Overview:
The new draft FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials marks the first update in nearly 20 years. This revision introduces several significant changes to the management and operation of DMCs in clinical trials.
Join our webinar to explore these important updates and their implications for DMCs. Attendees will learn how the potential changes to the guidance will affect the operational aspects of DMCs, including management, statistical analysis, and delivery.
Key takeaways:
- Understand the history and evolution of DMC guidance and get a comprehensive look at the major revisions and their rationale
- Learn about new requirements for committee formation and function and discover best practices for adapting to the new guidance
- Learn about updated guidelines on committee membership, managing conflicts of interest, and ensuring confidentiality
- Get insights on how the new guidance affects statistical analysis and data interpretation and get up to speed on the latest reporting requirements for DMCs
Register today to stay informed about the latest developments and how they may impact your clinical trials.
Audience:
- Biostatisticians
- Data Monitoring Committee members
- Regulatory Affairs
- Ethics Committee members
- Clinical Operations
- Clinical Project Managers
- Safety Committee consultants & experts
Speakers:
Karen Shaffer
Karen is a registered nurse with over 25 years of clinical research experience spanning small biotech and large pharmaceutical companies. Her diverse roles have included positions in clinical sites, medical information, drug safety, and over 15 years specialising in Data Monitoring Committees (DMCs). Karen has managed over 100 DMCs for government-led studies, major pharmaceutical firms, and small biotech clients. She currently oversees a team of 18 project managers, statisticians, and programmers across multiple therapeutic areas.
Patricia Braschayko
Patricia has 18 years of biostatistics and programming health research experience spanning pre-clinical to Phase III clinical trials, including 7 years in management roles. She has led studies for federal, large pharma, and small biotech clients across a wide variety of indications. She is dedicated to protecting patient safety by ensuring data review committees are provided with accurate, complete, timely data to support trial oversight.
Birgit Geiger
Birgit is a registered nurse and a seasoned manager with 19 years of clinical research experience, including 16 years in Data Monitoring Committee (DMC) management and 8 years in Pharmacovigilance and Regulatory Affairs. Since 2015, she has led the ICON DMC team across Europe, India, and Japan, providing portfolio oversight for major pharmaceutical companies and small biotech firms. Birgit excels in organisational skills, effective risk management, and process improvement, consistently delivering high-quality results in fast-paced environments.