Friday May 18, 2012 Friday May 18, 2012
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| Date: Monday, April 2, 2012 | |
| Registration Single Attendee: CAD $195.00 Group rates are available. (see below) All rates are subject to the Canadian 13% Harmonized Sales Tax (HST) |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 2 hours |
Successful use of FDA- Sponsor meetings and interactions is essential to CMC success in new drug development. This webinar describes from the CMC scientist’s perspective the opportunities and strategies for interactions with FDA at IND and pre-NDA meetings.
Participants will understand their responsibilities for preparation and participation in FDA- Sponsor IND and pre-NDA meetings. Strategies for End of Phase 2 and pre-NDA meetings will be a point of emphasis.
This presentation is targeted to:
Dr. Bernstein is a pharmaceutical consultant with expertise in the CMC development of small molecules. He is the principal of Live Oak Pharmaceutical Consulting Inc., with over 28 years of industry experience. Live Oak provides clients with a complete CMC team for drug development through its network of associates. He has led many CMC projects from pre-IND through Phase III for oral and sterile products. Dr. Bernstein is a member of the American Association of Pharmaceutical Scientists, the American Chemical Society, and the American Society for Quality. Dr. Bernstein earned a B.S. in Chemistry and Physics from Centenary College of Louisiana and a Ph.D. in Physical Chemistry from the University of North Carolina at Chapel Hill.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.