Pharmacovigilance and Vigilance

Laboratory
Quality
rd

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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
3 days (2 days can be customized)
Course fee
-

Program Description

Topics to be covered with this training includes:

  • Part1: Pharmacovigilance and Vigilance Definitions.
  • Part2: Adverse Events (AE) classifications and categories.
  • Part3: Drug clinical trial AE reporting process (USA, Europe, and Jordan).
  • Part4: Drug post-marketing AE reporting process (USA, Europe, and Jordan).
  • Part5: Periodic Safety Update Report (PSUR) checklist and template.
  • Part6: Medical Device (MD) AE reporting process (USA, Europe, and Jordan).
  • Part7: Qualified Person Responsibilities in the Pharmacovigilance Department (Europe and Jordan).
  • Part8: Pharmacovigilance Coding of AEs (MedDRA).
  • Part9: Pharmacovigilance System (PSMF / PSSF) Checklist, contents, format, and preparation.
  • Part10: How an Individual Case Safety Report (ICSR) Is Handled from Start to Finish.
  • Part11: USA vs. EU Risk Requirements.
  • Part12: What Is the Risk Management Plan (RMP)? (Europe)
  • Part13: RMP Content and Format.
  • Part14: What Is Risk Evaluation and Mitigation Strategy (REMS)? (USA)

Target Level

  • Graduated pharmacists.
  • Graduated Biotechnology students.
  • Regulatory Affairs specialists and officers in drug stores.
  • Regulatory Affairs specialists and officers in medical devices stores.

Description

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

Handout.

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232