Best Practices for Maintaining an IND and IDE Application with FDA

Why Should You Attend:

If your company has active IND or IDE applications with the FDA or are planning to file one soon, this seminar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial. You can get valuable tips and training in less than an hour on practical methods for collecting required documents for submission to the FDA, submitting the amendments, follow-up on submissions, and maintaining adequate communications with regulatory project management staff at the FDA. The presenter will share practical tips from his extensive personal experience.

Areas Covered in the Seminar:

• IND and IDE annual reports
• Amending clinical protocols and informed consent, manufacturing information, providing additional preclinical and clinical information, etc.
• Format, content, editing and submission of various documents to an IND or an IDE.
• What should or should not be submitted in an IND or IDE.
• Adverse event reporting.
• Adding new clinical protocols to or creating a new IND or IDE for each new protocol.
• Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc.
• Written and verbal request for comments and FDA meetings for further guidance.
• Suspending, reopening, closing and withdrawing an IND or an IDE.
• Differences and similarities between an IND and IDE application logistics and management.
• Dos and don'ts of communicating with project management staff at the FDA.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Compliance/Regulatory affairs professionals
• Clinical trial professionals (e.g., CRAs, coordinators)
• Investigators participating in clinical trials
• Sponsors and investigator-sponsors of clinical trials
• Clinical trial specialists
• Project Managers
• People investing in FDA-regulated product development projects

Instructor Profile:

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 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. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

An IND or an IDE is a “living” document. A sponsor is required to submit various reports and updates to keep the FDA aware of all new information regarding the product under investigation under the IND or IDE. In addition, FDA may contact the sponsor with additional information requests. Depending on the nature of the new information, the sponsor may simply notify FDA or have to wait for FDA guidance before proceeding further. A sponsor may also decide to amend an IND or an IDE for business or logistical reasons. This session will discuss the best practices to keep an IND/IDE in regulatory compliance, and contacting FDA for guidance. Role of the sponsor, all the reports and documents that need to be submitted to an IND or IDE, what needs to pre-approval and what can just be notified to FDA, process for IND/IDE amendments, differences between IND and IDE application management and submissions, and practical tips to assure best practices with regards to FDA project management staff will be discussed.

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