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What you need to know to submit Study Data to the FDA and what the new FDA Technical Rejection Criteria means for you

From: 25 Feb 2021 | To: 25 Feb 2021 | Location: WEBINAR/ONLINE

Time: 11AM EST / 8AM PST / 5PM CET

About the webinar

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.

Already a while ago the US FDA laid out conformance requirements in the Data Standards Catalog. Specifically, rules with rejection criteria were formulated for studies started after a defined date (Dec. 17, 2016 for NDAs, BLAs ANDAs and Dec. 17, 2017 for INDs). It is expected that these rejection criteria will be enforced soon. Experts from PharmaLex and the LORENZ Life Sciences Group will help you navigate this complex topic and present an overview of the requirements for submitting clinical and nonclinical study data to the US FDA. We will discuss aspects of specific validation criteria, including a look at some details of validation rules 1734 to 1737. This will be followed by a short LORENZ eValidator sample demonstration.

Our webinar series will continue with one more topic on March 23, 2021.

About the presenters

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.

Jan Wermusch 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.