The Programme

The future of PSURs: crossroads between waiving and synchronisation

Bernd Eberwein
Managing Director
BAH

Quantitative screening in the interest of early signal detection

Ola Caster
Drug Safety Analyst
Uppsala Monitoring Centre
WHO

Integrating a safety risk management strategy into pharmacovigilance plans

Henry Goebe
Safety Risk Management Lead
Pfizer

Regulations and their implications

Bert Van Leeuwen
Director of Global Drug Safety
Organon
(now part of the Schering Plough Corporation)

Implementation of RMPs

Robin Geller
Director of Risk Management
Baxter

Programme Day One Wednesday 4 March 2009
08:30		Registration
08:50	Thomas Steinbach Former QP Pharmacovigilance Senior Director Global Safety Surveillance and Risk Management Wyeth	Opening remarks from the Chair
Pharmacovigilance: a new epoch in drug safety
09:00	Monica Rusu Director Pharmacovigilance Solvay	Regulatory Framework on Pharmacovigilance: Present and Future Clarifying existing regulations and latest EU commission initiatives Roles and responsibilities of Marketing Authorization Holders (MAH) and Competent Authorities in the conduct of Pharmacovigilance, as described in Volume 9A Potential implications on pharmaceutical companies’ business processes Exploring the possibilities given by the new medicines legislation Keeping track of the evolving regulatory framework of European pharmacovigilance.
09:30	Bert Van Leeuwen Director of Global Drug Safety Organon (now part of the Schering Plough Corporation)	Applying the regulations Applying directives for the benefit of the organisation Creating awareness of regulations throughout the company Creating company awareness of regulations
10:00	Jeff Aronson Reader in Clinical Pharmacology University of Oxford President of the British Pharmacological Society (BPS)	Classifying adverse drug reactions (ADRs) as a gateway to risk management Giving insights into aspects of ADRs: the dose relation, time course of the reaction and the susceptibility of the patient (DoTS) Making decisions about product licences The chief features of the adverse effect that are relevant in making such decisions
10.30		Morning Refreshments
11:00	Dieter Konrad Manager Information Processing Boehringer Ingelheim	Moving forward with electronic reporting E2B: enabling electronic submission of Individual Case Safety Reports (ICSRs) Evaluating the modification of business rules at the EMEA FDA guidelines Identification of medicinal products
11.30	Ola Caster Drug Safety Analyst Uppsala Monitoring Centre WHO	WORLD HEALTH ORGANISATION (WHO) CASE STUDY International ADR surveillance in the interest of patient safety: current and future challenges of the Uppsala Monitoring Centre Maintaining and analysing the worlds largest collection of ICSRs: Vigibase Remaining at the forefront of both the science and practice of ADR signal detection Recent development in the area of ADR surveillance
Ensuring the transparency in drug safety
12:00	Barbara Dawson QP Pharmacovigilance Regional Head Europe Middle East and Africa Head of Regional Care Processing Centre Schering Plough	Increasing transparency in pharmacovigilance Considering the growing commitment to achieving transparency Better partnerships with regulatory authorities Are we as transparent as we think we are?
12:30		Lunch
13:30	Thomas Steinbach Former QP Pharmacovigilance Senior Director Global Safety Surveillance and Risk Management Wyeth	The growing importance of the Qualified Person (QP) Clarifying the role of the QP in pharmacovigilance Investigating the potential legal responsibility Actively influencing decision making
Regulations in the spotlight
14:00	Petra Heyen VP Regulatory Affairs and Pharmacovigilance Therabel	Organising a regulatory department in a pharmaceutical company Embedding of the regulatory authority (RA) department in the overall company organisation Understanding the multidimensional nature of the RA department Considering the appropriate solutions for your company
14:30	Jan Monzer Solution Engineer Aris Global	Easing the burden of affiliate compliance Optimising both receipt/submission of safety data and liaising with health agencies and business partners Meeting local regulatory obligations while seamlessly working with corporate safety Mastering today’s challenges in drug safety and risk management with total safety
15:00	Kevin Perkins Senior Pharmacovigilance Inspector MHRA	Interaction with clinical trials Pharmacovigilance in clinical trials Pharmacovigilance outside of clinical trials Practical examples of failure
15:30		Afternoon refreshments and networking
16:00	Elmar Kroth Head of Pharmacovigilance Division German Medicines Manufacturers Association	The future of EU pharmacovigilance requirements Implementing good pharmaceutical practice New expedited reporting requirements Presenting the future of Periodic Safety Update Report (PSUR) preparation Navigating Risk Management Plans (RMPs) and post approval safety studies Understanding key safety information
16:30	Jean-Paul Fagot Pharmaco-Epidemiologist in charge of the coordination of RMP activity Afssaps	AFSSAPS CASE STUDY Pharmacovigilance and risk management An overview of the French approach
17:00	Alejandro Arana Director Risk Management Resources	Writing successful RMPs Discussing what makes an effective RMP Dealing with well established and new products RMP for a new registration upon request from the company initiative Updating the RMP
17:00		Closing remarks from the Chair and end of Day One

Programme Day Two Thursday 5 March 2009

08:30

Registration

08:50

Gerd Kassel
VP, Pharmacovigilance
Takeda Global R&D Centre

Opening remarks from the Chair

09:00

Roundtable morning sessions

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of pharmacovigilance and risk management

Developing RMPs

14:45

Ulrich Hagemann
Head of Pharmacovigilance
Bfarm

BFARM CASE STUDY
RMPs: a German approach

RMPs as a new tool in pharmacovigilance
Implementing RMP guidelines
Evaluating the appropriateness of a RMP
Publication and communication of RMPs

14:15

Lolkje T.W. de
Jong-van den Berg
Professor in Social Pharmacy and Pharmacoediemiology
University of Groningen

THERAPEUTIC CASE STUDY
RMPs in pregnancy

Understanding the unique aspects of drug safety in pregnancy
Which epidemiologic methods do we need to assist risk-benefit profiles of drugs in pregnancy?
The role of the pregnancy registries
Implementing RMPs in pregnancy

14:45

Afternoon refreshments

15:15

Henry Goebe
Safety Risk Management Lead
Pfizer

Integrating risk management strategies from drug development into pharmacovigilance plans

Explaining risk management activities through product life cycle
Understanding benefit-risk
Risk identification: building a risk knowledge base
Safety review and teams
Risk management strategies

Overcoming pharmacovigilance challenges

15:45

Enrica Alteri
Head Medical Safety Group Neurology
Merck Serono

Suspected unexpected serious adverse reactions (SUSARs), PSURs, RMPs: navigating the pharmacovigilance boat

Evaluating the waters of multiple expectation
Coping with numerous reporting mechanisms
Conducting pharmacovigilance whilst formatting the data

16:15

Gerd Kassel
VP Pharmacovigilance
Takeda Global R&D Centre

Safety surveillance during development - challenges and solutions

Importance of early access to safety data
Prerequisites for efficient review
Understanding the use of blinded data
Explaining the shortcomings of a statistical approach
Consequences for development programmes
Evaluating the impact on developing RMPs

16:45

Closing remarks from the Chair and close of conference