During the course of clinical research, the Investigator’s Brochure (IB) is the data repository for an investigational product; effectively this is the product’s “label” during the investigational stage. The IB is a dynamic document which changes as the information about the compound changes, and is critical in clinical research as physicians and IRBs refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing information, manufacturing information, clinical and nonclinical study results. The IB needs to be updated during the course of the clinical investigation; update frequency is dictated by the product and the company.
To facilitate the transfer of information, the IB must be concise, well written and provide a summary for a physician to quickly reference. While ICH E6 and 21 CFR 312.23 provide an outline of the requirements, how companies address these requirements and the degree of information provided differs. We will review the IB’s required contents, tips and techniques for creating a “highlights” synopsis, strategies for gathering the required data, effective writing techniques with teams, and strategies for the editing, review, and frequency of content updates.
- Describe the IB, section by section
- Discuss regulatory requirements and definitions of an IB per ICH E6 and 21 CFR 312.23
- Identify who contributes to the IB
- Provide timing of construction of the IB
- Identify the IB audience (s)
- Regulatory Affairs
- Medical Writers
- Clinical Research
- Research and Development
The course will be led by one of the following instructors:
Meredith Brown-Tuttle, R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Review the need and regulatory requirements for an IB
- Review of the IB, Section by Section
- Managing the review team and timeline for first drafts and updates
Length of IB
- How a Target Product Profile or Draft Package Insert can be drafted based on IB
- When should the IB be updated, by who and what documents the update effects
- Audience for the IB (including their needs and perspective)
- How to write the various sections of the IB
- How best to conduct the IB team review and edit the IB (initial and update)
- How to write the Draft Package Insert based on the IB
- When to update the IB and what to include
- Review of effective and not so effective Investigator Brochure’s.
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-11-083-L01-P. Released 9/11.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.