Day & Time:
October 9, 9:00AM - 10:30AM
Mary Gardner Stewart, MSc
Divisional Director, Medical Documentation
H. Lundbeck A/S, Denmark
Marketing authorisation applications (MAAs) have typically focussed initially on Europe and the US, and occasionally Japan. These are also the regions responsible for the ICH guidelines. But now the pharmaceutical industry is thinking globally already in the early stages of drug development. So what do sponsors need to know to navigate through the myriad regulations so that clinical development programmes are designed to address these regional differences from the outset? What documentation is required for countries and regions outside the ICH regions? And for smaller markets, what should the export dossiers contain so that the submission is acceptable for approval without compromising the confidentiality of the sponsor’s data?
Presentation(s) & Speaker(s):
Bridging Study Waivers and Subgroup Analysis Reports for regulatory submissions in Asian countries
Team Leader Medical Writing Europe / Senior Medical Writer
Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Approval of New Drugs in India – A bird’s eye view!
Divya K Bhati, MBA,MSc,PMP
Institute of Health Management Research (IIHMR), India
Export Dossiers – Global submissions that do not compromise proprietary information
Vice President and Head, Global Regulatory Affairs
Quintiles Inc., United Kingdom