Ontario Chapter Webcast: When FDA does not agree: An Analysis of FDA disagreements with the sponsor

1.0
RAC Credits
Chapter Events
Friday, 22 October 2021 (12:00 PM) - Friday, 22 October 2021 (1:00 PM) Eastern Time (US & Canada)

Member: $10
Nonmember: $25


What should a sponsor do when the USFDA disagrees? This presentation will include an analysis of data extracted from milestone meeting minutes related to interactions between applicants and the FDA for approvals under the Center for Drug Evaluation and Research (CDER). The data is used to classify and categorize the interactions to facilitate continuous improvement and increased awareness of the FDA’s approach and current thinking.

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 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.

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:

Amin Osmani, is the co-founder and CEO of Biotech Square. He spent the last 10 years supporting the business development of pharmaceutical companies and contract research organization at various stages of the drug development process. He became passionate about addressing process delays that add significant development costs and make medical innovation less sustainable. He founded Biotech Square to uncover insights drug development teams can learn from to avoid delays and failures. Amin is a McGill University B.Sc. graduate in Biology and a Concordia University M.Sc. graduate in Cell & Molecular Biology.


Thank you to our Platinum Chapter Sponsors:


Event Policies

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


Questions

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