Regulatory Compliance: How to accelerate your medicinal product launch in Europe

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Our experts at BlueReg are covering the different pathways to accelerate your medicinal product launch in Europe.

The different subjects covered are :

1. Regulatory Strategy – How to prepare the regultory launch sequence for your first medicinal product in Europe?

• EU Marketing Authorisation (MA)
• Regulatory Strategy Considerations
• How to Plan the Regulatory Activities of your Medicinal Product Launch?
• Planning of Activities for Local Market Launch is Crucial

2. Compliance with Regulatory Requirements

• European Definition
• Brexit Impact
• Key Requirements to Launch a Product in the EU
• Local Representatives
• National Codes
• Blue Box
• Serialisation
• Local Databases
• Local Launch Date Notification
• Promotional Materials
• Educational Materials
• Local Wholesale Distribution Authorization (WDA)
• Shared Pack and Stock Keeping Unit (SKUs)

3. A tailored outsourcing regulatory platform

• Outsourcing Platform to Support EU Local Market Launch

4. Q&A’s