Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
to create a clear picture of what we know, what we don’t know and how to
address harm minimisation and benefit maximisation for patients and
customers.
Monday, March 08, 2010
16:30 Session 0601/0901
RISK MANAGEMENT FOR SWITCH PRODUCTS
(JOINT SESSION WITH THEME 6)
Session Chair:
Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance,
GlaxoSmithKline, UK
This session will cover the challenges of taking prescription products to overthe-counter
use at the European level and how these can be addressed with
creative pharmacovigilance and risk management approaches. There is an
increasing desire for making medicines available without a prescription and for
patients to take greater responsibility for their health. The criteria that define a
successful OTC switch will be discussed using data collected across key
pharma/consumer companies, from a case study and from the perspectives of
the European Regulatory authorities.
Current and Optimal Approaches, Including Industry Perspectives for
Innovative Switches
Chris Holmes, Director, World Class International, UK
A Case Study of Risk Management Planning for a Novel Switch: Orlistat
Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance,
GlaxoSmithKline, UK
Regulatory Expectations of Risk Management Programmes for Innovative
Switches
Jan Petracek, Head of Risk Management, European Medicines Agency, EU
Tuesday, March 09, 2010
09:00 Session 0902
REGULATORY DEVELOPMENTS IN RISK MANAGEMENT IN THE EU AND US
Session Chair:
Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut,
Germany
The objective of this session will be to provide an update of the implementation
of risk management regulations by the European Medicines Agency and FDA
over the last few years. In the EU there will be feedback from a project
completed on the quality and completeness of risk management plans
submitted by companies during the first two years of the new EU risk
management legislation. Deficiencies in RMPs will be outlined and proposals for
improvement as well as changes to current guidelines will be described. More
generally there will be a draft outline of new legislation being proposed in the
EU for the future in the context of risk management planning. An FDA
representative will describe the latest developments at FDA and
implementation of the FDAAA and REMS. A pharmaceutical industry
representative will provide their company’s experience in meeting the differing
risk management regulations in the EU and US. The session will be completed
with a roundtable panel discussion on global risk management.
Regulatory Update from the EU
Peter Arlett, Head of Pharmacovigilance and Risk Management, European
Medicines Agency, EU
Regulatory Update from the US
FDA speaker invited
Industry Update
Jacques Mascaro, Senior Vice President, Global Regulatory Affairs,
Pharmacovigilance and Quality, Elan Pharma International Ltd., Ireland
Theme 9 - Theme 10
Panel discussion: Global Approach to Risk Management with speakers and
Panos Tsintis, Medical Director, Choice Pharma, UK
11:00 Session 0903
NON-CLINICAL SUPPORT TO AID RISK MANAGEMENT IN EARLY PHASE
STUDIES
Session Chair:
Phil Wilcox, Vice President, Non-Clinical Safety Projects, Safety Assessment,
GlaxoSmithKline, UK
This session looks at 3 different situations where non-clinical data are very
important in managing safety risks in early clinical studies. The topics to be
discussed include the selection of starting and stopping doses for Phase I
studies (including exploratory clinical trials), managing compounds with an
identified cardiovascular hazard, and how to progress compounds that have
been shown to induce convulsions in non-clinical species.
Use of Non-Clinical Data in Selecting Starting and Maximum Clinical Dose for
Phase I Studies, and Dose Escalation Strategy
David Jones, Expert Pharmacotoxicologist, MHRA, UK
Integrated Non-clinical Cardiac Safety Assessment and Translational
Biomarkers to Support the Design of Clinical Studies on Cardioactive
Compounds
Mark Holbrook, Executive Director, Global Safety Pharmacology, Pfizer, UK
How to Manage Convulsion Risk Identified in Non-Clinical Species: Approach
to early clinical studies
Andrea Terron, Director of Neuroscience Projects, Safety Assessment,
GlaxoSmithKline, Italy
14:00 Session 0904
WHEN DO ADVERSE EFFECTS QUALIFY AS UNDESIRED EFFECTS?
Session Chair:
Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany
This session will review the challenges of evaluating a causal association of
adverse drug effects in different scenarios during a product lifecycle and
provide recommendations for decision making.
Decision Making in Drug Safety: Science or prejudice, public health or politics,
medical or medico-legal?
Glyn Belcher, Vice President, Drug Safety and Risk Management International,
Biogen Idec Ltd., UK
The Tamiflu Example – What complete analysis can mean
Barbara Donner, Safety Science Leader, F. Hoffmann-La Roche AG, Switzerland
Decisions – Are they evidence based?
Stephen Evans, Professor of Pharmacoepidemiology, The London School of
Hygiene & Tropical Medicine, UK
16:00 Session 0905
RESEARCH AND INTERNATIONAL INITIATIVES IN RISK MANAGEMENT
Session Chair:
Panos Tsintis, Medical Director, Choice Pharma, UK
The session will describe international research initiatives in the area of risk
management. These will include the latest developments in methodologies for
signal detection and data mining and feasibility of using electronic health
records and large automated healthcare databases. Speakers will cover major
initiatives undertaken by regulators (European Commission, European
Medicines Agency, FDA), academia, CIOMS and public-private partnerships.
Latest Developments in Signal Detection and Data Mining
Stephen Evans, Professor of Pharmacoepidemiology, The London School of
Hygiene & Tropical Medicine, UK
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