Download - ExL Pharma's 3rd Annual European Investigator Initiated Trials Conference, October, London
3rd
European Investigator- Initiated Trials
Register by
17 September, 2010
to Receive our Discounted Rate!
The ORIGINAL is still the best!
Proudly Presents:
Join us and share best practices with
organizations including:
Actelion Pharmaceutics
Biocompatibles
Celgene
Centocor
European Brain Council
GlaxoSmithKline
Johnson & Johnson
Shire Pharmaceuticals
Takeda Oncology
CO-lOCaTED- Medical/Scientific
advisor and Medical Science liasion Best Practices
Conference.
REGISTER TODay anD GaIn aCCESS TO
PRESEnTaTIOnS FROM BOTh
EvEnTS!
Overview of a Successful IIT Implementation Process
28-29 October, 2010 | Ambassadors Bloomsbury, London, UK
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT
Sponsored by:
SESSIOn hIGhlIGhTS InCluDE:
OPENING KEYNOTE SPEAKER— THE VALUE OF IITs
Realizing the Benefits of Funding IITs and the Impact on the Product, the Patient, and the Company
Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL, Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director,
GLAXOSMITHKLINE, UK
PANEL DISCUSSION—MAXIMIZING THE EFFICIENCY OF IITsIncreasing the Efficiency of IITs through Enhanced Management and Clear Communication
Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UKOuadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division,
BIOCOMPATIBLES, SpainJackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK
EU REGULATORY ENVIRONMENTUnderstanding the EU Rules and Regulations and How to Achieve Compliance for IITs
Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland
PHASE IV TRIALSOptimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored
Models that Support Regulation and Reimbursement GoalsMichael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence,
GLAXOSMITHKLINE, UK
ven
ue I
nfor
mat
ion
ExL Pharma’s 3rd European Investigator-Initiated Trials conference offers educational discussions with expert industry leaders explaining the value and reasons for supporting an IIT, the implementation and process of IITs, and solutions to common problems. This event offers valuable lessons and techniques on safety reporting, an explanation of the EU regulatory environment, and over-coming the sponsorship challenges when conducing IITs in dif-ferent countries. Presentations discuss tools and techniques on maximizing the value of IITs and overcoming the difficulties, while valuable Q&A time and refreshment breaks provide excel-lent networking opportunities! This is the only European IIT conference and ExL Pharma is proud to continue providing infor-mation for pharmaceutical, medical device, and biotechnology companies who are interested in expanding their knowledge and business within IITs.
This is a must attend event and we look forward to welcom-ing you 28-29 October, 2010 at ambassadors Bloomsbury in london, England!
Sincerely,
Mary Ruggiero Kristen HunterConference Director Team Leader, [email protected] ExL Pharma
Who Should attend?Professionals from pharmaceutical,
biotechnology and medical device companies with responsibilities in the following
departments:
• Investigator Initiated/ Sponsored Trials and Research• Medical Affairs/ Medical Directors• Clinical Trials/ Research • Clinical Development/ Operations• Clinical Project Management• Business Development• Medical Education• Director Processes & Compliance• Scientific/Clinical Affairs• Medical Marketing/ Communication• Medical Grants• QP (Qualified Person)• Phase IV
This conference is also of interest to:
• Data Management and Technology Service Providers• Law Firms• Clinical Research Organizations• Consultants
Ambassadors Bloomsbury12 Upper Woburn PlaceLondon, UK WC1H 0HX, United Kingdom020 7693 5400
Ambassadors Blommsbury is a stylish, contemporary hotel, which prides itself on exceptional standards of customer service. New rooms designed for comfort and style. Visionary conference suites. Cutting edge restaurant and bar. Located just five minutes walk from both Euston and King’s Cross St Pancras stations (the Eurostar terminal), Ambassadors Bloomsbury is ideally located for both business trips and short leisure breaks.
Room ReservationsIf you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s European Investigator Initiated Trials confer-ence by Thursday, 30th September, 2010. We encourage conference partici-pants to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate by the aforementioned date.
