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.
Regulatory & Ethical Considerations in a Pediatric Trial
Patient-Focused Drug Development: What Must We Still Do?
Interchangeable Biosimilars: A Global Perspective
Game Technology Opens New Path to Clinical Endpoints
Challenges and Opportunities for South Africa’s New Regulatory System
Clinical, Data, and Quantitative Science Now Converging
Realizing the Full Potential of CRISPR: Is the Hype Getting in the Way of Progress?
Tackling Ethical Questions in Clinical Research and Drug Development
WHO 2030 Framework for Efficient, Effective Regulation
AI: Opportunity for More Informed Drug Development Decisions
Clinical Training Critical in China’s Cancer Fight
Changing Research in China: From Generics to Innovators
Running Away from Addiction Has Caught Up with US
Has the Time for Big/Real World Data Finally Arrived?
Will AI Make Workers More (or Less) Valuable?
PvPI: Technology Meets Opportunity to Improve Safety
New EU CTR: One Application, One Portal, One Decision
US Generic Drug Policy: Less Cost, Same Impact
Multiple Pathways Complicate Opioid Pain Management
Breakthrough for Patients & Regulatory Science
Create your
podcast in
minutes
It is Free
DNA Today: A Genetics Podcast
Short Wave
Unexplainable
Stuff To Blow Your Mind
پادکست آذرخش مکری - azarakhsh mokri