Short description
This training is specific for PRRCs that are outsourced to manufacturers of medical devices and IVDs. This NOT for in-house PRRCs and PRRCs working for an authorized representative.
When
This training will be provided on Tuesday 8 and 15 April 2024 at 16:00 – 18:00 CET (Amsterdam time)
Who should participate
This training is for PRRCs that want to be hired by manufacturers for the role of the PRRC. The timing would allow US based PRRCs to participate
Goals & revenues
After this training the students will be able to set up their role as an outsourced PRRC at a manufacturer
Topics and outline
This training will address in short the expectations of the notified bodies and competent authorities regarding the PRRC. The use of several template documents will be discussed (justification, initial assessment, appointment letter, procedure, justification, annual plan, annual report and interim report)
Costs and organization
- Costs are € 595 excluding VAT, for TEAM PRRC members the rate is € 545
- The training is presented online in two sessions of two hours, plus several hous of homework.
- After the training all participants will receive a training certificate and a Super PRRC T-shirt
Additional personal coaching
For PRRCs that want additional personal training, there is the option of booking this together with their training. They can use this coaching budget to set up their role.
