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Pharmacovigilance (PV)
Pharmacovigilance Training Program: Good Health is the most expensive and precious aspect of life and therefore is the first priority of the human being. Experts from the pharmacovigilance team keep watch on the use and the adverse effects shown by the drugs present in the market. This way the pharmacovigilance team monitors and guides about the rational use of the drugs.
Topic covered in Pharmacovigilance (PV)
- Introduction to Pharmacovigilance
- Adverse drug reactions and safety reports
- Pharmacovigilance regulatory requirements
- Methodologies in Pharmacovigilance
- Pharmacovigilance process flow
- Aggregate reporting
- Signal management Pharmacovigilance of:-
- Medical Devices – I (Classes)
- Medical Devices – II (Data Entry Part)
- Herbals,
- Vaccines
- Pharmacovigilance Compliance & Inspections:-
- Hands-on training on PV safety database software platforms – ACPL’s test database
- CLINEVO including case study of different case scenarios in PV practical training.
- Three months offline /online course in Drug Regulatory Affairs (DRA)
- One month offline/online course in Drug Regulatory Affairs (DRA)
(Placement assistance, Study Material, Resume Designing, Mock Interview Practice)
- Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
- M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, biochemistry)
- MBBS/ BDS/ BAMS/ BHMS -Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
- Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
- Experience of working in the health/ pharmaceutical sector.
- Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.
The students will take up Weekly/monthly tests at the end of each module. On successful completion of the final examination. Our faculties will evaluate the student on the technical and vertical skills, and provide feedback to the course coordinator, followed by training participation certification.
DURATION
- Three months offline /online course in Drug Regulatory Affairs (DRA)
- One month offline/online course in Drug Regulatory Affairs (DRA)
(Placement assistance, Study Material, Resume Designing, Mock Interview Practice)
TEST
The students will take up Weekly/monthly tests at the end of each module. On successful completion of the final examination. Our faculties will evaluate the student on the technical and vertical skills, and provide feedback to the course coordinator, followed by training participation certification.
ELIGIBILITY
- Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
- M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, biochemistry)
- MBBS/ BDS/ BAMS/ BHMS -Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
- Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
- Experience of working in the health/ pharmaceutical sector.
- Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.
CERTIFICATE
