eTMF - Challenges, Opportunities & Trends
Thursday, December 10th I 11 AM - 12pm EST / 4pm - 5pm GMT
Essential Documents are the evidence that demonstrate Investigators, Sponsors, and Monitors have met the expectations of Good Clinical Practices (GCPs) and related regulations. The documentation stored in the Trial Master File is becoming increasingly digitized driving eTMF adoption across the industry. The trends in industry best practices, regulations and technology will change the models of today and the associated business processes. The careful planning and astute attention to the environment will ensure awareness and timely decision making. It is evident that the changing landscape of partnerships, outsourcing, regulations and guidelines will affect the roles and responsibilities of stakeholders including authors, reviewers and users of eTMF.
This webinar will examine the impact these changes would bring to document management using eTMF. The Sponsor/CRO, Monitors and Investigator/Site roles will be assessed for opportunities in the transition to eTMF trends. Attention will be paid to the anticipated evolution of industry best practices, regulatory guidance and the underlying technology innovations. The action plans will be outlined to optimize changes to eTMF implementation & management processes while ensuring efficiency and compliance. The change management proposals to encourage endorsement and adoption will be discussed.The webinar will cover:
- Describe the potential of eTMF for impact on the business processes currently utilized by regulators, researchers and patients
- Recognize the benefit and challenges, anticipated eTMF trends would bring to business processes
- Identify the opportunities future trends may facilitate for increased compliance and patient safety
Ms. Betsy Fallen is an expert in TMF metrics and MCC Risk-Based Monitoring initiatives. She has proficiency in regulatory and clinical operations, data management, and ancillary supply chains, among other areas.
Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives and SIACs, including the TMF Reference Model, Chair of the SAFE-BioPharma Global Business and Regulatory Group, PhRMA Electronic Regulatory Submissions Working Group, NCI caBIG CRIX and the IRISS Steering Committee Chair.
Currently, Betsy is an independent consultant providing expertise to industry and an active member of DIA