices, smart devices, special application systems for challenging formulations. Together with these innovations new manufacturing, handling and testing requirements need to be developed. Furthermore, regulatory demands are constantly changing as well, posing challenges to everyone involved in pharmaceutical science, technology and manufacturing of parenterals.

The Universe of Pre-filled Syringes and Injection Devices brings together industry and regulatory experts annually to share their experiences, new developments, regulatory considerations, trends and best practices. Do not miss the opportunity to gain access to and network with key decision makers from the pharmaceutical industry as well as suppliers and manufacturers.

The Austria Center in Vienna has proven to be the ideal location for PDA Europe‘s largest event, offering seemingly endless space and possibilities to create a very unique atmosphere, thereby contributing to the event‘s tremendous success in 2015. Austria‘s largest conference centre is located in the heart of the United Nations’ City Department of Vienna, only a few minutes from the center of one of Europe’s most vibrant cities. Join us there, the perfect place to explore and get immersed in the pre-filled syringes universe!

Sincerely, the Co-Chairs

LETTER FROM THE CO-CHAIRS

SCIENTIFIC PROGR AM PL ANNING COMMIT TEE

Mathias Romacker, Conference Co-Chair, Pfizer

Hanns-Christian Mahler, Conference Co-Chair, Lonza

Markus Bauss, SHL Group

Michael Betz, Roche/Genentech

Christina Braden-Moore, BD Medical

William Dierick, Terumo

Olivia Henderson, Amgen

Laurent Jeanmart, GlaxoSmithKline

Lei Li, Eli Lilly & Co.

Manfred Maeder, Novartis

Brigitte Reutter-Härle, Vetter

Mike Schäfers, West

Michael Selzer, Regeneron

Ian Thompson, Ypsomed

Georg Roessling, PDA Europe

Sylvia Becker, PDA Europe

Hanns-Christian Mahler, PhD Conference Co-Chair, Lonza

Mathias Romacker, PhD Conference Co-Chair, Pfizer



CONFERENCE AGENDA


Tuesday, 7 November

9:00 Welcome: Opening Remarks & Introduction Georg Roessling, PDA Europe

Mathias Romacker, PfizerHanns-Christian Mahler, LONZA, Conference Co-Chairs

Opening Plenary: Current Trends & Future Outlook

Moderator: Mathias Romacker, Pfizer

Our conference on Pre-filled Syringes and Injection Devices aims to highlight future technology and regulatory trends of all aspects related to application device technology. At the center of our Universe of Pre-filled Syringes and Injection Devices, however, is the patient. Working in the pharmaceutical industry, regulatory agencies or industries supplying and enabling us to develop and to market these cutting-edge pharmaceutical products and delivery systems, we all are committed to serving patients both in developing countries as well as industrial nations. Safe and efficient application of complex biologics, whether to merely reduce fear of needle and pain, or to increase patient s adherence, improve compliance, reduce waste, etc., are our core goals. Smart devices and connected technologies will open up new horizons in our healthcare universe, providing patients with easier, safer and more effective solutions of drug administration. This and more key drivers for advancing the development of pre-filled syringes and injection devices will be presented over the course of these two days!

KEYNOTE PRESENTATIONS

9:15 The Evolving Perspective of the Pharma Company on Devices and Connectivity

Simon Wilson, Pfizer

9:50 Finding the Right Solution for the Patient: Using Novel Devices to Deliver Molecules from an Increasingly Complex Pipeline

Sheldon Moberg, Amgen

10:25 Coffee Break, Poster Session & ExhibitionFeaturing live Demo OPTIMA Machinery Booth #1

11:10 Device Development for Biosimilars Florian Turk, Sandoz Biopharmaceuticals

11:45 Smart Devices - How to Unlock their Potential in the Real World Tobias Handschuh, Ernst & Young

12:20 Discussion, Q&A

12:45 Lunch Break, Poster Session & ExhibitionFeaturing live Demos

13:45 Transition to Parallel Tracks

Hal

l D




CONFERENCE AGENDA

P A R A L L E L T R A C K S

Hall D Hall G Hall K

TRACK A TRACK B TRACK CPatient-Device Interface Manufacturing and Technology Marketing and Business

Development

Session 1 New Applications & Challenges Development Marketing & Lifecycle Management

Moderator: Janice Adkins, BD Hanns-Christian Mahler, LONZA Manfred Maeder, Novartis

14:00 Foundational Research on Subcutaneous Injection Physiology to Improve Biologics Delivery Systems and Patient Experience

Michael W Harrison, Eli LillyGraham Jones, Tufts Medical School

Formulation & Administration of Ocular Dosage Forms – Requirements and Challenges

Dhanajay Jere, Lonza AG

Syringe Auto Injector Portfolio Commercialization Development – Challenges and Opportunities

Chris Mitchener, Eli Lilly

14:25 Advances in Intradermal Drug Delivery - From Vaccines to Immunotherapy and Beyond

Gal Admati, NanoPass Technologies

High Volume Injectors: Case Study of an Assessment & Compatibility Test with a Biologic Drug Product

Pierre Goldbach, Roche

Wearable Injectors – Would The Real Driver Stand Up Please

James Blakemore,Cambridge Consultants

14:50 Lucentis Pre-filled Syringe – Challenges and Opportunities

Marie Picci, Novartis

Control Strategy for Combination Products

Christof Golla, Novartis

Commercial Success of a 3rd Generation Digital-Auto Injector: Commercialization, Sustain ability and Environmental Impact

Steven Lynum, Panasonic-Healthcare Takashi Hanada, JCR Pharmaceuticals

15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion

15:30 Coffee Break, Poster Session & ExhibitionFeaturing live Demo OPTIMA Machinery Booth #1




CONFERENCE AGENDA




Development

Session 2 Smart Devices Manufacturing Investment

Moderator: Markus Bauss, SHL Connect Mike Selzer, Regeneron Mathias Romacker, Pfizer

16:30 Highlights of Smart Devices Pre-Conference Workshop

Markus Bauss, SHL Connect

Challenges in the Filling of Drug Product Formulations

Simon Hanslip, GSK Vaccines

Pharma Perspective on Device and Development Models and Investment

Nic Bowman, Pfizer

16:55 The Changing Diabetes Landscape – Linking Diagnostics with Injection

Aileen Kinsella, WEST

Building a Flexible Robotic Small Scale Filling Line

Martin Bultmann, AbbVie

Technical Integration of Device Systems and Associated Business Process to Accelerate Innovation

Justin Wright, Eli LillyMarty Coyne, Matchstick

17:20 Smart Drug Delivery Devices for Home Use

Martin Koch, Roche

Clinical Manufacturing Flexibility

Susanne Resatz, Vetter

Funding and Building a Business that Provides Pharma Innovations in Drug Delivery

John Merhige, Credence MedSystems

17:45 Improving Patient Outcomes with Mixed Reality and Artificial Intelligence Technologies

Kai Worrell, WorrellMatt Gottschalk, Worrell

Pre-fillable Syringe Selection Criteria for Vaccine: Technical Comparison of Several Syringe Types

Laurent Jeanmart, GSKNicolas Eon, SCHOTT

Case for Re-Usable Autoinjector

Björn Knud Andersen, Medicom


18:30 Networking Event Color the Night

I n c l u d e d i n f u l l C o n f e r e n c e a n d E x h i b i t i o n R e g i s t r a t i o n F e e . F i r s t c o m e f i r s t s e r v e d . S e e d e t a i l s o n R e g i s t r a t i o n F o r m .

