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
What is covered?
Day one: Drug Substance
|
Day two: Drug Product
|
- 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.
|
- 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”
CPD
This course offers 12 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
To register, please log in or create an account
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.
Course price:
Member: £925.00+VAT
Non-member: £1095.00+VAT
Those working for regulatory agencies or government agencies or academic institutions:
Member: £693.75+VAT
Non Member: £821.25 +VAT
Those working for charities, patient groups or in full time education:
Member: £231.25+VAT
Non Member: £273.75+VAT
For the discount code please contact meetings@topra.org
- Please note the number of discounted places may be limited.
- All fees are shown in Pounds Sterling and do not include VAT
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).