EGA Regulatory Conference 2002

LONDON — 14-15 February 2002

This Eighth Annual EGA Meeting, with its panel of experts and decision-makers from regulatory authorities and industry throughout Europe, will provide participants with an overview of the 2001 Review of Pharmaceutical Legislation. Delegates will gain insight into solving the problem of generic registrations, including how Member State Authorities are coping with the situation and what solutions they see for generics in the 2001 Review. The situation regarding registrations in Accession Countries will be addressed and bioequivalence and biotechnology issues will be reviewed.

This conference will provide ample opportunity for delegates to meet colleagues from the generics industry and regulatory authorities for informal discussions.

In addition, all those attending are invited to the Cocktail Reception sponsored by Teva Europe Pharmaceuticals, to be held at the end of the first day. This will be the perfect setting for networking with other attendees and speakers in an informal and relaxed atmosphere.

Key Issues addressed during this important conference:

• Latest Developments affecting the Generic Medicines Industry and the Commission Proposal for Amending Pharmaceutical Legislation;
• Overview of Key Issues of concern for the Generics Industry in the EU Regulatory Area;
• Key Legal Issues affecting the Generics Industry: Update on developments — The European Commission View;
• Key Issues in the UK Regulatory Area and UK’s views on the proposed new Pharmaceutical Regulations;
• Developments in Belgium, Spain and France and the Authorities’ view on the proposed new pharmaceutical legislation;
• Latest Developments affecting the Summary of Product Characteristics Harmonisation — Viewpoint of Industry and Regulators;
• Impact of the changes to the Bioequivalence guideline;
• Regulatory developments in CEE countries;
• Development of a multisource biotech industry and the need for an EU regulatory framework — Viewpoint of Industry and Regulators
• Recent Developments in ICH — Issues affecting the generic industry
• Implementation of CTD for generics in the EU.

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