Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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European Pharmaceutical Legislation/Regulation

Seminar 1: European Pharmaceutical Regulatory Environment - Geneviève Michaux

    • The European Pharmaceutical Legislation
    • Essential terms and provisions of the framework defining the marketing of pharmaceutical medicinal products in the EU/EEA


    • The common market in the EU/EEA
    • Approval and distribution of medicinal products in the EU
    • Regulations and directives determining the pharmaceutical legislation applicable to the EU/EEA and national pharmaceutical law of the EU member states
    • Notice to applicants
    • Obligations of the marketing authorisation holder
    • Global marketing authorisation
    • Data protection and patents
    • Types and procedures of referrals

    Length: 73 min

plus 19% VAT
Access time 2 day(s)
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The Speaker:
Geneviève is a Belgian and French qualified attorney who focuses on issues surrounding the regulation of drugs, biologicals, medical devices, cosmetics and food in Europe, both at the Union and national level.
Geneviève specialises in European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labelling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Paediatrics Regulation. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
Geneviève is recognized as a leading regulatory lawyer in legal directories and by many organizations. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.