NETWORKING EVENT

7 NOVEMBER 2017

18:30 - 21:30 ■ Hall X1

VIENNA AUSTRIA CENTER

DRESS CODE: CASUAL COLORFUL ATTIRE

CONFERENCE AGENDA

Wednesday, 8 NovemberHall D Hall X

7:30 Morning SessionModerator: Georg Roessling, PDASpeakers: Tony Stauffer, ptiChristopher Bureau, Stevanato Group Jack Auld, Altaviz

PDA Interest Group Meeting Packaging ScienceJoin us for discussion of selected technologies and posters!Moderators:Derek Duncan, LIGHTHOUSEBettine Boltres, WEST

8:45 Welcome Coffee, Poster Session & Exhibition




Development

Session 3 Clinical Needs Processing & Assembly Market Trends & Reimbursement

Moderator: Mike Schäfers, WEST Michael Betz, Roche Brigitte Reutter-Haerle, Vetter

9:00 Future of Parenteral Drug Delivery - Wearable Injector: Latest Trends Development and Innovation

Sudeshna Dutta Ray, Amgen

Injectable Drug Delivery - Rethinking Best Practice in Manufacturing based on Smart Objects & Intelligent Machinery

Markus Bauss, SHL ConnectEgmont Semmler, Groninger

Market Trends & Developments

Brigitte Reutter-Haerle, Vetter

9:30 De-risking Clinical Trial Outcomes through Preclinical In-Vivo Models for Large Volume Subcutaneous Injections

Natasha Bolick, BD Medical

Finished Pre-filled Syringes Integrity Testing: Method Development, Validation and 100% in-line High Speed Solution

Giovanni Golinelli, Bonfiglioli Engineering

Influence of Outcomes-based Reimbursement on Drug Delivery Technologies

Scott Gibson, Amgen

10:00 Assessing the Pain in Different Injection Sites

Chris Muenzer, Roche

Device Assembly: Best Practices and Lessons Learned for Successful Device Assembly Execution and Industrialization

Jovo Dragicevic, AbbVie

Payer Perspectives on the Drug Delivery Device Value Proposition: Opportunities, Challenges and Implications

Max Cambras, LEK

10:30 Coffee Break, Poster Session & Exhibition Featuring live Demo Booths







Development

Session 4 Human Factors Inspection Business Strategies

Moderator: Ian Thompson, Ypsomed Hanns-Christian Mahler, LONZA William Dierick, Terumo

11:15 New Methods of Measuring Device Usability: Bridging The Gap Between Human Factors and Clinical Studies

Vladimir Matejak, Pfizer

High Speed Automated Inspection with Container Closure Integrity Testing for Pre-filled Syringes

Wes Maharas, Eli Lilly Rene de Munk, Seidenader

The Crossroads of Pharma Lifecycle Management - How Best Practices Determine Winners and Pitfalls

Christian Herget, BD Medical

11:35 An Actual-Use Human Factors Study for an Autoinjector

Florian Wildenhahn, Roche

A Case Study for Mitigation of Visual Particulate in Glass Syringe Manufacturing

Luis Baez, Amgen Anthony Vico, OMPI

The Furosemide Story: Transforming a Heart Failure Drug from IV to SC On-body Injection

Gerhard Mayer, Sensile-Medical John Mohr, SCPharmaceuticals

11:55 Application of Eye-Tracking for the Development of New Self-Injection Systems: Insights from the SmartPilot Case Study

Andreas Schneider, Ypsomed

A New Option: Silicone-Free Plunger and Bare Glass Barrel

Russell Hornung, WL GoreJohn Holcombe, WL Gore

Autoinjector Selection Process for a Pharmaceutical Drug Product

Jörg Sielemann, Roche


12:30 Lunch Break, Poster Session & Exhibition – Featuring live Demo OPTIMA Machinery Booth #1

Closing Plenary Moderator: Georg Roessling, PDA Europe

13:45 Manufacturing Highlights: Syringe Filling, Device Manufacturing

Jerry Cacia, Roche

14:15 Evolution of UPFS - From Little Beginnings to a Vastly Extended Universe

Mathias Romacker, PfizerHanns-Christian Mahler, LONZA

14:30 Coffee Break, Poster Session & Exhibition – Featuring live Demo Booths

15:00 The Future of Parenteral Drug Delivery in a Connected Health Ecosystem

Divakar Ramakrishnan, Eli Lilly

15:30 Closing Panel Discussion: Improving Patient Outcomes with Innovative Drug Delivery - Expectations for the Future

Moderators:Manfred Maeder, NovartisLaurent Jeanmart, GSK

16:30 Closing Remarks & End of the Conference Georg Roessling, PDA Europe

Hal

l DCONFERENCE AGENDA



l Data Communication via NFC (Injection History, Temperature, All data log)

l Whole Device stored in the fridgel Guidance for next step by LCDl Reminder Message by LCDl Build-in Thermometer

l Handy and Needle Hidden for kidsl Data Communication with server via NFCl Dosing Volume Control by Remote

Controllerl Animation and Music during Injectionl Stable Injection by Large Positioning End

CE Mark PendingDemonstration purpose OnlyConcept Design

Not for Salesin Europe

Panasonic Healthcare’s Digital Injectors

Mr. Rentaro Nakaya2-38-5 Nishishimbashi, Minato-ku, Tokyo105-8433, Japan

In April 2018, Panasonic Healthcare Co., Ltd will be renamed PHC Corporation

T : +81-70-1457-2273E : [email protected] : https://www.panasonic-healthcare.com/

Come Join us!Tuesday, November 7th14:50 Hall K, Track C

Commercial Success of a 3rd Generation Digital-Auto Injector:Commercialization, Sustainability and Environmental Impact

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For more information visit www.ypsomed.com/yds Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland T +41 34 424 41 11 // [email protected]

ypsomed_PDA_ups.pdf 1 26.09.17 10:20

How can taking something away make it more?Introducing the new UniSafe® springless, passive safety device

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The single-use, large volume wearable injector.

