Initial authorization applications for new drugs and biologics in the US and Europe are among the most challenging tasks faced by Regulatory Operations. The applications typically include approximately 1,000 documents and hundreds of thousands of pages that need to be authored, reviewed, and published (usually under very tight timelines). While the harmonization brought to us with the eCTD format has certainly increased the efficiency of preparing multiple regional dossiers at once, differences in the required content and format between health authorities persists.
If you intend to cover both markets, simultaneously or sequentially, efficient submission planning and preparation is crucial. Detailed knowledge regarding the content and format requirements of each Health Authority is necessary to determine whether documents can be re-used in multiple dossiers. In addition, thoroughly understanding how your eCTD tool can utilized to achieve synergies can save you valuable time.
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.
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.
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.
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.
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.
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.