Diploma in Pharmacovigilance and Clinical Research
- Offered byElite Institute Pharma Skills
Diploma in Pharmacovigilance and Clinical Research at Elite Institute Pharma Skills Overview
Duration | 6 months |
Mode of learning | Online |
Official Website | Go to Website |
Credential | Certificate |
Diploma in Pharmacovigilance and Clinical Research at Elite Institute Pharma Skills Highlights
- Earn a diploma upon completion of course from Elite Institute Pharma Skills
Diploma in Pharmacovigilance and Clinical Research at Elite Institute Pharma Skills Course details
Those with a background in pharmacology, biotechnology, biochemistry, or related fields who wish to specialize in pharmacovigilance or clinical research
Doctors, nurses, and pharmacists looking to transition into clinical research or pharmacovigilance roles
Individuals working in or aspiring to work in regulatory affairs and drug safety monitoring
Overview of pharmacovigilance and its role in drug safety.
Introduction to clinical research, phases of clinical trials (Phase I to IV), and the lifecycle of a clinical trial
Role of clinical research coordinators (CRCs), clinical research associates (CRAs), and principal investigators
The Diploma in Pharmacovigilance and Clinical Research is a specialized program designed for individuals looking to build a career in the dynamic and critical fields of drug safety, clinical trials, and pharmaceutical research
This diploma program provides students with a deep understanding of the processes involved in the development, monitoring, and regulation of pharmaceutical products, with a focus on ensuring the safety and efficacy of drugs and treatments
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems
Diploma in Pharmacovigilance and Clinical Research at Elite Institute Pharma Skills Curriculum
Module 1: Introduction to Clinical Research & Advancement of ICH-GCP
Clinical Research in India
Phases of Clinical Trials
History & Background of Good Clinical Practice
Introduction to ICH, ICH-GCP Guideline & its advancement
Module 2: Ethical & Regulatory Aspects of Clinical Trials
Ethics Committee
Indian Council of Medical Research
Declaration of Helsinki
Drug & Cosmetic Act 1940, Schedule Y & its appendices
Module 3: Operations Aspects of Clinical Trials
Clinical Trial Design
Conduct of the study
Data Safety Monitoring Board (DSMB)
Clinical Data Management (CDM)
Module 4: Pharmacovigilance at Glance
Introduction to Pharmacovigilance
Pharmacovigilance-Glossary and related terms
Pharmacovigilance Methods
Pharmacovigilance Data Management and Case Processing
Module 5: Signal Management, ADR Reporting System & Dictionaries
Signal Identification, Development and Analysis
Adverse Drug Reaction Reporting System
Medical Dictionary for Regulatory Activities
WHO Drug Dictionary
Module 6: Regulatory Aspects of Pharmacovigilance
Different ICH & Other requirements for Drug Safety
Periodic Safety Update Report (PSUR)
Good Pharmacovigilance Practice (GPP)
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