From: 25 Feb 2021 | To: 25 Feb 2021 | Location: WEBINAR/ONLINE
Time: 11AM EST / 8AM PST / 5PM CETRegister here
We are happy to announce the second in our series of free webinars. This webinar focuses on Technical Rejection Criteria when submitting Study Data to the US FDA. Registration is free of charge and you will be able to pose your questions to our experts directly during the one-hour presentation.
Our webinar series will continue with one more topic on March 23, 2021.
Adair Turner, Principle, Consultant, Director RegOps, PharmaLex
Adair joined PharmaLex in April 2017 as Principal Consultant, Director Regulatory Operations, where she is responsible for electronic submission activities, regulatory information management and related topics in the US. She has a wealth of experience in managing hundreds of Regulatory submissions throughout the product lifecycle, leading cross-functional project teams, and implementing innovative technologies.
Product Manager, LORENZ Life Sciences Group
Jan Wermusch studied mathematics at the Humboldt University in Berlin and has more than 20 years of experience in the IT business. He joined LORENZ in 2004 as Quality Assurance Manager. In 2006 he assumed the position of Product Manager for LORENZ eValidator.
Akira Yamaguchi, CTO LORENZ Life Sciences Group
Since 1995, Akira Yamaguchi's main field of activity has been electronic submission projects and the development of the entire docuBridge product line. Akira has frequently been a speaker around the world on the topic of electronic submissions and is one of the top internationally recognized experts in electronic submission design and processes. Between 1983 and 1994, he pursued an international career in management consulting and information technology at Hoechst AG and Software AG in Germany as well as Comshare International Ltd. in the UK.