When: 22-23 September 2020
Where: ONLINE
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 meetings@topra.org.
Course overview
You will be provided with an update on the latest scientific requirements, an insight into the data requirements and common regulatory issues for substance and drug product. You will hear from a Regulatory Authority on 'how to get it right the first time', including potential pitfall areas; what makes a good quality summary and practical issues in the presentation of Module 3 of Marketing Authorisation Applications. You will also have the opportunity to take part in case studies to illustrate lessons learned.
Benefits to delegates
- Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier
- Participate in case studies and interactive lessons - learn by doing
- Have the opportunity to interact with speakers from Regulatory Agencies in a neutral environment
- Learn from experts in the field
- Build a network to support the rest of your career
- Learn the common pitfalls to avoid
- Take a course developed by professionals for professionals with a proven track record.
CPD: This course provides 14.5 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 include
Suitable for
- Less experienced regulatory professionals who require comprehensive information on CMC (Synthetic molecules)
- Experienced professionals who are newcomers to CMC (Synthetic molecules)
- Anyone who wishes to update their knowledge in CMC (Synthetic molecules)
- Anyone who wishes to obtain an introduction to Biotech (CMC)
Pricing
Simply log in or create an account and register below.
Course *fees:
| Type |
Member |
Non-member |
| Standard |
£925+VAT |
£1,095+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
|
£693.75+VAT
|
£821.25+VAT |
Those working for charities, patient groups or in full-time education
|
£462.50+VAT |
£547.50+VAT |
|
*VAT, if applicable, is charged at the rate of 20%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
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Next steps