Pharma / Biotech
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).
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.
Please note: This course covers the requirements for synthetic, small molecules and does not address biologics. Biologics are addressed in our course "CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics"
9:00 – 10:00 ICH Process and CTD Organization
10:00 – 4:30 Requirements for the Drug Substance (Module 3 of CTD)
4:30 – 5:00 Drug Master Files (DMFs)
9:00 –2:30 Requirements for the Drug Product (Module 3 of CTD)
2:30 – 3:00 CMC Appendices/Regional Information
3:00 – 3:45 Quality Overall Summary (Module 2 of CTD)
3:45 – 4:00 FDA Interactions
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.
"The course director is a very good communicator and exceptional instructor. She was very patient in explaining the various modules and coordinating the discussions. I learned much more with this course and can say that my knowledge regarding the CMC preparation has improved significantly after attending this course. I will be on the lookout for other courses offered by CfPIE" Sheetal M., Principal Scientist, Purdue Pharma L.P.
"The course director was an excellent presenter. I am a project manager and took this course as a way to get an overview of the CMC. I learned so much! This will be very useful as reference as I lead my project teams in Drug Development. She did an excellent job managing and answering questions from SMES from all areas - Analytical Regulatory, Formulation, DP Development, DS Development, Quality." Karen B., Sr. Project Manager, Pfizer
"An excellent seminar for everyone coordinating, writing or reviewing the CMC sections of drug substance and drug product NDAs/INDs for small molecules." A. Agidotan, Manager, PharmaLex GmbH
"This was an excellent instructor with great real-world experiences who presented the information very clearly!" David D., Scientist, Upsher Smith Laboratories
"This course was a great class for me! Previously, I had only been involved with the early R&D activities and never have written any submission sections. This course helped me clarify the relationships between ICH guidelines and NDA submissions, as well as delineate between the different types of ICH guidelines." David A., Global Program Manager, Synthes
"I thought this course was excellent and very relevant to my work. It will benefit me greatly as I move closer to preparing for NDA filing. The instructor encouraged questions and discussions which provided different perspectives and other companies' experiences/practices. This was very beneficial as well." Elizabeth G., Research Scientist, BMS
"The course director was very knowledgeable in presenting her material. She was able to provide real life examples to support her discussion. The course notes will be a valuable reference tool for future use." Sylvie A., Project Leader, Regulatory Affairs, Sanofi-Aventis Canada
"I am involved in Research and Process Development of API. By attending this excellent course I really could see what my role was in the overall regulatory filings process and how important it was from the quality perspective." Hitesh B., Manager, R&D, United Therapeutic
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.
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.
The course addresses submission of Comparability Protocols for post-approval changes but not other guidances related to post-approval changes.
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.
Participants with experience filing NDAs have found the course valuable in assessing whether they are filing too much or too little information and data.
Meet Maria Geigel, CfPIE’s Course Director for “Preparing the CMC Section for NDAs/INDs/CTDs”. Maria gives a snapshot of the 2-day classroom course which focuses on the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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