Pre-filled and pre-assembled for easy patient training and use Attach, inject and dispose for simple and ergonomic handling Clearly communicates via audio and visual signals before, during and after injection Sterile ready-to-fill cartridge and needle unit for easy drug filling and final assembly Unique electromechanical drive system offers flexibility for a range of viscosities and fill volumes

For more information visit www.ypsomed.com/yds Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland T +41 34 424 41 11 // [email protected]

ypsomed_PDA_ups.pdf 1 26.09.17 10:20

E X H I B I TO R Booth

3p Innovation X113

Afton Scientific Y42

altaviz G8

Apex Aseptic Products X40

Aptar Pharma X48 + X49

Atec Sterile Technology Y51

Balda X60 + X61

Batelle Memorial Insititute X123

Baumann Medical X27

Bausch Advanced Technologies X06

Bausch + Ströbel X15 + X16 + X17

BD Medical X81 + X89

Bespak X80

BioCorp X90 & G10

Bosch X09

Brevetti Angela X105

Brevetti CEA X102 + X103

Bühler Motor X32

Cambridge Consultants X62

Cambridge Design Partnership X92

CAS Clean-Air-Service Y33

CC Biotechnology Corporation X66

Cook Pharmica X50 + X51

Copernicus X26

Credence MedSystems X11

CSS - Connecticut Spring & Stamping Y44 + Y45

Dali Medical Devices X65

Dara Pharmaceutical Packaging X84

Datwyler Pharma Packaging X97

DuoJect Medical Systems X115 + X116

Dymax X124

E3D Elcam X44

Enable Injections X 120

Eveon X111

Fareva X01

Fargo Automation X53

Flextronics Medical X21

Fresenius Kabi X104

Früh X121

Gateway Analytical X87

Gerresheimer X93 + X94

Getinge Y46

Gore X108 + X119

Groninger X85

Harro Höfliger X15 + X16 + X17

Haselmeier X35

Heuft X04

IGS GeboJagema X37

IMA Life Y35

Insight Product Development X63

Insulet X99 + X112

Kahle Automation X98

Lighthouse Instruments X07

Lonza X79

Lyophilization Technology X106

Medicom Innovation Partner X68 + X69

Medtech Y35

Merck X34

MGC Mitsubishi Gas Chemical Company X76

Mikron Automation X47

Multivac X55

Nemera X 45

Nipro Europe X12 + X13 + X14

Noble X41+X42

OMPI X60 + X61 & G3

One World X46

OPTIMA Machinery Booth 1

Owen Mumford X86

Panasonic Healthcare X43

PDA Europe Y48

Phillips Medisize X68 + X69

100

X01

X50

X51

X52

X53

X55

X56

X57

X58

X02 X03 X04 X05 X06 X07 X08 X09 X11 X12 X13 X14 X15 X16 X17 X18

X21 X22 X23 X24 X25 X26 X27 X28 X29 X30 X31

X59 X60 X61 X60 X61 X62 X63 X64 X65 X66 X67

X70 X75 X76 X71 X72 X73 X74 X75 X76

X88 X89 X90 X91 X92 X93 X94

X82 X83 X84 X85

X36 X37 X38 X39 X40 X41 X42 X43 X44 X45

X32 X33 X34 X35

X46 X47 X48 X49

X68 X69

X78

X95

X98 X99 X100

X112

X101 X102 X103 X104 X105 X106 X107

X121 X122 X123 X124 X125 X128 X129

X113 X114 X115 X116 X117 X118

X109 X110 X111

X119 X120

X87 X79 X80 X81 X86

X108 X97

1MACHINERY

BOOTH BOOTH

3

Exhibition AreaX

Conference Area

WC

WC

CATERING

OWEN MUMFORDWORKING LOUNGE

VETTER WORKING LOUNGE

DATWYLERWORKING LOUNGE

BESPAKWORKING LOUNGE

CATERING

ROCHE LOUNGE

H H

H H

H

Schla

uchkaste

nfr

eih

alten

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Halle:

EXPOXX MESSEBAU GmbHMesseplatz 1, Postfach 277, A-1021 WienT: +43 (0) 1 / 727 20-6101F: +43 (0) 1 / 720 [email protected] - UID-Nr.: ATU 37633003

Messe:Auftragsnr.:

Kunde:

Standnr.:

M: Blatt:

Benennung:

Projektleiter:

Bearbeiter:

Alle Angebotsunterlagen bleiben Eigentum der Expoxx Messebau GmbH und können jederzeit zurückverlangt werden. Sie dürfen nicht vervielfältigt oder Dritten zugänglich gemacht werden.

Datum:

1:

Plan-NrZng-Nr

001 2016M.Ebner 04.10.PDA Europe

A0 PHACV

X3

002

80

BAR

POSTER SESSION

P DA Lo u n geY 4 8

COMMUNICATIONS CORNER

Y36 Y37

Y46 Y47 Y51

Y62

G2 G3 G4 G5

G8 G9 G10

Y30 Y31 Y33 Y34 Y35

Y41 Y42 Y44 Y45

INNOVATION GALLERY

NOBLE WORKING LOUNGE

CATE

RIN

G

MAIN ENTRANCE

PDA REGISTRATION

WARDROBE

E X H I B I T I O N F L O O R P L A N

Machinery BoothLounge Area

Poster SessionCatering Area

Sponsor

Emergency Exit

Hydrant

Innovation Gallery



Plas-Tech Engineering Y36

Portal Instruments G5

Preh IMA Automation X109 + X110

Primequal Y31

PTI X24

rap.ID Particle Systems X88

Raumedic X08

Roche Roche Lounge

Rommelag X03

Rovi CM X36

Sartorius X70

Scherdel Medtec X128

SCHOTT X82 + X83

Schreiner Medipharm X107 + X118

SCS Specialty Coating Systems X05

Sensile X71 + X72

SHL Group X73 + X74 + X75

SiO2 Medical Products X64

SKAN X15 + X16 + X17

Smart Skin Technologies G2

Smithers Rapra & Smithers Pira X117

Sonceboz X78

SMC & Oval Medical Technologies X100 + X101

Steriline X39

Steris X18

Sumitomo Rubber Industries X59

TASI Test X91

Team Consulting X38

teamtechnik Maschinen & Anlagen X28 + X29

Terumo Booth 3

Topas X129

Transcoject X95

Toxikon X58

TriboGlide - IVEK X114

TTP The Technology Partnership X122

Vanrx Pharmasystems X33

Vetter X56 + X57 & G4

Weidmann Medical Technology AG X125

West X67 & G9

Whitehouse Labs X25

Wilco X15 +X16 + X17

YPSOMED X30 + X31

Yukon Medical X52

Zahoranski X02

Zebrasci Inc Y62

Zenius Y30

Zeon Y37

Zwick X22 + X23

I N N O VAT I O N G A L L ER Y Booth

altaviz G8

BioCorp G10

OMPI G3

Portal Instruments G5

Smart Skin Technologies G5

Vetter G4

West G9

100

X01

X50

X51

X52

X53

X55

X56

X57

X58

X02 X03 X04 X05 X06 X07 X08 X09 X11 X12 X13 X14 X15 X16 X17 X18

X21 X22 X23 X24 X25 X26 X27 X28 X29 X30 X31

X59 X60 X61 X60 X61 X62 X63 X64 X65 X66 X67

X70 X75 X76 X71 X72 X73 X74 X75 X76

X88 X89 X90 X91 X92 X93 X94

X82 X83 X84 X85

X36 X37 X38 X39 X40 X41 X42 X43 X44 X45

X32 X33 X34 X35

X46 X47 X48 X49

X68 X69

X78

X95

X98 X99 X100

X112

X101 X102 X103 X104 X105 X106 X107

X121 X122 X123 X124 X125 X128 X129

X113 X114 X115 X116 X117 X118

X109 X110 X111

X119 X120

X87 X79 X80 X81 X86

X108 X97

1MACHINERY

BOOTH BOOTH

3

Exhibition AreaX

Conference Area

WC

WC

CATERING

OWEN MUMFORDWORKING LOUNGE

VETTER WORKING LOUNGE

DATWYLERWORKING LOUNGE

BESPAKWORKING LOUNGE

CATERING

ROCHE LOUNGE

H H

H H

H

Schla

uchkaste

nfr

eih

alten

-------

Halle:

