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Session 1: Global Regulatory Updates
Session Chair(s)
Kathleen Salazar, MA, MBA
Head, Global Labeling Operations, Johnson & Johnson Innovative Medicine, United States
Deborah Bebbington
Head Global Labeling, Bayer Plc, United Kingdom
The global regulatory environment in the pharmaceutical industry is dynamic, especially in light of the growth of new product modalities and the continued evolution of transformative technologies and practices for product and labeling development. Health Authorities are engaged with these changes and providing input and feedback in the face of emerging developments and their application to labeling. In this session, we will review some areas of change and how Health Authorities are responding.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify area of emerging change related to new drug modalities and technologies impacting labeling
- Review Health Authority input and actions in face of emerging changes
- Identify best practices in the use of new technology and data sources
Speaker(s)
Jennifer Sekawungu, MS
Global Labeling Product and Initiative Lead, Johnson & Johnson Innovative Medicine, United States
US: Utilization of RWE in Labeling
Koen Nauwelaerts, PHARMD, PHD, MBA
Regulatory Policy and Innovation Lead, Bayer AG, Belgium
Global Regulatory Updates – EU
Mohamed Oubihi, DRSC, MSC
President and CEO, Yakumed limited, United Kingdom
Introduction to Labelling Regulations in Japan
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