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How to create an aligned global co-development strategy for drug with device component combination products

Post thumbnail How to create an aligned global co-development strategy for drug with device component combination products

Drug delivery technologies are becoming increasingly complex and integrated, combining various advanced technologies with the intent to deliver the drug with the right dose, at the right time and right location, in the right way.

The goal of this webinar is to look at this drug-device co-development journey from 5 key aspects: Regulatory & Quality Assurance, Time & Costs, Legal/Contracts, Global Development, and Knowledge & Resources. We utilize a drug/device case study to illustrate the importance of co-development and communication between device and pharma industry. We also compare and contrast the current US and EU combination product regulatory pathways and provide considerations for strategy and good practices for drug/device combination products.

Key topics include:

  • Comparing and contrasting the differences between device and drug regulation to bridge gaps in understanding and develop integrated combination product strategies.
  • Integrating Regulatory & Quality Assurance, Time & Costs, Legal/Contracts, Global Development, and Knowledge & Resources into an overall product development strategy and assessing their impacts on FDA and EU Medical Device Regulation.
  • As the new MDR coming into force soon and FDA guidance evolves, anticipate it whenever possible during the co-development journey.

We were pleased to receive so many questions during our webinar. We have compiled a Q&A summary for you to use as a quick reference guide. Webinar Q&As

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    Sample of the webinar

    How to create an aligned global co-development strategy for drug

    Featured Speakers

    Marielle Fournier
    Marielle Fournier, Pharm.D.
    Senior Director, Drugs, Devices & Combination Products
    As a Senior Director at VCLS, Marielle is responsible for leading the Medical Device and Combination Products Group, as well as the VCLS Microbiome Task Force.   Marielle follows closely the evolution of new regulations and she has specific expertise in the design…
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    Michael Husband
    Michael Husband
    Director, Medical Devices and Combination Products
    Michael Husband received his Bachelor of Engineering in Biomedical and Chemical Engineering from Vanderbilt University and his Masters of Science…
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    Brian Monks thumbnail
    Brian Monks
    Business Development