EXPOXX MESSEBAU GmbHMesseplatz 1, Postfach 277, A-1021 WienT: +43 (0) 1 / 727 20-6101F: +43 (0) 1 / 720 [email protected] - UID-Nr.: ATU 37633003

Messe:Auftragsnr.:

Kunde:

Standnr.:

M: Blatt:

Benennung:

Projektleiter:

Bearbeiter:

Alle Angebotsunterlagen bleiben Eigentum der Expoxx Messebau GmbH und können jederzeit zurückverlangt werden. Sie dürfen nicht vervielfältigt oder Dritten zugänglich gemacht werden.

Datum:

1:

Plan-NrZng-Nr

001 2016M.Ebner 04.10.PDA Europe

A0 PHACV

X3

002

80

BAR

POSTER SESSION

P DA Lo u n geY 4 8

COMMUNICATIONS CORNER

Y36 Y37

Y46 Y47 Y51

Y62

G2 G3 G4 G5

G8 G9 G10

Y30 Y31 Y33 Y34 Y35

Y41 Y42 Y44 Y45

INNOVATION GALLERY

NOBLE WORKING LOUNGE

CATE

RIN

G

MAIN ENTRANCE

PDA REGISTRATION

WARDROBE

Access to Wireless InternetNetwork: PDAEU | Password: SHLGroup 27

That’s why we are committed to discovering and developing personalised medicines and targeted diagnostic tests to help people live better, longer lives.

People are different and so are diseases.

deep sciencerobust engineering

your solutionfrom simple and standalone, to complex and connected

ttp creates medical devices for its clients

TTP has been working with clients to design and develop medical devices for over 30 years. Our multi-disciplinary team has completed numerous parenteral

developments for pharma companies with our projects routinely covering front-end innovation and product definition through to industrialisation support.

From simple and standalone to complex and connected, come to our stand X122 to start the conversation.

ttp.com/engineeringoutcomes

IMPROVING PATIENTS‘ LIVES THROUGH OUR INNOVATIVE HEALTH CARE SOLUTIONS IS THE CORE OF OUR BUSINESS. BECAUSE WE CARE.

www.sealing.datwyler.pda.org/EU-UPS2017


The Complete Program for the Week

THE UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES

is available on the app

Create your own schedule, check the speaker profiles and prepare your visit to the exhibition from the palm of your hand!

Download the app from the App Store - search PDA UniverseYou can also access the desktop version at www.pda2017.com

2017UPS_app_FP_EU.indd 1 10.10.17 10:45

Training & Education Program



PDA Education offers courses that are developed and

taught by experts. They are uniquely targeted to professionals involved in the development and manufacturing of quality pharmaceutical and biopharmaceutical products.

Facts that Make a DifferenceUp-to date training courses and workshops taught by internatio-nally renowned instructors

Customized in-house training courses and workshops available

Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation

9 November 2017Container Closure DevelopmentOne-Day Training Course

9–10 November 2017Container Closure Integrity Testing:Regulations, Test Methods, ApplicationTwo-Day Training Course

9–10 November 2017Rapid Microbiological MethodsTwo-Day Training Course

9–10 November 2017Best Practices and Points to Consider in Aseptic ProcessingTwo-Day Training Course

9–10 November 2017Development and Manufacturing of Pre-filled Syringes - A Hands-on Training CourseTwo-Day Training Course

9–10 November 2017Drug Delivery Sytems:Global Technical, Regulatory and Quality ChallengesTwo-Day Workshop



34

ONE-DAY TRAINING COURSE

Container Closure DevelopmentOverviewThe course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered, like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.

For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.

Jörg Zürcher, Senior Scientist, BayerJörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.

Learning Objectives: • Set-up of a target product profile of a container closure system

• Select appropriate container closure materials, components, and systems

• Apply the appropriate regulations and standards to container closure systems for parenteral formulations

• Prepare a development plan of a container closure systems from the early development until market phase

• Specify container closure system regarding technical aspects and regulatory requirements

• Understand compendial requirements and quality as well as technical standards regarding container closure components and systems

Who Should Attend: • Scientists in Drug Product Development

• Scientists/ Engineers in Packaging Development

• Regulatory Affairs Experts

pda.org/eu/CCD2017

https://pda.org/eu/CCD2017

TRAINING COURSE AGENDA

35

2 Nov 2017

Thursday, 9 November 2017 9:00 - 17:009:00 Welcome & Introduction

9:10 Setting up a Target Profile• Influence of formulation (small molecule, biological)• Use of product (patient, nurse, physician....)• Regulatory requirement

9:30 Material Selection• Ph.Eur. / USP / JP• Plastic vs. glass• Coating of material• Stopper material

10:30 Coffee Break

11:00 Selection of Packaging Solution

11:30 Assessment of Packaging Solutions – Development Data• Testing of injection vials/bottles and their respective components• Testing of pre-filled syringes (PFS) and their respective components• Extractables & Leachables (E&L) testing• Mechanical and functional testing

12:30 Lunch Break

13:30 Manufacturing of Packaging Solutions• Test runs• Process validation (risk assessment, critical parameters)• Container closure integrity (physical vs. microbiological testing – USP 1207)• Shipping test for PFS

14:00 Setting of Specifications• Technical drawings• Technical / quality specification• Testing standard, defect evaluation list• Examples

15:00 Coffee Break

15:30 Preparing the Submission• Relevant eCTD sections (drug substance and drug product)• Regulatory drawings• DMF for US

16:00 Routine and Release Testing• Certificates• Routine E&L testing• Reduced testing

16:15 Change Management• EU requirements

16:30 Wrap-up, Discussion, Q & A

17:00 End of Training Course

pda.org/eu/CCD2017

https://pda.org/eu/CCD2017

36

TWO-DAY TRAINING COURSE

Container Closure Integrity TestingOverviewThis workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a system-atic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The Workshop will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this Workshop, participants gain critical problem solving skills through:

• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers

• hands-on testing training on the newest innovations and state-of-the-art instruments

• real-world case studies.

Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly

Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain dis-tribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting

commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

Learning Objectives This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

• Understanding up-to-date regulatory and pharmacopeia requirements on CCI.

• Defining CCI requirements for various container and drug product types using a risk-based approach.

• Explaining working principles of various CCI testing techniques and their practical applications, with focus on

deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, mass extraction leak test.

• Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.

• Defining CCI testing method development and validation approach and best practices.

• Avoiding common issues and pitfalls in CCI testing applications

Who Should Attend• Parenteral drug packaging engineers and formulation scientists

• Laboratory scientific staff and managers

• Parenteral manufacturing staff

• Sterility Quality Assurance

• Regulatory affair scientists

• Pharmaceutical packaging component manufacturing staff

pda.org/eu/CCI2017

Presentation of Technology, Instruments Demo and Hands-on Training kindly supported by

ATC, Genesis Packaging Technology, Lighthouse, Pfeiffer Vacuum, pti, Wilco


37

Jennifer Roark, B.S., Manager Chemistry & Container Testing, Eurofins Medical Device Testing

As Manager of Chemistry and Container Testing, Jennifer Roark oversees testing to support the container and package testing needs of both pharmaceutical and medical device clients. Her group specializes in various CCI testing technologies such as vacuum decay, high-voltage leak detection, FMS oxygen headspace, pressure decay, and dye immersion. She also supervises the physiochemical testing associated with the USP, EP, and JP General Chapters on plastics, elastomeric closures, glass, and container performance testing. Jennifer has more

than 22 years of analytical testing experience and serves as one of Eurofins’ leading subject matter experts for Extractables and Leachables Testing. She currently serves on ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, Subcommittee E55.04 General Biopharmaceutical Standards, leading the efforts to draft standard WK43945. Jennifer Roark has been involved with small molecule methods development and validation for over 12 years, and has co-published a series of articles on method validation.

Thursday, 9 November 2017 9:00 – 17:309:00 Welcome and Introduction

9:30 Opening Remarks:CCI Introduction, Regulatory Requirements, and Industry Trends

10:00 Introduction:Packaging Integrity Profile and CCI Testing • Introduction to container closure integrity• Testing requirement definition – risk based

approach• CCI Profile & Testing strategy development

10:20 Introduction to Group Exercise #1: Product life cycle testing and method selection

10:30 Coffee Break

11:00 CCI test methods: Fundamentals

11:30 CCI test methods: Overview

12:00 Lunch Break

13:00 Introduction to Group Exercise #2: Method Characteristics

13:30 Advanced CCI Testing Technologies and Seal Quality Testing Technologies1. Vacuum and pressure decay 2. Mass Extraction 3. Headspace analysis

15:00 Coffee Break

15:30 Advanced CCI Testing Technologies and Seal Quality Testing Technologies4. HVLD5. Tracer gas (helium leak detection) 7. Seal Integrity method example –

residual seal force

17:00 Group Exercise #1 & #2: Break Out Discussion/review of survey resultsDay-1 Summary Q&A

17:30 End of Day 1

Friday, 10 November 2017 9:00 – 16:309:00 Day-1 Review

9:10 Method Application Case Studies – Helium Leak Detection 1. HeLD for syringe testing (Eli Lilly)2. API Container Testing using HeLD

(Satorius Stedim)

10:00 Instrument Demo and Hands-on Training1. HVLD station2. Vacuum decay3. Headspace4. Helium leak detection5. Mass extraction & Residual Seal Force

10:30 Coffee Break

11:00 Instrument Demo and Hands-on Training (cont.)

12:30 Lunch Break

13:30 Group Exercise #2 Method Characteristics Review, Discussion, and Q&A

13:50 Development and Validation of Integrity Test Methods• Method development best practices• Method validation strategy• Pitfalls and solutions

14:30 Coffee Break

15:00 Approaches to CCI Testing Method Selection• Method selection considerations• Class discussion - examples

15:30 Group Exercise #1 Method Selection Review, Discussion, Q&A

16:00 Course Summary


pda.org/eu/CCI2017

38


Rapid Microbiological Methods

Learning Objectives: • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological

methods• Describe the scientific basis for a variety of technologies that may be qualified as alternative methods

to classical microbiology procedures; explore case studies and actual workflows for dozens of com-mercially-available technologies

• Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels

• Develop business plans and return on investment justifications, follow an actual case study in signifi-cant cost savings and cost avoidances by implementing a RMM for environmental monitoring

• Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, the new USP 1223 chapter and the proposed Ph. Eur. Chapter 5.1.6

OverviewThis comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expec-tations, financial justification models and implementation plans. Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

Who Should Attend: • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation,

Regulatory Affairs, Research and Development, Validation, QP• Level of Expertise: Senior Management, Scientists/Technicians• Job Function: Supervisor, Researcher, Analyst, Operative Personnel

Michael J. Miller, PhD, President, Microbiology Consultants, President

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceu-tical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies. Michael currently serves on a number of PDA’s program and publication committees and ad-

visory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.

pda.org/eu/RMM2017

https://pda.org/eu/RMM2017


39

2 Nov 2017

Thursday, 9 November 2017 9:00 – 18:00

9:00 Welcome

9:15 Introduction to RMMs, Applications, Implementation Strategies, Opportunities

Growth-based RMMs; Scientific Principles, Applications and Case Studies

10:30 Coffee Break

11:00 Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO

12:30 Lunch Break

13:30 Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies

Viability-based RMMs; Scientific Principles, Applications and Case Studies

15:30 Coffee Break

16:00 Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies

Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies

18:00 End of Day 1

Friday, 10 November 2017 9:00 – 16:30

9:00 Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies

10:30 Coffee Break

11:00 MEM-based RMMs; The Future of Alternative Technologies

Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics

12:30 Lunch Break

13:30 Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, the New USP 1223 and the Proposed Ph. Eur. 5.1.6

A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations

15:00 Coffee Break

15:30 References, On-line Resources and Final Remarks

16:30 End of Training Course

pda.org/eu/RMM2017

https://pda.org/eu/RMM2017

40


pda.org//bestpractices-aseptic

Best Practices and Points to Consider in Aseptic Processing

Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH

For the past five years, the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide. In many projects he has been engaged as “Aseptic Process-ing Expert” for projects worldwide in remediation of companies cited with Warning Letters, audits and other assignments. In his previous career, Guenther spent 20 years in the pharmaceutical industry as Head of QA/QC Microbiology and as Sterility Assurance Expert and Troubleshooter. During this period, he gained in-depth

experience in aseptic processing key elements. He has been a subject matter expert in more than 20 FDA audits. Guenther also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of sterile products, and this method is now in use worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. Since 2017 he is also member of PDA Task Force groups regarding Aseptic Processing Industry Survey and the EU Annex 1 revision, and member of the PDA Science Advisory Board. A brand new initiative is to assess and improve the current hygiene conditions and aseptic working practices in local Austrian hospitals, aiming to reduce the threatening “nosocomial infection rates” of patients.

