ISoP Training Course 2004

29-30 January | Berlin, Germany

New EU Post-Licensing Legislation and Benefit-Risk Management & Future Perspectives for EU Pharmacovigilance

Decision-Making in Pharmacovigilance – Managing Risk, Berlin 2004

People who are interested in getting abstracts from this course, ‘Decision-Making in Pharmacovigilance – Managing Risk’ please contact administration@isoponline.org.

This well-attended two-day training course opposed and combined the views of industry, government and academia on the criteria, in terms of underlying data, necessary for each of the six main pharmacovigilance decisions:

1. Anticipating risks, i.e. planning post-marketing studies or surveillance on the basis of data and concerns emerging during drug development or the assessment of the application for marketing authorisation
2. nvestigating risks, i.e. planning and conducting new studies if during the post-marketing phase new unresolved questions as to the safety and risk/benefit balance come up and demand urgent answers or if new techniques for the evaluation of special risks become available
3. Informing about risks, i.e. describing newly detected ADRs or interactions per quality or numerical quantity in the relevant sections of the SPC if the body of evidence reaches a certain level
4. Warning of risks, i.e. instructing patients and doctors how they can avoid or minimise those risks mentioned in the SPC
5. Eliminating risks, i.e. suspending or withdrawing the marketing authorisation of those drugs where precautionary measures including contra-indications were either not followed or not sufficient to keep the benefit/risk balance favourable
6. Communicating about risks, i.e. adequately informing patients and their doctors about how they can use a drug safely or why their drug is no longer available

Speakers stressed and discussed

• The scientific tools necessary to provide the data for decision making, in particular large modern databases, record linkage techniques and large simple safety trials
• The frequent inadequacy of data underlying even far-reaching actions
• The need to plan risk-management pro-actively rather than in a merely re-active manner
• The inter-relations of different risk-reducing measures like minimising and informing about risks as well as communicating to the public which decisions had been taken and what was the reason
• The importance of providing well-balanced, understandable and true information in due time to consumers and their doctors

The faculty was composed of very senior and experienced pharmacovigilance experts throughout and there was an impressive similarity in scientific thinking between regulators and company people. The forum of an ISoP Seminar proved extremely useful for in-depth and lively discussions between speakers and the audience and for ‘networking’ during the breaks. Participation of independent academics and a senior veterinary regulator widened the scope, and there was much appreciation that efforts will be made to compile and publish the ‘take-home-messages’.