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT
Main conference Begins–Day one
13:00 CHAIRPERSON’S WELCOME AND OPENING REMARKS
Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain
13:15 OPENING KEYNOTE SPEAKER-THE VALUE OF IITs
Realizing the Benefits of Funding IITs and the Impact on the Product, the Patient, and the Company
• Understanding the link between IITs and the achievement of corporate objectives
• Tools needed to support the IIT process and demonstrating this to your management team
• Exploring the financial impact when supporting an IIT • Demonstrating the value of IITs to upper management
Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL, Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director, GLAXOSMITHKLINE, UK
14:00 EU REGULATORY ENVIRONMENT
Understanding the EU Rules and Regulations and How to Achieve Compliance for IITs
• Explanation of the current EU regulations and guidelines• Understanding the purpose of the EU Clinical Trial Directive• Discussing multi country compliance “hot” buttons
Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland
14:45 NETWORKING AND REFRESHMENT BREAK
15:15 PANEL DISCUSSION: MAXIMIZING THE EFFICIENCY OF IITs
Increasing the Efficiency of IITs through Enhanced Management and Clear Communication
• Getting to know your investigator and improving communications• Discovering IIT management trends and establishing which
method works best • Overcoming IIT challenges to ensure proper data reports, results,
and clarifying expectations
MODERATOR: Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain
SPEAKERS: Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UKJackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK
16:15 CASE STUDY
Developing an IIT Program: Balancing Patient and Investigator Interests
• Interaction between investigator and company within EU legal frame• Identifying the common ground and why the medical community can
benefit from IITs• Understanding the patients when participating in an IIT and how to
communicate this benefit
Gavin Collins, Director, Medical Affairs, CELGENE CORPORATION, Switzerland
17:00 ROUNDTABLE DISCUSSIONS
Roundtable sessions with attendees from the Medical/Scientific Advisor and Medical Science Liaison Best Practices:
1. Challenges and Solutions when Working on an IIT, and the Impor-tant Participation of CROs
2. Managing a Budget and Time Line for IITs: Lessons learned on successful budgets and time lines, and how to handle unforeseen expenses and delays
3. Overview of Intellectual Property: Explanation and overview of IP and understanding when it is important to include in a contract, how to protect your company and data ownership
4. Enhancing Cross Country IITs and Safety Reporting: Overcom-ing the sponsorship challenges when conducting IITs in different countries and explaining safety reporting obligations needed to satisfy requirements
5. EU Rules and Regulations: Explanation of the different EU rules and guidelines
17:45 CLOSE OF DAY ONE
8:00 REGISTRATION AND BREAKFAST FOR WORKSHOP PARTICIPANTS
9:00 PRE-CONFERENCE WORKSHOP
THE BASIC OVERVIEW AND APPLICATION OF A SUCCESSFUL IIT IMPLEMATION AND EXECUTION• Training sessions on the following areas include:
- Development of an IIT- How to determine the cost of the investment- Time management skills- Balancing your company’s role in and oversight of the research
• Learning how to find new investigators• Choose the right investigator to research the right topic for maximum results• Understanding the review process of an IIT• Issuing grants and proposals, and how to review the material before submission
Rudolf Schopf, MD, FAAD, Professor of Medicine, Dept Dermatology, JOHANNES GUTENBERG UNIVERSITY, GermanyMarc Urich, PhD, Clinical Program Manager, ACTELION PHARMACEUTICALS, Switzerland
10:30 30-Minute Networking & Refreshment Break12:00 Workshop Concludes; Luncheon for Workshop Participants
Day one Thursday, 28 October 2010
“Very good overview of the regulatory environment, and clear examples” —PAC Coordinator, ABBoTT VASCULAR, Belgium
“This program met my expectations and provided a great networking opportunity”
—Publication Manager, FERRINg INT’T PHARMA
SCIENCE CENTRE, Denmark
“Easy listening with great examples” —CTA, THRoMBogENICS, Belgium
“Great presentations!” —Senior Medical Advisor, CSL BEHRINg Ag,
Switzerland
“Very good discussions and presentations! Great to hear how other companies are organized” —Medical Information Manager,
BIoVITRUM AB, Sweden
conference Day two Friday, 29 October 2010
7:00 BREAKFAST FOR CONFERENCE PARTICIPANTS
8:00 CHAIRPERSON’S RECAP OF DAY ONEOuadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain
8:15 IIT KEY PERFORMANCE INDICATORS
Identifying and Evaluating Key Performance Indicators when Measuring and Tracking the Progress of an IIT
• Understanding what key performance indicators are when supporting an IIT • Identifying what types of tracking methods to use when interpreting data • Measuring IIT performance, and establishing evaluation criteria to