Overview

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Pro-cessing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Process-ing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all.

Who Should Attend: Personnel involved in Aseptic Processing from sterile production departments such as:• Production Management and Shop Floor

Supervisors• QA and QC Microbiologists• Qualified Persons• Personnel from technical department

A basic understanding of Aseptic Processing is a prerequisite.

Learning Objectives: • Gain deeper knowledge and insights into specific topics like steriliza-

tion, training and motivation of shop-floor staff, correct aseptic work-ing practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.

• Understand key requirements and challenges in parenteral production• Understand the importance of a good quality culture within a company• Apply the executed and presented case studies and team exercises in

her/his daily job • Get answers and interpretations about - potentially - unresolved

questions and problems• Gain confidence for audits

https://pda.org/bestpractices-aseptic

http://pda.org//bestpractices-aseptic


41pda.org//bestpractices-aseptic

2 Nov 2017

Thursday, 9 November 2017 9:00 – 18:00

9:00 Welcome

9:30 Introductional Test about Selected Hot Topics in Aseptic Processing - Discussion of Answers

10:30 Coffee Break

11:00 Importance of a Good Quality Culture in Aseptic Processing – What May Go Wrong

11:30 Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

12:30 Lunch Break

13:30 Aspects of Clean Room Concepts and Good Aseptic Working Practices - Conventional Filling Lines, RABS Systems and Isolators

14:30 Team Exercise: Preparing a New Concept for Start-Up of an Aseptic Filling Line

15:30 Coffee Break

16:00 Hot Topics in Pharmaceutical Water Systems and Best Control Practices

16:30 Effective Oversight at the shop-floor, Good Training Methods

18:00 End of Day 1

Friday, 10 November 2017 9:00 – 16:30

09:00 Guidance How to Execute in Media Fills and Process Simulations (Definition of Worst Case Criteria), Sterile Active Product Ingredients, PDA TR 22

10:00 EU Annex 1: What Are the Changes

10:30 Coffee Break

11:00 Important Aspects in Environmental Monitoring and Team Exercise, PDA TR 30

12:30 Lunch Break

13:30 Applications of Risk Assessments for Microbial Contamination Control and for Supporting Decisions in Case of EM-Deviations (HAZOP and FMEA)

14:30 Selection of Case Studies About Microbiological Deviations, Related Root Causes and CAPAs in Aseptic Processing

15:30 Coffee Break

16:00 Summary & Discussion of Open Questions

16:30 End of Course

https://pda.org/bestpractices-aseptic

42


pda.org/eu/dev_syringe

Development and Manufacturing of Pre-filled Syringes A Hands-on Training Course

Moderator:Egmont Semmler, PhD, Director Research & Development, Groninger

Speaker:Erik Berndt, Industry Manager Medical/Pharmaceutical, ZwickAlessandro Morandotti, Product Manager Syringes, Nuova OmpiChrista Jansen-Otten, Director Marketing PFS Europa, WestHorst Koller, CEO, HK-Packaging ConsultingOliver Valet, PhD, Managing Director, rap.IDBernd Zeiss, Manager Technical Support Medical Systems, Gerresheimer

Overview

This two-day interactive course will provide an overview of relevant practical aspects and trends of develop-ing and processing of bulk and pre-sterilized primary packaging systems, especially pre-filled syringes. It will also address relevant regulatory aspects and topics such as container handling in the filling process, glass defects, particulates and visual inspection and the relevant test methods. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art tech-

nology. There are discussion and Q&A sessions with real case examples.

Who Should Attend This course offers valuable insights and updates for anyone involved in development, produc-tion, quality, auditing, project management and purchasing

Learning ObjectivesUpon end of this course you know about and have an overview of:• Processes involved in primary packaging manufacturing, filling

and processing• Test methods for development, IPCs and quality testing • Relevant machines and test equipmentsLearn about the complexity and interdependencies of the develop-ment and manufacturing of Pre-filled Syringes and get an under-standing what to consider for a successful project.

Faculty

https://pda.org/eu/dev_syringe


43pda.org/eu/dev_syringe

2 Nov 2017

Thursday, 9 November 2017 9:00 – 18:009:00 Welcome Egmont Semmler,

Groninger

9:05 Advantages of Pre-filled Syringes and Market Trends in Primary Packaging• Properties and advantages of Pre-filled Syringes• Market overview of the injectables markets• Trends in parenteral applications

Christa Jansen-Otten, West

9:30 Development and Regulatory Aspects of Primary Packaging• The relevant guidelines• Vial- syringe life cycle management considerations

Horst Koller, HK Packaging

10:00 The Complete Manufacturing Process of Pre-filled Syringes• Washing, endotoxin testing• Siliconization, types of silicon oils and application• Sterilization and silicon oil fixing• Ready to fill glass syringe handling

Egmont Semmler, Groninger

10:30 Coffee Break

11:00 The Complete Manufacturing Process of Pre-filled Syringes (cont.)• Filling methods, pumps• Stoppering methods• Selection criteria for filling and stoppering

Egmont Semmler, Groninger

11:30 Q&A on Manufacturing

12:00 Lunch Break

13:00 Testing of Pre-filled Syringes (Siliconization, Visual Inspection)• Silicon oil layer measurements• Visual inspection, criteria

Oliver Valet, rap.ID

13:30 Testing of Pre-filled Syringes (ISO 11040-4 and more)• The ISO standards• Flange and Luer cone

breakage resistance• Glide force tests

• Needle penetration test• Pull-off forces on tip caps• Test equipments• Luer-lock tests

Erik Berndt, Zwick

14:00 Q&A on Testing

14:30 Coffee Break

15:00 Interactive Hands-on Session• Manufacturing machines: Siliconization, filling procedures, stoppering methods• Testing equipment: Silicon layer, particle identification, glide force and methods

acc. to ISO 11040-4• Container closure integrity testing

17:00 Q&A, Discussion and Real Case Examples• What can go wrong and how to avoid or fix it

18:00 End of Day 1


44 pda.org/eu/dev_syringe


Friday, 10 November 2017 9:00 – 17:009:00 Glass Syringes

• Manufacturing of glass• Glass forming• Physical and chemical properties• Bulk and Ready to fill concepts• Quality aspects

Alessandro Morandotti, Nuova Ompi

9:45 Polymer Syringes• Materials • Physical and chemical properties• Processing and quality

Bernd Zeiss, Gerresheimer

10:15 Q&A

10:30 Coffee Break

11:00 Elastomeric Closures for Pre-filled Syringes and Cartridges• Manufacturing of elastomers • Physical and chemical properties• Processing: washing / siliconization • Quality aspects / coated and uncoated /bulk and ready to use

Christa Jansen-Otten, West

12:00 Q&A

12:30 Lunch Break

13:30 Assembly of Syringes into Devices• ISO Standards 11608• Tests of the primary containers• Tests on the assembled primary container-device• Equipment and test procedures

Erik Berndt, Zwick

14:15 Q&A

14:30 Coffee Break – Parallel to next Agenda Topic

14:30 Interactive Hands-on Session, small groups:• Polymer and glass syringes• Elastomer types and selection criteria• Devices• Test Methods

16:00 Q & A, Discussion with Real Life Examples

17:00 End of Course

Learn more at bd.com/Discover-BD1

BD Libertas™ wearable injector, BD Libertas™ wearable injector with Smart option and BD Intevia™ autoinjector are products in development; some statements made are subject to a variety of risks and uncertainty.

