PRRC Days
Team PRRC NL hosts two great events for new and experienced PRRC’s. Join us today, there are limited seats available
- June 13: PRRC Essentials
- June 20: PRRC Deep Dive
- Time: 08.30 – 13.00 (including lunch)
- Location: Zeist (The Netherlands)
- Costs: €184.67
PRRC Essentials
What to expect
Are you a newly appointed Person Responsible for Regulatory Compliance (PRRC) or a medical device manufacturer required to designate a PRRC? Join us for an engaging and interactive session tailored specifically for professionals navigating this crucial role.
Organized by TEAM-PRRC Netherlands, this session provides a comprehensive introduction to the responsibilities of a PRRC, offering valuable insights and practical guidance. The program, facilitated by The Kader Group and NAMCO, will cover key regulatory requirements, common challenges faced by PRRCs, and best practices for ensuring compliance.
What to Expect:
- A clear explanation of the PRRC’s role and its importance.
- Interactive discussions and experience-sharing among peers.
- Identification of common challenges and strategies to address them.
- Validated templates in Dutch or English for practical application.
- A certificate of participation to demonstrate your commitment to maintaining regulatory expertise.
This is a must-attend event for medical device manufacturers and PRRCs seeking to deepen their knowledge and network with industry professionals.
Agenda
| Time | Subject | Speaker |
| 08.45 – 09.15 | Receiption with coffee and tea | |
| 09.15 – 09.20 | Welcome and opening | Annemieke van Kerkwijk |
| 09.20 – 09.30 | Introduction Certification Experts and Namco | Rene Drost, Annemieke van Kerkwijk |
| 09.30 – 09.45 | Introduction Team PRRC, current status MDR-IVDR | Rene Drost |
| 09.45 – 10.15 | News from the market | Rene Drost |
| 10.15 – 10.45 | Declaration of Conformity and Technical Documentation | Annemieke van Kerkwijk |
| 10.45 – 11.15 | BREAK | |
| 11.15 – 11.45 | PMS and Vigilance | Rene Drost |
| 11.45 – 12.15. | plenair forum en evaluatie | All speakers |
| 12.15 – 13.00 | Lunch |
PRRC Deep Dive
What to expect
Welcome to the PRRC Deep Dive event hosted by TEAM-PRRC The Netherlands! This event is exclusively designed for experienced PRRCs looking to deepen their expertise and stay ahead of regulatory developments.
During this exclusive event Experts from leading regulatory authorities will share their valuable insights.
- Inspectorate for Health and Youth Care (IGJ) – Gain crucial regulatory updates and compliance expectations directly from the Dutch authority.
- Notified Body BSI Group – Understand certification challenges and best practices from a leading notified body.
What to Expect:
- In-depth discussions on PRRC responsibilities, regulatory challenges, and industry developments.
- Interactive Q&A sessions with IGJ and BSI experts.
- Case studies and real-world compliance strategies.
- Networking opportunities with fellow experienced PRRCs and regulatory professionals.
This is a must-attend event for PRRCs committed to mastering regulatory compliance at an advanced level.
Agenda
| Time | Subject | Speaker |
| 09.00 – 09.30 uur | Reception with coffee/tea | |
| 09.30 – 09.40 uur | Welcome and opening | Annemieke van Kerkwijk |
| 09.40 – 10.00 uur | News from TEAM-PRRC | René Drost and Annemieke van Kerkwijk |
| 10.00 – 10.45 uur | Non-conformities related to article 15 per MDR and IVDR (PRRC); and why should the Notified Body audit PRRCs…? | Alex Laan (Head of IVD BSI) |
| 10.45 – 11.00 uur | Coffee break | |
| 11.00 – 11.45 uur | View of the NL Competent Authority | Leo Klomp (IGJ) |
| 11.45 – 12.15 uur | Paneldiscussion | All speakers |
| 12.15 – 12.30 uur | Wrap-up | |
| 12.30 – 13.00 uur | Network and lunch |