Our Faculties: Professionally qualified with MD and PhD degrees, who have over decades of working experience in American Pharmaceutical Companies, USA Federal Government Institute, University and Medical Institute.

Drug Safety/Pharmacovigilance Training Course Description:   We will provide materials and demonstration for the Pharmacovigilance function and principles. In this program candidates not only get the fundamental understanding of the Pharmacovigilance in the drug development process we also prepare you to do the day to day hands on responsibilities of the position. Training includes clinical data practice; serious adverse event data processing; coding of medical history, events and drugs; case narrative writing; data reporting-management and safety case review etc.

Who Should Attend? Bachelors or Masters Degree in any Bio or Life sciences, BPharm/MPharm/PharmD, MBBS, BDS, RN, OT/PT, MD or Postdoctoral Fellows.

Demo for the Training: We have scheduled FREE demo for Drug Safety Training Program every weekend. Please call or email to attend FREE demo.

Course Content for Pharmacovigilance Training:

Introduction to clinical research: Fundamentals and basics of Pharmacovigilance

Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile

Clinical Laboratory Safety Data in Drug Studies

Ethical Issues in Drug Safety

Operational aspects of the drug safety function within a pharmaceutical company

Regulations in pharmacovigilance: FDA, EU, ICH, Global regulations

Introduction to safety databases and different types

Serious Adverse events (SAE) and its types

Different types and sources of Adverse events reporting

Regular and expedited adverse event reporting and its timelines

Interactions with different departments working on pharmacovigilance

Roles and responsibilities of case Intake, Triage, Process, Quality control and Medical Review units

Vital factors for the case deportability for seriousness criteria of adverse event

Expectedness or listedness of serious adverse event

Causality assessment of the serious adverse event

Triage, Process, QC-ing of SAE cases

Regulatory Aspects of Pharmacovigilance

Reporting Forms: Medwatch, CIOMS

Legal Aspects of Pharmacovigilance

Management of initial and follow-up information and documention for individual safety reports.