New York New Jersey Chapter Webcast: Cell and Gene Therapy – An Overview & Regulatory Experiences

RAC Credits
Thursday, 10 December 2020 (12:00 PM) - Thursday, 10 December 2020 (1:00 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


The first part of the webcast will describe an approved gene therapy treatment of an inherited retinal disease that otherwise leads to vision loss. The session will also cover highlights of the regional regulatory experiences around the approvals. Attendees will learn some of the key considerations when developing gene therapy for global registration in a rapidly evolving regulatory landscape. Next, there will be an overview of an approved CAR-T therapy and a discussion of some considerations for development success. Lastly, attendees will learn about CMC's most commonly encountered challenges in development and registration of cell and gene therapy products. There will be a Q&A session at the end. 

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: Basic

Basic:  Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as 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 speaker will follow the presentation. 

Featured Speakers:
Orin Tempkin, Ph.D., global therapeutic area lead, ophthalmology, Novartis
John Noh, PharmD, global program regulatory director, Novartis 
Edyta Pawelczyk, Ph.D., regulatory CMC cell & gene therapy portfolio head, Novartis