×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
STORYLINE DOCUMENTS
Session Chair(s)
Thomas Schindler, PhD
Director Global Regulatory Affairs - Regulatory Operations
BioNTech SE, Germany
Learning Objective : To learn about a new document format that is being used for pre-submission meetings with regulatory authorities. To evaluate the advantages and disadvantages in comparison with other approaches such as submitting mock documents.
Speaker(s)
The Storyline - a new document format for pre-submission meetings with regulatory authorities
Thomas Schindler, PhD
BioNTech SE, Germany
Director Global Regulatory Affairs - Regulatory Operations
Cookbook Writing vs. Narrative Writing in Regulatory Documents
James Visanji, PhD
Synchrogenix, a Certara company, Germany
Associate Director, Regulatory Services Management
Creating a Storyline in Briefing Packages and Presentations for Scientific Advice Meetings
Susan Bhatti, PhD
Merck Healthcare, Netherlands
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs
Have an account?