Biopharmaceutical/Biotech

Access thought leadership from YourEncore Experts on the Biopharmaceutical & Biotech industry.

  • 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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  • Understanding the RTF Letter - White Paper

    Understanding the RTF Letter - White Paper

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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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  • The Clinical Development Plan - Ensuring Success; Part 1: Developing the Clinical Strategy

    The Clinical Development Plan - Ensuring Success; Part 1: Developing the Clinical Strategy

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  • The Clinical Development Plan - Ensuring Success; Part 2: Executing the Clinical Strategy

    The Clinical Development Plan - Ensuring Success; Part 2: Executing the Clinical Strategy

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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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  • Quality Management Systems: A Business Imperative

    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.

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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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  • 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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  • 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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  • The Path to Patient Centricity: Part IV

    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

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