What you need to know to submit Study Data to FDA

& what the new FDA Technical Rejection Criteria means for you

Duration:  1 hour 


Registration

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Why watch

Summary

Beginning later this year FDA will reject regulatory submissions that include study data that does not conform to the required standards specified in the FDA Data Standards Catalog.  

In this webinar, expernts from PharmaLex and Lorenz will provide:

  •  An Overview on the requirements for submitting clinical and nonclinical study data to FDA 
  •  Details on the specific validation criteria that FDA will use to determie conformance 
  •  A demonstration of the eValidator tool used to check conformance
  •  Specific technical instructions for ensuring successful submission
speakers

A full hour of inspirational speakers

 

 

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.

Parul Patel

Senior Product Consultant, LORENZ Life Sciences Group

Parul Patel joined LORENZ in 2016 as a Regulatory Solutions Engineer for LORENZ docuBridge. Since then, she has evolved into Senior Product Consultant for the NA market. She performs product trainings and prepares training materials for various customers globally. In addition to representing LORENZ at RAPS workshops since 2016, she led the training effort for a new regional regulatory agency client, including training content development; session schedules as well as working as the principal trainer and overall educational service delivery activities. Parul has worked in the RA field since 2002 and holds a B.S. in Industrial Engineering from New Jersey Institute of Technology, USA.

Karl-Heinz Loebel

Director, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex

Karl-Heinz Loebel has spent the last 15 years in Regulatory Affairs, focusing on electronic submission, data management and systems implementation. He has been responsible for PharmaLex eCTD submissions in traditional ICH regions ever since and is now also coordinating the extension of the company’s publishing capabilities to the requirements of the regions that joint the eCTD community most recently, like China and EAEU.

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.

Melissa Rapp

Manager, RegOps, PharmaLex

Melissa Rapp is a RegOps manager with 17 years of experience in submission publishing and management. At PharmaLex she has submitted 397 sequences through the FDA gateway. She has successfully managed the submission activities of two simultaneous ANDAs and has experience with applications in the US, Health Canada and EU. Her managerial role has involved conducting issue resolution and managing global resources to ensure client and agency-mandated timelines are met. 

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.