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DIA 2021 Global Annual Meeting
Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange
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Many regulatory filing processes use outdated technologies that result in manual or duplicative work.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.
Jerry Stewart, JD, MSc, RPh
- Vice President Global Regulatory Policy and Intelligence, Global RA
- Pfizer Inc, United States
Mary Ann Slack
- Director, Office of Strategic Programs, CDER
- FDA, United States
- Head of Business Analysis and Design
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Hilmar Hamann, PhD
- Head of Information Management Division
- European Medicines Agency, Netherlands
Dominique Lagrave, PharmD
- Regulatory Strategic Innovation Leader , Global Regulatory Affairs
- Amgen Inc., United States