An investigator-initiated trial (IIT) is a special kind of clinical trial where the investigator proposes a research study to a pharmaceutical company, often in an attempt to find new uses for approved drugs, research that results in publications, good partnerships, and the protection of human subjects and ensuring regulatory compliance. IITs are often regarded as critical pieces of product development strategy because it can often complement a company’s R&D goals. A pharmaceutical company stands to gain a tremendous amount of revenue if an IIT finds a drug to be successful or gains another indication. ExL Pharma’s 3rd European Investigator-Initiated Trials conference offers educational discussions with expert industry leaders who explain the value and reasons of 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 important contractual obligations. Learn how to maximize the value of IITs and increase communication and shared data. ExL Pharma continues to be the only provider of this type of conference in Europe, and we have had continued success with our US IIT conference, which we are running for the 12th time in September of this year. We provide our audience an outstanding educational opportunity with industry leading experts, EU compliance officers, panel discussions including time for Q&A, and a great networking experience!

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Join us and share
best practices with
organizations including:
Initiated Trials
Overview of a Successful IIT
Actelion Pharmaceutics Implementation Process
Biocompatibles
Celgene 28-29 October, 2010 | Ambassadors Bloomsbury, London, UK
Centocor SESSIOn hIGhlIGhTS InCluDE:
European Brain
OPENING KEYNOTE SPEAKER—
Council THE VALUE OF IITs
Realizing the Benefits of Funding IITs and the Impact on the Product,
GlaxoSmithKline the Patient, and the Company
Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL,
Johnson & Johnson Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director,
GLAXOSMITHKLINE, UK
Shire Pharmaceuticals
Takeda Oncology PANEL DISCUSSION—MAXIMIZING THE EFFICIENCY OF IITs
Increasing the Efficiency of IITs through Enhanced Management and Clear Communication
Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UK
Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division,
BIOCOMPATIBLES, Spain
CO-lOCaTED- Jackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK
Medical/Scientific
advisor and Medical EU REGULATORY ENVIRONMENT
Science liasion Best Practices Understanding the EU Rules and Regulations and How to Achieve Compliance for IITs
Conference. Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland
REGISTER TODay PHASE IV TRIALS
anD GaIn aCCESS TO Optimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored
PRESEnTaTIOnS Models that Support Regulation and Reimbursement Goals
FROM BOTh Michael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence,
EvEnTS! GLAXOSMITHKLINE, UK
Sponsored by:
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT

2. ExL Pharma’s 3rd European Investigator-Initiated
Trials conference offers educational discussions with
Who Should attend?
expert industry leaders explaining the value and reasons
Professionals from pharmaceutical,
for supporting an IIT, the implementation and process
biotechnology and medical device companies
of IITs, and solutions to common problems. This event with responsibilities in the following
offers valuable lessons and techniques on safety reporting, departments:
an explanation of the EU regulatory environment, and over-
coming the sponsorship challenges when conducing IITs in dif- • Investigator Initiated/ Sponsored Trials
ferent countries. Presentations discuss tools and techniques on and Research
maximizing the value of IITs and overcoming the difficulties, • Medical Affairs/ Medical Directors
• Clinical Trials/ Research
while valuable Q&A time and refreshment breaks provide excel-
• Clinical Development/ Operations
lent networking opportunities! This is the only European IIT • Clinical Project Management
conference and ExL Pharma is proud to continue providing infor- • Business Development
mation for pharmaceutical, medical device, and biotechnology • Medical Education
companies who are interested in expanding their knowledge and • Director Processes & Compliance
business within IITs. • Scientific/Clinical Affairs
• Medical Marketing/ Communication
• Medical Grants
This is a must attend event and we look forward to welcom- • QP (Qualified Person)
ing you 28-29 October, 2010 at ambassadors Bloomsbury in • Phase IV
london, England!
