EUCRAF is pleased to announce the names of the speakers of Seminar 1.

Dr. John Purves, formerly EMA and Dr. Geneviève Michaux from Covington and Burling LLP are the Course Leaders of Seminar 1.

Dr. Geneviève Michaux and Dr. Gabriele Dallmann from EUCRAF give an introduction into the European regulatory system.

Dr. Geneviève Michaux gives also a talk on the European Pharmaceutical Legislation and the essential terms and provisions of the framework defining the marketing of pharmaceutical medicinal products in the EU/EEA

Dr. Hoss Dowlat from PharmaBio Consulting discusses the international collaboration of agencies.

Dr. Gabriele Dallmann from EUCRAF speaks on the topic “Legal particulars for biopharmaceuticals” which includes the regulations for Advanced Therapies and Biosimilars and the Plasma Master File.

Dr. Gesa Pellier, Dr. Judith Creba and Dr. Silvia Pfaff from Novartis speak on the regulatory institutions and other stakeholders of the European System of Pharmaceuticals, their functions and role.

The topic “The particular conditions applicable to Small and Medium Size Enterprises (SME) and the SME office of the EMEA, regulations and incentives, type of companies” is presented by Dr. Juergen Regenold from Dr. Regenold GmbH.

Dr. Monika Eck-Schaupp from NDA Regulatory Service GmbH presents the details on the format and content of the marketing authorisation application: The Common Technical Dossier (CTD) - Module 1. She also speaks on "Labelling, Package Leaflet and Summery of Product Characteristics (SmPC)" and on the Module 2 of the CTD. Further she gives a talk about the Risk Management Plan (RMP).

Another interesting topic is “The regulatory framework for drug/device combination products” which is presented by Dr. Marielle Fournier from Voisin Consulting.

The topic "Orphan Medicinal Products in the EU/EEA" is presented by Dr. Rembert Elbers from BfArM.