Course offering number:1004-504
Course ID:
1989
CMC Submissions in CTD Format
April 26-27, 2010
New Brunswick, NJ
Who Should Attend
This course is intended for individuals responsible for
R&D/technical writing/quality management/submissions in
pharmaceutical companies, especially those in:
• Regulatory Affairs
• Process Chemistry
• Preformulation and Formulation Development
• Scale-up and Technology Transfer
• Analytical Chemistry
• QA/QC
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
applications in the US and Europe. Additional considerations
and integrative approaches for submissions in Japan and
other markets will be discussed. Emphasis will be placed on
current FDA, EU and ICH guidelines for the CTD Quality
section and will cover development, manufacturing (including
sterilization), analytical, controls and stability issues.
Successful regulatory filing strategies will be illustrated with
examples and case studies. Overviews of Quality By Design
(QbD) submissions, Drug Master Files and special
requirements for biologics will be presented.
Other Courses of Interest
Analytical Methods Validation for FDA Compliance
Apr 19 2010, Amsterdam, The Netherlands
Best Practices in SAS Statistical Programming for Regulatory Submission
Developing Specifications for Drug Substances (APIs) and Drug Products
Drug Product Stability and Shelf-Life
May 31 2010, Dublin, Ireland
Drug Regulatory Compliance/Drug Approval and Preapproval Inspection
Generic Drug Approvals
May 03 2010, New Brunswick, NJ
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Apr 26 2010, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 07 2010, New Brunswick, NJ
INDs/NDAs/CTDs
Mar 22 2010, Burlingame, CA
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