© 2017 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BDPS24234

FOR BETTER TREATMENT OF CHRONIC DISEASES. Across the healthcare continuum, BD is the industry leader in parenteral delivery devices that help health systems treat chronic diseases. We not only continually advance clinically proven, prefillable drug delivery systems, we do so with a vision to help healthcare providers gain better understanding of how patients self-inject their chronic disease therapies outside the healthcare setting. This is why we partner with leading pharmaceutical and biotech companies worldwide to develop digitally-connected self-injection devices—including wearable injectors and autoinjectors— to capture valuable data that can be shared with caregivers. Discover how BD brings new ideas and solutions to customers, and new ways to help patients be healthy and safe. Discover the new BD.

BD Libertas™ wearable injector with Smart option

BD Libertas™ wearable injector BD Intevia™ autoinjector


Learn more at bd.com/Discover-BD1

BD Libertas™ wearable injector, BD Libertas™ wearable injector with Smart option and BD Intevia™ autoinjector are products in development; some statements made are subject to a variety of risks and uncertainty.

© 2017 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BDPS24234

FOR BETTER TREATMENT OF CHRONIC DISEASES. Across the healthcare continuum, BD is the industry leader in parenteral delivery devices that help health systems treat chronic diseases. We not only continually advance clinically proven, prefillable drug delivery systems, we do so with a vision to help healthcare providers gain better understanding of how patients self-inject their chronic disease therapies outside the healthcare setting. This is why we partner with leading pharmaceutical and biotech companies worldwide to develop digitally-connected self-injection devices—including wearable injectors and autoinjectors— to capture valuable data that can be shared with caregivers. Discover how BD brings new ideas and solutions to customers, and new ways to help patients be healthy and safe. Discover the new BD.

BD Libertas™ wearable injector with Smart option

BD Libertas™ wearable injector BD Intevia™ autoinjector


TWO-DAY WORKSHOP

Drug Delivery Systems: Global Technical, Regulatory and Quality Challenges

Overview

The FDA started to address Drug Delivery Systems as combination products almost 20 years ago and have more recently instituted a growing number of unique ways to regulate the development, registration and control of these products. To make issues more complicated, there are an increasing number of regions that are also starting to treat these products differently. One of these examples is the upcoming Medical Device Regulation (MDR) to be considered also for Drug Device Combinations in Europe. Independent of the reg-ulations, the number, scope and complexity of these products is expanding exponentially. This workshop will provide attendees with insight into the challenges, and potential solutions to dealing with the require-ments and regulations related to the development, registration and control of Drug Delivery Systems. The workshop will include speakers from regulators and industry and allow interactive audience participation with panels of experts on each issue to provide a forum for information and discussion on navigating the challenges presented by these products.

Who Should Attend: This course will be geared towards in-dividuals who are responsible for, have input into, oversight for or actively participate on, drug delivery product development teams. This includes the following practitioners, managers and directors in Medical Device, Pharma-ceutical or consulting companies:

• Project Management• Marketing• Regulatory Affairs• Quality Assurance• Clinical Affairs • Product Safety• Human Factors Engineering• Device Development Engineering

• Quality Engineering• Formulation • Testing laboratories• Design Verification Department

Lee Leichter, P/L BiomedicalManfred Maeder, Novartis

Workshop Leader



WORKSHOP AGENDA

Lee H. Leichter, RAC, MBA, President P/L Biomedical

Lee Leichter has over 40 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and inter-national Pharmaceutical, Biotechnology and Medical Device companies for the last 20. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances

with high-tech device systems. Serving as an independent expert on ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices and Human Factors committees, he assists in establishing international standards for safety and performance of these products. He initiated, and leads the ISO Workgroup developing a standard for On Body Delivery Systems (OBDS). His education includes a Bachelor’s degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast Univer-sity. Lee is currently certified in USA and EU Regulatory Affairs from RAPS and was certified as a Quality Engineer from ASQ.

2 Nov 2017

Thursday, 9 November 2017 9:00 – 17:009:00 Welcome and Introduction Manfred Maeder,

NovartisLee Leichter, P/L Biomedical

Current Challenges and Changes Due to New Regulatory Expectations

9:15 Recent and Upcoming Changes and Challenges in the EU Manfred Maeder, Novartis

9:45 Recent and Upcoming Changes and Challenges in the USA Lee Leichter, P/L Biomedical

10:15 FDA 21 CFR 4 cGMP Requirements - Impact on Drug Delivery Systems Viky Verna, confinis

10:45 Coffee Break

Regulatory Considerations – How to Submit a Drug Device Combination Worldwide?

11:15 Global Perspective on Drug Delivery Submissions - Regulatory Chin-Wei Soo, Genentech

12:00 Regulatory Considerations for Drug Device Combinations Nick Lee, HPRA - Irish Agency

12:45 Lunch Break

13:45 Notified Body Position – How Will this be Implemented? Giovanni DiRienzo, TUEV Sued


15:00 Coffee Break

When There are Two Separate Products, How Do the Companies Coordinate? Labeling/Promotion/Distribution/Complaints/PMS/Changes

15:30 Successful Drug Delivery Requires an Integrated Approach Tibor Hlobik, West


16:30 Q&A

17:00 End of Day 1



WORKSHOP AGENDA

Friday, 10 November 2017 9:00 - 16:00Technical Considerations During Drug Device Combination Products Development

9:00 How Can Pharma Benefit from a Well-defined and Robust Delivery Device Platform

Thomas Schoenknecht, SHL

9:30 Platform Technology Stephan Affolter, Ypsomed

10:00 Coffee Break

Human Factors Considerations

10:30 Product Development and Human Factors Considerations for NDAs and BLAs: Navigating the Halls of FDA/CDER

Irene Chan, FDA

11:00 HFE regulation implementation: Industry perspective Muriel Didier, Novartis


12:00 Lunch Break

Life Cycle Management Activities of Drug Device Combinations [eg. Changes, PMS, …..]

13:00 Company Position – ISO Standard – Risk Based Approach to Combination Product Change Management

Suzette Roan, Biogen

13:30 Risk Management – Activities During Development and Life Cycle Management Alice Maden, BD

14:00 Discussion

14:15 Coffee Break

14:45 Using Risk Management to Establish Product Risk Benefit as Part of the Development Process per ISO 14971 , ICHQ9 and Future GMP Annex 1

Horst Koller, HK Packaging

15:15 Processes/systems for Risk Based Decisions for Specification etc. Lee Leichter, P/L Biomedical

15:45 Discussion


Manfred Maeder, PhD, Head Device Development & Commercialization of BTDM, Novartis

Since 2015 Manfred Maeder is Head Device Development & Commercialization of BTDM (Biologics Technical Development and Manufacturing) at Novartis. Before that he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Re-search and Development starting in 2011. Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs at Ypsomed. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site.

