The Programme

Registration

Opening remarks from the Chair

The evolving environment for pharmacovigilance and risk management

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

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

Morning refreshments

Pharmacovigilance aspects of licensee agreements

• How to ensure compliance
• What to include in the agreement
• How to structure templates
• Practical examples

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

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

Lunch

Implementing RMPs

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?

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?
  

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?

Afternoon refreshments

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

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

Closing remarks from the Chair and close of Day One

Day Two Thursday 19 June 2008

Registration

Opening remarks from the Chair

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.

Lunch

Improving safety and lowering risk for marketed products

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

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

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

Afternoon refreshments

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

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

Closing remarks from the Chair and end of the conference