This conference is also
Sincerely, of interest to:
• Data Management and Technology
Service Providers
• Law Firms
• Clinical Research Organizations
Mary Ruggiero Kristen Hunter
• Consultants
Conference Director Team Leader, Production
mruggiero@exlpharma.com ExL Pharma
Ambassadors Bloomsbury
12 Upper Woburn Place
venue Information
London, UK WC1H 0HX, United Kingdom
020 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 Reservations
If 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

3. Day one Thursday, 28 October 2010
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, Germany
Marc Urich, PhD, Clinical Program Manager, ACTELION PHARMACEUTICALS, Switzerland
10:30 30-Minute Networking & Refreshment Break
12:00 Workshop Concludes; Luncheon for Workshop Participants
Main conference Begins–Day one
13:00 CHAIRPERSON’S WELCOME AND OPENING REMARKS SPEAKERS:
Belinda Carlsen, Clinical Project Manager, HOFFMANN-LA ROCHE, UK
Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products
Division, BIOCOMPATIBLES, Spain Jackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS
HEALTH PARTNERS, UK
13:15 OPENING KEYNOTE SPEAKER-THE VALUE OF IITs
16:15 CASE STUDY
Realizing the Benefits of Funding IITs and the Impact on the
Developing an IIT Program: Balancing Patient and Investigator
Product, the Patient, and the Company
Interests
• Understanding the link between IITs and the achievement of
• Interaction between investigator and company within EU legal frame
corporate objectives
• Identifying the common ground and why the medical community can
• Tools needed to support the IIT process and demonstrating this to benefit from IITs
your management team • Understanding the patients when participating in an IIT and how to
• Exploring the financial impact when supporting an IIT communicate this benefit
• Demonstrating the value of IITs to upper management Gavin Collins, Director, Medical Affairs, CELGENE CORPORATION,
Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, Switzerland
EUROPEAN BRAIN COUNCIL, Belgium, Former SVP for Pharmacovigilance
and VP/European Medical Director, GLAXOSMITHKLINE, UK 17:00 ROUNDTABLE DISCUSSIONS
Roundtable sessions with attendees from the Medical/Scientific
14:00 EU REGULATORY ENVIRONMENT Advisor and Medical Science Liaison Best Practices:
Understanding the EU Rules and Regulations and How to Achieve 1. Challenges and Solutions when Working on an IIT, and the Impor-
Compliance for IITs tant Participation of CROs
• Explanation of the current EU regulations and guidelines
2. Managing a Budget and Time Line for IITs: Lessons learned on
• Understanding the purpose of the EU Clinical Trial Directive
successful budgets and time lines, and how to handle unforeseen
• Discussing multi country compliance “hot” buttons
expenses and delays
Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe,
CELGENE R&D, Switzerland 3. Overview of Intellectual Property: Explanation and overview of IP
and understanding when it is important to include in a contract,
14:45 NETWORKING AND REFRESHMENT BREAK how to protect your company and data ownership
4. Enhancing Cross Country IITs and Safety Reporting: Overcom-
15:15 PANEL DISCUSSION: MAXIMIZING THE EFFICIENCY OF IITs ing the sponsorship challenges when conducting IITs in different
Increasing the Efficiency of IITs through Enhanced Management countries and explaining safety reporting obligations needed to
and Clear Communication satisfy requirements
• Getting to know your investigator and improving communications 5. EU Rules and Regulations: Explanation of the different EU rules
• Discovering IIT management trends and establishing which and guidelines
method works best
• Overcoming IIT challenges to ensure proper data reports, results, 17:45 CLOSE OF DAY ONE
and clarifying expectations
MODERATOR:
Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products
Division, BIOCOMPATIBLES, Spain

4. conference Day two Friday, 29 October 2010
7:00 BREAKFAST FOR CONFERENCE PARTICIPANTS 12:45 IIT TECHNOLOGY AND DATA PROGRAMS
8:00 CHAIRPERSON’S RECAP OF DAY ONE New Technology Systems to Organize Data, Improve Project
Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Management and Increase Productivity
Division, BIOCOMPATIBLES, Spain • Learning how new technology systems can improve IIT data organi-
zation and management
8:15 IIT KEY PERFORMANCE INDICATORS • Applying how this information can be shared between both the spon-
sor and the provider
