ComplianceOnline, Online Event
2012-06-29
Why Should You Attend: All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator’s brochure and other relevant information. These requirements are particularly tough for sponsors of Phase I and First-in-Man (FIM) clinical trials since these trials are usually planned early on in the development phase with limited preclinical information and may use a preliminary formulation of the investigational product.
This 3-hr virtual seminar would discuss general and specific issues to be considered for IND containing Phase I and FIM trials. This seminar is a must for those writing their first IND application, particularly those moving a new product from R&D phase into clinical phase of development. Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. This workshop contains a collection of practical tips from the trainer’s extensive IND submission experience. Agenda:(PDT) - 10.00am PDT to 11.30am (Session 1)
- 11:30am - 12.00 Noon (Break)
- 12.00pm to 1.30pm (Session 2)
Areas Covered in the Seminar: Session 1:
What you must know about an IND: Content and Format of IND sections - Overview of IND regulations.
- 10 essential sections of an IND.
- Creating product background (CMC), preclinical and clinical testing, clinical protocol, and Investigator's Brochure for an IND for a Phase I trial.
- Rationale and justification for IND for FIM clinical trials.
- Acceptable clinical development plan, clinical procedures for Phase I clinical trials.
- Using non-IND information and publications.
- Best practices for format and content arrangement.
- What information to be included and what to be avoided.
- Overview of practices at FDA regarding review and management of INDs.
- List of common mistakes and tips to address the same.
Session 2:
Practical Issues and Potential Solutions for an IND for FIM and Phase I Clinical Trials - Evaluating adequacy for available information in support of a clinical trial.
- Creating an IND submission strategy.
- Logistics of a pre-IND meeting with the FDA.
- Amending clinical protocols and informed consent, manufacturing information, providing additional preclinical and clinical information, etc.
- Subject recruitment and adverse event reporting.
- Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc.
- Special protocol assessments, orphan indications, fast-track designation and small business incentives available to early developers.
- Written and verbal request for comments and FDA meetings for further guidance.
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Invited Speakers:
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Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India.
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