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pharmacovigilance course







Advance Diploma in Pharmacovigilance trains the professionals in advance pharmacovigilance and drug safety. This course gives practical knowledge of the functionalities of Pharmacovigilance with practical exposure. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants.

The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance. The course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.

Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

Course Title: KPE’s Advance Diploma in Pharmacovigilance

Nature of the Course: Distance & e-Learning

Course Features

Course provide detailed understanding on the following –

  • Historical Perspectives
  • Basic Principles of Pharmacovigilance: Definitions
  • Regulations in Pharmacovigilance in Clinical Research
  • ADR Reporting and Signal Detection Systems
  • Pharmacovigilance in Clinical Research
  • Setting up a Pharmacovigilance Centre in Industry
  • Causality Assessment of Suspected Adverse Drugs Reactions
  • Management of Pharmacovigilance Data
  • Risk Management in Pharmacovigilance
  • Pharmacoepidemiology

Course provide extensive understanding and simulation on Pharmaceovigilance training.

1 Year

Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e. Doctors of all disciplines, junior professionals in Pharmaceutical and IT Industry, Clinical Research professionals.

1. Printed Book dispatched to correspondence address

2. Access the E-Modules online with user id and password.

3. Attend lectures with live interactions with faculty.

4. Access to case study file online

5. All e-study material contains self assessment computer based test.

6. Flexible online final examination.


The course has been designed and tailored specifically to the needs of research industry.

• Introduction to Clinical Research and Pharmacovigilance

• Global Pharmacovigilance System

• Sources and Documentation of Individual Case Safety Reports (ICSRs)

• Case processing and Reporting

• Medical dictionary (MedDRA) and Medical aspects in Pharmacovigilance

• Special cases in Pharmacovigilancepharmacovigilance training

• Medical Information System

• Safety monitoring in Clinical Trials

• Signal detection

• Periodic Safety Update Reports (PSURs)

• Risk –benefit assessment and management in Pharmacovigilance

• Standard operating procedures in Pharmacovigilance

• Compliance monitoring and Pharmacovigilance inspections

• Global regulatory requirements and guidelines in Pharmacovigilance

• Pharmacovigilance communications

• Pharmacoepidemiology

Section 1R&D Process - Learning on Drug Discovery Development and Regulation
Lecture 1Introduction
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act  (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10Expedited Program
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity 
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug Designation 
Lecture 18Advance Learning on 505B2 Pathway
Section 2Clinical Research - Pre-marketing Trials
Lecture 19Clinical Trials Terminologies 
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Introduction: Pharmacovigilance
Section 4Adverse Effect : Detailed Study
Lecture 25ADR - Introduction
Lecture 26ADR - Pharmacology
Lecture 27Controversies on ADR
Lecture 28Classification - ADR
Lecture 29PV and ADR Monitoring
Lecture 30ADR and Related Terminologies
Lecture 31ADR Reporting System 
Lecture 32DoTS Priciple
Lecture 33Four Elements of AEs
Lecture 34ADR Reporting Limitations
Lecture 35ADR Detection - Pre Marketing Vs. Post Marketing Trial
Section 5Pharmacoviglance process
Lecture 36Why Pharmacovigilance Process
Lecture 37PSURs
Lecture 38Risk Management - Pharamcovigilance
Section 6Pharmacovigilance regulatory authorities
Lecture 39Introduction
Lecture 40USFDA
Lecture 41COSTART
Lecture 42MedDRA
Lecture 43Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 44Pharmacovigilance in Europe
Lecture 45WHO
Lecture 46WHOART
Lecture 47The International Conference on Harmonization (ICH)
Lecture 48The Council for International Organizations of Medical Sciences (CIOMS)
Lecture 49The International Society of Pharmacovigilance (ISoP)
Section 7Regulatory body adopting pharmacovigilance program
Lecture 50Active surveillance schemes
Lecture 51EudraLex
Section 8Pharmacovigilance Framework
Section 9The Summary of Product Characteristics (SmPC, SPC)
Section 10Pharmacovigilance Software
Lecture 54introduction
Lecture 55Effectiveness of pharmacovigilance software
Section 11Pharmacovigilance in India
Section 12Good Pharmacovigilance Process (GPVP)
Section 13Case Study: How ADR is monitored?
Section 14Final Certification Examination