Identifying and Evaluating Key Performance Indicators when • Understanding how a technology system can help keep track of com-
Measuring and Tracking the Progress of an IIT plete grants program across multiple products, therapeutic areas,
• Understanding what key performance indicators are when supporting an IIT and indications and how this helps facilitate submission, review, ap-
• Identifying what types of tracking methods to use when interpreting data proval and financial management
• Measuring IIT performance, and establishing evaluation criteria to
achieve the clinical objective 13:30 EXAMINING SOLUTIONS TO COMMON IIT PROBLEMS
Michael Montgomery, MD, CPI, President, investigator initiated/
sponsored research association (iisra), Director, Worldwide Medical
Identifying IIT Obstacles and an Explanation of the Answers
Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA through Lessons Learned
• How to identify and address an IIT issue before it becomes a problem
9:00 IMPROVED IIT MANAGEMENT TECHNOLOGIES • Successful solutions to problems that arise before, during, and after
an IIT
IIT Management Systems to Support Scalability Globalization, • Working within a reasonable time frame to ensure company wide
Compliance, and Documentation success, and investigator satisfaction
• Deciding on the use of technology to coordinate and manage IIT Michael Montgomery, MD, CPI, President, investigator initiated/
programs from application through grant close out sponsored research association (iisra), Director, Worldwide Medical
• Considerations for support of multi-national programs Affairs, Immunology Research, CENTOCOR ORTHO-BIOTECH, USA
• Audit readiness to support program compliance and transparency
initiatives, including FMV documentation need Marc Urich, PhD, Clinical Program Manager, ACTELION
• Support of program scalability without large personnel investment PHARMACEUTICALS, Switzerland
Anton Ehrhardt, PhD, Sr. Medical Director, Global Medical Affairs, 14:15 CLOSE OF CONFERENCE
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 “Very good overview of the regulatory
• Understand the pros and cons of investigator-initiated versus
company-sponsored Phase IV trials environment, and clear examples”
• Examine budget, resource, and infrastructure necessary for each
model, including the role of cooperative groups
—PAC Coordinator, ABBoTT VASCULAR, Belgium
• Share case studies illustrating opportunities, perceived risks, and
decision-considerations when evolving toward company-sponsored
model
“This program met my expectations and
Michael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre provided a great networking opportunity”
of Excellence, GLAXOSMITHKLINE, UK —Publication Manager, FERRINg INT’T PHARMA
10:45 QUALIFIED PERSON ROLE IN IITs SCIENCE CENTRE, Denmark
How to Effectively Use and Plan for a QP and Understanding
their Unique Responsibilities and Cost Benefits “Easy listening with great examples”
• Identifying a Qualified Person (QP) that is not associated with a company
• Necessary steps and considerations when using a QP —CTA, THRoMBogENICS, Belgium
• Selecting a QP and how to make this determination
Martine Tratsaert, Qualified Person, Senior Director, Global Qualified
Person Group, JOHNSON & JOHNSON, Belgium
“Great presentations!”
—Senior Medical Advisor, CSL BEHRINg Ag,
11:30 IISRA UPDATE
Switzerland
Investigator Initiated Sponsored Research Association: Industry-
led Initiatives Promoting Standards and Best Practices for
Investigator Initiated-Sponsored Research (IISR) “Very good discussions and presentations!
• Introduce Investigator Initiated-Sponsored Research Association (IISRA)
• Learn industry lead initiatives for Investigator Initiated-Sponsored Re-
Great to hear how other companies are
search (IISR) standards/best practices organized” —Medical Information Manager,
• Discuss the expansion of IISRA to Europe
Ran Frenkel, RPh, CEO, PHARMA FOCUS ISRAEL, Switzerland
BIoVITRUM AB, Sweden
11:45 LUNCHEON
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT

5. Media Partners 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 Carrasco
Business Development Manager
+1 212-400-6231, lcarrasco@exlpharma.com
Four Ways to Register Group Discount Program:
Save 25% Per Person when Registering Four
Mail: ExL Events, Inc. For every three simultaneous registrations from your
555 8th Ave, Ste 310 company, you will receive a fourth complimentary registra-
New York, NY 10018 tion to the program (must register 4 at one time). This is a
savings of 25% per person.
