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REGIONAL CONSIDERATIONS
Session Chair(s)
Mary Stewart, MSc
Vice President
H. Lundbeck A/S, Denmark
Learning Objective : Gain an overview of the country-specific subgroup analyses and documents required for regulatory submissions in China, India, Korea, and Taiwan. Learn about and share best practices and examples for structure, content, and preparation of Bridging Study Waiver Reports and Subgroup Analysis Reports to support drug approval in these countries.
Speaker(s)
Bridging Study Waivers and Subgroup Analysis Reports for regulatory submissions in Asian countries
Kirsten Herbach, DrSc
Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Principal Medical Writer / Team Leader
Approval of New Drugs in India – A bird’s eye view!
Divya Kanwar Bhati, PhD, MBA, MSc, PMP
Institute of Health Management Research (IIHMR), India
Senior Research Officer
Export Dossiers – Global submissions that do not compromise proprietary information
Peter Lassoff, PharmD, RPh
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
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