Safety Reporting and MedDRA Excellence

This course provides an in-depth exploration of pharmacovigilance, focusing on adverse drug reactions, safety reporting, and advanced MedDRA coding techniques. Participants will gain expertise in data analysis, risk management, and standardized query building, ensuring comprehensive drug safety and regulatory compliance.

Module 1 : Fundamentals of Pharmacovigilance and Drug Safety Reporting

  • Definition of pharmacovigilance
  • Role of regulatory agencies
  • Adverse event reporting systems
  • Signal detection and risk assessment

Module 3 : Medical Dictionary for Regulatory Activities (MedDRA) Essentials: History, Scope, and Structure

  • MedDRA history and development
  • Scope and purpose of MedDRA
  • Hierarchical structure (System Organ Classes, Preferred Terms)

Module 5 : Data Analysis Techniques and Query Generation

  • Data visualization techniques
  • Query design (e.g., custom queries, aggregate reports)
  • Interpretation of query results

Module 2 : Pharmacovigilance Techniques and Approaches

  • Signal detection methods
  • Signal validation and assessment
  • Benefit-risk assessment frameworks

Module 4 : Advanced Techniques in MedDRA Coding

  • Detailed coding rules
  • Handling complex cases
  • Case examples and exercises

Module 6 : Utilization of Standardized MedDRA Queries and Handling Medication Errors

  • Standardized MedDRA Queries for specific ADRs
  • Medication error categories
  • Strategies for preventing and managing medication errors

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure