Introduction To Pharmacovigilance
- Offered byElite Institute Pharma Skills
Introduction To Pharmacovigilance at Elite Institute Pharma Skills Overview
Duration | 6 months |
Total fee | ₹12,000 |
Mode of learning | Online |
Schedule type | Self paced |
Official Website | Go to Website  |
Credential | Certificate |
Introduction To Pharmacovigilance at Elite Institute Pharma Skills Highlights
- Earn a diploma certificate after completion of course
Introduction To Pharmacovigilance at Elite Institute Pharma Skills Course details
Individuals working in the pharmaceutical, biotechnology, or medical device sectors, particularly those involved in drug development, clinical trials, or regulatory affairs, who need to understand pharmacovigilance processes and safety monitoring
Graduates and students pursuing degrees in pharmacy, life sciences, medicine, or related fields who want to explore careers in pharmacovigilance, regulatory affairs, or drug safety
An introduction to the field of pharmacovigilance, its objectives, and its importance in maintaining drug safety throughout a product's lifecycle
Understanding what constitutes an adverse drug reaction, how they are classified, and the mechanisms by which they occur
The Introduction to Pharmacovigilance course provides foundational knowledge and practical skills related to the science and activities surrounding the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems
Pharmacovigilance is a critical aspect of ensuring drug safety and is essential in protecting public health by monitoring and evaluating the safety of medicines once they are marketed
Introduction To Pharmacovigilance at Elite Institute Pharma Skills Curriculum
Module 1: Introduction to Clinical Research & Advancement of ICH-GCP
1.1 Clinical Research in India
1.2 Phases of Clinical Trials
1.3 History & Background of Good Clinical Practice
1.4 Introduction to ICH, ICH-GCP Guideline & its advancement
Module 2: Ethical & Regulatory Aspects of Clinical Trials
2.1 Ethics Committee
2.2 Indian Council of Medical Research
2.3 Declaration of Helsinki
2.4 Drug & Cosmetic Act 1940, Schedule Y & its appendices
Module 3: Operations Aspects of Clinical Trials
3.1 Clinical Trial Design
3.2 Conduct of the study
3.3 Data Safety Monitoring Board (DSMB)
3.4 Clinical Data Management (CDM)
Module 4: Pharmacovigilance at Glance
4.1 Introduction to Pharmacovigilance
4.2 Pharmacovigilance-Glossary and related terms
4.3 Pharmacovigilance Methods
4.4 Pharmacovigilance Data Management and Case Processing
Module 5: Signal Management, ADR Reporting System & Dictionaries
5.1 Signal Identification, Development and Analysis
5.2 Adverse Drug Reaction Reporting System
5.3 Medical Dictionary for Regulatory Activities
5.4 WHO Drug Dictionary
Module 6: Regulatory Aspects of Pharmacovigilance
6.1 Different ICH & Other requirements for Drug Safety
6.2 Periodic Safety Update Report (PSUR)
6.3 Good Pharmacovigilance Practice (GPP)
Module 7: Career orientation and Interview Preparation
7.1 Career guide
7.2 Aptitude test, Group discussion & Personal Interview
Introduction To Pharmacovigilance at Elite Institute Pharma Skills Entry Requirements
To avail the integrated course in regulatory affairs in EIPS candidates have to be graduates any lifesciences discipline
- Not mentioned
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