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Thursday, July 1 • 10:00am - 11:00am
#413 SL: Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-671-L04-P; CME 1.00; IACET 1.00; RN 1.00

Many regulatory filing processes use outdated technologies that result in manual or duplicative work.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 Objectives

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.

Chair

Francisco A. Nogueira, MA

Speaker

Industry Update
Jerry Stewart, JD, MSc, RPh

FDA Update
Mary Ann Slack

MHRA Update
Andrea Johnson

EMA Update
Hilmar Hamann, PhD

Industry Update
Dominique Lagrave, PharmD



Speakers
FN

Francisco Nogueira

Chief Executive Officer, Accumulus Synergy, United States
Frank Nogueira joined Accumulus Synergy Inc. as Chief Executive Officer in November 2020 from Genentech, Inc. At Accumulus Synergy he is focused on applying his 20 years of enterprise, regulatory strategy, asset development and commercialization work to the impending revolutionary... Read More →
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management Division, European Medicines Agency, Netherlands
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency with a focus on modernizing IM capabilities for the EMA, NCAs and its stakeholders to implement the vision for a modern, efficient and data-driven Agency of the future. Prior to joining EMA, from... Read More →
AJ

Andrea Johnson

Head of Business Analysis and Design, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Andrea started her career in genetic toxicology before joining the MHRA in 1996. She initially worked in the Licensing Division before moving over to work on System Development and Support. Andrea has held several positions within the sphere of IT to business relationships. She has... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Director, Global Regulatory Affairs and Safety Operations, Amgen, United States
Dominique has over 20 years of international regulatory affairs experience with the last 15 years spent in global regulatory operations management. Since 2015, Dominique is a Director at Amgen where he is leading the global regulatory operations organization with responsibility for... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →
avatar for Jerry Stewart

Jerry Stewart

Vice President Global Regulatory Policy and Intelligence, Global RA, Pfizer Inc, United States
Jerry Stewart, JD, MS, RPh, is Vice President at Pfizer. He is responsible for leading the Global Regulatory Policy and Global Intelligence team, serving as a strategic partner to the Pfizer business on regulatory policy issues, and representing Pfizer externally to advance the company’s... Read More →


Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   09: Regulatory, Session
  • Beginner Intermediate
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  • Credit Type ACPE, CME, IACET, RN
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