Before then, being based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC. By training he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.


TAKE THE PODCHALLENGE

VISIT US

AT BOOTH X99

Visit Insulet’s booth and see why the Omnipod® is trusted by more than 100,000 people every day.

For every demo Insulet will donate $5 to the Juvenile Diabetes Research Foundation

© 2017 Insulet Corporation. Omnipod and the Omnipod logo are trademarks or registered trademarks of Insulet Corporation. All rights reserved. Forbes is a registered trademark of Forbes Media LLC.

19320-5A-AW R1 09/2017

For more details on how Omnipod® Delivery Systems can work for you, call +1 978-600-7000 or visit www.insulet.com

Insulet Corporation Ranked #4

on Forbes 2017 The World's Most Innovative Growth

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Leader in glassprimary packaging

Ready to �ll systems

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Integrated Tip Cap (ITC)A twist-o� closure systemfor pre�lled syringes

Integrated Safety System (ISS)The ready to �ll syringe withintegrated needle stick protection

stevanatogroup.com

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InteractiveExperience!

booth# 60 & 61

We are Swiss pioneersin Large Volume Injector DevicesOffering a clever platform for unique devices

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CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & [email protected]

Conference Program InquiriesSylvia [email protected]

Registration Customer CareTel: +49 30 [email protected]

Education Program InquiriesElke von [email protected]

Exhibition/Sponsorship Inquiries Nadjeschda [email protected]

G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

V E N U EAustria Center ViennaBruno-Kreisky-Platz 1A-1220 Viennawww.acv.at

H OTE L ACCO M M O DATI O NPDA Europe is cooperating for hotel accommodation with:

If you have any questions regarding hotels or reservations, please get in touch with optiMICE directly.

Contact: Sven Wilfling; [email protected]

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017. We recog-nize that attendees have many options with area hotels and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

Please note that Exhibition Housing Services (EHS) do not represent PDA Europe or its events, nor have we authorized them to use our name or trademarks on informa-tion they send out to exhibitors and participants. If you are contacted by EHS using our name or the name of our events, offering advertising space in Event-Fair Guides, website or hotel reservation services, please do neither respond nor sign anything.

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lh.com/event-flight-booking and enter the access code DEZJPAN in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.

AUSTRIA CENTER VIENNA

© Google – For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/oHDeG

How to find the Venue:

INFORMATION


https://goo.gl/maps/oHDeG



Your registration is only complete upon filling in and submitting both pages of this form.

1 Registration

Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact Antje Petzholdt at [email protected]. Other discount cannot be applied.

The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.

All registrations received after 3 November will be subject to a 200€ late fee

All fees given in Euro, excluding VAT (20%)

LATE REGISTRATION FEE:

Registration Form Page 1

7–8 November 2017 | Vienna | Austria

** Conference Registration Fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).

Conference The Universe of Pre-filled Syringes & Injection DevicesPDA Member Nonmember Regulatory, Academic

7–8 November * Regulatory Early Bird 850 € 1995 2295** 950*

Pre-Conference Workshop Innovative Drug Delivery Sytems / Combination Products6 November All Participants 795

Pre-Conference Workshop Impact of Pre-filled Syringe Packaging Components for Biopharmaceuticals 6 November All Participants 795

Pre-Conference Workshop Connected Health & Drug Delivery6 November All Participants 795

One-Day Training Course Container Closure Development 9 November All Participants 845

Two-Day Training Course Best Practices and Points to Consider in Aseptic Processing 9–10 November All Participants 1495

Two-Day Training Course Rapid Microbiological Methods 9–10 November All Participants 1495

Two-Day Training Course Container Closure Integrity Testing9–10 November All Participants 1495

Two-Day Training Course Development and Manufacturing of Pre-filled Syringes9–10 November All Participants 1495

Two-Day Workshop Drug Delivery Sytems: Global Technical, Regulatory and Quality Challenges9–10 November All Participants 1495

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1345 € per ticket. No further discounts are applicable with this option (as PDA Membership discount or Group Ticket discount).

Discount for Exhibiting Companies


This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.


pda.org/EU-UPS2017 55

Date Mandatory Signature

Your registration is only complete upon filling in and submitting both pages of this form.

3 Payment Options

Billing Address: Same as contact information address above. If not, please send your billing address to: [email protected]

By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

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* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

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If this form is an update to a previously submitted form, please check here.

Mr. Ms. Dr. NonmemberI want to become a PDA Member. Please send me a subsription form

• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.

• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for sub-mitting documents by courier.)

• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

2 Information about Visa Matters

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 10 September 2017, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

PDA Europe VAT I.D.: DE254459362Your Company VAT I.D.:

This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)

3 WAYS TO REGISTER

ONLINE: pda.org/EU-UPS2017 FAX: +49 30 436 55 08-66EMAIL: [email protected]

123

Registration Form Page 2


7–8 November 2017 | Vienna | AustriaThis PDF-file provides an automatic fill-in function. Your signature, however, is needed

in writing.


Events with additional Education Program. More information – http://t1p.de/7p9z

Events with additional Education Program. More information – europe.pda.org

europe. pda.org

General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 [email protected]

Connecting People, Science and Regulation®

2 0 1 7 P D A E U R O P E C O N F E R E N C E S 7-8 November The Universe of Pre-filled Syringes and Injection Devices Vienna, Austria

21-22 November Outsourcing & Contract Manufacturing Munich, Germany

2 0 1 8 P D A E U R O P E C O N F E R E N C E S 26 February26 February27-28 February

IG Meeting Pre-filled Syringes IG Meeting Parenteral PackagingParenteral Packaging

IGIG

Rome, Italy

24-25 April Vaccines Location TBC

15-16 May Virus Forum Florence, Italy

29-30 May Pharmacopoeia Conference Vienna, Austria

5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands

25 June25 June25 June26-27 June

IG Meeting Visual InspectionIG Meeting Freeze DryingIG Meeting Quality Systems3rd PDA Europe Annual Meeting

IGIGIG

Berlin, Germany

15-16 October Pharmaceutical Microbiology Berlin, Germany

23-24 October Visual Inspection Forum Berlin, Germany

6-7 November Pharmaceutical Freeze Drying Technology Location TBC

6-7 November 11th Workshop on Monoclonal Antibodies Location TBC

27-28 November Outsourcing & Contract Manufacturing Location TBC

27-28 November Pharmaceutical Cold Chain & Supply Chain Logistics Location TBC

Subject to change For latest info: europe.pda.org Shortlist 2 Nov 2017

https://europe.pda.org

https://www.pda.org/pda-europe/home/




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