Pharmacovigilance and Vigilance
- 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 understand all the current PV regulations of USA, Europe, and Jordan for drugs and biologics during clinical trials and post-marketing.
- Participants will understand all the current Vigilance regulations of USA, Europe, and Jordan for medical devices.
- Participants will adequately classify the adverse event and manage the reporting for the required ones to the regulatory authorities to ensure the safety of all registered drugs and medical devices.
- Participants will understand all the steps for handling the Individual Case Safety Report (ICSR) from Start to Finish for drugs, biologics, and medical devices.
- Participants will be introduced to the contents and formats of the Pharmacovigilance system, PSUR, Risk Management Plan (RMP), and REMS.
Others Training Materials
Trainer Languages English/Arabic
Interested in signing up a group of people for this course?
Please contact our Business Development team: