The Programme

 

Day One Wednesday 18 June 2008

08:30

 

Registration

09:00  

Opening remarks from the Chair

The evolving environment for pharmacovigilance and risk management

09:10 Janet Hormbrey
Executive Director, EU Qualified Person for Risk Management and Pharmacovigilance
Merck & Co

Further defining post-authorization safety studies: their role in the EU Risk Management Plan (RMP)

  • Clarifying the current definition of PASS contained in Volume 9A and briefly commenting on proposed new EU legislation
  • Building a case for the critical role in the pharmacovigilance section of the EU RMP
  • Providing practical examples and helpful tips to guide pharmacovigilance and regulatory people as well as EU Qualified Persons in pharmacovigilance
09:50 Enrica Alteri
Global Drug Safety, Medical Safety Group Neurology
Merck Serono

Safety Issues of biologicals

  • Are there specificities in conducting pharmacovigilance of biological products?
  • Regulatory environment
  • Safety implications of immunological and non-immunological aspects of biologicals
  • Safety profiles of biologicals: the example of interferon beta 1a
10:30  

Morning refreshments

11:00 Gro Laier
Deputy Qualified Person, International Product Safety
Novo Nordisk

Pharmacovigilance aspects of licensee agreements

  • How to ensure compliance
  • What to include in the agreement
  • How to structure templates
  • Practical examples
11:40 Vicki Edwards
Director European Pharmacovigilance
Abbott

Monitoring and inspecting on pharmacovigilance compliance

  • Setting-up processes for pharmacovigilance inspections
  • Requirements for the inspection and audit process
  • Good pharmacovigilance practices and quality risk management in GCP
  • Preparing the organisation for pharmacovigilance audits and minimising the risk of inspection findings
  • Post-analysis of the audit and lessons learned
12:20 Saad Shakir
Director,
Drug Safety Research Unit
Southampton UK

The role of academia in risk management

  • How to define safety specifications
  • How to build risk management on safety specification, known and potential risks
  • Approaches to monitor the effectiveness of risk management
13:00  

Lunch

Implementing RMPs

14:00

Corinne de Vries
Professor of Pharmacoepidemiology, Department of Pharmacy and Pharmacology
University Of Bath

Integrating epidemiology and risk management - a streamlined approach to pharmacovigilance

  • Epidemiology as a sub sector in drug safety and risk management -benefits to the process?
  • Utilising epidemiological methods to align risk management to drug safety
  • What is understood by the term “pharmacoepidemiology”: how does it relate to the areas of risk management and post-authorisation studies?
14:40

Tjeerd van Staa
Head of Research
General Practice Research Database (MHRA)

Risk management: counting events or something more?

  • There have been several major safety issues in recent history: can we improve?
  • What to do and what not to do for risk management
  • Can benefit-harm models that quantify the risks and benefits of treatment be useful?
15:20

Thys Kruger
Medical Director EMEA
Ranbaxy

Risk management and new dimensions in product safety

  • The implications of the current regulatory environment on the generics industry and regulators in relation to risk management
  • What is the current situation and the potential impact on generic companies and regulators?
  • Is this a manageable situation?
  • What will/should the future bring?
16:00  

Afternoon refreshments

16:30

Ennis Lee
Vice President, QPPV Pharma, Benefit Risk Management
Janssen Cilag

RMPs: implementation and follow up

  • Regularly updating and reviewing RMPs
  • Reviewing the reasons to update the RMP document
  • Linking the RMP to PSUR, ASR, Labelling, HA Commitments such as annual review for a centralised authorisation under exceptional circumstances
17:10

Bledar Haderi
Drug Safety and Epidemiology Manager
AstraZeneca

Intelligent internal and external risk communication

  • Responding to growing public concerns about the safety of new medicines
  • Minimising risk by applying evidence and communication skills
  • Improving the organisation’s performance in risk communication
  • Increasing transparency towards the public
  • Promoting awareness and providing education on safety matters
17:50  

Closing remarks from the Chair and close of Day One

     
   

Day Two Thursday 19 June 2008

08:30

 

Registration

09:00

 

Opening remarks from the Chair

09:10

Roundtable morning session

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.

 
             
1. Critical success factors for risk management programmes

William Gregory
Director, Safety and Risk Management
Pfizer
2. Pharmacovigilance practices in academic trials 

Corinne de Vries
Professor of Pharmacoepidemiology, Department of Pharmacy and Pharmacology
University Of Bath
3. Data collection techniques and improving signal detection practices

Johan Hopstadius
Research Engineer, Research & Development
The Uppsala Monitoring Centre
 
             
4. Managing pharmacovigilance programmes and responding to pressure from the public and media

Brian Edwards
Director, Pharmacovigilance and Drug Safety
NDA Regulatory Service
5. Optimising the way drug safety data is handled across the drug lifecycle

Daniel Reshef
Director, PDS Risk Management
Roche
6. Post-marketing studies and preventing adverse reactions

Vicki Edwards
Director, European Pharmacovigilance
Abbott
 
             
12:30  

Lunch

Improving safety and lowering risk for marketed products

13:30 Johan Hopstadius
Research Engineer, Research & Development
The Uppsala Monitoring Centre

Adverse drug reactions surveillance - the experience of Uppsala Monitoring Centre

  • The need and the use of spontaneous reports in early detection of previously unknown suspected drug - ADR relationships
  • The implementation of routinely used data mining in signal detection
  • The need for other datasets in effective ADR surveillance
14:10 Dieter Konrad
Manager, Department of Information Processing
Boehringer Ingelheim

EMEA guidelines on the use of statistical signal detection methods in the EudraVigilance Data Analysis System

  • Legal basis
  • Statistical methods
  • Analysis queries
  • Validation studies
  • Data quality
14:50 William Gregory
Director, Safety and Risk Management
Pfizer

Interdependence of data mining and RMPs on Electronic Data Standards in pharmacovigilance

  • Electronic Data Standards for the exchange of individual case safety reports (ICSRs)
  • Implications of dictionaries and coding practises for enhanced understanding of pharmacovigilance information
  • Database considerations for support of queries, data mining, signal detection, and Annex 1 of the EU RMPs
  • Critical success factors that drive the value proposition of Electronic Data Standards in pharmacovigilance
15:30  

Afternoon refreshments

16:00 Daniel Reshef
Director, PDS Risk Management
Roche

Signal detection in modern  drug safety

  • Detecting potential safety signals
  • Identifying information about potential new hazards
  • Monitoring the safety of marketed medicines and adverse drug reactions
16:40 Thomas Verstraeten
Director of Worldwide Safety and Regulatory Management
GSK Biologicals

The specifics of pharmacovigilance for vaccines

  • Vaccines are given to healthy populations and exposure to vaccines is often universal
  • Examining the impact of vaccines adverse effects on public and media
  • Why methods applied to drug safety may not always apply to vaccine safety?
  • Importance and need of huge databases for vaccine safety research as safety concerns are mostly on rare events
  • Monitoring safety and vaccines adverse reaction – very few reactions have a proven link to vaccines
17:20  

Closing remarks from the Chair and end of the conference