Phone: +1 212-400-6240
Save 15% Per Person when Registering Three
Online: www.exlpharma.com
Registration Information
Can only send three? You can still save 15% off of every
Email: register@exlpharma.com 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
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Events, Inc. and write code P1703 on your check. You may
Registration Fees also use Visa, MasterCard, Discover or American Express.
Payments must be received in full prior to the commence-
ment of the conference.
EARLY BIRD PRICING Conference registrations may be transferred to other col-
leagues in the event you are unable to attend. Please
Register by Friday, 17th September, 2010: notify ExL Pharma, info@exlpharma.com, prior to the event
with the name and contact information of the replacement
to Take Advantage of Early-Bird Pricing: attendee. There will be an administrative charge of $300
Conference + Workshop £1,450 to substitute, exchange, and/or replace attendance badge
Conference Only £1,300 with a colleague occurring within five business days of
the conference.
STANDARD PRICING Cancellations: If you need to cancel your registration for
an upcoming ExL conference, please note the following
Register After Monday, 20th September, 2010:
policies derived from the Start Date of the event:
Conference + Workshop £1,600 Four weeks or more: A full refund (minus a $95 processing
Conference Only £1,450 fee), or a voucher to another ExL event valid for two years
from the voucher issue date.
ONSITE PRICING Four weeks or Less: A voucher to another ExL event valid
for two years from the voucher issue date.
Conference + Workshop £1,750
To receive a refund or voucher, please email your request
Conference Only £1,600 to register@exlpharma.com.
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.*
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To Register: Call +1 212-400-6240 or visit us aT www.exlpharma.com/Kolsummit

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organizations including:
Overview of a Successful IIT
New York, NY 10018
Actelion Pharmaceutics Implementation Process
Biocompatibles
Celgene
Centocor 28-29 October, 2010 | Ambassadors Bloomsbury, London, UK
Card Type:
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Council SESSION HIGHLIGHTS INCLUDE:
GlaxoSmithKline
OPENING KEYNOTE SPEAKER—
Johnson & Johnson THE VALUE OF IITs
Email: register@exlpharma.com
Realizing the Benefits of Funding IITs and the Impact on the Product,
Shire Pharmaceuticals the Patient, and the Company
❑ I wish to receive email updates on ExL Pharma’s upcoming events
Takeda Oncology Alastair Benbow, MB BS MRCPI FFPM, Interim Executive Director, EUROPEAN BRAIN COUNCIL,
Belgium, Former SVP for Pharmacovigilance and VP/European Medical Director,
GLAXOSMITHKLINE, UK
Phone: +1 212 400-6240
PANEL DISCUSSION—MAXIMIZING THE EFFICIENCY OF IITs
❑ I’m interested in marketing opportunities at this event
CO-LOCATED—
Increasing the Efficiency of IITs through Enhanced Management and Clear Communication
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Advisor and Medical
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Ouadah “Waza” Hadjebi, Clinical Project Liaison, Oncology Products Division, BIOCOMPATIBLES, Spain
Registration Form
Science Liasion Best Jackie Pullen, Quality Manager, Joint Clinical Trials Office, KINGS HEALTH PARTNERS, UK
Practices Conference
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EU REGULATORY ENVIRONMENT
Understanding the EU Rules and Regulations and How to Achieve Compliance for IITs
❑ Register Me for the Conference Only
YES! Register me for the conference: REGISTER TODAY Fabien Peuvrelle, PharmD, Director, Regulatory Operations Europe, CELGENE R&D, Switzerland
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Title
PRESENTATIONS PHASE IV TRIALS
FROM BOTH Optimizing European Phase IV Trials via Investigator-Initiated or Company-Sponsored
New York, NY 10018
555 8th Ave, Ste 310
Models that Support Regulation and Reimbursement Goals
Sponsored by:
EVENTS!
Michael L. Lim, PharmD, Scientific Affairs Director, Oncology Centre of Excellence, GLAXOSMITHKLINE, UK
Mail: ExL Events, Inc.
Please contact me:
Sponsored by:
Telephone
Company
Address
Name
Email
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City
To Register: Call +1 212-400-6240 or visit us at www.exlpharma.com/3rdeuroIIT