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Tuesday, June 21 • 4:15pm - 5:15pm
#271: Building the First Cloud-Based Submission Review Collaboration Platform

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-584-L04-P ; CME 1.00; RN 1.00

This forum will discuss a highly secure cloud-based data exchange platform between biopharma companies and global health regulators enabling new ways of collaborations between HA’s (Orbis, ACCESS) by leveraging the most advanced cloud technologies.

Learning Objectives

Define how new and innovative cloud-based technology solutions can transform sponsor-HA data flow and HA to HA collaboration, introducing new ways of working to reduce regulatory review times; Discuss how this cloud platform performs in partnership with HA’s and industry will facilitate real-time, simultaneous, and global submissions, reviews, and assessments of therapies.

Chair

Dominique Lagrave, PharmD

Speaker

Development of a Cross-Industry Collaboration and Cross-Functional Integration of a Data Exchange Platform
Dominique Lagrave, PharmD

Agency Update
Jesper Kjær, MS

Industry Update
Louise Gill, PhD



Speakers
avatar for Louise Gill

Louise Gill

Vice President, Regulatory Policy, Global Regulatory Affairs, GlaxoSmithKline Ltd, United Kingdom
Louise Gill is VP, Regulatory Policy at GlaxoSmithKline. She leads the regulatory policy and intelligence organisation accountable for defining and driving the global regulatory policy topics. Louise also co-leads the Accumulus Synergy Europe team. Louise has worked in the pharmaceutical... Read More →
avatar for Jesper Kjær

Jesper Kjær

Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre, Danish Medicines Agency (DKMA), Denmark
Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Vice President of Regulatory Innovation, Accumulus Synergy, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel, Dendreon and TCS. Dominique joined Amgen in 2015 as the... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session |   01: ClinSafety-PV, Session