Sponsor's Responsibilities for an Active IND
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 ObjectivesUnderstanding each and every Sponsor responsibility in greater detail helps mitigate any delays in the clinical study or minimize the chances of a clinical holdThe 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 studyLearning the IND safety reporting Regulations, follow up reporting and timelines Insight into IND inactivation and withdrawalAreas 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 involvedProtocol amendments (New protocols, protocol revisions, new investigator)Information amendmentsIND Safety reporting regulations and timelinesIdentification and options for resolution of the clinical holdAnnual reportsInactivation of an IND, Withdrawal of an INDSome tips on the best practices to circumvent any delays or clinical hold Who Should AttendRegulatory affairs professionalsSenior management executives (CEO, COO, CFO, etc)Drug discovery and development professionals (R&D and CMC)Intellectual property expertsProject Managers and Clinical trial specialistsRegulatory Compliance Associates and ManagersPeople investing in FDA-regulated product development projectsWhy Should You AttendIt 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.
Single
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.
