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Next dates TBC
Online Academy,
6 module series over 4 weeks

Regulatory and Compliance Requirements for CMC Analytical Studies

Discover key regulatory requirements for CMC analytical studies to ensure global compliance on this online course

Course 1/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series - Discover the key regulatory, technical and quality elements

In light of recent developments

If you would like to start the course sooner than advertised please contact us and we will arrange this for you as soon as possible.

Course Overview

The first course in the online biopharmaceutical and biosimilar CMC analytical series. This course provides the foundations for course 2 and 3 in the series. Learn more about the series here.

The course will provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and, crucially, when they must be completed to minimise development delays affecting your protein products (breakthrough or biosimilar).

In addition, you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved.

What will you learn?

Global regulatory requirements

Discover the global regulatory requirements for CMC biologics

CMC data sets

Learn what CMC data sets are required for all protein products, including biosimilars

CMC timelines

Examine when CMC analytical studies must be conducted during development and understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products

GxP standards

Learn best practice for taking your R&D laboratory work to GxP standards and explore the GxP requirements for analytical CMC biologics

R&D quality and documentation

Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products

Who is this course for?

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.


Purchase a place on all 3 online academies in the series and receive the final place at half price, saving you a total of £440 + VAT. Attending all 3 courses will provide you with a complete understanding of the regulatory, technical and quality requirements for CMC analytical studies.

To take advantage of this offer please get in touch with our training consultants at or call +44 (0)20 7551 9521. 

Methods and Reference Standards for CMC Analytical Studies

Gain a comprehensive understanding of technical standards for CMC analytical studies

Find out more
Product Specifications, Stability, Comparability and Similarity for CMC Analytical Studies

Learn best practices for ensuring the quality and efficacy of your products

Find out more

Find out more about online courses...

BioProcess International Academy online courses are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

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