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An Industry Perspective on the Future Changes in Pharmacovigilance and Safety Assessment for IND Reporting


This Solution Provider Webinar is brought to you by DIA in cooperation with
Sciformix Corporation

It has been several years since GVP module VI went into effect, and at the end of 2016 EMA closed the public consultation for the proposed changes. EMA will be releasing a revised GVP module VI in the near future. In addition, R3 has been widely discussed for several years and will be implemented this year. Each of these changes is likely to have a significant impact on safety and pharmacovigilance operations. This webinar will detail how these guidelines and regulations are being viewed in different organizations and how they may impact your own safety operations.

In December 2015, FDA released a draft guidance on safety assessment for IND safety reporting in support of the changes in the IND safety reporting regulations. These recommendations have presented challenges for many organizations and this webinar will give a perspective from a company that has worked with FDA to implement the key elements of the guidance. 

Featured topics

  • GVP Module VI: Key changes in the proposed revisions and how it impacts safety operations
  • E2b R3: Key changes and challenges, and pharma’s readiness
  • Safety assessment for IND safety reporting: A best practice example on how to navigate the challenges for a successful implementation
  • Ask the experts: Round table Q&A discussion with four industry leaders

Who should attend?

Professionals who work in the area of:

  • Pharmacovigilance
  • Risk Management
  • Aggregate Reporting
  • Signal Detection
  • Regulatory Affairs

Learning objectives

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

  • Understand and evaluate the upcoming changes in regulations and their impact on safety operations
  • Learn how pharmacovigilance professionals from leading organizations are approaching the proposed changes in safety regulations
  • Apply the knowledge shared by safety and risk management experts to your own operations

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