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#30: Regulatory Affairs in the European Union: An Overview of Registration Procedures for Medicinal Products in the EU

Tutorial name:
#30: Regulatory Affairs in the European Union: An Overview of Registration Procedures for Medicinal Products in the EU

Day & Time:
June 24, 1:00PM - 4:30PM

Room Number:
124

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

This tutorial will provide an overview of the three regulatory procedures in the European Union — centralized, decentralized, and mutual recognition — including details on the review time to approval and opportunities for sponsor/agencies dialogue from scientific advice to granting the Marketing Authorization. It will discuss which procedure is available for NCE including orphan drugs, OTC, and generic products, and examine the business strategic opportunities for each procedure.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

•Explain the background to the development of the European Union

•Describe the three regulatory procedures for a marketing application in the European Union for NCE, OTC, and generic products

•Identify the business considerations of translations, co-marketing, co-promotion, patents, and trademarks



Target Audience:
This tutorial is designed for attendees with an interest in European regulatory affairs (regulatory affairs staff, clinical research and development managers, and project managers).

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