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Understanding Sponsor's Responsibilities for an Active IND

Duration : 60 Minutes

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 D Read more

This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail the 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.

Course 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 new protocol, Protocol revisions, new investigator) as well as the information amendments and its associated timelines for seamless conduct of clinical study
• Learning the IND safety reporting Regulations, follow up reporting and timelines 
• Insight into IND inactivation and withdrawal

Why Should You Attend:

It is important for the sponsor(s)/ Pharma companies to understand the every aspect of the Sponsor’s obligation once an active IND is in place for a clinical study.  Understanding 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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• The following professionals or disciplines will benefit from attending this Webinar:
• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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