From: 26 Jan 2021 | To: 26 Jan 2021 | Location: WEBINAR/ONLINE
Time: 11AM EST / 8AM PST / 5PM CETRegister here
Join us for the first in our series of three webinars, where experts from PharmaLex and LORENZ Life Sciences Group will be sharing their experience on submissions to the US FDA with you.
The registration is free of charge and you are able to direct your questions to our experts directly during this 1-hour presentation.
eCTD sequences for BLA, NDA, and IND submissions have become high-volume work, but the requirements and specifications are evolving constantly. There is also strong pressure to lower the cost of the publishing and submission process by accelerating it.
In two parts, this first webinar will provide you with both the theory and a live demonstration of how to submit compliant eCTD sequences to the US FDA.
The first half will focus on how to plan, prepare and execute highly efficient eCTDs, with emphasis on the mandatory requirements, how to increase effiency during preparation and avoid last-minute hurdles. These insights are drawn from the experience of PharmaLex in using LORENZ docuBridge to prepare more than 2500 eCTD sequences per year.
The webinar's second portion will feature a live demonstration of compiling submissions based on the BLA template. The session will focus on compiling modules 1 and 3 and on lifecycle operations, while also highlighting the key differences versus the IND and NDA templates.
Our webinar series will continue with two further topics on February 25, 2021 and on March 23, 2021.
Parul Patel, Senior Product Consultant, LORENZ Life Sciences Group
Parul Patel joined LORENZ in December 2016 as a Regulatory Solutions Engineer for LORENZ docuBridge, performing demos. Since then, she has evolved into Senior Product Consultant role for the NA market and project managing industry workshops. She performs product trainings and prepares training materials for various customers globally. In addition to representing LORENZ at RAPS workshops since 2016, she lead 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 Regulatory Affairs field since 2002 and holds a B.S. in Industrial Engineering from New Jersey Institute of Technology, New Jersey, USA.
Melissa Rapp, Manager, Regulatory Operations,PharmaLex
Melissa Rapp is a Regulatory Operations Manager with17 years of experience in submission publishing and management. In the last 2 years 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, at Health Canada and in the EU. Her managerial role has involved conducting issue resolution and managing global resources to ensure client and agency-mandated timelines are met. She is an active contributor to learning presentations and training endeavors within the organization. Melissa currently lives with her husband, 3 kids and their cane corso mastiff in northern Arizona.