December 15 & 16, 2008 - Raleigh, NC
This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Note that the course does not cover a BLA, which is for biologics. However, personnel who are not involved in CMC document preparation, but want a general understanding of what is involved for both the drug substance and drug product, will also benefit from the course.
Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address issues during CMC meetings with the FDA.
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This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Note that the course does not cover a BLA, which is for biologics. However, personnel who are not involved in CMC document preparation, but want a general understanding of what is involved for both the drug substance and drug product, will also benefit from the course.
Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address issues during CMC meetings with the FDA.
Discuss Add this link to... Bury
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