Distance Learning

Advanced Post Graduate Diploma in Drug Regulatory Affairs & Pharmacovigilance

✔ ACCRE USA Accredited
✔ Program developed by senior industry experts
✔ eBooks – Presentation & Notes on Cliniminds LMS
✔ Cliniminds Certification after completion of program
✔ MCQ based final exams
✔ Introduction to Regulatory Affairs | Pharma Regulations Practices and Procedure | Global Pharmaceutical Industry Scenario | Indian Pharmaceutical Industry | Global Regulatory Environment | Regulations Governing Clinical Trials and New Drugs | Schedule Y | Regulatory Inspections in Clinical Research (FDA, EMEA, UK and Indian) | Future of Regulatory Compliance | Orphan Drugs | Import and Export of Drugs | Good Manufacturing Practice | Quality Assurance and Regulations | Global Drug Policies | Regulation in Pharmaceutical Devices | TRIPPs and Pharma Industry | Intellectual Property Right Management | Patents | Pharmacovigilance (Introduction, global reporting requirements) | Overview of Clinical Research | Pharmacology- General Principles | Introduction, Definition & Methods in Pharmacovigilance | Essentials Documents in Pharmacovigilance | Pharmacovigilance Regulations | Safety Reporting (including Medical Information) and Processing ICSR | Aggregate reports, Signal detection & Risk Management | Audits and Inspections | Advanced Pharmacovigilance & Analytics | Hands On Training on Case Processing and Report generation