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DIA 2018 Global Annual Meeting


Novel Approaches to Clinical Trials Safety and Value Stratification of Data

    Session Chair(s)
      Jose  Vega, MD

      Jose Vega, MD

      • Vice President, Chief Safety Officer
      • Merck & Co., Inc., United States
    Following the success of its clinical initiatives, TransCelerate launched its first pharmacovigilance projects in 2017, which are now actively engaging with health authorities and delivering both near-term and long-term value. This session will feature a panel of leaders from TransCelerate’s pharmacovigilance teams, as they discuss the future of pharmacovigilance (challenges associated with globalization, data automation, new PV requirements, etc.) and discuss initiatives that TransCelerate has undertaken to address these challenges.
    Learning Objective : • Understand expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space • Discuss what TransCelerate has been doing to address pharmacovigilance challenges, and what it plans to deliver in the long-term
    Speaker(s)
      Jose  Vega, MD

      Industry Collaboration to Improve Patient Safety: TransCelerate’s Long-Term Vision to Address Pharmacovigilance Challenges

      Jose Vega, MD

      • Vice President, Chief Safety Officer
      • Merck & Co., Inc., United States
      Peter  Verdru, MD

      Evaluating the Value of Safety Information Data Sources: Gathering Evidence to Illustrate a Hierarchy of Value

      Peter Verdru, MD

      • Vice President, Head of Patient Safety
      • UCB Biopharma S.P.R.L., Belgium
      Robert M Baker

      Interpretation of Pharmacovigilance Regulations

      Robert M Baker

      • Vice President, Global Patient Safety
      • Eli Lilly and Company, United States