Sponsor's Responsibilities for an Active IND
Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iteration 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 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 a breadth 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.
This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. What’s more; the discussion will also detail the safety reporting regulations and associated timelines.
Learning Objectives
- Understanding each and every Sponsor responsibility in greater detail helps mitigate any delays in the clinical study or minimize the chances of a clinical hold
- The webinar will help the sponsor, or the company understand the each of the processes (including the new protocol, Protocol revisions, new investigator) as well as the information amendments and its associated timelines for seamless conduct of the clinical study
- Learning the IND safety reporting Regulations, follow up reporting and timelines
- Insight into IND inactivation and withdrawal
Areas Covered
- Overview of the basic responsibilities of a sponsor of an Active IND
- Understanding each step and the associated process(es)s in greater detail along with timelines involved
- Protocol amendments (New protocols, protocol revisions, new investigator)
- Information amendments
- IND Safety reporting regulations and timelines
- Identification and options for resolution of the clinical hold
- Annual reports
- Inactivation of an IND, Withdrawal of an IND
- Some tips on the best practices to circumvent any delays or clinical hold
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
It is important for the sponsor(s)/Pharma companies to understand every aspect of the Sponsor’s obligation once an active IND is in place for a clinical study. Understanding the process and its associated timelines are critical in order for the sponsor to avoid or mitigate delays or risk of Clinical hold. Also critical is understanding the regulations around mandatory safety reporting.
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$200.00
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