World Drug Safety Congress: UBC Talks Safety and Reporting Requirements

Proactive risk management for pharmaceutical products

World Drug Safety Congress: UBC Talks Safety and Reporting Requirements

Every year since 2008, Health Network Communications organizes the World Drug Safety Congress to address drug safety and pharmacovigilance challenges. Join me this year in Chicago on April 23 and 24 where, on day one, I’ll be giving a presentation titled, “Safety and Reporting Requirements for INDs and BA/BE Studies.” I’ll be discussing important topics such as:

  • Definition of “Reasonable Possibility” and causality assessment determination
  • Investigator’s Brochure: determining unexpected events
  • Importance of sponsor’s causality assessment: empowering healthcare professionals to use medical judgment
  • BA/BE studies: IND exclusion and reporting guidelines for SAEs

I look forward to speaking with you at the conference. If you’d like to connect before or after, feel free to contact me.