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Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)

1.0 RAC Credits Member: $0 NonMember: $25
Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)

This is an on-demand recording from the February 2022 event 

This event is brought to you by:  

Successfully navigating the development and regulatory process for any new therapeutic requires proven strategies that help reduce risk of failure, streamline clinical development, and increase speed to market.

When launching cell and gene therapies it becomes even more critical to anticipate unique challenges specific to cell and gene therapies that arise throughout all stages of product development.

Learning Objectives 

View this recorded webcast to gain an understanding of:

  • CMC: Considerations for Starting and Ancillary Materials control and Potency Assay development
  • The delivery of cell and gene therapies and how to approach the use of novel delivery devices
  • Regulatory strategy to include leveraging OTAT INTERACT and Pre-IND interactions or expedited programs such as Regenerative Medicine Advanced Therapy, Fast Track, Break Through, Orphan Product, and Rare Pediatric Disease designations

Audience Learning Level 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend

  • Regulatory Affairs
  • Research and Development
  • Clinical Affairs


Yi Hwa Lai, PhD, MSc, RAC

Yin Lai, PhD, MSc, RAC Cardinal Health Regulatory Sciences

Ashwinder Kaur, MD, RAC

Ashwinder Kaur, MD, RAC Cardinal Health Regulatory Sciences

Matthew Varkey, MSc, PhD

Mathew Varkey, MSc, PhD Cardinal Health Regulatory Sciences

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Contact Us

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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