Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
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This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
Wednesday, <strong>March</strong> 10, <strong>2010</strong><br />
<strong>09</strong>:<strong>00</strong> Session 0206<br />
QUALITY RISK MANAGEMENT: MYTH, PROMISE OR A SOLUTION TO THE<br />
OPERATIONAL CHALLENGES OF CLINICAL DEVELOPMENT AND<br />
REGULATORY COMPLIANCE?<br />
Session Chair:<br />
Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany<br />
Acknowledging the costly and time-consuming quality management measures<br />
that sponsors, CROs, vendors and other service providers respectively take to<br />
reach compliance with GCP, the extent of findings, frequently identified by<br />
European GCP inspectors during inspections, indicate that the current approach<br />
to clinical quality management frequently fails to achieve the required quality<br />
standards. Sponsors are expected to cope with this challenge and to move<br />
towards a more systematic and holistic approach. This session will give an<br />
insight into what Health Authorities expect from risk-based quality<br />
management, what progress has been made by Pharmaceutical Companies<br />
implementing QRM and what academic sponsors think of all of this.<br />
Risk-Based Quality Management of Clinical Trials - An inspector view<br />
Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany<br />
Risk Analysis and Risk-Based Quality Management in Non-Commercial Clinical<br />
Trials<br />
Oana Brosteanu, Coordination Centre for Clinical Trials Leipzig, Germany<br />
<strong>Pre</strong>venting Investigator Fraud and Non-Compliance<br />
Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug<br />
Development, Tufts University; Chairman, CISCRP, USA<br />
Panel Discussion: What Was Accomplished and What Have We Learnt?<br />
Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG,<br />
Switzerland<br />
11:<strong>00</strong> Session 0207<br />
NEW EFFORTS TO IMPROVE QUALITY AND EFFICIENCY IN CLINICAL<br />
DEVELOPMENT<br />
Session Chair:<br />
Raffael Jovine, Vice <strong>Pre</strong>sident and Global Head of Business Development and<br />
Head for Stakeholder Engagement, ii4sm, Switzerland<br />
CTTI: Challenging dogma, changing research practice<br />
Martin Landray, Reader in Epidemiology, Clinical Trial Service Unit, University of<br />
Oxford, UK<br />
Risk Based Contracted Services Relationship Model<br />
Siegfried Schmitt, Principal Consultant, PAREXEL, UK<br />
A New Model and Approach to Share and Leverage Compliance and Quality<br />
Information<br />
Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG,<br />
Switzerland<br />
Panel discussion with Leslie Ball, Director, Division of Scientific Investigations,<br />
Office of Compliance, CDER FDA, USA, Gabriele Schwarz, Head, GCP Inspection<br />
Services, BfArM, Germany, Fergus Sweeney, Head of Compliance and<br />
Inspections, European Medicines Agency, EU<br />
14:<strong>00</strong> Session 0208<br />
GOVERNANCE CHALLENGES WHEN MANAGING PARTNERS SUCH AS CROs<br />
AND LICENSING PARTNERS<br />
Session Chair:<br />
Janis Little, Senior Director, Development Quality & Compliance, Genentech<br />
Inc., USA<br />
Risk-Based Contracted Services Relationship Model<br />
Siegfried Schmitt, Principal Consultant, PAREXEL, UK<br />
Theme 2 - Theme 3<br />
Pharmacovigilance in Licensing Situations<br />
Christine Benert, PV Contract Management, Bayer Schering Pharma AG,<br />
Germany<br />
FDA View<br />
David A. Lepay, Senior Advisor for Clinical Science, Science and Health<br />
Coordination, OC, FDA, USA<br />
Theme 3<br />
Paediatric Medicines on their Way to Patients<br />
Theme Leaders:<br />
Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme<br />
(Europe) Inc., Belgium<br />
Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland<br />
The Paediatric Theme at the 22nd DIA EuroMeeting will reflect on opportunities<br />
and current challenges of paediatric drug development. The new Paediatric<br />
Legislation was established in Europe over 3 years ago and some early<br />
stocktaking can already be made: The impact of the new framework is multidimensional<br />
and touches on many aspects of new product development and<br />
lifecycle management. Regulators and Industry are discussing the adequate<br />
implementation of the new requirements and are negotiating Paediatric<br />
Investigation Plans. The overall goal is to meet the needs of children in many<br />
therapeutic areas whilst delivering the best possible safety protection for the<br />
population. Researchers and industry are collaborating to set up the necessary<br />
infrastructure to conduct numerous paediatric studies within a global R&D<br />
scope. They define new uniform standards as well as clinical and non-clinical<br />
methodologies to overcome the various challenges in the unique paediatric<br />
environment. Better and more innovative paediatric formulations are needed to<br />
address the selective preferences of children and enable good compliance with<br />
a treatment for optimal outcomes. Involvement of patent attorneys and lawyers<br />
is recommended for the development of a strategy to claim and achieve the<br />
deserved benefits in compensation for undertaking the additional research<br />
investments. A preliminary assessment of the positive impact on public health<br />
in balance with required resources will be made.<br />
<strong>Monday</strong>, <strong>March</strong> 08, <strong>2010</strong><br />
16:30 Session 0301<br />
REGULATORY CHALLENGES AND EXPERIENCE WITH NEW PAEDIATRIC<br />
REQUIREMENTS<br />
Session Chair:<br />
Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme<br />
(Europe) Inc., Belgium<br />
In this session experts will share their experiences with the regulatory<br />
requirements and their interpretations under the Paediatric Regulation.<br />
Participants will learn more about the European Medicines Agency Paediatric<br />
Committee’s (PDCO) evaluation and decision criteria related to the PIP scope to<br />
be able to factor those aspects into their regulatory strategy development.<br />
Specific case studies illustrating the challenges of regulatory input from<br />
different bodies, authorities and regions during the global paediatric<br />
development and their impact will be presented. Specifically, the impact of the<br />
global marketing authorisation concept for Article 8 PIPs and the access to<br />
incentives related to orphan drugs will be discussed. Major inconsistencies<br />
caused by interpretation of several provisions of the regulation and their impact<br />
on industry will be highlighted and constructive suggestions for improvements<br />
presented.<br />
PDCO Experience, Evaluation and Decision Criteria<br />
Daniel Brasseur, Chair PDCO, European Medicines Agency, EU, Senior Member,<br />
Federal Drug Agency, Belgium<br />
Challenges for Manufacturers of Orphan Medicinal and PIP Case Studies<br />
Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs & Scientific<br />
Communication, Switzerland<br />
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