Home » Medical Devices & Diagnostics » [WEBINAR] EU Medical Device Regulation: Preparing for Disruptive (Yet Incomplete) Regulation
Alternative Regulatory Pathways for Rare Disease: Breaking the ICE
There is a heightened sense of urgency by all stakeholders to accelerate development of therapie...
How to Address Culture in Mergers & Acquisitions Integration
Ilana Meskin, Managing Expert, YourEncore Clinical Center of Excellence, reviews M&A Culture within biopharma, the strides it has taken, and the peaks organizations have yet to reach.
Getting the Lingo Right: Expedited Review Programs for Drugs and Biologics
Understanding these terms to pursue your investigational research and the timing of when to partner with the FDA are an important part of navigating the regulatory pathway.
Artificial Intelligence in the Health Care Industry: Part III
In Part III of our series, Tony Ettwein, Managing Expert, Quality Center of Excellence, looks at the role AI can take within drug discovery, early safety signal detection, and diagnostics.
EU MDR Preparation: Ensuring Compliance with Newly Adopted Regulations
The introduction of new EU MDR regulations brings updated requirements and challenges to device manufacturers. Read more from YourEncore Expert Judith Meritz on the future of EU MDR Regulations.
Artificial Intelligence in the Health Care Industry: Part II
In Part II of our series, Tony Ettwein, Managing Expert, Quality Center of Excellence, looks at the challenges and different opportunities for process integration of AI in the Health Care industry.
Artificial Intelligence in the Health Care Industry: Part I
In this brief discussion, Tony Ettwein, Managing Expert, Quality Center of Excellence, looks at the growth of AI, including its use in the health care industry.
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.
Bioethics: Application and Implementation
In this Expert Q&A session, Luann Van Campen, Ph.D., M.A., and Don Therasse, M.D., provide valuable insights into the implementation of bioethics best practices within life sciences organizations.
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