Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS RESOURCES WEBINARS UNLOCKING THE EMA MEETINGS: THE PROCESS AND HOW TO PREPARE ADEQUATELY Webinar EMA UNLOCKING THE EMA MEETINGS: THE PROCESS AND HOW TO PREPARE ADEQUATELY Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it is a Scientific Advice meeting or a CHMP meeting. In this webinar, we will use CHMP meeting as an example to walk you through the complex processes and share insights on the preparation, for you to get the best out of the EMA meetings. 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Yes, I would like to receive communications regarding VCLS services and events UNLOCK DOWNLOAD SAMPLE OF THE WEBINAR Unlocking the EMA Meetings: the Process and How to Prepare Adequately FEATURED SPEAKERS FRÉDÉRIC PAILLOUX, PHARM.D., M.SC. Eugenio Fernandez-Alanis Ph.D., M.Sc. Senior Regulatory Scientist, Drugs & Biologics / Complex Biologics Eugenio providing support to both the Drugs & Biologics and Complex Biologics teams. Eugenio is involved in the preparation of orphan drug designation (ODD) applications in the EU and in the US, as well as the preparation of Paediatric Investigation Plans (PIP) and the authoring of Briefing documents for Scientific Advices. He also provides recommendations on the feasibility of these applications and on the strategy to develop to meet Agencies’ expectations. Peri Aghadiuno, MBBS, MRCOG Medical Director As a Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a variety of… View profile ALL OUR RESOURCES Blog Glossary Presentations Publications Webinars Whitepapers Case Studies ALL OUR RESOURCES MORE RESOURCES Brexit Cell & Gene Therapy Clinical Trials Digital health EMA FDA IVD IVD Market Access Medical Device Microbiome Orphan & Rare Disease Paediatric BROWSE BY TOPIC... WEBINAR IVD Ask the experts: Will you be ready for the new IVD regulation? The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies… PUBLICATION Market Access Advanced therapies in the EU: challenges with HTA and real-world evidence Market access aims to make a health technology not only available and affordable for every patient, but also profitable for… WEBINAR EMA How to use Scientific Advice to enhance your product development strategy Scientific Advice (SA) is one of the important interactions a developer can have with a regulatory agency (national or European… PRESENTATION Brexit How to overcome the regulatory challenges due to BREXIT This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th 2020. 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