When: On-demand - This is a recording of the live webinar which took place on Tuesday 24 October 2017
Overview
The webinar will address the types of submissions and reports that are provided to FDA as part of maintaining a compliant New Drug Application or Biologics Licence Application for approved products.
Target audience
Primarily for Regulatory Affairs and Regulatory Operation staff who are/ will be responsible for US submissions in support of approved NDA and BLAs. Additional participants may include Labeling, CMC and Safety personnel.
Learning objectives
This webinar will serve as a great introduction to US NDA/BLA maintenance and it’s unique aspects while drawing parallels, where possible, to EU submissions.
After this webinar, attendees will be able to:
- Understand US Annual Reporting requirements and formats
- Be familiar with the various types of supplements to NDA and BLA.
Presenter
Nancy Smerkanich, DRSc, MS is an Assistant Professor, Clinical Pharmacy, School of Pharmacy at the University of Southern California (USC). As the former (Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior Consultant in Regulatory Affairs at Accenture, Dr. Smerkanich was responsible for advising sponsors on regulatory filing strategy and submission development.
With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.
How do I register?
Prices
| Type |
Member |
Non-member |
| Standard |
£75 + VAT |
£95 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
| Type |
Member |
Non-member |
| Discount |
£35 + VAT* |
£47.50 + VAT* |
* VAT, if applicable, is charged at a rate of 20%.
Terms and conditions
Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.