Watch the On-Demand Webinar

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About the Webinar

CROs are expected to stay on top of the constantly changing safety reporting requirements for investigators and ethics committees in every country, but where does a CRO turn for the latest regulations, guidance and best practice rules for global regulatory requirements?

Hear from Heather Kresge, Executive Director, Pharmacovigilance at Worldwide Clinical Trials as she discusses how Worldwide has joined the Global Safety Reporting Harmonization Working Group and adopted the “Gold Standard” Country Reporting Rules reference model to ensure compliance and eliminate over distribution.

In this webinar, we’ll address this topics and questions such as:

  • Why do organizations struggle with interpreting the rules and regulations for global safety reporting?
  • What is the impact on investigators when sponsors and CROs over-report what is required by local regulations?
  • What do sponsors expect and demand of their CRO partners when it comes to global safety reporting?

Meet the Speakers

Speaker:

  • Heather Kresge, Executive Director, Pharmacovigilance, Worldwide Clinical Trials

Moderator:

  • Steven Beales, Vice President, Scientific & Regulatory Review Division, WCG