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.
This training will be provided on Tuesday 7 and 14 February 2023 at 10:00 – 12:00 CET (Amsterdam time).
Who should participate
This training is for PRRCs that want to be hired by manufacturers for the role of the PRRC
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 in two sessions of two hours, plus several hours of self study.
- After the training all participants will receive a training certificate
- Training material will be send after payment has been received
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.