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TOPRA/RAPS Workshop on Alignment of Global Combination Products

Post thumbnail TOPRA/RAPS Workshop on Alignment of Global Combination Products

The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel of speakers included representatives from the European Medicines Agency (EMA), EU notified bodies, US FDA officials, regulators from Health Canada, the Malaysia Medical Devices Agency, Anvisa, the UK’s Medicines and Healthcare products Regulatory Agency and industry experts, all exploring the challenges and looking for commonalities in the regulation of medical products with both drug and device components.

Brian Savoie, VP of Educational and Professional Development at RAPS and Samantha Cooper, Director of Professional Development at TOPRA, welcomed the attendees and presenters and opened the workshop with an innovative poll about priorities. The focus of the workshop was to discuss different perspectives, share best practices, quality management and solutions for challenges for combination products.

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    publication by

    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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