Pharmacovigilance/ Drug Safety Training

ABOUT CISPACT TRAININGS

‘Cispact Trainings’ is an online education platform providing rigorous industry-relevant training programs designed and delivered in collaboration with world-class faculty and industry. Merging the latest technology, pedagogy, and services, Cispact is creating an immersive learning experience – anytime and anywhere.

We provide high-end professional education for aspiring and experienced professionals in Pharmaceutical and IT domains. Our hybrid platform delivers unique online experience that helps to build cutting-edge expertise, for today and tomorrow.

In Pharmaceutical sector, we provide trainings in Pharmacovigilance (Case Processing and Aggregate Report writing), Medical Writing, Management, Regulatory Affairs, Clinical Research Operations, Computer System Validation, Oracle Argus Configuration and Administrator, Clinical SAS (Base and Advanced) and Intellectual Property Rights.

Course Curriculum

  • Drug Discovery, Development and Preclinical Studies
  • Basics of Clinical Trials & Clinical Research
  • Terminology & Definitions in Clinical Trials
  • Types and Phases of Clinical Trials
  • Good Clinical Practices (GCP) and Drug Recall
  • Responsibilities of Clinical Research Professionals
  • 21 CFR Part 11
  • Introduction to Various Regulatory Bodies Across the Globe
  • Introduction to Pharmacovigilance Process
  • Types of Adverse Events
  • Case Seriousness Assessments
  • Various Guidelines Related to Pharmacovigilance
  • Various Types of Adverse Events Forms
  • Pharmacovigilance Workflow in the PV Industry
  • Coding of Adverse Events and Drugs (Using MedDRA,WHODD and COSTART Software’s)
  • Causality Assessment
  • Labelling Assessment
  • Expedited Reporting (Including SUSARS)
  • Narrative Writing (Initial and Follow-Up)
  • Basics Terminology Related to Aggregate Reporting
  • Various Types of Aggregate Reporting
  • Aggregate Reporting Timelines
  • Live Examples in ICSR-Clinical, PMS, Spontaneous, Literature etc…
  • Pharmacovigilance Database Training
  • Three Rounds of Mock Interview
  • Interview Question and Answers Discussions
  • Six Online Courses Included (From UMC)

FINAL ASSESSMENTS

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