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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 BV, Netherlands
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs
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