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APGDCR PV Advanced Post Graduate Diploma in Pharmacovigilance
CURRICULUM
1 Concept of “drug”. Drug Development. Ethical principles Pre-clinical development. Clinical Phases of drug development
2 Pharmacovigilance: concept. The importance of Pharmacovigilance in DrugSafety. History of Pharmacovigilance. Who must participate in Pharmacovigilance.
3Adverse Drug Reaction: definition, classification, clinical manifestation. Adverse Effect. Side Effect. Secondary Effect: differences and similitude Assessing causality of ADR. Methods in Pharmacovigilance.
4 The National Administration of Food, Drug and Medical Devices. The National System of Pharmacovigilance. Internacional organization of Pharmacovigilance: WHO, Uppsala Monitoring Center
5 The Spontaneous Reporting System. The Yellow Card: how and what report. Systems of coding ADR: WHO-ART, MedDRA terminologies Reporting therapeutic ineffectiveness. Vaccine’s Pharmacovigilance.
6 Generics drugs. Bioavailability/bioequivalence trials. “Parallel” products
7 The role of Pharmaceutical Industry in Pharmacovigilance Technovigilance. Quality control of medicines and biomedical products. How to send medicine’s samples for analysis.
8 Alerts in Pharmacovigilance. Withdrawal of products from the market. res , Farmaindustria, 1991
Eligibilty : Doctors, Pharmacists.
Program Venue :
First 6 months in Cochin
Second 6 months internship in the industry(India/UK)
Online CPEP during Internship
Program Duration:
I year
Program Benefits :
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Placement Assistance provided
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Gain 6 months work experience at ICRC Kard Scientific
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3 months optional internship in UK
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Online CPEP
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Toppers to USA (after 1 year)
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International faculty from USA/UK
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100% banking assistance provided
Award:
Goa University
Certification from Campbell University USA
Certification from IFCR India
ACPE Approval (USA)
Fellowship from UK
For More information Please Contact
Ph: +91 484 4024316
Mob : +91 9995685736
e-mail: helpdesk@ifcr.in
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