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Deep Dive into the Impact of the New Pharmaceutical Legislation on Regulatory Operations: The Impact on Data, Technology, and Processes in Regulatory Affairs
Session Chair(s)
Remco Munnik
President, IRISS Forum, Spain
Building on the DIAmond session planned on the topic of ‘The New Pharmaceutical Legislation’ - This session will deep dive into its impact on Regulatory Operations; highlighting the role of automation and interoperability within regulatory affairs in Europe and how sector hopes to achieve regulatory efficiency from the process, data and technology point of view. The session will also be complemented by sharing a case study that will deep dive into electronic product information to address what is perceived as missing both from a content and technical point of view.
Learning Objective : After this session, participants should recognize the impact of the implementation of the new EU pharmaceutical legislation on Regulatory Affairs. Be able to describe and discuss the impact on internal processes and systems, while analyzing priorities and decide on crucial initiatives of the company´s Regulatory strategy
Speaker(s)
Remco Munnik
President, IRISS Forum, Spain
New Pharmaceutical Legislation: The Impact on Data, Technology, and Processes in Regulatory Affairs
Juan Garcia-Burgos, MD, PHD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Impact of the New Pharmaceutical Legislation on EMA's Strategy and Roadmap
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Impact on Industry's Regulatory Operations Systems and Processes
Paul-Etienne Schaeffer, PHARMD
Life Sciences Regulatory Affairs Manager, AESGP, Belgium
Building a Healthier and Empowered Society: Package Leaflet Content Well-Needed Improvements
Julie Spony, MA
Policy Officer, European Patients' Forum, Belgium
Panelist
Elizabeth Scanlan, PHD, MSC
ePI Product Owner, European Medicines Agency, Netherlands
Panelist
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