Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance

The objective of this program is to provide complete understanding of the clinical research and pharmacovigilance process and to provide working knowledge to the students which would enable them to work in the industry with minimal training. In the first phase we would provide a comprehensive practical knowledge to the clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials and various other related issues. In the second phase extensive training on Pharmacovigilance (PV) is provided. PV is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. In general terms, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbals and traditional medicines with a view to: - Identifying new information about hazards associated with medicines - Preventing harm to patients. The program would cover:  Clinical Research Introduction  Principles of Pharmacology & Drug Discovery & Development  Roles & Responsibilities of Key Stakeholders  Preparations & Planning for Clinical Trials  Essential Documentation in Clinical Research & Regulatory Submissions Clinical Trials Project Planning & Management  Study Start Up Process  Clinical Monitoring Essentials  Compliance, Auditing & Quality Control in Clinical Research  Clinical Data Management, Biostatistics, Analysis & Reporting  General Overview of Pharmacovigilance  Medical Dictionary for Drug Regulatory Activities MedDRA  Regulatory Aspects in Pharmacovigilance  Diagnosis And Management of Adverse Drug Reactions  Medical Evaluation of Adverse Events  Quality System in Pharmacovigilance  Expedited Reporting Requirements  Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)  Pharmacovigilance Database And Signal Detection Tools  Risk Assessment, Evaluation And Management  EudraVigilance  Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting