YourEncore Blog

  • How to Address Culture in Mergers & Acquisitions Integration

    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.

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  • Getting the Lingo Right: Expedited Review Programs for Drugs and Biologics

    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.

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  • Artificial Intelligence in the Health Care Industry: Part III

    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.

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  • EU MDR Preparation: Ensuring Compliance with Newly Adopted Regulations

    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.

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  • Artificial Intelligence in the Health Care Industry: Part II

    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.

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  • Artificial Intelligence in the Health Care Industry: Part I

    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.

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  • The Growing Field of Regulatory Policy & Intelligence

    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.

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  • Defining Regulatory Policy & Intelligence

    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.

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  • Strategic Planning in Clinical Trials and Drug Supply

    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.

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  • Bioethics: Application and Implementation

    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.

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  • Audits: A Brave New World, Time for a Refresh?

    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.

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  • Good Laboratory Practices - The Importance of Preparation and Execution

    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.

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  • Compliance, Clinical Operations, or Quality: What Team Do You Play For?

    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.

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  • Data Integrity - It's All About the Data!

    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.

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  • Clinical Regulatory Inspections – and why I love them

    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.

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  • Quality Best Practices From an IT Perspective

    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.

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  • A Call to Action for Impactful Clinical Audit Reports

    A Call to Action for Impactful Clinical Audit Reports

    Jane Wood, Principal of YourEncore's Quality Center of Excellence, discusses what constitutes a great audit report.

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  • For FDA Inspection Readiness, Accountability is Key

    For FDA Inspection Readiness, Accountability is Key

    Dawn Wydner, former FDA Consumer Safety Officer, LCDR, and Managing Expert for YourEncore’s Quality Center of Excellence discusses best practices for getting and staying inspection ready.

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  • Has Anything Really Changed in Clinical Quality?

    Has Anything Really Changed in Clinical Quality?

    Read about some shifts and changes in the Clinical Quality landscape, authored by Jane Wood, YourEncore's Quality Center of Excellence Principal.

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  • State of the Industry: The Evolution of Quality and its Upcoming Challenges

    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.

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