Date: 10-11 May 2021
Time: 13:00-17:00 BST (14:00-18:00 CEST)
Location: Online
Please note, this course is split into two half days.
Course overview
The purpose of this course is to provide an overview of the regulatory environment in the US, including:
- The history and legal basis of drug and biologic regulation in the US
- Common application types (IND, NDA, BLA)
- NDA maintenance and post approval obligations
- FDA expedited development pathways and designations
- Communicating with the FDA.
Benefits to delegates
This course will enable you to:
- Understand the key principles and requirements for FDA approval of a medicine for the US market
- Gain some insight into the expedited development pathways and special designations available
- Understand the differences between the US approval process and that it the EU
- Know how and when to interact with FDA for the best outcome
CPD: This course provides 7.5 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the programme here.
Presenters
-
Carlos Langezaal - Senior Director, Regulatory Affairs, Bristol-Myers Squibb
- Mark Cierpial - CEO & Principal Regulatory Consultant at Impact Pharmaceutical Services, Inc.
- Nancy Pire-Smerkanich - Assistant Professor, University of Southern California School of Pharmacy
Suitable for
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the US regulatory environment
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Pricing
Standard
- Member: £550 +VAT*
- Non-member: £675 +VAT*
Discounted places
A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.
- Those working for regulatory agencies, government agencies or academic institutions: £435+VAT*
- Those working for charities, patient groups or in full-time education: £290+VAT*
* VAT, if applicable, is charged at the rate of 20%.
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.