practices (2001)

CIOMS drug safety working groups are composed of pharmacovigilance specialists from regulatory agencies and pharmaceutical manufacturers principally from North America and Europe. Historically, members were selected for their personal expertise and contributions rather than to represent specific organisations. Observers from organisations such as the WHO and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) are also invited. The size of the groups has usually been restricted to 20-30 members to ensure optimum discussion and completion of tasks. Considerable overlap of membership between consecutive working groups has enhanced productivity. Consultation with various specialists has also occurred when appropriate.

Each working group is co-chaired by a member from a regulatory agency and a pharmaceutical manufacturer. Win Castle deserves particular mention for co-chairing all the working groups until her retirement in 2000. Her enthusiasm, determination and hard work often provided the impetus necessary for the successful completion of each initiative.

As the CIOMS working groups have no legal jurisdiction, reliance is placed on other bodies to incorporate the CIOMS recommendations and guidelines into a regulatory or legislative framework. For example, the International Conference on Harmonisation (ICH) has progressed the CIOMS initiatives on expedited and electronic reporting as well as having used the CIOMS II recommendations as the basis for the requirements for periodic safety update reports (Table 25.2). The ICH process is based on five steps:

• Step 1—Technical discussion by the Expert Working Group who produce a preliminary draft document

• Step 2—The consensus text is released for a six-month period of consultation

• Step 3 —Formal consultation outside ICH

Therefore, Step 4 is the stage at which the document is finalised and released with the intention that the countries represented by the ICH

Table 25.2. Uptake of CIOMS initiatives by ICH.

Working group



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