When: 25-27 and 30-31 March 2020
Where: Online
Time: Sessions begin at 16:00 GMT (25-27 March) or 16:00 BST (GMT +1) (30-31 March). Each session will last between two and three hours.
TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers.
All delegates already booked on the course will be individually contacted and if you require further information please do e-mail meetings@topra.org
Course overview
The purpose of this Module is to provide an understanding of the regulatory environment in the US in order to place its global influence in perspective.
Lectures and workshops will cover understanding of US drug development including:
- The history of drug regulation in the US
- The legal basis of regulatory affairs in the US
- Common application types (eg, IND, NDA, BLA, ANDA and SNDA)
- OTC products
- Orphan drugs
- Fast track approvals
- Adverse event reporting
- Labelling
- Advertising and advertising controls
- Communicating with the FDA.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable students to contextualise their understanding and knowledge.
Suitable for
- Students of the TOPRA MSc programme
- 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
Benefits for delegates
This course will enable you to:
- Posses a systematic understanding of knowledge, and a critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the US and regulatory marketing authorisation in the context of drug development
- Demonstrate a conceptual understanding of the regulatory requirements, FDA requirements, regulatory authorisation and associated documentation for marketing submissions
- Display originality in the application of knowledge of the US regulatory aspects of drug development to evaluate critically current research in the discipline
- Demonstrate the ability to critically analyse the legal documentation for US drug development
- Critically appraise and evaluate communications from regulatory bodies (such as the FDA) and critically evaluate research publications
- Deal with complex issues related to the US regulatory authorisation, both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
You can download the programme here.
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500 + VAT |
£1700 + VAT |
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT
Please email us at meetings@topra.org for a discount code before making your booking.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer
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- VAT, if applicable, is charged at 20%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee
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Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
Related Courses
Module 12 Data Management and Digitilisation in Regulatory Affairs
Module 21 US Regulation of Medical Devices