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Mar 27, 2018 12:00 PM - Mar 27, 2018 1:30 PM

Online

Complimentary - CHMP Meetings: How to Prep for, Manage, and Excel at EU Regulatory Meetings

Presenters

Kell  Cannon, MBA

Kell Cannon, MBA

Principal, 3D Communications, United States

Kell Cannon brings more than 20 years of U.S. and global lifecycle and pharmaceutical marketing expertise to 3D's clients. Kell uses his analytical and organizational skills to help clients identify the strengths and weaknesses in their data and define their competitive differentiation. He has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA advisory committee presentations. This assistance enables companies to win approval, expedite product access, and achieve competitive reimbursement.

Marie  Deneux, PhD, MSc

Marie Deneux, PhD, MSc

Chief Regulatory Officer, Lysogene S.A., France

Marie Deneux is in charge of defining and executing the regulatory strategy for the development and registration of Lysogene’s gene therapy products. Prior to joining Lysogene, Marie Deneux spent 15 years in consulting, where she assisted life sciences companies throughout the development of their products. Involved in the development of biotechnology products, new chemical entities, cell and gene therapy drugs and repurposed drugs, Marie Deneux has extensive experience in interactions with the European Medicines Agency (EMA), national European health authorities and the Food and Drug Administration (FDA).

Florence   Bine-Scheck, MD

Florence Bine-Scheck, MD

Senior Medical Director, Voisin Consulting Life Sciences, France

As Senior Medical Director with VCLS, Florence is Head of the Non Clinical and Clinical Development group. She provides advice on medical and clinical aspects of projects involving the design of clinical development plans, clinical trial protocols, Scientific Advice Procedures, regulatory document writing, Risk Management Plans and Paediatric Investigation Plans.

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