ISoP Training Course 2009

26-27 March | Verona, Italy

2 ISoP training courses and 1 workshop were organized in Verona, Italy on the 26 and 27 March 2009:

1. Ecopharmacovigilance workshop

Chair: Giampaolo Velo

Programme

2. Keeping the lights green – your risk management roadmap

Chair: Deirdre McCarthy

Programme

Entitled ‘Your risk management roadmap – keeping the lights green’ the course covered perspectives on both safety and quality risk management over two days. Twenty participants availed of the opportunity to learn from a range of international speakers from industry, WHO, academia, regulatory authorities and EMEA. We had presentations on risk management theory followed by a number of practical examples from within and outside the EU. A workshop was also held during which participants were given a proposed SmPC and background clinical and pre-clinical data on a fictitious drug. They were then asked to identify possible risks and state how best to minimize these. We also had an interactive tutorial on the future of risk management globally. During the quality risk management part of the course we heard from a regulatory authority inspector on the inspection process and the industry perspective on how to prepare for an inspection.

Participant feedback was very positive and the course proved to be a valuable learning exercise in the historic and cultural city of Verona.

3. Basic Concepts in Pharmacovigilance

Chair: Kenneth Hartigan-Go

Programme

The basic course on pharmacovigilance was well received in the lovely city of Verona with 28 participants coming from 11 countries (incl.1 bursary). Eminent speakers from the pharmacovigilance community were on hand to deliver wonderful lectures and undertake practical exercises on case studies and causality assessments. The 2 day intense course was sectioned in a logical sequence into 4 sections: basic principles, tools and methodologies, translational pharmacovigilance and risk management principles (in preparation for higher courses).

A new exciting lecture on signal pattern recognition and ADR phenomenon looking at why �ADR epidemics� occur in the context of regulations actions, perception by health professionals and patients, industry behavior and media intervention was delivered. This is new insights and cutting edge for pharmacovigilance. Interesting topics included the medication errors and pharmacogenetics and patient safety.

The evaluation of the basic course by the participants was very good in general.