Training on QRM & RbM – hands-on learning sessions to grasp trial control
Let the drug architects guide you on how to shield your trials against threatening risks, and benefit from the know-how of PPH plus Project Leaders.
PPH plus will show you the value of setting the ground of a quality-by-design strategy as well as how risk-based monitoring (RbM) integrates into quality risk management (QRM) from trial conception.
In our learning groups, creativity marries with systematization for better envision of the RbM advantage against customary approaches.
Learn by doing in interactive training sessions about the RbM background, terminology, methods, workflow, preventive potential, and looked-for resources. Easy examples transform complexity into simplicity.
Careful preparation is a must for successful implementation. PPH plus will train you and build in RbM competence across your team.
The training sessions will be held in English or German language, according with the customer preference, and will include the following service items:
- In-house training
- Adaptive duration and training contents according with the participants requirements
- Introduction to quality risk management (ICH-GCP, EMA, and FDA guidelines)
- Comprehensive description of risk monitoring and control tools
- A practical training session on risk-based monitoring (RbM)
- Reference to available instruments for optimization of clinical trial oversight
- Learning material with expert input
- Unlimited number of participants
After completion of the learning session, each participant will receive a certificate of attendance.