Distance Learning

Advanced Post Graduate Diploma in Drug Regulatory Affairs & Medical Writing

✔ 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) | Introduction to Scientific/ Medical Writing | Literature search | Basic Statistics | Structure of a manuscript, and writing the introduction | Methods | Results | Discussion | The rest of the paper: Title, abstract, and keywords, cover letter, acknowledgments, conflicts | Referencing | Tables, graphs, figures | Reviews, Systematic reviews and meta-analyses | Miscellaneous: Ethics and paper submission | Writing Better