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

Public Relations Presentation
April 28, 2021
57min
  • Launch Regulatory Compliance
image_pdfPDF

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

 

Access the Full Webinar and the slide deck

    By sending this form, I agree that my personal data will be saved and processed according to data protection regulations and will be used only for commercial and marketing purposes only.

    Learn more


    BlueReg undertakes to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 applicable as from 25 May 2018 (hereinafter, "the General Data Protection Regulations" or GPDR) and the national laws resulting therefrom.
    Any inquiries, correction or declaration of event related to personal data processed should be sent to: GDPR data request

    GDPR data request

    Thank you! You can watch the webinar now.

     
    Download your document