achieve the clinical objective
Michael Montgomery, MD, CPI, President, investigator initiated/sponsored research association (iisra), Director, Worldwide Medical Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA
9:00 IMPROVED IIT MANAGEMENT TECHNOLOGIES
IIT Management Systems to Support Scalability Globalization, Compliance, and Documentation
• Deciding on the use of technology to coordinate and manage IIT programs from application through grant close out
• Considerations for support of multi-national programs• Audit readiness to support program compliance and transparency
initiatives, including FMV documentation need• Support of program scalability without large personnel investment
Anton Ehrhardt, PhD, Sr. Medical Director, Global Medical Affairs, MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY, USA
9:45 NETWORKING AND REFRESHMENT BREAK
10:15 PHASE IV TRIALS
Optimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored Models that Support Regulation and Reimbursement Goals
• Understand the pros and cons of investigator-initiated versus company-sponsored Phase IV trials
• Examine budget, resource, and infrastructure necessary for each model, including the role of cooperative groups
• Share case studies illustrating opportunities, perceived risks, and decision-considerations when evolving toward company-sponsored model
Michael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence, GLAXOSMITHKLINE, UK
10:45 QUALIFIED PERSON ROLE IN IITs
How to Effectively Use and Plan for a QP and Understanding their Unique Responsibilities and Cost Benefits
• Identifying a Qualified Person (QP) that is not associated with a company• Necessary steps and considerations when using a QP• Selecting a QP and how to make this determination
Martine Tratsaert, Qualified Person, Senior Director, Global Qualified Person Group, JOHNSON & JOHNSON, Belgium
11:30 IISRA UPDATE
Investigator Initiated Sponsored Research Association: Industry-led Initiatives Promoting Standards and Best Practices for Investigator Initiated-Sponsored Research (IISR)
• Introduce Investigator Initiated-Sponsored Research Association (IISRA)• Learn industry lead initiatives for Investigator Initiated-Sponsored Re-
search (IISR) standards/best practices• Discuss the expansion of IISRA to Europe
Ran Frenkel, RPh, CEO, PHARMA FOCUS ISRAEL, Switzerland
11:45 LUNCHEON
12:45 IIT TECHNOLOGY AND DATA PROGRAMS
New Technology Systems to Organize Data, Improve Project Management and Increase Productivity
• Learning how new technology systems can improve IIT data organi-zation and management
• Applying how this information can be shared between both the spon-sor and the provider
• Understanding how a technology system can help keep track of com-plete grants program across multiple products, therapeutic areas, and indications and how this helps facilitate submission, review, ap-proval and financial management
13:30 EXAMINING SOLUTIONS TO COMMON IIT PROBLEMS
Identifying IIT Obstacles and an Explanation of the Answers through Lessons Learned
• How to identify and address an IIT issue before it becomes a problem• Successful solutions to problems that arise before, during, and after
an IIT• Working within a reasonable time frame to ensure company wide
success, and investigator satisfaction
Michael Montgomery, MD, CPI, President, investigator initiated/sponsored research association (iisra), Director, Worldwide Medical Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA
Marc Urich, PhD, Clinical Program Manager, ACTELION PHARMACEUTICALS, Switzerland
14:15 CLOSE OF CONFERENCE
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT
Reg
istr
atio
n In
form
atio
nM
edia
Par
tner
s Sponsorship and Exhibiting Opportunities
Do you want to spread the word about your organization’s solutions and services to poten-tial clients who will be attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a net-working event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these opportu-nities, please contact:
Lucas CarrascoBusiness Development Manager+1 212-400-6231, [email protected]
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit
Four Ways to RegisterMail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018
Phone: +1 212-400-6240
Online: www.exlpharma.com
Email: [email protected]
Registration Fees
EARLY BIRD PRICING
Register by Friday, 17th September, 2010: to Take Advantage of Early-Bird Pricing:Conference + Workshop £1,450 Conference Only £1,300
STANDARD PRICINGRegister After Monday, 20th September, 2010: Conference + Workshop £1,600Conference Only £1,450
ONSITE PRICINGConference + Workshop £1,750 Conference Only £1,600
Group Discount Program:
Save 25% Per Person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registra-tion to the program (must register 4 at one time). This is a savings of 25% per person.
