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Strategic Recommendations for Adapting Your Safety Signal Management System to Evolving PV Regulations

1 hour, 1 minute

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May 20, 2015

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Regulatory expectations for proper safety signal management are more stringent than ever, with 50% of all signals reviewed by the EU Pharmacovigilance Risk Assessment Committee (PRAC) in 2013 resulting in changes in labeling. In the EU, transparency, compliance and quality are critical elements of the pharmacovigilance (PV) legislation. In the U.S., the FDA continues to expect strong and swift signal detection and analysis throughout a product’s lifecycle.

Whether your company holds one or multiple product authorizations, a fit-for-purpose, clear and transparent safety signal management system fully integrated in an IT solution – including signaling strategy setting, prioritization rules, and clear decision points – is core to the success of your PV program.

In this webinar, our presenters will provide key considerations for a successful PV signal management system.

Key Learning Objectives:

You will learn:

  • How to set the right framework to keep your signal management system simple and adaptable.
  • Ways to develop a useful SOP, WI and templates keeping the bigger PV picture in mind.
  • Challenges of choosing the right signal detection strategy depending on the available safety data sources and product lifecycle status.
  • Key points for a compliant powerful e-tool supporting the signal management process: Quintiles signal management database.
  • What the “must have” built-in reports are for any signal management database, to ensure full oversight in expected and unexpected situations.

Who Should Attend:

Key decision makers involved in the following areas for medicinal products:

  • Clinical operations
  • Quality Assurance
  • Regulatory
  • Pharmacovigilance
  • Research and Development

Job functions also include:

  • Qualified Persons (QPPV)
  • Drug safety officials
  • Medical directors
  • Compliance officers
  • Risk management specialists