The working group is focusing on ensuring effective working relationships with EMEA, CHMP, and the European Commission to create a positive regulatory environment for healthcare biotechnology
products in Europe.
Currently the Working Group is mainly dealing with the following topics:

 Review of the Clinical Trials Directive 2001/20 EC
 Transatlantic Administration Simplification
 Review Variations Regulations
 Counterfeit Medicines and Parallel Trade
 Paediatrics
 Pharmacovigilance
 Parallell Scientific Advice 

Related Documentation

Chair: Ms. Patricia PELLIER (Merck Serono)
Secretary: Ms Stefanie PINGITZER (EuropaBio)

Documentation

Consultation regarding community action on health services 

EuropaBio key responses to the EC consultation paper regarding better regulation of pharmaceuticals towards a simpler, clearer and more flexible framework of variations

BIA EuropaBio White Paper "Promoting Consistency of Implementation and Interpretation of the
Clinical Trials Directive across EU Member States"
 

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