citywest hotel, dublin eu mdr & ivdr: the end is in sight€¦ · 22 - 26 june 2020 citywest...

22 - 26 JUNE 2020Citywest Hotel,Dublin

EU MDR & IVDR: THE END IS IN SIGHTNavigate EU And Global Regulations For Medical Devices, IVDs And Combination Products With Dedicated Coverage Of PMS & Vigilance, Clinical Strategies, Law And Sterilisation

NEW FOR 2020: Software & AI, Plus Clinical Data Management Training Course

informaconnect.com/medtech-summit#MEDTECH | @MedTechIC

MEDTECH SUMMIT AT A GLANCE

DAY 1Monday 22nd June

DAY 2Tuesday 23rd June

Including an evening networking drinks reception

DAY 3Wednesday 24th June

DAY 4Thursday 25th June

Including an evening networking drinks reception

DAY 5Friday 26th June

EU Medical Device Regulation

EU Medical Device Regulation

Medical Device Regulatory Affairs in Global Markets



Clinical Evaluations & Investigations

Clinical Evaluations & Investigations Software & AI

Post Market Surveillance & Vigilance


Drug Device Combination Products

Drug Device Combination Products

EU Medical Device Law EU Medical Device LawTRAINING COURSE

Medical Device Regulatory Project Management

EU IVD Regulation & Strategy

EU IVD Regulation & Strategy

TRAINING COURSEUS Regulatory Affairs for

Medical Devices

TRAINING COURSEMedical Device Clinical

Data Management

Sterilisation & Reprocessing of Medical

Devices

2 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

AGENDA: DAY 1: MONDAY 22ND JUNE 2020EU Medical Device Regulation EU Medical Device Law

08:00 Registration

08:20 Opening Remarks from the Chair

Amanda Maxwell, Managing Editor, Informa, UK

08:30 COMPETENT AUTHORITY FEEDBACK: First Experiences under the EU MDR

• First experiences with class I devices under the EU MDR

• First experiences with class IIa and b, and class III devices under the EU MDR

• First experiences with Clinical Investigation applications under the EU MDR

• Harmonized standards: What is the latest?

• Assessing the transition phase until commendations for products are available

• Advice for industry on how to best prepare for the EU MDR audit and what to expect

• Where documents and structures are not yet available (eg EUDAMED), what do you do?

• Specific requirements for Class l reusable surgical devices

Thomas Wejs Møller, Head of Medical Devices, DKMA, Denmark

09:10 National RequirementsGavia Taan, Unit Manager – Devices Regulatory Policy Devices Division, MHRA,UK

09:50 NOTIFIED BODY FEEDBACK: Implementation of the EU MDR• Addressing the capacity issues

• The success rate of MDD prolongations

• How will workload be split among MDD certifications and EU MDR certifications?

• What have the trends been with successful CE marks?

• Class Ir (reusable surgical instruments)

• Software (upgraded from class I to IIa/IIb)

Senior Representative, BSI

10:30 How Technology Can Simplify Compliance in the World of Global Regulatory Changes• The ‘new normal’ for regulatory professionals: Managing regulatory information in a dynamic global environment

• Keeping up with the pace of international regulatory change: Improving efficiency through a global platform approach

• Prioritizing needs: Driving process consistency, addressing regulatory complexity and speeding time to market

Annemien Pullen, Director Strategy, Vault Medical Devices & Diagnostics, Veeva Systems

AGENDA: DAY 1: MONDAY 22ND JUNE 20203 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

*Timings for the training course are rough guides and may change on the day.

We recommend you stay in the course for most of the day to ensure optimal learning

11:00 - Coffee and Networking Break

11:30 PANEL DISCUSSION: Industry Feedback on the Implementation of the EU MDR • Reviewing the process of becoming EU MDR compliant

• Which processes worked as planned and which didn’t?

• Understanding where the bottlenecks were? Are?

• Were the resources as expected in regard to time, money and staff?

• Addressing the extent of reliance on transitional provisions

• Which aspects took longer than planned?

• The stumbling blocks throughout the process

Juliette Cook, Regional Regulatory Director EMEA, Cochlear, Switzerland

Inge Vandenbussche, Director Regulatory Affairs EMEA, Medtronic, United States

Shokoufeh Khodabandeh, EU MDR Implementation Lead, Straumann, Switzerland

Daniela Leal, Regulatory Affairs Team Leader, Zimmer Biomet, United States

Alexander Natz, Director General, EUCOPE, Belgium

12:15 KEYNOTE PANEL DISCUSSION: Implementation of the Person Responsible for Regulatory Compliance (PRRC) in your Organisation • Roles, responsibility and liability for the named individual responsible for EU MDR

• Understand the lines between personal and organisation liability and risk

• Examining European national legislation and the impact on the accountability for PRRC

• How is PRRC being used as an extra means to increase the level of compliance of manufacturers?

James Whitehead, Patient Safety Medical Device Lead, AstraZeneca, UK

Sponsorship opportunities available

13:00 - Networking Lunch

AGENDA: DAY 1: MONDAY 22ND JUNE 2020

EU Medical Device Regulation EU Medical Device Law


EU Medical Device Regulation EU Medical Device Law14:30 Spotlight Session from NSF

Oliver Christ, CEO, NSF, United States

DUAL DIALOGUE: Transitional Provisions under the EU MDR and IVDR• Key transitional provisions and understanding the legal meaning for the provisions

• Understanding what constitutes a significant change in design or intended purpose

• What will the transitional period look like for companies?

• Competitive monitoring

David Van Passel, Legal Director – Regulatory Law EMEA & APAC, Johnson & Johnson, Belgium

Alex Denoon, Partner, Bristows LLP, UK

15:10 DUAL DIALOGUE: Economic Operators and Manufacturers• Strategies to ensure a good working relationship between economic operators and manufacturers

• Resolving contractual issues

• Concerns?

Carol Mahon, Senior Director, EMEA Regulatory Compliance & Technical Service, Medtronic BV, The Netherlands

Legal Advice on the Economic Operators Regime: Have You Gone Far Enough?• Definitions of manufacturer, importer and distributor (MAID) and the impact of tax structures

• What should be in your commercial contracts and quality agreements through the supply chain?

• How to leverage your supply chain in light of Post Market Surveillance requirements under the EU MDR

• Working with your Notified Body on the economic operator’s regime

• Preparation for audit: Legal tools to manage and demonstrate compliance

• Distributor perspective on new economic operators’ regime

Peter Bogaert, Partner, Covington & Burling LLP, Belgium


16:20 Path to Compliance: Industry EU MDR

• Tips and tricks for streamlining the EU MDR certification process

• Biggest hurdles faced with the EU MDR

• Key strategies that help achieve EU MDR status

• Differences between class 1 and class 3 compliance paths

Shokoufeh Khodabandeh, EU MDR Implementation Lead, Straumann, Switzerland

Your Legal Relationship with your Notified Body• The ability to challenge: Can you challenge the legal decisions of your Notified Body?

• Susceptibility to freedom of Information applications

• When is changing a Notified Body allowed?

• Legal advice on involuntary change of your Notified Body

Erik Vollebregt, Partner, Axon Lawyers LLP, The Netherlands

17:00 CASE STUDY: How to Achieve CE Mark for Medical Devices• Assessing the biggest hurdles to conformity assessment and how these were handled

• What I would do differently

• Advice to reach EU MDR compliance

Jeffrey Cyr, Senior Manager, Regulatory Affairs, SirTex, United States

DUAL DIALOGUE: Article 7: Putting Claims Requirements into Practice - Labelling, Advertising & Instruction• Specific rules on liability claims in the EU MDR: Ensuring you meet Article 7 conditions for standards

on failing to inform

• Provision of public information: Guidance on listing adverse events, side effects and risk

• Practical guidance on next steps for manufacturers: Careful vetting of supporting evidence and safeguarding for competitor challenges to claims

• Update on regulations, promotion and advertising for medical devices across Europe

• Understanding liability when lines are crossed on digital platforms and social media

• Promotional issues for combination pharmaceuticals with devices

Laure Le Calvé, Managing Partner, LCH, France

Wojciech Olszewski, Senior Legal Counsel EMEA, Align Technology, B.V., The Netherlands

17:40 - End of Conference Day 1

AGENDA: DAY 1: MONDAY 22ND JUNE 20205 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

AGENDA: DAY 2: TUESDAY 23RD JUNE 202008:00 Registration

EU Medical Device Regulation EU Medical Device Law Post Market Surveillance & Vigilance



Elena Kyria, Founder, Elemed, Switzerland

Opening Remarks from the Chair Chairperson

Sponsorship opportunities available

Opening Remarks from the Chair

Sabina Hoekstra-van den Bosch, Independent, Advisory Board Member, Switzerland

09:00 EU MDR READINESS: Where Are We Now and What is the Impact on HCPs and Patients• Feedback from hospitals – are they still

accepting MDD registered products?

