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According to the Food and Drug Administration (FDA), cellular and gene therapy-related research and development in the United States continue to grow fast, with several products advancing in clinical development.
The New York/New Jersey chapter invites you to join your regulatory colleagues for a presentation on this topic from an accomplished regulatory policy and strategy leader with a successful track record of initiating and advancing pivotal policy topics in cellular and gene therapies. The presentation will highlight some of the different regulatory pathways exclusive to gene therapies within the larger area of regenerative medicine, followed by an overview of recent FDA Guidance for industry-specific retinal diseases. The session will conclude with a summary of Health Authority interaction mechanisms and designations that can enable gene therapy development.
A live Q&A portion with the speaker will follow the presentation.
This event is brought to you by the RAPS New York/New Jersey Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.
Learning Level: Intermediate
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.
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.
Dr. Snehal Naik, PhD, regulatory policy and strategy leader, Spark Therapeutics, Inc.
Thank you to our Platinum Chapter Sponsors:
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.
Registration fees for this event are nonrefundable.
Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.