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Clinical Reporting
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Study Operations & Management
Trial Design & Planning
Commercialization *
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Market Access & Policy *
Global Market Access
Government Policy
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Leman Street, London, ENG, GBR
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Series topic: Vigilance Medical Device Guidance Part 2: “Post-Marketing Safety Surveillance, EU & USA"
Kalina S. from Qinecsa
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!
Kalina S. from Qinecsa
Kalina S. from Qinecsa
Heej K. from DIA
Series topic: Vigilance Medical Device Guidance Part 1- topic: “Vigilance Medical Device Regulations (EU) 2017/745
Florence D.
Join our insightful webinar exploring the latest developments in the EU medical device vigilance landscape, with industry-renowned specialist Veronika Valdova. Learn how to seamlessly integrate medical devices into your pharma portfolio, gain practical strategies for navigating regulations, and establish robust management processes.
Key topics include:
• Introduction to Medical Device Regulatory Requirements
• Addressing Practical Challenges
• Key Takeaways
• Q&A Session
🎯 This webinar is ideal for:
• MedTech company leaders in acquisition by pharma
• Pharma company leaders expanding their portfolio to include device products.
For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy!
Florence D.
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