Qinecsa
Qinecsa

Webinar: Mastering Medical Device Regulations (EU) 2017/745 

Qinecsa Webinar Series: Vigilance Medical Device Guidance

Navigate through the latest EU medical device regulatory landscape to successfully adapt your pharma portfolio

Join us for Part 1 of our webinar series, “Vigilance Medical Device Guidance – Mastering Medical Device Regulations (EU) 2017/745” for an in-depth presentation of medical device regulations – essential for pharmacovigilance professionals seeking mastery in compliance and operational excellence. Participants will be guided through key regulatory requirements, integration challenges, and actionable steps for building resilient processes to support combined drug and device portfolios within primarily pharma-focused organizations. By the end of this webinar, attendees will possess the knowledge and tools necessary to navigate the complex EU device vigilance regulatory landscape, appreciate the obligations of individual entities in the device lifecycle compared to medicinal products, understand the conceptual differences in drug and device surveillance requirements, and confidently adapt their department to the change. 

📅 Save the date: Choose from three sessions on Wednesday, April 17th:

🕚 Session 1: 6am ET | 12am CET
🕚 Session 2: 10am ET | 4pm CET
🕚 Session 3: 2pm ET | 8pm CET

Can’t make it to either of these sessions? Don’t worry, you can request a recording of the webinar by writing to: [email protected]

 

Agenda

Introduction to Medical Device Regulatory Requirements  

  • EU MDR overview  
  • Applicable MDCG, MEDDEV and IMDRF guidelines  
  • ISO 13485 quality management system   
  • Obligations of economic subjects in the device sector (e.g., MAH vs. Manufacturer)  
  • Introduction to MDSAP  

Addressing practical challenges  

  • Explaining the differences between drugs and device safety surveillance   
  • Integrating medical devices into drug safety portfolios   
  • Interface between Quality, Vigilance, and Regulatory departments and other entities   
  • QPPV vs. PRRC  
  • Establishing entity ownership interface agreements

Key takeaways

  • Understanding the differences between drug and device requirements   
  • Importance of continuous education  
  • Identifying strategies to embrace and integrate products subject to a different set of regulations. 

 

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 

 

About our expert speaker

Veronika Valdova, DVM, Senior Vigilance Device Consultant, Arete-Zoe, LLC 

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. 

Connect with Veronika 

If you have any questions about our webinar, please feel free to contact us. 

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