Halloran Senior Consultant, Sam Zappia presents a webinar in partnership with the Life Science Training Institute on May 7, 2015, when she will teach
Your team has been working around the clock to meet your corporate objective of an IND submission in Q4 of this year, but you’ve had some delays. You’re still waiting on the final GLP toxicology study report from your CRO, the Certificate of Analysis from your CMO of the GMP run to supply the clinical trial, and the final version of investigational brochure from your contract medical writer. The phone rings: you hear your CRO on the other side say that their QA won’t release the final GLP toxicology report for two weeks. Will you be able to submit your IND on time? This is just one of many scenarios that can thwart your best efforts, but fortunately can be avoided.
This 90-minute session will help prepare you to have a successful IND filing, while reducing the risk of last minute changes, and how to effectively handle any submission issues that derive from the IND development process. Topics include:
- Overview of IND development process
- How to effectively write and review IND documents
- How to effectively handle documents from CROs and CMOs
- Common IND pitfalls
- How to effectively handle pitfalls and reduce risk of occurrence
After attending this interactive live session and you will be able to:
- Identify common pitfalls associated with IND preparation and filing
- Apply effective tools to mitigate risks during IND development
- Resolve issues that derive from the IND development process swiftly and effectively
Whether you are new or a veteran to preparing and submitting INDs to the FDA, this session will provide key strategies to help you streamline your IND development process, and to help you manage any last minute hiccups.
WHO SHOULD ATTEND
This course will benefit anyone who plans to file an IND with the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. This session is specifically beneficial for sponsors with novel products in discovery and early stages of product development, who are looking ahead at the next steps.
Time: 1:00-2:30pm EDT
Date: May 7, 2015
Duration: 90 minutes
Price: $299 Introductory Rate
For more information and to register, please click here.
(Thursday) 10:00 am - 11:30 am