PRACTICAL GUIDANCE AND BEST PRACTICES FOR DEVELOPING AND MAINTAINING INVESTIGATOR BROCHURES

Pharmaceutical medical writers, in collaboration with the appropriate key team members, are responsible for the creation of the Investigator’s Brochure (IB), as well as the management of updates. The purpose of the IB is to inform the Investigator and study personnel about the nonclinical, chemical and manufacturing, and clinical (efficacy/safety) aspects of the drug, as well as safety monitoring procedures and the clinical management of study participants. The medical writer must ensure the IB is a living document that is concise, non-promotional and unbiased, readable, always up to-date, and in accordance with Good Clinical Practice (GCP). Topics of discussion will include:

• Determining when a new IB or update is needed
• Planning the IB, including the inclusion of appropriate content to support clinical participation
• Organizing and facilitating strategic meetings
• Writing and managing the IB content
• Facilitating strategic review of the IB

Speaker:
Lynne Munno
Senior Manager of Medical Writing
Pharmacyclics (an Abbvie company)

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​