Save 15% Per Person when Registering Three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call +1 212-400-6240.
IMPORTANT!! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write code P1703 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commence-ment of the conference.
Conference registrations may be transferred to other col-leagues in the event you are unable to attend. Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee. There will be an administrative charge of $300 to substitute, exchange, and/or replace attendance badge with a colleague occurring within five business days of the conference.
Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.
To receive a refund or voucher, please email your request to [email protected].
Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit
3rd
Eu
ropean
Investigator- In
itiated Trials
Register by
17 September, 2010
to Receive our D
iscounted Rate!
Sponsored by:
The O
RIG
INA
L
is still the best!
Proudly Presents:
Join u
s and sh
are best practices w
ith
organization
s inclu
ding:
Actelion Pharm
aceuticsB
iocompatibles
Celgene
Centocor
European B
rain C
ouncilG
laxoSmithK
lineJohnson &
JohnsonShire Pharm
aceuticalsTakeda O
ncology
CO
-LO
CA
TE
D—
M
edical/Scientific
Advisor an
d Medical
Science L
iasion B
est P
ractices Con
ference
R
EG
ISTE
R T
OD
AY
A
ND
GA
IN A
CC
ESS T
O
PR
ESE
NT
AT
ION
S FR
OM
BO
TH
E
VE
NT
S!
Overview
of a Successfu
l IIT
Implem
entation
Process
28-29 October, 2010 | A
mbassadors B
loomsbury, L
ondon, UK
To R
egister: Call +1 212-400-6240 or visit u
s at ww
w.exlph
arma.com
/3rdeuroIIT
Sponsored by:
SESSIO
N H
IGH
LIG
HT
S INC
LU
DE
:O
PENIN
G KEYN
OTE SPEA
KER—
THE VA
LUE O
F IITsRealizing the B
enefits of Funding IITs and the Impact on the Product,
the Patient, and the Company
Alastair B
enbow, M
B B
S MRCPI FFPM
, Interim Executive D
irector, EURO
PEAN
BRA
IN CO
UN
CIL, B
elgium, Form
er SVP for Pharmacovigilance and VP/European M
edical Director,
GLA
XOSM
ITHKLIN
E, UK
PAN
EL DISCU
SSION
—M
AXIM
IZING
THE EFFICIEN
CY OF IITs
Increasing the Efficiency of IITs through Enhanced Managem
ent and Clear Comm
unicationB
elinda Carlsen, Clinical Project Manager, H
OFFM
AN
N-LA
ROCH
E, UK
Ouadah “W
aza” Hadjebi, Clinical Project Liaison, O
ncology Products Division, B
IOCO
MPATIB
LES, SpainJackie Pullen, Q
uality Manager, Joint Clinical Trials O
ffice, KING
S HEA
LTH PA
RTNERS, U
K
EU REG
ULATO
RY ENVIRO
NM
ENT
Understanding the EU
Rules and Regulations and How
to Achieve Com
pliance for IITs Fabien Peuvrelle, Pharm
D, D
irector, Regulatory Operations Europe, CELG
ENE R&
D, Sw
itzerland
PHA
SE IV TRIALS
Optim
izing European Phase IV Trials via Investigator-Initiated or Company-Sponsored
Models that Support Regulation and Reim
bursement G
oalsM
ichael L. Lim, Pharm
D, Scientific A
ffairs Director, O
ncology Centre of Excellence, GLA
XOSM
ITHKLIN
E, UK
Registration Form
Mail: ExL Events, Inc. Phone: +1 212 400-6240 555 8th Ave, Ste 310 Email: [email protected] New York, NY 10018 Online: www.exlpharma.com
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