Join IDDIs Tara Kervin – VP, Global Operations; VP, IDDI Inc. and ASAP Process Consultings Greg Ball – ASAP Expert as they discuss the following:

• Overview of the nature and purpose of aggregate data and safety assessment as required for trials under an investigational new drug (IND) application.
• Overview of the new draft FDA guidance on Independent Data Monitoring Committees (IDMCs) (published February 2024), highlighting how it differs from previous FDA materials on IDMCs (March 2006).
• The pros and cons of utilizing IDMCs to review aggregate safety assessment reporting vs. other distinct committees.
• Commentary on the necessity of competent independent statistical reporting to best support an IDMC and protect patients, with an emphasis on best practices and advancements to improve the identification of safety issues and produce efficient and tailored IDMC data review meetings
• Why is excellence in safety monitoring essential for new drug
  development?