EuroMEEting - Genetic Alliance UK

14
TUTORIALS
This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
Pre-Conference Tutorials | Monday, 28 March 2011 | 09:00 - 12:30
Target Audience
• Hospital pharmacists
• Physicians, in particular oncologists, where this approach is common
• Pharmaceutical company executives with responsibility for pricing,
reimbursement and market access
Tutorial 16
INTRODUCTION TO CRISIS MANAGEMENT
Jan-Willem van der Velden, CEO, Founding Director, Mesama Consulting,
Switzerland
Michael Forstner, Integrated Safety Risk Manager, F. Hoffmann-La Roche Ltd.,
Switzerland
In this introductory tutorial the participant will be made familiar with the
definition of a crisis and understand which processes in their own working
environment could be vulnerable for possible crises. Examples are given and
participants are invited to join in exercises and learn which parties are all
involved within and outside their organisation. The participant will be provided
with the tools with which to plan for a potential crisis and how to build a
preventive strategy. The roles of the Crisis Management Team members are
shown and examples are given of right and wrong actions, including attitude
towards the media.
Learning Objectives
At the conclusion of this tutorial, participants will be able to:
• Distinguish between an issue, a risk and a crisis and recognize the flow of
events that lead from an issue to a crisis
• Recognise a potential crisis on time and approach a crisis appropriately when
it happens
• Set up a crisis team that should be able to deal with the crisis in all its stages
Target Audience
• Regulatory authorities
• PV experts
• Pharmaceutical industry
• Medical affairs
• Drug safety department
• Marketing department
• Legal department
• Corporate communications department
Tutorial 17
INCENTIVES TO DRUG DEVELOPMENT: EXPAND YOUR
REGULATORY INTUITION
Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU
Christelle Bouygues, Regulatory Affairs Advisor, European Medicines Agency,
EU
This tutorial will present, in the light of an ever-changing EU legislative
environment, the recent incentives to drug development which are of scientific,
financial and regulatory procedural nature or a combination of those. The
tutorial will cover in detail the various data exclusivity provisions, the orphans,
paediatrics and ATMPs incentives as well as provide an insight into the
experience with the operation of “early access tools” such as the accelerated
review, the conditional and exceptional circumstances MAs by EMA/CHMP.
Each aspect will be applied in practice through interactive case studies.
Learning Objectives
At the conclusion of this tutorial, participants will be able to:
Having a detailed knowledge and early consideration of these incentives and
tools should enable the participants to expand their regulatory intuition; as a
result:
• Anticipate, plan and streamline the milestones for their drug development
and registrations
• Develop a sound regulatory strategy optimizing the use of the various
incentives and tools provided for.
• Discuss advantages and disadvantages of different regulatory strategies for
their business pipeline with concerned regulatory authorities
Target Audience
• All persons involved in business intelligence, regulatory affairs, business
pipeline and regulatory authorities.
Continuing Education
DIA Europe has applied for credits from the Faculty of Pharmaceutical Medicine (FPM) of
the Royal College of Physicians (RCP) of the UK.
DIA Europe's meetings are accredited by the SwAPP (Swiss Association of Pharmaceutical
Professionals) Commission for Professional Development and SGPM (Swiss Society of
Pharmaceutical Medicine).
Always Stay One Move AheadWith DIA Training Courses
The Best Value Training Available Anywhere.
First-rate instructors and best-in-class content are what make DIA’s training programmes the highest quality training programmes available
anywhere. DIA offers a variety of courses in regulatory affairs, clinical research, non-clinical safety sciences and pharmacovigilance. Benefits
include:
• Expert instructors actively practicing in their particular discipline
• Continuing education credits
• Up-to-the-minute coverage of important industry hot topics
• Networking opportunities
• Consistent course materials from one offering to another
• Limited attendance allows for a more personal quality
learning experience
• Tailor-made case studies and instructor-led group work
• In-depth discussion of specific contemporary issues
For more information and a complete listing of all training courses, please visit www.diahome.org and click on Training.