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


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/-

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