This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug Master Files (DMF) and preparation of the CTD Quality Overall Summary (Module 2).
Who Should Attend
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product.
Note that the course covers the requirements for synthetic, small molecules and does not address biologics.
This course will provide participants with a thorough understanding of the requirements for each CMC/Quality section of the Common Technical Document (CTD), the format to be used for NDAs, including preparation of the Quality Overall Summary (Module 2). It will also present techniques for making the CMC submission easy to review, including sample tables and figures, and discuss how to address issues during meetings with FDA and NDA review.
Frequently Asked Questions
How much of the course deals with NDAs and how much with INDs?
The course discusses all the ICH requirements for the CMC section of NDAs, i.e., Module 3 and the Quality Section of Module 2. This provides participants who are working on NDAs with a detailed outline from which to construct an NDA. For participants who are working on INDs, the course provides the scope of studies that will be needed to prepare an NDA and a discussion of the reduced requirements for each Module 3 section for INDs in Phase 1, 2 and 3.
Does the course cover biologics and ANDAs?
The course does not cover the information and data required for filing a biologically produced active ingredient to be filed with CBER nor specific requirements for ANDAs.
Does the course cover post-approval changes?
The course addresses submission of Comparability Protocols for post-approval changes but not other guidances related to post-approval changes.
I am new to CMC and regulatory affairs. Will I understand what is being presented?
The course covers the requirements for NDAs and INDs in a very systematic way and provides a complete overview so it is a good introduction to this field.
I have filed several NDAs already. Will I get anything out of the class?
Participants with experience filing NDAs have found the course valuable in assessing whether they are filing too much or too little information and data.