26 November 2015: Drug Substance
- Information on the latest scientific and technical updates and/ or requirement
- An insight into the data requirements and common regulatory issues for Drug Substances including an overview of the Drug Master File (DMF) and EU Certificate of Suitability procedures; use of pharmacopoeial monographs; issues often faced at different phases of development concerning specifications, production, validation, stability; ICH regional requirements; Active ingredient manufacturer inspections: other current issues
- A Regulatory Authority’s perspective on “how to get it right first time” including potential pitfall areas; what makes a good quality summary; practical issues in the presentation of Marketing Authorisation applications.
27 November 2015: Drug Product
- An insight into the data requirements and common regulatory issues for Drug Products including an outline of the issues often faced at different phases of development such as specifications, production, validation, stability; specific data requirements for and issues associated with different dosage forms; ICH regional requirements, other current issues
- A Regulatory Authority’s perspective on “how to get it right first time” including potential pitfall areas; what makes a good quality summary; practical issues in the presentation of Marketing Authorisation applications.
What previous delegates have said:
“Excellent presentations and Case Study”
“Great range of content”
Who should attend?
- The less experienced regulatory professional who requires comprehensive information on the pharmaceutical section of the dossier (Module 3)
- The experienced professional who is a newcomer to the CMC area
- Anyone who wishes to update their knowledge in the CMC area
CPD
This course offers 12 CPD hours for successful completion
Why is Continuous Professional Development important?
As a professional in regulatory affairs you have a personal responsibility to maintain your level of knowledge and competence; you are therefore encouraged to participate in Continuous Professional Development.
CPD is important to you as;
- It demonstrates to your employer that you have planned, updated and maintained your knowledge and experience.
- It enables you to develop your knowledge and experience for your present role and any potential future roles.
To register, please log in or create an account
Course price (including VAT):
Member: £1,110
Non-member: £1,314
Those working for regulatory agencies or government agencies or academic institutions:
Member: £832.50
Non Member: £985.50
For the 25% discount please contact meetings@topra.org for the code
Those working for charities, patient groups or in full time education:
Member: £277.50
Non Member: £328.50
For the 75% discount please contact meetings@topra.org for the code
Please note the number of discounted places may be limited.
All fees are shown in Pounds Sterling and include VAT
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £100 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.