1 The European Union: The Basics Introduction The EU: Structure How the EU is Governed Healthcare Trends in the EU
2 Supporting the Pharmaceutical Regulatory Process EudraNet Portal The European Agency for the Evaluation of Medicinal Products (EMEA) Heads of Agencies in Europe European Experts The Pan European Regulatory Forum (PERF) The Enterprise DG of the EU Commission Enterprise DG Unit F2 - Pharmaceuticals - Regulatory Framework and Market Authorisations European Federation of Pharmaceutical Industries and Associations (EFPIA) Association of the European Self-Medication Industry (AESGP) Other Important Interested Parties
3 European Pharmaceutical Regulatory Processes Relevant Historical Perspectives Centralised Procedure - Overview Mutual Recognition Procedure - Overview Purely National Procedures - Overview The Basis of the System Product Name The Dossier Centralised Applications - Pre-submission Guidance Common Technical Document (CTD) The Electronic Common Technical Document (eCTD)
4 Types of Application Complete/full and Independent Abridged Fixed Combination New Authorisation with an Already Authorised Active Substance Orphan Medicinal Products
5 The Reform Process Initial Proposals for Reform The Industry's (EFPIA) Response The Commission's Response and Current Position
6 International Perspectives Expansion of the EU International Harmonisation
7 The Rules: Governing Medicinal Products in the European Union The Rules: Introduction The Rules: Volume 1 - Pharmaceutical Legislation The Rules: Volume 2 - Notice to Applicants The Rules: Volume 3 - Guidelines - Medicinal Products for Human Use The Rules: Volume 4 - Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use The Rules: Volume 9 - Pharmacovigilance for Medicinal Products for Human and Veterinary Use