• Is there a danger of losing products from outside Europe?

• Are there concerns of a lack of, or reduced stock of, certain medical devices

• What are the next steps to prevent product loss under the EU MDR

Stuart Parks, Head of Clinical Engineering, NHS, Scotland

BREXIT IMPACT ON THE MEDTECH SECTOR: Plans and Priorities for 2020 and Beyond• Anticipating similarities and divergence from EU

regulations

• Update on gaining marketing authorisation in the UK

• Impact on the MedTech industry: What can we expect in the coming year?

Alison Dennis, Medical Device and Pharmaceuticals Lawyer, Head of Life Sciences Sector Group, Fieldfisher LLP, UK

NOTIFIED BODY FEEDBACK: Post Market Surveillance - How to Succeed in the First Year Under EU MDR• Advice on building a robust Post Market

Surveillance plan

• Tips and advice to ensure compliance

• How Notified Bodies can help during Post Market Surveillance stages

• Post Market Surveillance class Ir (reusable surgical instruments) and accessories (e.g. separate or combined with main device?)

Daniele Bollati, Product Conformity Assessment, IMQ, Italy

COMPETENT AUTHORITY FEEDBACK: First Clinical Aspect of the EU MDR

• Assessing the key challenges for Competent Authorities implementing the clinical aspect of the EU MDR

• Expectations on industry for Clinical Evaluations under the EU MDR

• Expected timelines for processing EU MDR applications for clinical investigations

Steve Eglem, Head of Unmet Medical Needs and Clinical Investigation Units, FAMPH, Belgium

AGENDA: DAY 2: TUESDAY 23RD JUNE 20206 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC



09:35 Divesting and Rationalising: Experience with Streamlining Portfolios

• Decision process for streamlining portfolios including concerns

• Assessing the factors that decisions are based on

• Practical feedback on how this was achieved

• Consequences of product streamlining

• Pros and cons of streamlining the process

Mellissa White, EU MDR Programme Lead, Bausch and Lamb, Ireland

Legal Support through the Regulatory Framework Transition: Lessons Learnt from EU MDR and How They Can Help Prepare for the EU IVDR• Legal’s role(s) through a major regulatory

transition

• EU IVDR: Similarities and differences in legal challenges

• Lessons learnt from guiding industry through the regulatory overhaul

• One thing I wish I had done differently….

Amelie Chollet, Legal Regulatory Counsel, EMEA, Abbott Laboratories UK Ltd, UK

First Post Market Surveillance Experiences from Early EU MDR Adopters• Initial experience with Post Market Surveillance

under the EU MDR for a high-risk device

• Issues raised during first few months under the EU MDR

• What would I do differently in the future?

David Roe, Medical Device & Combination Products Executive, Novartis, Switzerland

PANEL DISCUSSION: First Experiences of Notified Bodies on the Clinical Module under the EU MDR• The main differences for the device classes for

clinical evaluations

• First applications: What were the common mistakes made

• Scientific expert consultation and scientific expert opinion format

• Validation of SSCP

• Notified Body and yearly CER updates


Pedro H A Eerdmans MD. PhD, MSc, VP of Business Line Medical, Service Division Product Testing, Global Director Clinical, Dekra Certification BV, Switzerland

Robert Madjno, Director, Clinical Assessment, TÜV SÜD, Germany

10:10 CASE STUDY: Strategy for Maintaining MDD and EU MDR Products

• Practical feedback on handling products under EU MDD and EU MDR within the same portfolio

• Best practices to achieve compliance during the transition period

• Sharing strategies to manage workloads for parallel systems efficiently

• Defining “significant changes” to MDD products and how to manage this

Dr. Alexandra S. Rieben, MBA, Global Lead Clinical Research & University Account Management, Nobel Biocare Services, Switzerland

Product Liability, Sufficient Financial Coverage and EU MDR: Where are we?• Specific rules on liability claims under the EU MDR

• Concept of sufficient financial coverage as a quality management requirement: What does this mean in practice?

• Update on the European product liability regime

• Latest developments for the collective redress directive and legal considerations

• Guidance on identifying your potential liability and mitigating risks

Michaela Herron, Partner, Mason, Hayes & Curran, Ireland

MANUFACTURER PERSPECTIVE: Interpreting the Requirements for Post Market Surveillance Under the EU MDR • Industry interpretation of the Post Market

Surveillance requirements

• How data systems need to be updated and with what information

• Example of full Post Market Surveillance plans

Yaman Tunaboylu, Post Market Surveillance Manager, BioTronik AG, Switzerland



11:15 NOTIFIED BODY PANEL DISCUSSION: EU MDRPaint Points• Update on who has received Notified Body

designation

• How many Notified Bodies are in the pipeline and what are the timelines for designation?

• Q&A with Notified Bodies

Dr Elaine Darcy, European Medical Device Operations Manager, NSAI, Ireland A representative from BSI, UK

Bart Mersseman, Certification and Business Enhancement. Global Medical Devices Certification Manager Notified Body, SGS, Belgium

Martin Witte, Global Director, Active Implantable and Cardiovascular Devices, TÜV SÜD, The Netherlands

Legal Requirements for Medical Device Clinical Investigations• The narrowing scope of equivalence: Legal

definitions and practical considerations

• What’s new under the EU MDR?

• Practical advice on interacting with ethics committees and responsible authorities

• Best practice on SOPs, contracting agreements and governance for clinical investigations

Alexander Meier, Partner, Preu Bohlig & Partner, Germany

Streamlining the post-market surveillance planning for biomedical literature• Applications of peer-reviewed literature for the

MDR

• Identifying medical device information from biomedical literature

• Identifying directly linked adverse device effects for a specific medical device and patient group from clinical studies

• Automating the post-market surveillance plan with regular updates on relevant medical device safety signals

IVETA PETROVA PHD, Lead Product Manager Embase, Elsevier

DEEP DIVE CASE STUDY: Industry Feedback on the Clinical Module• Hands on experience on preparing the clinical

module for the EU MDR

• Understanding the pitfalls during the process

• What was the expected time and effort into the CER?

Dr Ela Bingel-Erlenmeyer, Deputy Director of Clinical Affairs, Geistlich, Switzerland

11:50 Data Obligations for Clinical Investigations• Clinical trial data: GDPR data requirements, EU

MDR obligations for disclosure and managing issues around consent and the withdrawal of consent

• Reconciling potential inconsistency with GDPR data requirements

• Transparency for commercially sensitive data: Update on the CJEU case law in the pharmaceutical sector and its relevance under the EU MDR and IVDR

• Requirements for publishing data: What can be considered commercially sensitive?

Cristiana Spontoni, Partner, Jones Day LLP, Belgium

Creating a Robust Post Market Surveillance Plan Under the EU MDR• Streamlining timelines for Post Market

Surveillance plans

• Strategies for implementation of Post Market Surveillance under the EU MDR

• Avoiding common pitfalls

Phillip Auclair, Senior Director, Abbott, Belgium

Spotlight Session from Maetrics




12:25 EUDAMED UPDATE: Status and Future Timelines of Implementation of the EUDAMED Database• Addressing the causes of delays to EUDAMED

modules (EC & Industry responsibilities) – actions (if any)

• Proposed IT support for Economic Operators

• Stages of registering people to the database: How is this done in practice? – Registrations, Validations and SRN issuing

• Outlining the complexity and sheer size of the EU MDR EUDAMED

• Reassurance that the database can function with a large workflow of data

• Data input options overview – in-house and 3rd party options

— Warning about public availability of the data

• Changes and IT project – long term maintenance and implications

— Required IT skills gap analysis

• What can companies do now to be prepared?

