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Content and Format of an Initial IND submission 21 CFR 312.23
- Outline of IND content and format for the Initial IND
- Understanding the various components of the Common Technical Document (CTD)
- In -depth understanding on the contents of each module of the CTD
- Overview of additional and relevant information as well as the IND application format
- Highlight of information/ content under three broad areas:
- Animal Pharmacology and Toxicology Studies
- Manufacturing information
- Clinical protocols and Investigator information
Overview of the webinar
This webinar is designed to help pharma companies through the content and format of every module of the common technical document for an initial IND. The presentation will cover the in depth understanding of the contents of every module in the CTD.
Who should attend?
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Drug discovery and development professionals (R&D and CMC)
- Intellectual property experts
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development projects
Why should you attend?
This webinar would help the sponsor/ pharma company understand the requirements in terms of data, forms, documents and reports for every module of the CTD for an initial IND application. This knowledge not only helps the sponsor to accelerate submission and subsequent commencement of the Clinical study but also facilitates understanding any gaps in terms of data or requirements for the initial IND application.
Faculty - Ms.Gowri Sukumar
Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner. Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society. She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.