Home » Biopharmaceutical/Biotech » [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.
[WEBINAR] Lunch Briefing: Understanding and Maximizing the Califf FDA
Dr. Robert Califf’s confirmation as FDA Commissioner will shape the future of American healthcare. So what ...
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.
Understanding the RTF Letter - White Paper
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.
The Clinical Development Plan - Ensuring Success; Part 1: Developing the Clinical Strategy
The Clinical Development Plan - Ensuring Success; Part 2: Executing the Clinical Strategy
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 Management Systems: A Business Imperative
Quality management used to be about completing checkbox audits, meeting compliance requirements, and correcting problems after the fact. Read our FREE White Paper to learn more.
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.
The Path to Patient Centricity: Part IV
Learn more from Regina Shanklin on how maximizing engagement with your audience and patients will help increase the relevance of your brand communications
The Path to Patient Centricity: Part III
Learn more from Regina Shanklin on how being useful to your audience and patients will help increase the relevance of your brand communications
The Path to Patient Centricity: Part II
Learn more from Regina Shanklin on how being completely understandable to your audience will help increase the relevance of your brand communications
The Path to Patient Centricity: Part I
Learn more from Regina Shanklin on how seeing things from the patient’s point-of-view will help you meet them where they are and increase the relevance of your brand communications
How Smart Biotechs Scale Organizations Fast and Maximize Value