CMC Submissions in CTD Format
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Who Should Attend
This course is intended for individuals responsible for
R&D/technical writing/quality management/original and
postapproval submissions in pharmaceutical companies,
especially those in:
• Regulatory Affairs
• QA/QC
• Process Chemistry
• Analytical Chemistry
• Preformulation and Formulation Development
• Scale-up and Technology Transfer
Experience of one year or more in one of the above areas is
recommended to fully benefit from this course.
Description
This course will provide in-depth instruction on Chemistry,
Manufacturing and Controls (CMC) requirements and review
processes for clinical trial, registration and postapproval drug
applications in the US, Europe and Japan. Additional
considerations and integrative approaches for submissions in
emerging markets ("Most of the World" countries/regions)
will be discussed. Emphasis will be placed on current national
and ICH guidelines, and special considerations for biologics
will be discussed. Development, manufacturing, analytical
testing, controls and stability issues will be presented for
solids, parenterals and other dosage forms. Overviews of
Quality By Design (QbD) submissions and Drug Master
Files will be presented. Successful regulatory filing strategies
and best practices will be illustrated with examples and
case studies.