Pharmacovigilance & Clinical Trials and Clinical Data Analysis
- Offered byskillyaari
Pharmacovigilance & Clinical Trials and Clinical Data Analysis at skillyaari Overview
Duration | 26 hours |
Total fee | ₹3,000 |
Mode of learning | Online |
Credential | Certificate |
Pharmacovigilance & Clinical Trials and Clinical Data Analysis at skillyaari Course details
- At the end of this course learner will gain comprehensive knowledge to the pharmacovigilance basics, clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials, extensive training on Pharmacovigilance (PV) related issues
- Extensive knowledge with detailed understanding of basics imparted to equip learner to work at any global Clinical research organizations (CROs) or Pharmaceutical companies or Pharmacovigilance service providers
- Understand the topic to gain the skills, knowledge and competencies of a right candidate for the Pharmacovigilance sector
Pharmacovigilance & Clinical Trials and Clinical Data Analysis at skillyaari Curriculum
Session 1
Introduction to Pharmacovigilance, history, background
Session 2
Introduction and Evolution of Pharmacovigilance Regulatory And International Agencies
Session 3
Signal Detection and Risk Management Agreegate safety reporting
Session 4
Adverse drug reactions, Individual Case Safety Report, Different types of safety reports
Session 5
Case processing overview (ICSR), Case Receving and Triaging, Labeling Assessment, Causality Assessment
Session 6
Understanding MedDRA and other drug dictionaries, Medical Coding, MeDRA Coding Conventions
Session 7
Narrative writing workshop
Session 8
Understanding workflow, growth and future aspects of PV industry
Session 9
Preparation for Pharmacovigilance interview
Session 10
Question & Answers session
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