Home » Medical Devices & Diagnostics » [WEBINAR] YourEncore Regulatory R.A.N.T: PDUFA and Other Pressing Policy Issues
With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is a dynamic and uncertain time in the biopharma industry. The outcomes of these key policy debates, along with others, will impact how industry pursues drug development and works with patients and regulators to improve public health. To advance the conversation and propose practical ways forward, YourEncore assembled a panel of regulatory experts, including former industry and FDA leaders, to share their best thinking on pressing regulatory policy issues in the biopharma industry.
YourEncore Insights Greatest Hits of 2015
Billboard recently released its “Hot 100 Songs of 2015,” and it inspired me to think about YourE...
The Growing Field of Regulatory Policy & Intelligence
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 2 of her Expert Q&A.
Defining Regulatory Policy & Intelligence
Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence defines Regulatory Policy & Intelligence in Part 1 of her Expert Q&A.
Strategic Planning in Clinical Trials and Drug Supply
Jason Nolte, Clinical subject matter expert, discusses the importance of strategic planning teams and what they must utilize to stay relevant in the Clinical Trial & Drug Supply industry.
Audits: A Brave New World, Time for a Refresh?
Written by Jane Wood, this is an abbreviated version of an article in The RQA Magazine about the rapidly evolving world of clinical trials and the technology and data that rule within them.
Good Laboratory Practices - The Importance of Preparation and Execution
Deb Sedor, former Director of Quality Assurance at J&J, and Managing Expert for YourEncore’s Quality CoE, discusses the importance of preparation and execution when it comes to Good Lab Practices.
Compliance, Clinical Operations, or Quality: What Team Do You Play For?
Some pharma professionals need a gentle reminder that they are, in fact, on the same team – driving toward the same goals. Read more from Arti Bajpai about quality and compliance in a team setting.
Quality Best Practices From an IT Perspective
Tony Ettwein, Managing Expert of YourEncore's Quality Center of Excellence, provides valuable insights into audits in IT and the different AI systems that will soon affect the Quality landscape.
State of the Industry: The Evolution of Quality and its Upcoming Challenges
Jane Wood, former Head of R&D Quality at J&J, and Principal of YourEncore’s Quality Center of Excellence discuss the current state of Quality and the future of regulation adaptation.
Data Integrity - It's All About the Data!
Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses the importance of Data Integrity in any Quality system.
Clinical Regulatory Inspections – and why I love them
Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses the importance behind clinical regulatory inspection readiness.
How Smart Biotechs Scale Organizations Fast and Maximize Value
A Kickstart for Your Development Programs
Joseph Lamendola, PhD and Timothy Franson, MD walk through the requirements for kickstarting a new development program in a Biopharma organization.
Leveraging the Evolving Regulatory Landscape to Accelerate Drug & Medical Devices Development
The Food & Drug Administration has actively engaged in efforts to issue new regulations and guidance aimed at driving innovation, reducing risk, and improving patient safety.
[WEBINAR] Leveraging Evolving Regulatory Landscape to Accelerate Drug & Device Development
How Blockchain is Revolutionizing the World and Changing Healthcare as We Know It (Ep. 20 of The Pharmcast)
In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain. We've heard some people...
Ten Tips for Enterprise Technology Adoption in Pharma
The RFP processes are robust, the ROI models are compelling, the software is best of breed, and the expectations are high. So, why do so many software deployment programs in Pharma fail...
[WEBINAR] Drug-Device/Diagnostics Combination Products: Understanding the Rapidly Changing Landscape
State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)
In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently...
The Frontiers of Rare Disease Development: Advances in Regulatory Science with Dr. Tim Franson (Ep. 18 of The Pharmcast)
This week on The Pharmcast, we catch up with Dr. Tim Franson to discuss the leading edge of rare disease drug development. Dr. Franson has been actively helping Parent Project...
[WEBINAR] State of the Industry Webinar: U.S. Regulatory Policy Improvements