Intorduction to CMC Regulatory Affairs
Categories: Pharmaceutical
An introductory course for those with minimal experience in CMC or new to the discipline.

What Is The Course About?
Do you have problems finding the right course for staff who are new to the discipline of Chemistry and Pharmacy Regulatory Affairs? You don’t want new staff to be overwhelmed with information but they need to understand the type of data they will have to handle, what are the key issues to look out for and how to present this data in their submissions.

This course is introductory for those with minimal experience in CMC or new to the discipline. Emphasis is placed on the CMC documentation in relation to the Clinical Phases and highlights how quality is relevant to safety and efficacy. This course will give delegates the understanding how to achieve good quality IMPD and MAA submissions.

The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.

Course Programme:
-CMC in the drug development programme
-Drug substance - characterisation and synthesis related issues
-Drug master files and Certificates of Suitability
-Drug product and formulation considerations
-Control of Drug Substance and Drug Product
-Setting specifications - drug substance and drug product
-Stability - drug substance and drug product
-The Quality Overall Summary
-What level of CMC detail is needed in the IMPD in relation to clinical phases
 
Course Dates
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
Tools
 
Key Details
Duration1 day
 
£590
per delegate