Pre-Conference Workshop Day

WORKSHOP A: Implementing New Regulatory Guidelines on Real World Evidence Approaches for Regulatory Submissions

Tuesday, October 11, 2022 - 10.00 - 12:00pm

While regulatory guidelines grow more complex, drug developers, clinical trial sponsors and other life-sciences stakeholders, must adapt and expand their RWE strategies in a new regulatory landscape. Let David Martin, Moderna (bold), start by guiding you through your challenges with the latest FDA guidelines followed by a deep dive into interactive roundtable discussions where you will have the opportunity to bring your challenges to the table.

Join this interactive workshop to:

  • Understand current FDA guidance on data sources, data standards and regulatory considerations to drive successful use of RWE for regulatory submissions
  • Explore how data security and patient privacy is maintained in a global regulatory landscape to ensure Data standards or best practices, as well as transparency, discoverability, interoperability and cloud infrastructures

Workshop Leaders:

25278DavidMartin
25278AlexanderCole

David Martin
Vice President Pharmacovigilance
Moderna

Alexander Cole
Executive Director, Global Head Epidemiology
Alexion

25278JesperKjaer

Jesper Kjær
Director of Data Analytics Centre
Danish Medicines Agency

WORKSHOP B: Highlighting Best Analytical Approaches to Achieve High-Quality Real World Evidence from Data Sets Available

Tuesday, October 11, 2022 - 13:00 - 16:00pm

With ever evolving analytical techniques and technologies, now is the time for you to transform how you approach real world data. Analytical expert, Akshay Vashist, Otsuka will explore the use of RWD in a new regulatory landscape at our in-depth and hands-on workshop.

Join this interactive workshop to:

  • Outline methodologies for real world data analysis accepted by the FDA to ensure high quality data
  • Explore analytical tools and techniques
  • Discuss how data can be quality checked more thoroughly and successfully
  • Leverage current artificial intelligence, natural language processing and analysis tools to achieve quality data in the shortest time

Workshop Leader:

25278YanGe

Yan Ge
Director Data Analytics Global Lead of Real World Data
Takeda

25278AkshayVashist

Akshay Vashist
Head of Medical and Real World Data
Otsuka