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4th RAPS German Chapter Meeting – Online Session on Postmarket Surveillance (conducted in the German language)

3.0
RAC Credits
Monday, 28 September 2020 (4:00 PM) - Monday, 28 September 2020 (8:00 PM) Amsterdam, Berlin, Bern, Rome, Stockholm, Vienna
With the passage of the Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR) on May 25, 2017, new requirements impacting Postmarket Surveillance (PMS) have significantly raised the bar for manufacturers.

Join us and learn about new processes and governance that will be needed to support this assessment and ongoing technical documentation updates for both the MDR and IVDR.

The aim of the event is to review new requirements, key changes and transition strategies from a company and notified-body/authority perspective.

Engage with professionals from your local regulatory community for an interactive session where you will learn strategies for planning and implementation of PMS requirements.

Agenda:
• Expectations of the processes
• Trend reporting and risk management
• ISO / TR 20416
Short presentations and panel discussion

Admission and networking from 4:30 p.m.
Lecture and panel discussions 17h-20h
Networking


Faculty:
• Martin Witte, TÜV-Süd
• Angela Schulz, Merz-Pharmaceuticals, MDGC working group PMS
• Sonja Bruhn, C-RA Consulting Bruhn
 
Participation fee:
-RAPS Deutschland e.V. members: 20 €
- RAPS US members: € 30
- Participation without membership: 40 €

Registration:
Email to: carla.lemos@rapschapters.org

Registration closes on September 20, 2020
This program is brought to you by the RAPS German Chapter to promote knowledge sharing and engagement with others in the local regulatory community. The program will be conducted in the German language.
 
 
 
Register