Richard Houlihan, CEO, EUDAMED, Brussels

DUAL DIALOGUE: A Digital Health Love Story - The Convergence of AI, Healthcare Data and Medical Devices• The growth and role of digital health in the

medtech sector

• Legal regulatory framework for medical device digital health

• Examining IP and data compliance considerations for healthcare data and AI

• Practical considerations and future synergies for medical device manufacturers and digital health firms

Giorgio Rizzello, Legal Director EMEA, Johnson & Johnson, Belgium

Carmelo Fontana, Senior Regional Counsel, Google, Italy

Notified Body FEEDBACK: PSUR Forms

• Explaining the PSUR Guidance document

• Tips and tricks for successful PSUR forms

• How the data from these forms is used by Competent Authorities

Max Singh, Global Director, TÜV SÜD, The Netherlands

SME VIEWPOINT: Practical Experience in Conducting CERs Under the EU MDR• Best practices on focusing clinical claims to help

shape CERs

• Feedback from conducting trials at an SME for clinical data

• Experience with outsourcing trials and remaining compliant

Marianna Luppi, Regulatory & Clinical Affairs

Director, Affluent Medical, France

12:50 EUDAMED : How to Be Ready in an Evolving Landscape - Functionality, Data Management and UploadArdi Bartmanghelidj, President and CEO, Innovatum, United States

MANUFACTURER PERSPECTIVE: PSUR forms

• How these have been implemented by manufactures

• Examples of successful forms

• Understanding where the data is coming from

• Best practice for compliant PSURs

Eliza Raymundo, Associate Director Clinical Risk Management Global Regulatory Operations, Abbott, United States

LARGE MANUFACTURER PERSPECTIVE: First Experiences Meeting Clinical Evaluation Report (CER) Requirements Under the EU MDR• First experience of putting a CEP and CER together

• Feedback on the quality of data accepted on a CER

• Challenges faced with creating a CER

• Comparisons of the data and detail needed for a class 1 vs class 3 device

Jessica Ward, CCRP, Sr. Clinical Affairs Manager, Stryker, United States


AGENDA: DAY 2: TUESDAY 23RD JUNE 2020




14:30 Implementing a UDI System to Meet EU MDR and Global Requirements

• Why UDI?

— Business strategies, uses and requirements

• Developing, implementing and maintaining a UDI program

— Differences between Basic UDI-DI (BUDI), UDI-DI and UDI-PI

— EUDAMED UDI Requirements

— Process of procuring UDI numbers

• Communicating UDI to Customers and End Users - Labelling and other requirements

• Developing a Global UDI strategy - harmonizing US FDA UDI, EU MDR UDI and the rest of the world requirements

Kristopher Williams, Associate Director, Engineering Services EU MDR Core Team, ZimmerMet, United States

Focus on Legal Obligations and Responsibilities for Combination Products• Classification and differing requirements

between integrated and non-integrated products

• Application of the EU MDR: Practical scenarios around challenging areas

• Practical guidance on managing changing obligations and legal responsibilities

Xisca Borrás, Of Counsel, Bristows LLP, UK

Using Real World Evidence for Medical Device Post Market SurveillanceAlexandros Charitou, Director, Life Sciences, Guidehouse (formerly Navigant), UK

FIRST INDUSTRY EXPERIENCES: Meeting Clinical Evaluation Requirements for Class I Devices (e.g. Reusable Surgical Instruments, Wound Care) and Accessories • Performance vs clinical performance

• Clinical benefit

Dr. Basil Yannakoudakis, Clinical Evaluation Specialist, Clinical Operations, Straumann, Germany





15:05 Practical Feedback on Labelling• Examples of accepted labels

• The differences, if any, between labels and the label posted on the website

• The implications of posting labelling online

• Languages required / language used for labelling

Paula McCarthy RAC, Manager Regulatory Affairs and Labelling, Stryker, United States

Own Brand Labelling and Virtual Manufacturing• Examining the changing contractual

arrangements and liability under the EU MDR

• Contractual measures to protect own brand labelling

• Legal advice on marketing products when you do not own the IP

Josefine Sommer, Associate, Sidley Austin LLP, Belgium

Andreas Balsiger Betts, Senior Advisor, Sidley Austin LLP, Switzerland

Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements• Competent authority expectations for Post

Market Surveillance under the EU MDR

• Industry concerns

• Timelines for meeting Post Market Surveillance requirements

• Any initial worries and concerns with being EU MDR compliant for Post Market Surveillance

Max Singh, Global Director, TÜV SÜD, The Netherlands

Dr Yvonne Ndefo, Chief Clinical Evaluator, NSAI, Ireland

Spotlight Session from EvidencePartners

Peter O’Blenis, CEO, Evidence Partners, Canada

15:40 Regulatory Life Cycle Management Under the EU MDRRyan Magee, Global Device Engineering (GDE) Director, Validation and Engineering Services, Mallinckrodt Pharmaceuticals Ireland Ltd, Ireland

Legal Recourse and Remedies for Tendering and Procurement in the MedTech Industry• Updates and new developments in legislation for

tendering and procurement

• Review of European national variances for tendering regulations

• To what extent will the industry be subjected to environmental rules?

• Practical strategies available for unfavourable tendering decisions

Annabelle Bruyndonckx, Counsel, Simmons & Simmons LLP, Belgium

Developing a Strategic Outlook on Clinical Evaluation Plans

• Creating a plan that works towards explaining claims rather than regulatory compliance

• Defining product claims to ensure it doesn’t hinder data requirements

• Examples of how phrasing will change outcomes of expectations of trial

• Building a robust evidence plan to meet CER requirements

• Future proofing your CER by using stakeholders to develop long term strategy

Dr. Juliana Witte, Clinical Evaluation Manager, Straumann, Switzerland

16:15 Post Market Surveillance Under the EU MDR. How Are You Handling This?

Sponsorship opportunities available. Please contact Linda Cole at [email protected], +44 (20) 7017 6631

First Experiences with Manufacturer’s Incident Report New Guidelines • First experiences from MIRs

• How is this working in practice?

• Best practices to simplify the process

• Streamlining the MIR process

Laure-Anne Thieren, Sr Manager, Quality EMEA, Johnson & Johnson, Belgium

Discussing “Sufficient” Clinical Evidence: What is Enough for CERs• Discussing “sufficient” evidence

• Experiences on how “sufficient” evidence has been achieved

• Advice for industry

Speaker Pending: HPRA, Ireland

Rita Dinora Ferreira Caramalho, Clinical Evaluations Manager / Research & Development, MedEl, Austria

Shaloo Sood, Development Manager (R&D),Valvoc, Switzerland






17:20 Creating a Robust QMS System that can Successfully Process the EU MDR

• Feedback from industry on updating QMS systems from the EU MDD to the EU MDR and having parallel QMS systems between May 2020 to May 2024

• Tips to ensure an easy to navigate QMS


PANEL DISCUSSION: Trends in Anti-Bribery and Anti-Corruption Law and Enforcement• EU anti-bribery, anti-corruption and

whistleblowing protection update

• US FCPA code changes: Update on the global impact of your operations

• Best practice and benchmarking advice for implementing a successful compliance strategy

David Morkan, Director and Senior Counsel EMEA, Cook Medical, Ireland

Veronique Ameye, General Counsel, LumiraDX, UK

Streamlining the Processes Between Clinical Evaluation and Post Market Surveillance to Better Leverage Data• Examining the cross over points between the deliverables needed to achieve EU MDR compliance

• The interface between different sub systems and strategies to improve their communication

• Best practices to schedule deliverables

• Building communication between Post Market and Clinical Departments

Gert Bos PhD, Executive Director & Partner, Qserve Group B.V, The Netherlands

17:55 Navigating Clinical Evidence Under the EU MDR• An overview of accepted clinical evidence on the

EU MDR

• Feedback on how this was collected and presented

Dr. Basira Salehi, Senior Manager, Clinical Science, Regulatory Clinical Evaluation, BIOTRONIK, Switzerland

DUAL DIALOGUE: Large and SME Manufactures: How to Handle Post Market Clinical Follow Up (PMCFs)?• Examples of PMCFs

• The standards used to produce PMCFs

• The balance between pre and post market data for PMCF

Alexandra Rieben, Head of External Studies & Clinical Evaluations, Nobel Biocare Services AG, Switzerland

18:20 - End of Day 2 Conference




AGENDA: DAY 3: WEDNESDAY 24TH JUNE 2020


08:00 Registration




TRAINING COURSE: Medical Device Regulatory

Project Management

TRAINING COURSE:US Regulatory Affairs for

Medical Devices08.50 Opening Remarks from the Chair

Jack Wong, Founder of ARPA (Asia Regulatory Professional Association) Associate Vice President Regulatory Affairs, Asia Pacific, Middle East & Africa, Allergan, Singapore


Melanie Crystal, Sr. Manager, Clinical Evidence and Compliance, Minimally Invasive Therapies Group, Medtronic, United States


Sponsorship opportunities availableLed by: Heikki Pitakänen, Consultant, Lean Entries Ltd, FinlandHeikki is the CEO /founder of Lean Entries Ltd, advising on medical device regulatory compliance for both start-up and experienced teams across the globe by utilising both traditional and lean digital methods. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.

