backKing & Spalding invites you to join our European colleagues for a series of CLE webinars on the fundamentals of EU pharmaceutical law. Marketing of medicinal products in Europe covers many aspects - from regulatory to compliance to market access – that are heavily regulated at the European and/or national level. Companies operating in or wishing to expand their activities to Europe should have a basic knowledge of those regulations to better understand not only rules as they currently exist but also ongoing and future legislative revisions.
The series will kick-off by setting the stage for the upcoming sessions. We will provide a general overview of EU pharmaceutical law, outlining the relevant legislations, regulatory authorities, key concepts, and interactions among the different product legislation in Europe, and then discuss the procedures and steps to be taken before submitting a marketing authorization application.
Future topics:
• MA Procedures/Applications, including early access
• Regulatory exclusivities
• Special categories of products: combination and personalized products, pediatrics and orphan products
• Manufacturing and distribution
• Advertising and promotion, kickback, transparency
• Pricing and reimbursement
Unable to join the first session but interested in future topics? Click here to be added to our mailing list.