Navigating EU Market Access: Strategies for Product Registration and Pharmacovigilance

On Demand Webinar

Unlocking the Potential of Artificial Intelligence: Strategies for Achieving GxP Compliance and Driving Innovation 

What will I learn?

• Navigate the main EU marketing authorization procedures, including centralized, DCP, MRP, and national routes 
• Meet regulatory expectations for CMC, non-clinical, and clinical data
• Plan timelines, resources, and strategies to achieve EU registration efficiently

Abstract

The European pharmaceutical market is one of the most sought-after markets in the global pharmaceutical industry, attracting manufacturers and distributors seeking to establish and expand their presence in the lucrative region. Although having the right pharmaceutical product is a prerequisite, it is not enough for regulators to grant you access to this multi-billion Euro market. Entering the European market, especially the EU’s single market, is not a game of chance; it all comes down to one key thing some pharma manufacturers often overlook: planning. 

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