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Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor’s Organization: Retooling R&D for ERS
Session Chair(s)
Peter Lassoff, PharmD, RPh
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
Syneos Health, United Kingdom
This session will assist pharmaceutical companies in reorganizing their R&D departments to fit the requirements of electronic regulatory submission development. This will speed up the writing and submission of eCTDs and other electronic submissions leading to faster time to market.
Learning Objective : Discuss reorganizing R&D departments to fit the requirements of electronic regulatory submission development; Identify how this will speed up the writing and submission of eCTDs and other electronic submissions leading to faster time to market.
Speaker(s)
Stories from The Frontline: Lessons Learned from Electronic Submissions in R&D
Peter Lassoff, PharmD, RPh
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
Electronic Submissions in R&D
Murali Chandrashekar, MBA
Sanofi, United States
Dossier Lead
Global Dossier Production: Utilizing Resources All Around the World
Jeffrey Morrison, MS
Genpact Regulatory, United States
AVP - Regulatory Consulting
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