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For any queries you may have, reach out to us at your convenienceAdvanced Post Graduate Diploma in Pharmacovigilance
(Program accredited by Accreditation Council for Clinical Research Education, USA)Pharmacovigilance begins at the clinical stage and continues throughout the life cycle of the drug, mainly divided as pharmacovigilance during the clinical phase and post marketing. The process of collection of such information about a drug begins in phase I of the clinical trial, before approval of the drug, and continues even after approval; several post-market safety studies are conducted, with many made mandatory by drug regulatory agencies around the world.
Program Structure
- General Overview of Pharmacovigilance
- Key Terms & Terminologies
- General & Systemic Principles of Pharmacology
- Regulatory Guidelines & Laws in Pharmacovigilance
- ICSR
- Medical Dictionary for Drug Regulatory Activities Med DRA
- Diagnosis And Management of Adverse Drug Reactions
- AE/ADR Reporting Systems & Forms
- Medical Evaluation of Adverse Events
- Narrative Writing
- Expedited Reporting Requirements
- Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
- Signal Detection Tools
- Quality System in Pharmacovigilance
- SOPs in Pharmacovigilance
- Pharmacovigilance Database
- Software Training
Course Details
Hands on training, online access to study materials, Printed study Materials and Workshops.
MBBS; BDS; BAMS; BHMS;BPT M.Pharm; PharmD and B.Pharm
3 Months Full time Class Room + 03 Months Optional Industry Internship, 6 Months Weekend (Saturday/Sunday).
INR 69000/- Plus GST as applicable
Classroom/online exams & Project work
Certificate would be awarded upon successful completion of the program certified by the Pharmaceutical Society of India and accredited by Accreditation Council for Clinical Research Education, USA.
Trainee Pharmacovigilance Executive/ Specialist, Drug Safety Physician, Pharmacovigilance Officer/ Drug Safety Associate, Team Lead, Pharmacovigilance Manager.
- Industry Accredited / Certified
- Short Duration
- Application of Clinical Research & Pharmacovigilance in real business like environment.
- Completely Job Oriented – Hands-on Training
- Internship Certificate Provision
- Accredited by the by Accreditation Council for Clinical Research Education, USA (ACCRE) & Certified by Pharmaceutical Society of India.
- 100% placement – Excellent Placement Record
- Training by the team of industry
Training would be imparted by the full time Cliniminds faculty and Visiting experts from the industry.