Led by: Kathleen Harris, Consultant, 2Harris Consulting, UK Kathleen runs her own consultancy, 2Harris Consulting, specialising in global regulatory strategy and quality compliance for medical devices, pharmaceuticals, clinical trial designs and regulatory due diligence for mergers and acquisitions. Kathleen has experience implementing global RA/QA strategy in a Class III IVD/medical device business working with government agencies such as the FDA and Health Canada.

09:00 KEYNOTE PANEL DISCUSSION: How to Succeed in China• Registration imperatives and lessons

learnt

• Make or break essentials for successful registration

• Sharing key strategies that have made the biggest difference

• One thing I wish I had done differently….

Ren Dazhi, ARQon China, and former Device Classification And Standards Executive Committee Member, National Medical Products Administration (NMPA), China

Jack Wong, Founder of ARPA (Asia Regulatory Professional Association) Associate Vice President Regulatory Affairs, Asia Pacific, Middle East & Africa, Allergan, Singapore

An Liu, CEO, Kai MedTech, China

Chao Xu, CEO, JMEDTEC, China

NOTIFIED BODY FEEDBACK: Summary of Safety of Application Performance Requirements• Expectations on industry from Notified

Bodies for SSCPs

• Guidance for SSCP explained

• Explaining how many versions are required – one for expert and layperson?

• How to populate the document?

Robert Madjno, Director, Clinical Assessment, TÜV SÜD

Examining Proactive Post Market Surveillance for Effective Strategies to be EU MDR Compliant • What is Proactive PMS as opposed to

Reactive PMS?

• The best sources for collecting proactive PMS data

• Mining Social Media for PMS data

• Value of user group meetings, advisory boards and consensus panels

• Practical experience with proactively collecting PMS data

Sharon Perez, Senior Director Medical Safety, Novocure, United States

Introduction to Project Management • Early development stages in a project:

- Capturing the value proposition

- Clinical and benefit-risk considerations

- Early validation through feasibility studies

- Regulatory strategy

Overview of FDA regulation • Comparison with EU Regulation

• Medical devices, drugs, and combination products

• FDA Structure: Divisions and offices

• FDA Center for Devices and Radiological Health (CDRH)

• Code of Federal Regulations (CFR)









Project Management


Medical Devices09:35 CHINA COMPETENT AUTHORITY

PERSPECTIVE: Keeping Pace with Chinese Regulations - Practical Advice for MedTech Manufacturers • NMPA priorities and focuses: Sharing

regulatory insight and timeframes

• Examining differences and divergence to international regulations: Avoiding common trip points for international firms

• Unique Device Identification (UDI) implementation timeframes: Next steps towards enforcing UDI requirements

Ren Dazhi, ARQon China, and former Device Classification And Standards Executive Committee Member, National Medical Products Administration (NMPA), China

First Experiences of Creating a Summary of Safety Application Performance Review• Hands on experience from first SSCP

forms

• Pitfalls

• Easier or harder than expected

• Time dedicated to this

• Manpower dedicated to this

• Examples of documents that have been accepted

• Showcasing successful examples

• Avoiding mistakes made with populating the form

• The importance of language

Huajie Bu, Clinical Evaluations Manager, Medel

PANEL DISCUSSION: Different Approaches to a Proactive Post Market Surveillance Strategy

• Representatives from large manufacturers and SMEs on their proactive strategies

• Highlighting successes with proactive Post Market Surveillance

• Lessons learnt while creating a proactive strategy

Yaman Tunaboylu, Post Market Surveillance Manager, BioTronik AG, Switzerland

Sharon Perez, Senior Director Medical, Safety, Novocure, United States

Introduction to Project Management• Planning and initiating the project

- Timelines, responsibilities and team communication

- Document and records management

Overview of FDA regulation• Regulatory requirements

- Establishment registration

- Medical device listing

- Clearance, approval, exemptions

- Investigational device exemptions for clinical investigations

- Quality system regulation

- Labelling

- Medical device reporting

Sources of Information

• FDA website / guidance / Standards / databases

10:10 CHINA Get Ready: Be Prepared for NMPA Focus on Post Market Surveillance• Keeping your hard-won registrations

under increased focus on post market surveillance

• Post market documentation requirements for product renewals

• Practical insight into the management and data reporting for post market compliance

• How to incorporate NMPA GMP requirements into your QMS/GMP system

Chao Xu, CEO, JMEDTEC, China

Spotlight Session from SMART-TRIAL

Applying Regulatory Requirements to Project Management• The role of global regulations and

standards in medical device project management

Routes to Market • Device classification using Section

513(g)

• Premarket notification – 510(k)

- Traditional

- Abbreviated

- Special

- de novo

- exemptions





11:30 CHINA Cost Effective Clinical Evaluations for Market Registration in China • Review of the NMPA requirements for

device testing and clinical evaluation

• Regulators preferences: Acceptance of evaluation report vs. local clinical trial data

• Clinical evaluation efficiency: Is it possible to bypass the need for local Chinese clinical trials?

An Liu, CEO, Kai MedTech, China

The Anatomy of Clinical Judgment for the Process of Clinical Evaluation• The nature and process of clinical

judgment

• Exploring how data are used in clinical judgment-making

• Optimizing uncertainties for clinical evaluators

• Applications for regulatory problem solving

Robert Mikan, MD, MBA, Medical Director (Global), Cactus Life Sciences

Risk Management and the New IMDRF Problem CodesKim Trautman, Executive Vice President, NSF, United States

Routes to Market• Predicates and Substantial equivalence

• Premarket Approval – PMA

12:05 ASEAN COMPETENT AUTHORITY PERSPECTIVE: Leveraging ASEAN Regulatory Harmonisation to Streamline Registration in South East Asia • 2020 deadline is here! Evaluating next

steps, successes and challenges

• Updates on the adoption, challenges and implementation progress of ASEAN MDD

• Update on Thailand regulatory redesign and reclassification programme

• Manufacturer’s shortcuts to regulatory access and registration

Sasikala Devi, Director, Policy, Code & Standard Division, Medical Device Authority, Ministry of Health, Malaysia

PANEL DISCUSSION - NOTIFIED BODY FEEDBACK: Clinical Evaluation for Legacy Devices• Expectation on the data requirements

for legacy devices

• Can competitor data not be leveraged?

• Data requirements for devices where equivalence had been used to get a CE mark

Pedro H A Eerdmans MD. PhD, MSc, VP of Business Line Medical, Service Division Product Testing, Global Director Clinical, Dekra Certification BV, Belgium

Dr Yvonne Ndefo, Chief Clinical Evaluator, NSAI, Ireland

Serious Incident ReportingCathal Donoghue, International Post Market Surveillance, Teleflex, Ireland

Applying Regulatory Requirements to Project Management• Key regulatory considerations

throughout the medical device lifecycle:

- General Safety and Performance Requirements

- Clinical Evaluation

- Risk Management

Verification and Validation• Preclinical safety testing






Project Management


Medical Devices





12:40 SOUTH KOREA Identifying Easy Win’s to Registration for South Korea• An overview of the South Korean

regulatory framework and requirements for product registration

• Practical considerations and easy wins when preparing Korean MFDS medical device registration documents

• Focusing in on the similarities and differences between US and EU requirements

• Best practice for working with Korea License Holders

• Requirements and implementation for a Korean Unique Device Identification (UDI) system

Hyun-Woo Cho, Manager Regulatory Affairs, Asahi Intecc Co., Ltd, The Netherlands

INDUSTRY CASE STUDY: CERs for Legacy Devices• Hands on experience making a legacy

product EU MDR compliant

• What investigations where needed for legacy products?

