戻る Agenda
Session 1: Global Regulatory Updates
Session Chair(s)
Kathleen Salazar, MA, MBA
Head, Global Labeling Implementation
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)
US: Utilization of RWE in Labeling
Jennifer Sekawungu, MS
Johnson & Johnson Innovative Medicine, United States
Global Labeling Product and Initiative Lead
Global Regulatory Updates – EU
Koen Nauwelaerts, PharmD, PhD, MBA
Bayer AG, Belgium
Regulatory Policy and Innovation Lead
Introduction to Labelling Regulations in Japan
Mohamed Oubihi, DrSc, MSc
Yakumed limited, United Kingdom
President and CEO