Qinecsa
Qinecsa

Webinar: Navigating Post-Marketing Safety Surveillance of Medical Devices and Drug-Device Combination Products, E.U. and USA

Navigate through post-marketing safety surveillance of medical devices and drug-device combination products in the E.U. and USA to successfully adapt your pharma portfolio.

We are pleased to invite you to join us for Part 2 of our webinar series on Vigilance Medical Device Guidance, where you will dive deeper into the intricate world of medical devices and drug-device combination products.

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. Our expert will guide you through current trends and challenges in the industry, offering valuable insights into best practices and regulatory expectations.

Save the Date: Wednesday, May 29th

You can choose one of the below sessions available:

🕚 Session 1: 6am ET | 12pm CE

🕚 Session 2: 10am ET | 4pm CET

🕚 Session 3: 2pm ET | 8pm CET

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.

This webinar is ideal for:

  • MedTech company leaders undergoing acquisition by pharma.
  • Pharma company leaders that are adding device products in their portfolio
  • Pharmacovigilance Heads of Department
  • PV Operations professionals from pharmaceutical and biotech companies
  • Global Heads of Materiovigilance
Veronika

About Our Expert Speaker

Veronika Valdova is a multi-disciplined professional in the pharma and medical device sectors, with extensive knowledge of all aspects of the product lifecycle. Veronika has an excellent record preparing clinical documentation for medical devices in the EU, specifically Clinical Evaluation Plans and Reports, Post-market Surveillance Plans, Post-Market Clinical Follow-Up (PMCF), and Biocompatibility assessment reports in compliance with EU MDR 2017/745. Since 2013, Veronika has shifted attention from medicinal products to medical devices.

In recent years, Veronika has been focusing on helping device manufacturers in transitioning from MDD to MDR. Veronika’s career spans roles in pharmacovigilance, consultancy, and leadership, offering valuable insights across routine and innovative initiatives.

If you have any questions about our webinar, please feel free to contact us Link to [email protected]