• Cost efficient ways to run Clinical Trials on legacy devices

Serious Incident Reporting: Practical Experience and Industry Guidelines

• First experiences with Serious Incident Reporting

• Best practices

• The decision tree based on the regulation with examples

• Examining companies plans and learnings

Maite Llacer, Director of Quality, Edwards Life Sciences, Spain

Angeles Sanfrancisco, Sr Manager, Quality Compliance International Transcatheter Heart Valves, Edwards Life Sciences, Spain

Applying Regulatory Requirements to Project Management• Other regulatory considerations for

project management:

- Quality system requirements (ISO 13485, FDA QSR)

- Design Control

- Vendor control

Verification and Validation• Clinical evaluation

- Clinical data

- Clinical evaluation reports

- Post-market clinical follow-up






Project Management


Medical Devices








Project Management


Medical Devices14:30 JAPAN Shortcuts to Swift and Cost-

Effective Registration in Japan• An update on the status of Japan’s

MDSAP program and future outlook

• Preparing PMDA’s Foreign Manufacturer Registration (FMR) application

• Costs, timelines, best practice and practical insight into working with Marketing Authorization Holder (MAH) to achieve your FMR swiftly

• Review of PMDA requirements for device testing and clinical evaluation

Bill Kurani, Head and Director of Regulatory Affairs & Quality Assurance, Agilent, United States

Spotlight SessionSponsorship opportunities available. Please contact Linda Cole at [email protected] +44 (20) 7017 6631

Strategies to Achieve a Robust Trend Reporting Programme• Feedback on how companies deal with

trend reporting

• Industry experience

• Methodology for data mining of statics

• Solutions for trends reporting

Representative from Stryker

Applying Clinical Evaluation in a Project

• The importance of conducting a literature review

• Clinical investigations and post-market activities

Quality Management and Manufacturing • Quality standards and guidance

• Manufacturing standards and guidance

• Quality assurance and quality control

15:05 Strategies to Manage your Distributor Regulatory Risk • How to find a good partner: Due

diligence and best practice when engaging a third party

• Managing distributors and agents: Practical checks and balances when implementing and monitoring new regional regulations and codes

Maham Ansari, Director Regulatory Affairs, Synaptive Medical, Canada

Manufactures Using Expert Panels as a Source of “Scientific Opinion”• What are they used for?

• Feedback on Expert Panels

• Outcomes of the processes


Applying Risk Management in a Project

• Risk management practicalities

- ISO 14971 and Design FMEA (Failure Modes & Effects Analysis)

- Relation to Biocompatibility, Electrical safety, Software life cycle and usability

• Benefit-risk analysis as the final outcome

Audits and Inspections• Examine FDA audits and inspections


AGENDA: DAY 3: WEDNESDAY 24TH JUNE 202017 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC








Project Management


Medical Devices16:15 INDIA Simplifying Registration

Under Expanding Regulatory Oversight in India

• CDSCO medical device registration in India: Risk classifications, cost, clinical data requirements and import licensing requirements

• Accessing the Indian market: Understanding the impact of pricing control regulations and public procurement policy with preferential market access

• Practical insight into common challenges and timelines for India’s registration process

Bhaveeka Dattani, Senior Manager, Regulatory Affairs, International, Devices, Allergan, UK

CASE STUDY: Examples of Own-Brand Labelling (OBL) Business Strategies under the EU MDR (Real World Implementation)Megan Critser, Global Head Regulatory Affairs Medical Devices, Guerbet, Belgium

Ensuring You Have a Robust Complaint Handling Programme in Place

• Examples of compliant systems in place

• Showcasing how this data is collected and stored

• Best practices for processing complaints

• Incident reporting under EU MDR while EUDAMED is not yet in place

Jaklin Aziz, Quality Manager – Post Market Surveillance Product Quality, Resmed, Australia

More information coming soon More information coming soon

16:30 Managing Medical Device Project Cycles

• Product life cycle thinking: Does the project have an end?

• Design Control as the middle cycle: The typical project cycle

• Design Inputs, Outputs, Verification, Validation, Process Validation, Transfer, Changes and Reviews

• The micro cycles of project management: The daily work

Labelling• Overview and guidance

• Unique Device Identification (UDI)

• UDI final rule and how it has been phased in

• Labels and instructions for use

16:50 Managing Medical Device Project Cycles• Plan-Do-Check-Act / Build-Validate-

Learn / Agile methodologies

• Maintaining alignment and adapting to change

- Corrective and preventive actions and methods

- Project metrics

Post approval considerations in the US• Post-Market Surveillance

• Vigilance

• PMCF

17:35 - End of Conference Day 3

AGENDA: DAY 3: WEDNESDAY 24TH JUNE 202018 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

08:00 Registration

Medical Device Regulatory Affairs in Global Markets Software & AI Drug Device Combination

ProductsEU IVD Regulation and

Strategy TRAINING COURSE:

Medical Device Clinical Data Management


Chairperson sponsorship opportunities available


Koen Cobbaert, Philips/COCIR, Belgium


Dr. David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy and Corporate Affairs, Eisai Europe Ltd., Belgium


Chairperson opportunities available. Please contact Linda Cole at [email protected] +44 (20) 7017 6631

Led by: Kathleen Harris, Consultant, 2Harris Consulting, UK Kathleen runs her own consultancy, 2Harris Consulting, specialising in global regulatory strategy and quality compliance for medical devices, pharmaceuticals, clinical trial designs and regulatory due diligence for mergers and acquisitions. Kathleen has experience implementing global RA/QA strategy in a Class III IVD/medical device business working with government agencies such as the FDA and Health Canada.

AGENDA: DAY 4: THURSDAY 25TH JUNE 2020



09:00 KEYNOTE PANEL DISCUSSION: Preparing for Change - The Global Impact of the EU MDR • Examining how and when global

markets will update their regulations to match the EU MDR

• Assessing the practical impact across quality management system certificates, labelling, and post-market surveillance requirements

• Manufacturer’s global regulatory strategy in response to the wide-reaching impact of the EU MDR

• Will emerging markets see a withdrawal of products due to EU MDR regulatory hurdles?

• How can the risk of product withdrawal be mitigated?

Hyun-Woo Cho, Manager Regulatory Affairs, ASAHI INTECC CO., LTD. Europe Office, The Netherlands

Iryna Berchak, Head of Department of Preclinical & Clinical Trials, YURiA-PHARM, Ukraine

Mercedes Bayani, Global Director Clinical and Regulatory Affairs, Bioness, United States

Classification of Medical Device Software Under the EU MDR• Understanding the classification of

software and devices with embedded software

• Use, interpretation and pitfalls of the IMDRF SaMD risk framework

• Examining the impact of classification on the certification path

Koen Cobbaert, Philips/COCIR, Belgium

COMPETENT AUTHORITY PERSPECTIVE: The Current Regulatory Landscape for Drug Device Combination Products in the EU • An overview of the new quality guidance

• Discuss guidelines that are being introduced and plans for the future of combination product development

• What is the four-year grace period? What products are classified under this extension?

• Where is guidance missing and what should industry collaboration with Competent Authorities look like?

Ann Jans, Medical Devices Quality Assessor, FAMHP, Belgium

COMPETENT AUTHORITY PERSPECTIVE: Practical Considerations for Preparing for the EU IVDR

• The 2-year countdown has started – where are we?

• Feedback on available guidance’s for the EU IVDR

Stephen Lee, MHRA, UK

Introduction to data management• Gain and overview of data management

in the context of medical devices

09:35 Clinical Evaluation of Medical Device Software• Practical construction of a clinical

evaluation report for medical device software

• Use of real-world evidence

• Considerations for clinical evaluations of adaptive intelligence

Zuzanna Kwade, Clinical Lead, AGFA Medical, Switzerland

CASE STUDY: Example of the First Successful CE Mark for Combination ProductsJourney and lessons learnt by the first company to achieve a certification of their QMS system and product under the EU MDR.

