Podcasts

  1. Safety Reporting Requirements For Marketing In The EU 7/6/2023

    Uncover the complexities of managing European pharmacovigilance legislation and the additional challenge of navigating individual requirements set by each EU Member State, which may implement regulations differently at the national level.

  2. How The Quality Culture Impacts GMP Activity 2/22/2023

    Londa Ritchey shares invaluable insights derived from her extensive experience, shedding light on the pivotal role of fostering a strong quality culture in maintaining GMP compliance.

  3. Managing The Medical Device Pre-Submission Process With The FDA 1/17/2023

    Mohammad Asad offers valuable insights and strategies gleaned from his expertise, illuminating effective approaches to navigate this critical regulatory pathway.

  4. Digitalization As A Tool In The Outsourcing Journey 1/9/2023

    Understand why the integration of digitalization, particularly automation and AI, is instrumental in optimizing processes and strengthening the effectiveness of these outsourcing relationships.

  5. Improve Efficiency And Mitigate Risk Through Strategic Development 12/5/2022

    Explore the concept of strategic product development as a pivotal component of an integrated strategy aimed at delivering new drugs to patients in need.

  6. How The MDR Has Changed The Roles And Responsibilities Of 'Economic Operators' 8/8/2022

    Explore the evolving roles and responsibilities of "economic operators" under the MDR as Clare Huntington offers insights from her experience navigating the regulatory landscape of medical devices.

  7. Opportunities In Pharmaceutical Outsourcing: Portfolio Maintenance 7/6/2022

    The emerging frontier in outsourcing involves managing established products, offering revenue sustainability, cost-efficiency, and compliance assurance.

  8. Solving The Innovation Dilemma With Integrated Product Development 6/1/2022

    Insights from a recent survey of senior pharmaceutical and biotech executives reveal the rising significance of IPD programs in efficiently launching new drugs to market.

  9. How Software Is Changing The Use Of And Types Of Medical Devices 5/13/2022

    In this episode, Yervant Chijian offers valuable insights regarding the transformative impact of software on the utilization and diversity of medical devices, derived from his expertise in navigating the evolving landscape of medical technology.

  10. Annex 1 – Are You Ready For Implementation Of The New Annex? 4/6/2022

    Dive into insightful discussions with PharmaLex expert Patrick Nieuwenhuizen as he highlights the key revisions and offers strategic insights on effectively implementing the updated Annex 1 guidelines.