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DIA 2021 Global Annual Meeting


Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange

Session Chair(s)

Francisco A. Nogueira, MA

Francisco A. Nogueira, MA

  • Chief Executive Officer
  • Accumulus Synergy, 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Many regulatory filing processes use outdated technologies that result in manual or duplicative work.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)

Jerry  Stewart, JD, MSc, RPh

Industry Update

Jerry Stewart, JD, MSc, RPh

  • Vice President Global Regulatory Policy and Intelligence, Global RA
  • Pfizer Inc, United States
Mary Ann  Slack

FDA Update

Mary Ann Slack

  • Director, Office of Strategic Programs, CDER
  • FDA, United States
Andrea  Johnson

MHRA Update

Andrea Johnson

  • Head of Business Analysis and Design
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Hilmar  Hamann, PhD

EMA Update

Hilmar Hamann, PhD

  • Head of Information Management Division
  • European Medicines Agency, Netherlands
Dominique  Lagrave, PharmD

Industry Update

Dominique Lagrave, PharmD

  • Regulatory Strategic Innovation Leader , Global Regulatory Affairs
  • Amgen Inc., United States