• Strategy used to adapt a quality system to the EU MDR

• Gap assessing your quality system and implementing a plan to adapt and upgrade to continuously improve and meet the EU MDR and other Global HA requirements

• What does ready look like? Key lessons learned on the transition

• Discuss the product strategy employed and the challenges faced in adapting a legacy platform product to the EU MDR, which also required an up classification

• Outcomes, challenges and strategies for transition and implementation

Mike Wallenstein, Executive Director QA / Senior Compliance Officer, Novartis, Switzerland

NOTIFIED BODY UPDATE: EU IVDR Implementation• Feedback on the timeline for Notified

Body designation and current designations received

- The impact on workload for the Notified Bodies with designations and how this will impact industry

• Defining the standards, clarifying the requirements and understanding what Notified Bodies are looking for from industry

• Advice for industry on how to best prepare for the IVD audit and what to expect

Dr Andreas Strange, TÜV SÜD, Japan

Examine the global regulatory requirements surrounding clinical data storage• Examine the requirements in the United

States

• Review the requirements in the European Union

- GDPR Requirements

AGENDA: DAY 4: THURSDAY 25TH JUNE 202020 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC





10:00 Examine the global regulatory requirements surrounding clinical data storage • Assess the requirements in the United

Kingdom

• GDPR Requirements

• Discuss the requirements in other countries such as Brazil, Japan and Australia

10:10 EAEU Leveraging Eurasian Economic Union (EAEU): Regulatory Harmonisation to Streamline Registration• An overview of the regulatory initiatives

on the registration of medical devices in the EAEU

• Legislation harmonisation: Updates on the adoption, challenges and implementation progress across the EAEU member states

• Practical quality system inspection insight for medical device registration

Alexey Stepanov, Quality Assurance and Regulatory Affairs Manager, Medical Devices in Russia, Russia

Regulatory challenges for AI according to the EU MDR Dr Matthias Neumann, Deputy Head, BMG, Germany (Pending Final Confirmation)

NOTIFIED BODY FEEDBACK: EU MDR Changes Affecting Drug-Device Products

Industry Preparations for the EU IVDR• Interpreting the guidance around

common specifications and product groups

• Tips for successful implementation of the EU IVDR

Alexandra Stamati, Director, Quality Assurance-PRRC, Medicon Hellas SA


11:15 RUSSIA Registration Systems in Russia: Similarities and Differences to EAEU Regulations• Sharing experiences and strategies for

bringing products to the Russian market

• Challenges, opportunities and best practice during the registration process

• Regulatory vs sales best practice

• Similarities and differences to EAEU regulations

Ruslan Kalachev, Development Director, BeAWire LLC, Russia

Neural Networks and Continuous Machine Learning Software

• The impact of black box design and model diversification after deployment

• Compliance implications with regards to regulations and current state-of-the-art standards

• Traceability of continuously evolving software and its impact on market surveillance and vigilance

Pat Baird, Senior Regulatory Specialist - Head of Global Software Standards, Philips, United States

INDUSTRY PERSPECTIVE: Examine the Impact of the EU MDR on the Borderline Between Medicinal Products, Substance-Based Devices and Combination Products with a Focus on Rule 21 • Clarifying the requirements due to Rule

21 on substance-based devices

• Understanding how to come up with the correct product category for your products

• Exploring the impact of the higher classification of substance-based devices

Dr. Jörg Plessl, Director Affiliate Regulatory Affairs, Norgine, Germany

Guidance on the Classification Process for IVDs• An update on the guidance’s for

classification

• Understanding the different classifications for IVDs under the EU IVDR

• Feedback on the guidance documents available for classification

Lakshman Prakash Balajepalli, Head of Regulation and Quality, RAS Lifesciences, India

Examine best practice for maintaining data integrity • Storage options

• Audit readiness






11:40 RUSSIA Industry Case Study - Navigating Russian Regulatory Requirements for Medical Devices• Exploring the latest regulatory

requirements from Roszdravnadzor

• Practical advice for successfully registering products in Russia

• Regulatory requirements for products with pharma substances

• Clinical evaluations requirements for Russian registration

Elena Voskresenskay, Senior Regulatory Affairs Manager, JGL Ljubljana, Croatia

CASE STUDY: Machine Learning as a Medical Device• Regulatory requirements of machine

learning under the EU MDR and IVDR

• The impact of black box design and model diversification after deployment

• Compliance implications with regards to regulations and current state-of-the-art standards

• Traceability of continuously evolving software and its impact on market surveillance and vigilance

Johan Ordish, Senior Policy Advisor, PHG Foundation, UK

PANEL DISCUSSION: EU MDR Article 117 Current Impact on Drug Delivery Devices• Gain insight into Notified Body

interpretations of Article 117 and expectations for manufacturers

• Understand the impact of additional Notified Body scrutiny during the conformity assessment

• Examine quality files and what will be assessed by Competent Authorities

• Medical device CE certification: What are Notified Body expectations?

Panelists:

Ann Jans, Medical Devices Quality Assessor, FAMHP, Belgium

Kirsten Paulson, Senior Director, Global CMC-Medical Device Lead, Pfizer Inc., United States

Understanding the Difference Between Intended Purpose and Intended Use to Ensure a More Effective Classification Process• Ensuring you meet the level of

description needed under the EU IVDR

• Undertaking a gap analysis to successfully manage the reclassification process

• Best practices for updating your intended purpose

Examine best practice for maintaining data integrity• Retrievability (1year, 5years, 10 years,

15 years….)

12:15 CIS Streamlining Clinical Evaluations for Market Registration Across CIS and the EAEU• Review of the EAEU requirements for

device testing and clinical evaluation for class IIB & III

• Assessing potential challenges during clinical conformity evaluations for device approval

• Sharing experiences with determining the appropriate route to clinical evidence generating

• Managing regulators preferences for local clinical trial data

• Practical experience of conducting clinical trials for medical device registration in the EAEU

Iryna Berchak, Head of Department of Preclinical & Clinical Trials, YURiA-PHARM, Ukraine

Reimbursement of Digital Health Solutions in Germany• Insights into the digital health

landscape in Germany, looking a bit above the rim

• Details on the first law (scope, application, limitations)

• Putting the law to application – how does it work to get reimbursement? Which parties are involved? What can be reimbursed, what cannot?

• Regulatory considerations in the product lifecycle

• Pricing – let’s talk about money

Tobias Schreiegg, Director Regulatory Affairs Siemens Healthineers, Germany

Moving Toward EU MDR Compliance for Commercial Combination Products in the Pharma Industry • Gain an overview of Articles 14 and 16

• Lessons learned from a post-approval stage product

• Key considerations for escalating information – reporting serious incidents, defects or complaints to the proper authorities

• Packaging and labelling – what should companies take into account to comply with Article 16?

• The challenges of complying with gaining commercial access in the EU, when your company is not based in the EU

Kerstin Cleek, Global Pharma Medical Device Expert, F. Hoffmann-La Roche Ltd., Switzerland

Clinical Evidence & Performance Evaluation Studies for IVDsThis presentation will expand on practical advice on the three clinical evidence pillars:

• Scientific validity reports & how to prepare them

• Practical approach to Analytical Performance

• Practical approach to Clinical Performance

Maurizio Suppo, Vice President Regulatory Affairs, QARAD, Italy

Review data migration• Merging study data

• Consolidating historical study data

• Merging study data across multiple platforms and sites








14:30 KEYNOTE PANEL: Designing an Effective Global Labelling Strategy - Can One Size Fit All? • Which markets pose unique labelling

challenges and special attention?

• Clarification on expectations of key market regulators and discussing the challenges

• How will EU MDR labelling changes impact your global labelling strategy?

• Does one size fit all? How to comply with labelling regulations across different regions

Gloria Schneider-Ferrer, Regulatory Manager LATAM, DePuy Synthes, Switzerland

Kristopher Williams, Associate Director, Engineering Services EU MDR Core Team, Zimmer Biomet, United States

Build Your Own Device• Case study: Placing a platform on the

market that enables end-users to train an artificially intelligent algorithm for their own medical or in-vitro diagnostic purpose

• Understanding regulatory roles and responsibilities of manufacturers, health institutions and patients for a device

• Practical considerations for placing a machine learning platform on the market

Nele Ooms, QA Manager UgenTec, Belgium

Koen Cobbaert, Philips/COCIR

INDUSTRY PERSPECTIVE: Regulatory Focus on Device Components Within the New EU Framework • An industry view on the impact of the

EU MDR on combination products

• What’s new in the Global Safety and Performance Requirements (GSPR)

• Understand new submissions and substantial changes

Stephan Affolter, Head of Quality System and Regulatory Affairs, Ypsomed AG, Switzerland

PRACTICAL WORKSHOP: Clinical Evaluation Under the EU IVDR

• Presentation on understanding the clinical evidence needed for IVDs

- Assessing what guidance information is currently available

- Assessing the main difference in data collection needed

• Three case studies of clinical packages for IVDs

- How much data is needed

- Intended purpose for clinical data

- What are the exceptions – are new clinical trials expected?

