Ontario Chapter Webcast: Innovation meets Regulations: Application for Clinical Trial for Cell and Gene Therapy Product

1.0
RAC Credits
Tuesday, 17 August 2021 (12:00 PM) - Tuesday, 17 August 2021 (1:00 PM) Eastern Time (US & Canada)

Member: $10
Nonmember: $25

Description

The novelty and complexities of cell and gene therapy products combined with the lack of experience with such products can pose many challenges. Regulations for these products were established relatively recently, are still evolving, and often involve a complicated regulatory approval process. This presentation will discuss the requirements and challenges of Chemistry, Manufacturing, and Controls (CMC), Nonclinical and Clinical sections of an application for cell and gene therapy clinical trial, with a focus on FDA requirements for an Investigational New Drug (IND).

This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

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. 

About Your Presenter:

Oxana iliach, PhD, has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. She has extensive regulatory expertise, but her major focus is on developing and executing regulatory strategies for drugs for rare diseases, pediatrics, and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). Oxana has experience with the United States (US) Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), and other smaller agencies. She is currently a Senior Director of Regulatory Strategy and Policy at Synchrogenix, a Certara Company. She is also a Member of the Canadian Organisation for Rare Disorder and a professor at Seneca College, Toronto, Canada, where she teaches a course on clinical trial regulations.

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