When: 3-5 April 2019
Where: De Vere Latimer Estate, Chesham, HP5 1 UG, UK
Start Day 1: 16:00 End Day 3: 16:00
Course overview
This Masterclass covers:
- Different classes of biological products such as vaccines, monoclonal antibodies and gene therapy medicinal products
- Practical regulatory aspects of regulatory strategy for biological, biotechnology and advanced therapy products
- Regulatory Requirements for clinical trial applications and marketing applications
- The quality, non-clinical and clinical changes specific to biological products
- Implications of changes to the production of biological products and the concept of compatibility
- Case studies to apply the regulatory principals
The combination of lectures and case studies and workshops will assist in the achievement of the learning outcomes and enable the students to contextualise their understanding and knowledge.
This course will enable you to:
- Display a systematic understanding of knowledge and a critical awareness of the unique nature and strategies for development of biological, biotechnology and advanced therapy products
- Possess a comprehensive understanding of the regulatory requirements and associated documentation with the licencing of biological, biotechnology and advanced therapy products
- Demonstrate a conceptual understanding of the legal and pharmaceutical requirements that define the regulatory strategy for biological, biotechnology and advanced therapy products
- Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non specialist audiences regarding biological, biotechnology and advanced therapy products
- Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of biological, biotechnology and advanced therapy products
- Critically appraise and evaluate communications from regulatory bodies and research publications regarding biological, biotechnology and advanced therapy products
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download the latest course programme
Module Leader
Alexis Cockroft - regulatory consultant at Lex Regulatory with a specialty in the provision of CMC regulatory science expertise for the development and registration of gene and cell therapy products.
Presenters
Presenter list for this event to be announced. TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of biological, biotech and advanced therapy products
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places for those working in regulatory or government agencies or academic institutions, charities and patient groups or in full time education only 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
|
|
£1275+VAT
|
Those working for charities, patient groups or in full-time education
|
|
£1275+VAT |
|
- VAT, if applicable, is charged at the rate of 20%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee
Next steps
Module 10: Leadership and Strategic Management in Regulatory Affairs
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