DIA: Driving Insights to Action
Science:Life Sciences
In April 2021, the Regulatory Information Management (RIM) Working Group of DIA’s Regulatory Affairs Community issued Version 2.0 of the RIM Whitepaper that provides insights relating to eleven key regulatory capability areas including RIM implementation considerations, processes, and best practices. The Whitepaper also provides context for the RIM Reference Model in development. “One of the key aspects of the model is standardizing terminology and relationships between information,” explains IQVIA Senior Regulatory Affairs Director Donald Palmer in this conversation moderated by Ennov Director of Product Management Kathie Clark. “It puts the stake in the ground in terms of the basic data elements required to support regulatory in its business process and also other functional areas which depend on regulatory,” continues Venkatraman Balasubramanian, Senior Vice President, Life Sciences, Orion Innovation. “If we can put the best practices out there, we all align on the hope that this will allow industry to bring life-saving or life-improving medications and therapies to patients faster. We're hoping to make a big difference,” concludes Pat Shafer, Managing Director, FTI Consulting. Download Version 2.0 of the RIM Whitepaper.
Cancer Data Ecosystem Powering Moonshot Relaunch
Complexity Continues to Challenge Clinical Costs
Maximizing Regulatory Resources Across Latin America
Data Intersections Connecting Drug Development with Clinical Care
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1
Advanced Tests and Therapies Making Daily Care Anything But Routine
Innovation Without Access Will Never Meet Patient Needs
Three Good Reasons to Use Artificial Intelligence in Pharmacovigilance
EU Regulatory Strategies Shaping and Shaped by Pandemic Response
Telehealth Emerging in Japan’s Clinical Research and Care
Aligned Review Timelines Key to Co-Developing Companion Diagnostics
Early Access Programs Complicating Comparative Data Analyses
New PAHO Report: Strength in Regulatory Reference and Reliance
eLabeling More than Moving from Paper to Digital
Australia: Growing Clinical Trials Even in Pandemic’s Wake
Remote Tools Keep Japan's Research Moving
DIA Promoting Community, Pushing Back Misinformation
Japan Healthcare 2035: Focus on Basic Science & Economics
Create your
podcast in
minutes
It is Free
DNA Today: A Genetics Podcast
Short Wave
Unexplainable
Stuff To Blow Your Mind
Breakthrough