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Regulatory and Compliance Requirements for CMC Analytical Studies

7-week online academy | 1 hour per week

26 June - 16 August 2019

Online Academy

Part of PTI’s new online biopharmaceutical and biosimilar CMC analytical series, this 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.

  • Discover the global regulatory requirements for CMC biologics
  • Learn what CMC data sets are required for all protein products, including biosimilars
  • Examine when CMC analytical studies must be conducted during development
  • Understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products
  • Learn best practice for taking your R&D laboratory work to GxP standards
  • Explore the GxP requirements for analytical CMC biologics
  • Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products

Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.

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.

PTI online academies 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.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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