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Premarketing Clinical Safety and Pharmacovigilance

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Overview 

Learn how to comply with evolving US and European regulations for clinical safety during product development that are changing how we approach our daily jobs.

Course Level: Intermediate

What You Will Learn 

  • Fundamental concepts of clinical drug safety and pharmacovigilance and their application to clinical development, with a focus on traditional small molecules
  • How to avoid common pitfalls in complying with FDA and European clinical safety regulations
  • What to expect in a preapproval safety inspection
  • Proven concepts of premarketing risk assessment and their important role in drug development
  • How to effectively use signaling tools and techniques to support premarketing risk assessment

 

Who Should Attend 

Professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical development, including sponsors and investigators
  • Regulatory affairs
  • Quality management
  • Clinical data management

Learning Objectives 

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

  • Discuss why premarketing clinical safety and pharmacovigilance are important to ensure Good Pharmacovigilance Practice
  • Explain the key requirements and differences in FDA and European regulations for premarketing clinical safety and pharmacovigilance
  • Explain concepts of a preapproval clinical safety inspection
  • Develop company policies and procedures for clinical safety
  • Explain how premarketing risk assessments are performed

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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