Best Practices for CMC Section Preparation for IND’s and IMPD’s

Preparation of an CMC section for an IND, IMPD, BLA, NDA, or MAA can seem like a daunting task due to large amount of information that must be collected and summarized.  This course will provide best practices to ease the pain of preparing a quality CMC section for a filing to a regulatory agency.  The preparation of a regulatory filing must start with the identification of what will be required and the responsible providers of the information.  The necessary information then needs to be delivered in a usable form to the authors of the filing.  Efficient CMC section preparation and review will be discussed along with the final steps prior to filing.  Finally the sponsor organization must be prepared to respond to review questions and information requests from the regulatory body.  Case studies will be provided in each section of the course.

The course will cover these subjects:

• Common Technical Document (CTD) M.2.3 Quality Overall Summary and M.3 Quality
  > Organization
  > Section elements
  > What to include in each section
  > Responsibilities
  > Regional differences
• Primary Source Documents
  > Best practices for content and completeness
  > Organization
  > QC
  > Archiving
• Section Technical Writing
  > Style and format
  > Review cycles
• Assembly and Publishing
• Responding to review questions and information requests