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

https://vimeo.com/684179150

April 28, 2021

57min

Launch Regulatory Compliance

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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

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