- For Class A, B-C and D

Stephen Lee, MHRA, UK

Review and discuss data management options available • Cloud based solutions

• Bespoke software solutions

• Mobile App solutions

15:05 Measuring the Value of Artificial Intelligence and Other Digital Technologies• Evolving policy and reimbursement

landscapes for digital health technologies

• Overview of the current and evolving assessment framework for digital health technologies and in assessing the impact

• Challenges in generating and leveraging (clinic-economic) evidence for market authorisation and market access

Tifanny Istamto, Health Economics & Market Access Manager, Philips, The Netherlands

Regulatory Body: An Update on Combination Products Policy Development in the United States • An overview of recent regulatory

changes for combination products

• Identify the top policy priorities for the FDA’s Office of Combination Products

• Discuss recently issued guidance and regulations as well as internal FDA changes affecting combination products

• Address policy developments from pre-market through to post market, including pathway availability, key review issues such as bridging and human factors, CGMPs and post market safety reporting

John Barlow Weiner, Associate Director for Policy, Office of Combination Products, Food and Drug Administration, United States

Review and discuss data management options available • Discussion task – In groups you

will discuss and share the options and solutions you have used either successfully or unsuccessfully.

- Why did you use that solution?

- What were the advantages/ disadvantages?






15:40 SOUTH AFRICA Efficient Submission Routes for Your Products in South Africa• Industry perspective of the expectations

and regulatory requirements during registration

• Discussing challenges and strategies for overcoming them

• Examining the growing trends towards UDI across the region

Avanthi Bester, Regulatory Affairs Manager Africa, Becton Dickinson, South Africa

Quality and Reliability of Health and Wellness Apps• The challenges faced for app

developers to have their app taken up in care pathways

• Role of technical specification for app checkers, repositories, quality and reimbursement frameworks

• Quality and reliability requirements

Petra Hoogendoorn, Owner, National eHealth Living Lab, The Netherlands

Biocompatibility Evaluation Requirements of Combination Products • An overview of biological risk evaluation

assessments of combination products

• Learn how to perform biocompatibility testing according to ISO 10993

• Case study in the selection an appropriate test strategy to address biocompatibility endpoints

Chris Parker, Associate Department Head, In-Vivo Biocompatibility, Toxikon, United States

Clinical workshop continued.. Examine the data requirements required for the following:• Different study sizes

• A clinical study


16:40 SAUDI ARABIA Tools and Tips for Navigating Saudi Arabian Regulatory Requirements • Industry perspective of the expectations

and regulatory requirements during registration

• Discussing challenges and strategies for overcoming them

• Experiences and practical guidance for the use of expedited pathways

Bhaveeka Dattani, Senior Manager, Regulatory Affairs, International, Devices, Allergan, UK

European Health Data Space: Towards a Better Patient Outcome• Governance and execution

• Patient perspective

• Potential role of the health data space for clinical evaluations and for measuring value of digital technologies

Danny Van Roijen, Digital Health Directors, COCIR, Belgium

INDUSTRY PANEL DISCUSSION: What’s Next for Combination Products Under the EU MDR? • Perspectives from large and small

pharmaceutical and medical device companies

• What are the pitfalls of the EU MDR programme and how to avoid them?

• Lessons learned

• Day one wrap-up

Panelists:

Dr. David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy and Corporate Affairs, Eisai Europe Ltd., United Kingdom

Khaudeja Bano, Head of Medical Affairs, Abbott Molecular, United States

Notified Body FEEDBACK: Post Market Surveillance for IVDs• Highlighting the difference between the

EU IVDD requirements and the EU IVDR

• Understanding how to satisfy Post Market Surveillance requirements

Marta Carnielli, TÜV SÜD, Italy

Examine the data requirements required for the following: • A marketing study

• Patient testimonials

17:15 Software Regulations Worldwide: Analysing the Trends As Europe left a distinct footprint for classification of software, other markets are looking for adoption as well. Each in a slightly different manner. This presentation shares an overview on current software discussions and modifications of regulatory systems worldwide (Australia, Brazil, Canada, Mexico, US….)

Tobias Schreiegg, Director Regulatory Affairs, Siemens Healthineers, Germany

Liability for Artificial Intelligence• Understanding who is liable for the

medical device software failures

• Grey zones in the legislative framework and strategies to cope with legal uncertainty

• Liability considerations of continuous machine learning software

Julie Hantson, Lawyer, HA Law Firm, Belgium

INDUSTRY FEEDBACK: Best Practices for Implementing Post Market Surveillance for IVDs under EU IVDR

• Displaying what changes were needed to ensure IVD compliance

• Timelines of requirements for successful Post Market Surveillance and strategies to meet these

• Tips and advice to ensure compliance

• Practical hands on advice for being compliant with the EU IVDR

Päivi Turta, Regulatory Affairs Manager, Medical Devices and In Vitro Diagnostics, Oy Medfiles Ltd, Finland

End of Conference Day Four






08:00 Registration


Sterilisation & Reprocessing of Medical Devices

Drug Device Combination Products EU IVD Regulation and Strategy

08:50 Opening Remarks from the Chair Opening Remarks from the Chair Opening Remarks from the Chair Opening Remarks from the Chair

09:00 KEYNOTE PANEL DISCUSSION: Preparing your Organisation for MDSAP• Experience of acceptance of MDSAP audit

approval across the other member regulatory jurisdictions

• How are inspections run and how are local authorities interpreting audit findings in practice?

• Sharing experiences and advice for successful MDSAP audits

• Common challenges: Manufacturer buy-in, time, audit costs, and resource limitations

Hendrik Heinze, Director Quality and Regulatory Affairs, Berlin Heart, Germany

Georg Bauer, Department Manager Foreign Affairs, TÜV SÜD, Germany

David Pieratos, International Regulatory Affairs Director, BD, United States

Augusto Bencke Geyer, Advisor of the General Management of Technology for Health Products, ANVISA, Brazil

EU MDR NOTIFIED BODY EXPERIENCE: Certification of Reusable Medical Devices• EU MDR update and timeline extensions:

Practical implications for reprocessing and sterilisation

• Step by step examination of the certification process under the EU MDR

• Sharing common pitfalls and trip points for reprocessing and validation

• Practical experience of additional challenges when outsourcing reprocessing

• Ensuring compliance of validation approaches

Jan Havel, Team Leader Nonactive Medical Devices Generic Group, TÜV SÜD Product Service GmbH, Germany

Presentation by Nelson Labs Lessons learnt from the EU MDR: Experience Sharing

09:35 BEST PRACTICE ADVICE: Designing an Effective Reprocessing Validation Study

• Practical challenges that need to be addressed during validation studies

• Validating reprocessing lifecycles: Case study experience of common trip points and bottlenecks

• From theory to practice: Solutions for designing an effective reprocessing validation study revealed

Lise Vanderkelen, Pharmaceuticals and Microbiology Expert, Nelson Labs Europe, Belgium

Constructing a Strong End-To-End Development Programme for Injectable Combination Products • Overview of practical drug-device combination

product development steps to assure justification for regulatory inquiries

• Best practices for risk-based testing using an iterative development approach

• Discussion of the approach for identification of Essential Performance Requirements (EPRs)

• Understanding the importance of the interrelationship among components, process, device and drug in understanding combination products

Fran DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services, United States

Best Practices for Working with a Notified Body • Experiences from gaining EU MDR compliance

• Sharing feedback on transferable lessons that can be shared with IVDs

• Avoiding the pitfalls that occurred during EU MDR implementation

Senior Representative from BSI


AGENDA: DAY 5: FRIDAY 26TH JUNE 2020

AGENDA: DAY 5: FRIDAY 26TH JUNE 202025 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

10:40 CANADA Registration in Canada: Navigating Mandatory MDSAP and Evolving Regulations• Canadian regulatory framework and

requirements for product registration

• Practical guidance on registrations, common nonconformities and trip points

• Sharing experiences and advice for successful MDSAP audits and the practical impact of requirements for MDSAP certification to sell medical devices in the Canadian market

Bill Kurani, Head and Director of Regulatory Affairs & Quality Assurance, Agilent, United States

Changes to EN ISO 11737-3: Microbiological Methods for Validation and Routine Control of Sterilisation• Updates to EN ISO 11737: Microbiological

methods for sterilisation and the impact on current practices

• Reviewing changing guidelines and the practical impact on your current practices

• Examining best practice: Main methods, suitability of products and validation of tests

• Endotoxin methods

Sean Hanley, Sterilisation Senior Fellow, Boston Scientific, Ireland

A Spotlight on Post-Market Safety Reporting • Discuss the challenges and solutions faced by

the industry in a global environment

• Key considerations for streamlining compliance for drug-device products

• Address the roles and responsibilities for a risk-based approach to PMSR decision-making

