Regulatory Requirement for Medical Devices / Europe and its application
- 3 days (2 days can be customized)
- Course fee
Topics to be covered with this training includes:
- Graduated pharmacists.
- Graduated Biotechnology students.
- Regulatory Affairs specialists and officers in drug stores.
- Regulatory Affairs specialists and officers in medical devices stores.
Objectives and Expected Results
- Participants will be introduced to the MD GMP process in Europe.
- Participants will understand the MD classification rules in Europe.
- Participants will be introduced to the MD clinical trial process in Europe.
- The participant will take an idea of the general requirements for the MD CE mark process.
- Participants will understand the CE marking process in Europe.
- The participant will take an idea of the MD modification process in Europe.
Others Training Materials
- The workshop, group work, and discussion question will be conducted during training.
- YouTube videos.
Trainer Languages English/Arabic