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Series topic: Vigilance Medical Device Guidance Part 2: “Post-Marketing Safety Surveillance, EU & USA"

Posted by
Kalina

377 days ago

Join us for Part 2 of our webinar series on post-marketing safety surveillance, where we dive deeper into the intricate world of medical devices and drug-device combination products.

Building upon the foundation set in Part 1, this session explores the reporting essentials and obligations associated with the post-marketing safety surveillance of these products in both the EU and USA markets. Industry expert Veronika Valdova will guide you through current trends and challenges in the industry, offering valuable insights into best practices and regulatory expectations. Attendees will gain a comprehensive understanding of how to navigate the complexities of safety surveillance and ensure compliance with international standards.

Agenda:

  • Introduction Drug-Device and Combination Products.
  • Types of DDCs in Europe and the U.S.
  • Reporting Essentials and Obligations
  • Essential Procedures to Cover
  • Comparison of Reporting Requirements in the EU vs the U.S.
  • Current Trends and/or Challenges
  • Best Practices
  • Key Takeaways
  • Q & A Session

For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy! 

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