Khaudeja Bano, Head of Medical Affairs, Abbott Molecular, United States

Understanding Labelling Requirements Under the EU IVDR• Clarifying labelling regulations for intended use

vs intended purpose

• Guidance on harmonised labels and meeting

Karin A. Hughes, Ph.D., Vice President Clinical & Regulatory Strategy, Astute Medical, UK

11:15 BRAZIL COMPETENT AUTHORITY PERSPECTIVE: Tools and Tips for Navigating the Complexities of Brazil’s Regulatory Requirements • Discussing the current regulatory requirements

for medical device registration and ANVISA plans for the future

• Insight into recent changes: Software regulations, reusable medical devices and INMETRO Ordinance 54/2016 certification review

• Practical guidance on registrations, common nonconformities and answering your questions

Augusto Bencke Geyer, Advisor of the General Management of Technology for Health Products, ANVISA, Brazil

New Updates and Developments for ISO Sterilisation Standards

• Review of new developments and updates from ISO and including:

— Development of general steriliser standards

— Revisions to ISO NP 22441 standards for vaporised hydrogen peroxide

— Updates on standards for moist heat sterilisation

• Timelines and next steps for European harmonisation

Richard Bancroft, Chairperson, ISO/TC 198 Sterilization of Health Care Products, UK

Combination Product Development - Real-World Considerations for a Pharmaceutical Organisation • Discuss the issues of device development and

maintenance within a pharma company

• Understand the process of marrying a pharma organisation with the device organisation to develop and maintain the product

• Identify the business SOPs involved and how to improve collaboration to optimise processes

• Cipher through the differing terminology and understand how this will boost productivity

Kirsten Paulson, Senior Director, Global CMC-Medical Device Lead, Pfizer Inc., United States

UDI Requirements for IVDs• Looking at guidance for UDI and IVDs

• Streamlining US and EU UDIs

• Incorporating UDI into EU IVDR implementation

11:50 MEXICO Efficient Submission Routes for Registration in Mexico

• Registration requirements in Mexico: Classification schemes and registration pathways

• Understanding the mindset and avoiding trip points: Practical advice for managing expectations and regulatory requirements during registration with COFEPRIS

• Quality management system and in-country representation requirements

Agustina Susott, Global Regulatory Affairs Consultant, Austria

Material Change Effects on Sterilisation• Focusing on the lifetime of the devices and the

impact of material changes to sterility assurance

• Examining the impact of different materials on the residual Ethylene Oxide (EO) gas remaining the device

Combination Product Lifecycle Management under the EU MDR Ryan Magee, Global Device Engineering Director of Validation and Engineering Services, Mallinckrodt Pharmaceuticals, Ireland



Medical Device REGULATORY Affairs in Global Markets




14:00 LATAM Growing Requirements for Real World Evidence (RWE) and Clinical Data Across LATAM• Managing the increasing trend towards clinical

trials for medical devices

• Review of RWE and clinical data requirements for device testing and clinical evaluation across the LATAM region

• Regulators preferences: Acceptance of evaluation report vs. local clinical trial data

• The increased focus on post market surveillance: What does RWE mean in LATAM countries and how is it interpreted?

Gloria Schneider-Ferrer, Regulatory Manager LATAM, DePuy Synthes, Switzerland

Driving Efficiency and Optimizing the use of Ethylene Oxide (EO) in Sterilization of Medical Products• Implementing lean processes to streamline

sterilisation and increase capacity

• How do we determine the ‘sweet spot’ for cycle efficiency?

• Optimisation through validation approach

Jan Douglas, Global Program Manager, AI - Thoracic, Vascular Division and EO Sterilization SME, Cook Medical, Denmark

Improving the Signal Evaluation and Management Process for Combination Products • Expectations from EU health authorities

• The impact that medical device safety and quality has on the efficacy of the companion drug

• An overview of the signal detection and management process

• Benchmarking opportunity - discuss key points for improvement

Rossella Messina, Manager, Safety Risk Lead, Pfizer Inc, Italy

Discussing Reference Laboratories for Class D Devices• Assessing the logistics of working with

Reference Labs

• Discussing equipment needed by reference labs

— Will Manufacturers have to provide this?

— Where will the cost of new machinery sit?

— Raising concerns of working with Reference Labs for IVDs

14:35 LATAM Accelerated Pan-LATAM Registration Strategy: Ensuring Access Across Argentina, Peru, Columbia & Chile• Industry perspective of the expectations and

regulatory requirements during registration

• Working with your designated authorised representative: Practical regulatory access and registration

• Sharing experiences and strategies for bringing products to market across LATAM countries

• Challenges, opportunities and best practice during the registration process

Mercedes Bayani, Global Director Clinical and Regulatory Affairs, Bioness, United States

Advantages and Opportunities for Novel Methods of Sterilisation• US focus on EO environmental emissions and

the impact of US facility closures on the global supply chain for sterilised products

• Outline of innovative methods and suitability for devices including:

— Peracetic Acid

— Nitrogen Dioxide

— Supercritical CO2

• Application of standards and methods used

• Advantages and disadvantages to consider

Challenges of Human Factors Studies for Regulatory Submissions • An overview of the regulatory imperative for

applying HFE (per FDA, IEC 62366, MHRA)

— Combination product-specific guidance for new drugs, generics and interchangeable biosimilars

• Review key HFE tasks and estimated timelines for regulatory submissions

LDT / in house developed tests requirement Anja Wirsema, Independent









15:40 Comparing China, the US and EU IVD Regulation

• Overview of the different global requirements of IVDs

• Highlighting the differences between the US and EU IVD regulation

• Understanding the additional requirements needed for IVDs in China

Moist Heat Sterilisation Validation and Monitoring

• Process overview for moist heat: Key process parameters and key product considerations

• Examining the implications of the expected ISO revisions for moist heat validation

• Different validation methods: Benefits and drawbacks

• Process development and process improvement: Sharing best practice advice

• Could moist heat sterilisation be used more widely?

Brian Kirk, former Senior Technical Specialist, 3M Health Care, Principal Consultant, Brian Kirk Sterilization Consultancy Group Ltd, UK

Regenerative Medicine and Advanced Therapy Medicinal Products (ATMPs) – Perspectives and Pitfalls • Identify challenges and opportunities in lifecycle

management programmes for complex CATMPs (Combination Advanced Therapy Medicinal Products)

• Address combined stability and shelf-life programme considerations and opportunities

• Discuss best practices in drug delivery change control for post-approval evaluations

Alexander Natz, Director General, EUCOPE, Belgium

Comparing China, the US and EU IVD Regulation

• Overview of the different global requirements of IVDs

• Highlighting the differences between the US and EU IVD regulation

• Understanding the additional requirements needed for IVDs in China

16:15 GLOBAL PANEL DISCUSSION: IVD Regulation

• The impact of the EU IVDR globally

• How will other CE countries outside of the EU approach re-registration?

• Discussing the harmonisation needed for IVDs

Anja Wirsema, Independent Lakshman Prakash Balajepalli, Head of Regulation and Quality, RAS Lifesciences, India

EU MDR Packaging and Labelling Validation: Standards of EN ISO 11607 and Regulatory Gaps• Strategies to ensure robust packaging processes

for transport, temperature and altitude

• Assessing the steps to take to ensure processes are in place to ensure packaging is supporting best practice for usebility evaluations: challenges to retain sterility

• Common pitfalls for packaging sterility

• Ensuring readability of UDI labelling and practical guidance on UDI label validation

Thierry Wagner, Regulatory Affairs Director, DuPont Medical and Pharmaceutical Protection, Luxembourg

Post-Market Surveillance Integration Throughout the Drug Device Combination Product Lifecycle• Best practices under the new EU MDR

• Assess the differences between medical device vigilance and pharmacovigilance and their reporting requirements

• Understand the importance of introducing post market surveillance into all stages of the combination products lifecycle

• Discuss internal communication strategies and why they are key to lifecycle management

GLOBAL PANEL DISCUSSION: IVD Regulation• The impact of the EU IVDR globally

• How will other CE countries outside of the EU approach re-registration?

• Discussing the harmonisation needed for IVDs

Anja Wirsema, Independent

Lakshman Prakash Balajepalli, Head of Regulation and Quality, RAS Lifesciences, India

16:50 - End of Conference


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