On April 17, 2024, Qinecsa launched its first webinar, offering a deep dive into medical device regulations. The on-demand session, “Mastering Medical Device Regulations (EU) 2017/745,” is designed for pharmacovigilance professionals aiming to excel in compliance and operational effectiveness.
The 50-minute webinar offers a thorough analysis of the latest EU medical device regulatory landscape, providing attendees with actionable strategies to integrate medical devices into their pharma portfolios successfully.
Key Takeaways:
- Understanding Differences: Learn to distinguish between drug and device requirements.
- Continuous Education: Stay up to date with regulatory changes.
- Integration Strategies: Develop methods for integrating products governed by various regulations.
The webinar explores practical topics, such as drug and device safety surveillance, the integration of medical devices into existing drug safety portfolios, and the interface between quality, vigilance, and regulatory departments.
Participants also delve into the roles of Qualified Persons for Pharmacovigilance (QPPV) and Persons Responsible for Regulatory Compliance (PRRC), as well as strategies for establishing entity ownership interface agreements.
The session features Veronika Valdova, DVM, Senior Vigilance Device Consultant at Arete-Zoe, LLC. Valdova, a seasoned professional, brings a wealth of expertise in the pharma and medical device industries. Her specialties include preparing clinical documentation for medical devices in the EU, such as Clinical Evaluation Plans, Reports, and Post-market Surveillance Plans.
Since 2013, Valdova has focused on medical devices, aiding manufacturers in their transition from MDD to MDR. Her experience spans pharmacovigilance, consultancy, and leadership roles, offering attendees insights into both routine and innovative initiatives.
For any inquires and additional information about the webinar or related services, please contact us
