IDDI Lunch & Learn in Durham, NC

May 2, 2024

Research Triangle Park, NC

SAILING SMOOTH SEAS: CHARTING THE COURSE THROUGH NEEDED ADVANCEMENTS IN SAFETY REPORTING AND NEW FDA GUIDANCE ON IDMCs

IDDI and ASAP Process Consulting are pleased to invite you to an exceptional complimentary Lunch & Learn on IDMCs and safety reporting.

Thursday, May 2 – 11:30am – 2:00pm |  Research Triangle Park, NC

REGISTER TODAY

 Limited availability! Register by April 25th to save your seat! 

WHAT YOU WILL LEARN:

  • IND Safety Reporting
  • Data Monitoring Committees (DMCs)
  • Development Safety Update Report
  • FDA Medical Queries (FMQs)
  • Standard Safety Tables and Figures
  • The Difference between DMC Reports and CSRs
  • 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?
    • Engages critical team members (partnerships between clinical safety professionals, safety data scientists, biostatisticians, and other stakeholders)
    • Supports the iterative nature of the process (learning and decision-making process throughout clinical development)
    • Recognizes advantages and availability of various data sources over time (leveraging technology and interactive safety graphics in the regulatory decision-making process)
    • Efficiently protects study participants and the future public health (not everything is a one-size-fits-all solution in clinical trials, drowning in useless data is not the answer to a risky problem)

SPEAKERS 

Tara Kervin, MPH: 
VP, Global Operations & Consulting; VP, IDDI Inc.

Greg Ball: 
Safety Data Scientist; ASAP Process Consulting

LOCATION

North Carolina Biotechnology Center
  • Board Room at the NC Biotech Center
  • 15 TW Alexander Dr., Durham, NC 27709

AGENDA

  • 11:30am: Registration
  • 11:45am – 12:15pm: Networking & Lunch
  • 12:15pm – 1:35pm: Speakers’ Presentations
  • 1:35pm – 2:00pm: Panel Q & A
REGISTER NOW

We hope you will be able to join us! 

SEATS ARE LIMITED –  Register by April 25th to save your seat!