Inhalation Drug Delivery Videos

  1. Nasal Spray Development And Manufacturing Services 7/11/2023

    See why partnering with experts with experience in complex, sensitive, and potent APIs, screening for the optimal formulation, and scaling up efficiently is vital for successful trials and commercialization.

  2. Post-Market Surveillance And Post-Approval Changes For Combination Products 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on post-market regulatory considerations and processes for combination products. Among the topics covered are post-approval changes, design outputs, patient safety, and various regulatory guidances.

  3. 3 Key 'Look Forwards' In Drug Delivery Regulatory 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.

  4. Risk Management and the New QMSR 7/11/2024

    What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.

  5. Pathways For Pulmonary Delivery

    As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.

  6. PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

    Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

  7. Public Health Drivers Of Delivery Enablers: An Emergency Use Case 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, traces the evolution of delivery technologies for the opioid overdose drug Naloxone to illustrate enablers of emergency use not requiring trained professionals to administer.

  8. What Happened to CAPA (Corrective and Preventive Actions) Requirements? 7/11/2024

    Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.

  9. Understanding Supplier Quality And Controls For Combination Products 5/12/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 10 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Fran DeGrazio. On the topic of supplier quality and controls, Susan and Fran discuss key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.

  10. Defining and Regulating Combination Products: An Evolutionary Journey 10/15/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.