ADVANCED CERTIFIED PROGRAM IN PHARMACOVIGILANCE ON ORACLE ARGUS SAFETYGratisol Academy Of Clinical Research
- 4 hours of class
Frequent Asked Questions
Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following: Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
What you'll learn on the course
Teachers and trainers (1)
Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.
This course will provide extensive theoretical & training in Pharmacovigilance. All the topics will be presented by team of Doctors. It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event) , Data Entry, Case Processing, MedDRA & WHODD coding & Narrative Writing.
Following Course Content will be covered during the training:
- Welcome and Introduction, History & Overview of Pharmacovigilance
- Drug Development and Clinical Trial Phases
- Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.
- Pharmacovigilance Process & Life cycle
- Introduction and responsibilities: USFDA, EMA and CDSCO
- Pharmacovigilance in India
- Clinical Development process
- Different phases of clinical Trials
- Adverse events and its types
- Drug Safety in clinical trials and post marketed drugs
- Different sources of Adverse events reporting
- Different types of AE reporting Forms
- Expedited reporting and its timelines
- Different departments working on Pharmacovigilance
- Roles and responsibilities of case receipt unit
- Roles and responsibilities of Triage unit
- Four factors for the reportable case
- Seriousness criteria of adverse event
- Expectedness or Listedness of adverse event
- Causality assessment of the adverse event
- Introduction to safety database and different types
- Narrative writing
- Case quality check, Medical review and its submission.
- The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
- PSUR and its submission timelines