Pharmacovigilance

Pharmacovigilance is the pharmacology that deals with the detection, evaluation, and prevention of adverse drug reactions. Improving drug safety is an important challenge not only for regulators and the pharmaceutical industry, but also for prescribing physicians. This is done from the drug research and development stage to post-market drug monitoring.

It includes comprehensive theoretical and hands-on training in all aspects of pharmacovigilance, including case assessment exercises, data entry, case processing, medical coding, and narrative writing.

Who can apply for this program?

The following life science degrees are advised for applicants: Bachelor's, Master's, or PhD; MBBS; MD; B.D.S; M.D.S; B.A.M.S; B.H.M.S; B.P.T; B.Tech (Biotechnology / Pharmaceutical Science); M.Tech (Biotechnology); B. Pharm; M.Pharm; BVSC; B.Sc. (Nursing); B.Sc./M.Sc

1Course Content will be covered during the training

Introduction, History & Overview of Pharmacovigilance
Clinical Trial and Drug Development Phases
Roles and responsibilities in pharmacovigilance for sponsors and CROs.
Pharmacovigilance Life Cycle & Process
Introduction and obligations: EMA, CDSCO, and USFDA
Indian pharmacovigilance
Process of Clinical Development
segments of clinical trials at various stages
Unfavorable events and their sorts
Clinical trials and after-market medications' drug safety
Reporting of adverse incidents from various sources
Various forms of AE reporting Forms
Timelines for expedited reporting
many departments involved in pharmacovigilance
Functions and duties of the case receipt unit
Triage unit responsibilities and roles
For the reportable case, there are four variables.
severity standards for adverse events
Adverse event expectedness or listedness
Evaluation of the unfavorable event's causality
a description of safety databases and their various forms
Case quality review, medical review, and submission for narrative authoring.
The PSUR and its submission deadlines for the Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area

Benefits of learning Pharmacovigilance at Solve Tech Training Institute

Our experienced professionals are instructing this course.
Solve Tech provides you the facility to schedule the classes according to your availability.
Following each session, you'll receive the course material for your own future reference.
You will receive an internationally recognised certification after completing the course.