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Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange
Session Chair(s)
Francisco Nogueira, MBA
Chief Executive Officer , Accumulus Technologies, United States
Many regulatory filing processes use outdated technologies that result in manual or duplicative work. This session will explore how cloud-based solutions can improve information exchange between global health authorities and sponsor organizations.
Learning Objective : Identify the data-exchange challenges that biopharma and global health authorities face in the current regulatory filing process; Explain how effective, cloud-based solutions can improve information exchange and accelerate product approvals; Discuss the barriers to adopting to cloud-based submission processes and strategies for driving and supporting industry convergence in the space.
Speaker(s)
Industry Update
Jerry Stewart, JD, MSc, RPh
Vice President Global Regulatory Policy and Intelligence, Global RA, Pfizer Inc, United States
FDA Update
Mary Ann Slack
Director, Office of Strategic Programs, CDER, FDA, United States
MHRA Update
Andrea Johnson
Deputy Director of Future System Business Requirements, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
EMA Update
Hilmar Hamann, PhD
Chief Information Officer, European Medicines Agency, Netherlands
Industry Update
Dominique Lagrave, PharmD
Chief Regulatory Officer, Accumulus Technologies, United States
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