REC Webcast - Clinical Evaluation: What have we learned and where can we find data?

1.0
RAC Credits
Live Webcasts, Europe
Thursday, 18 February 2021 (4:30 PM) - Thursday, 18 February 2021 (5:45 PM) Central European Time (CET)

Your participation in the regulatory community is vital. The RAPS European Council (REC) is offering this webcast so that global regulatory professionals maintain access to valuable knowledge about issues currently impacting our industry.

Description

As a result of the EU MDR coming into force, the complexity and requirements for clinical evaluation of medical devices have changed in Europe. In this webcast, one Notified Body clinical reviewer and two industry experts present their personal experiences around how to focus on these new challenges. They will present pitfalls and learnings from recent submissions to NB’s under EU MDR, and they will address solutions and possibilities to overcome these situations. Participants in the webcast will benefit from the hands-on sharing of experience from European experts and can engage in Q&A session at the end of the session.

This advanced level webcast is specifically aimed at global regulatory professionals, involved in regulatory submissions in the EU. A detailed knowledge on the clinical evaluation requirements of the EU Regulation 2017/745 and related MDCG guidance documents is expected from the participants to most optimally benefit from the experiences of the presenters.

This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

Learning Level: Advanced

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Pricing Amounts and Deadlines

Thursday, 18 February 16.30 – 17.45 CET
Member: € 10
Nonmember: € 25

Objectives

As a result of the EU MDR coming into force, the complexity and requirements for clinical evaluation of medical devices have changed in Europe. In this webcast, one Notified Body clinical reviewer and two industry experts present their personal experiences around how to focus on these new challenges. They will present pitfalls and learnings from recent submissions to NB’s under EU MDR, and they will address solutions and possibilities to overcome these situations. Participants in the webcast will benefit from the hands-on sharing of experience from European experts and can engage in Q&A session at the end of the session.

Who Should Attend?

This advanced level webcast is specifically aimed at global regulatory professionals, involved in regulatory submissions in the EU. A detailed knowledge on the clinical evaluation requirements of the EU Regulation 2017/745 and related MDCG guidance documents is expected from the participants to most optimally benefit from the experiences of the presenters.

Agenda

- Welcome attendees, explain Zoom Webinar features (5 min)
- Introduction to the subject and speakers – Robert van Boxtel (5 min)
- Clinical evaluation reviews – experiences from BSI NB – Richard Holborow (15 min)
- Gathering real world clinical data – possible solutions for high risk devices – Lucas Davy (15 min)
- Gathering real world clinical data – possible solutions for low risk devices – Robert van Boxtel (15 min)
- Q&A session (20 min)

Speakers

  • Richard Holborow, Head of Clinical Compliance, BSI Global
  • Lucas Davy, Managing Director, ECLEVAR-MedTech
  • Robert van Boxtel, Principal Consultant, Medical Device Project

Looking for More Euro-Centric Regulatory Content and Professional Development?

Take a deeper dive into some of the most pressing issues impacting our community today—including IVDR, Post-Market Surveillance in Europe, Design Controls and Data Management. Explore our up-coming European workshops produced in collaboration with the RAPS European Council (REC). Learn more and register.

Plus…registration is now open for RAPS Euro Convergence 2021. Visit the event site for programme details and to register.

Join our RAPS Community

RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Learn more about RAPS membership.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A Q&A portion with the speakers will follow the presentations, were selected questions posed through the chat will be discussed and answered.

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