The Masters in Pharmacovigilance with specialisation in Advanced ICSR Processing leads to hands-on training on Pharmacovigilance E2B Compliance Database along with MedDRA and WHO-DD coding which are essential specialisations for ICSR processing in Pharmacovigilance system. The first year involves theoretical and practical sessions in the following areas: General Pharmacology; Adverse Drug Reactions and Clinical Therapeutics; Pharmacovigilance in Clinical Trials; Pharmacovigilance System & Regulations – ICH, GVP, 21 CFR, CIOMS, etc. WHO Programme for International Drug Monitoring; Pharmacovigilance – Sources of ADRs (ICSRs); Pharmacovigilance Data Management; Signal Management and Regulatory Reporting in Pharmacovigilance; Pharmacovigilance Risk Management; and Pharmacovigilance Audit & Inspections. The second-year projects touch upon advanced levels of ICSR processing, different Case studies, and process management along with a minimum of 3 months of internship in the Pharmacovigilance department of leading Pharma companies and CROs.
This Program leads to specialisation in Quality management in Pharmacovigilance, which is an integral part of the good pharmacovigilance practices. These processes deal with the Quality Management system procedures and processes, and documentation, monitoring and planning.
The first year involves theoretical and practical sessions in the following areas: General Pharmacology; Adverse Drug Reactions and Clinical Therapeutics; Pharmacovigilance in Clinical Trials; Pharmacovigilance System & Regulations – ICH, GVP, 21 CFR, CIOMS, etc. WHO Programme for International Drug Monitoring; Pharmacovigilance – Sources of ADRs (ICSRs); Pharmacovigilance Data Management; Signal Management and Regulatory Reporting in Pharmacovigilance; Pharmacovigilance Risk Management; and Pharmacovigilance Audit & Inspections. The second-year projects touch upon Pharmacovigilance Quality Management including system procedures and processes, documentation, Monitoring and Planning and Communication, Action and Training along with minimum of 3 months internship in the Pharmacovigilance department of leading Pharma companies and CROs.
This Program offers a specialisation in aggregate report writing including PSURs, PBRERs, PADERs, etc. its technical aspects, management, writing and analysis. This specialisation offers exposure to writing PSURs, PBRERs, PADERs, etc. including Format and Structure, Data Management and Analysis, Processing and Reporting and Quality Reviews. The second-year projects touch upon writing different reports along with a minimum of 3 months of internship in the Pharmacovigilance department of leading Pharma companies and CROs.
This Program offers a specialisation in Pharmacovigilance Regulations & Compliances nationally and internationally including Pharmacovigilance Agreements, Pharmacovigilance System Master File (PSMF), Pharmacovigilance System Management, Pharmacovigilance Training and Quality Management Pharmacovigilance and Risk Management Systems and Pharmacovigilance Audit & Inspections. This specialisation offers exposure to Global Pharmacovigilance Regulations and develops competencies in Pharmacovigilance System Management. The second-year projects touch on different aspects of Pharmacovigilance System Management along with a minimum of 3 months’ of internship in the Pharmacovigilance department of leading Pharma companies and CROs.
