Certificate Course in Regulatory Affairs

Regulatory Affairs is a familiar title of an elective course in the pharmacy curriculum. Building on a scientific foundation, this course will offer opportunities to appreciate the difference between knowledge and information-based regulatory practice. The course content will be based in the context of new, generic, and biosimilar drugs and aim to facilitate the acquisition of foundational skills essential for career advancements in industry regulatory functions.

General Overview of Pharmacovigilance
Key Terms & Terminologies
General & Systemic Principles of Pharmacology
Regulatory Guidelines& Laws in Pharmacovigilance
Medical Dictionary for Drug Regulatory Activities MedDRA
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

Mr. Dharmesh Mehta

Mentor

About Mentor

At PharmaElite, all faculty and teaching staffs are NIPER Alumnus having experience of attempting GPAT & NIPER with Top ranks. we understand the dreams and aspirations that drive each one of you. Our GPAT classes are not just about preparing for an exam; they are crafted to be your stepping stone towards success in the pharmaceutical world. Whether you’re a recent Pharmacy graduate, in your final year, or already navigating the pharmacy landscape, our classes are tailored to meet your needs.

Rs 1,699/-

Rs 3,999/-