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Overview

Learn how to comply with evolving US and European (EU) regulations for clinical safety during premarketing development of traditional medicinal products. This basic two-day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety for interventional clinical trials in key regulatory jurisdictions, with focus on the US and EU. Topics will cover approaches to drug safety from first-in-human through the peri-approval phase of innovative product development and will include FDA expectations on IND reporting (single cases and new aggregate assessments), as well as new EU legislation coming into force at end-2016. The course will be delivered in a series of modules; didactic presentations will be supplemented with real world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.  
Course Level: Beginner

What you will learn

  • Legal basis for safety obligations during interventional clinical trials, including an historical perspective
  • Fundamental concepts, basic definitions, and pragmatic approaches for compliance, with a focus on traditional small molecules
  • Basics of Individual Case Safety Reports (ICSRs, e.g., SUSARs) and periodic reports (DSUR, IND AR)
  • Evaluation of seriousness, expectedness, and causality, including critical differences between US and EU approaches
  • Importance of consistent MedDRA coding
  • The safety reporting framework and inter-related roles of Sponsor, Principal Investigator, Investigational Review Board /Ethics Committee, Informed Consent, independent Data Monitoring Committee, etc.
  • How to avoid common pitfalls in complying with FDA requirements for interventional clinical trials conducted under an IND
  • What to expect in a preapproval safety inspection
  • Premarketing risk assessment concepts and their application to drug development

Who should attend?

Professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical development, including sponsors, investigators, and study staff
  • Regulatory affairs
  • Quality systems
  • Case processing, particularly serious ICSRs
  • Clinical data management
  • Medical writing
  • Independent Safety Data Monitoring Board
  • Outsourcing or off-shoring of drug safety activities
  • Clinical health care

This training course is also designed to provide the basics for those seeking a career change into a clinical drug safety function.

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Discuss why premarketing clinical safety and pharmacovigilance are important
  • Explain the key requirements and differences in FDA and EU regulations for premarketing clinical safety and pharmacovigilance
  • Review the concepts of a preapproval clinical safety inspection
  • Specify why processess, procedures, and documentation are in written form to ensure compliance with regulations and requirements
  • Explain how premarketing risk assessments are performed