On June 28-29, 2010 by the initiative of the RA Drug Agency and in cooperation with the Ministry of Health of the RA a TAIEX Workshop on Medicine Regulation Practices and Best EU Practices took place at the Scientific Center of Drug and Medical Technology Expertise. The aim of the workshop was to get acquainted with the EU best practice on medicines regulations, particularly marketing authorization (registration), drugs  pre-approval assessment of safety, efficacy and quality as well as  pre and postapproval inspection and pharmacovigilance for harmonization  of Armenian  regulatory requirements  in practice and optimisation of existing  resources.

The key experts on the subject from Germany and Italy referred to various angles of the subject doing emphasis both on the theoretical part and the practical basis in the EU overall and in particular member states. The agenda of the workshop contained the following issues:

• Overview of European medicines regulation system. Marketing authorization, dossier requirements
• Assessment of the dossier, review of quality, safety, efficacy
• Pre and post approval inspection (GMP, GCP, GLP)
• Variations, Extension, Renewal Pharmacovigilance system
• Structure of CTD and the EU regulatory perspective on the CTD & most common Pitfalls
• Pharmacovigilance system, review of PSUR
• Round table - Marketing authorization Decision making procedure

The list of participants included representatives of the Drug Agency and the Ministry of Health of the RA.

Agenda