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Essentials of EU Regulatory Intelligence Virtual Live Training Course

In our EU Regulatory Intelligence Course, you will learn how to identify and monitor reliable sources of information, assess the business impact of new requirements, and adapt to internal stakeholders needs when communicating key intelligence!


Faculty

  • Denis  Burkhalter, MSc

    Denis Burkhalter, MSc

    • Regulatory Intelligence Manager
    • Novartis Pharma AG, Switzerland

    Molecular biologist (MSc) by training. Currently based in Basel, Switzerland and part of the team responsible for regulatory intelligence and policy for the EU for Novartis. Supporting project teams in establishing their strategy for filing and responding to their regulatory questions. Daily organisation of regulatory intelligence activities and analytics (e.g preparation of newsletters and communications, benchmarking). Coordinator and owner of the commenting process on draft EU guidance. Point of contact for external and internal tools required for data submission.

  • Bettina  Doepner, PhD, RAC

    Bettina Doepner, PhD, RAC

    • Global Lead Regulatory Intelligence/Policy
    • CSL Behring Innovation GmbH, Germany

    Bettina started her career as a regulatory professional in the pharmaceutical industry more than 20 years ago. In global as well as European regional roles in headquarters of several pharmaceutical companies, she gathered comprehensive experience in the areas of drug development, clinical research, and the management of regulatory procedures, as well as a strong knowledge base of the regulatory environment. Her experience includes working actively with Industry Associations, consortia, and the EU RING, and providing relevant input in the monitoring, review, commenting and impact assessment of regulations and guidelines. She is currently working at CSL Behring GmbH in Marburg/Germany as Global Lead Regulatory Intelligence and Policy.

  • João  Duarte, MPharm, MSc

    João Duarte, MPharm, MSc

    • Director, Business Planning & Operations, Global Regulatory Affairs, R&D and Com
    • Alexion Pharmaceuticals, France

    João Duarte is currently Chief of Staff and Regulatory Science within the Global Regulatory Affairs team at Alexion Pharmaceuticals. João leads the regulatory intelligence and policy activities globally and supports Senior Management in steering internal activities based on the regulatory environment. He held several roles since 2012 in Regulatory Intelligence & Policy, notably at Lundbeck and Takeda, where he worked to help colleagues to better understand the shifting regulatory environment and to support drug development in several therapeutic areas globally. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee.

  • Bertrand  Fournier

    Bertrand Fournier

    • Director, Regulatory Policy & Intelligence
    • Shionogi BV, Netherlands

    Bertrand is a pharmacist by education and has almost 20 years of experience in Regulatory Affairs including more than 6 years in Regulatory Intelligence. Before he joined Shionogi, Bertrand did most of his career at Janssen, Pharmaceutical Companies of Johnson & Johnson and previously held positions at Baxter and 3M Pharmaceuticals. In his current role at Shionogi, Bertrand was asked to set up the brand new Regulatory Policy & Intelligence function for this fast-growing international organisation. Bertrand is a member of the EU-Regulatory Intelligence Network Group and representing Shionogi at the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).

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+41 61 225 51 51


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+41 61 225 51 61