IPAC-RS

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Past IPAC-RS news

2015 IPAC-RS/ISAM Workshop Paper

The paper entitled “Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop” has been accepted for publication in the Journal of Aerosol Medicine and Pulmonary Drug Delivery.

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GRRO European Union - June 2016

The GRRO European Union Working Group has conveyed consensus comments to the British Pharmacopoeia in its inhalation monographs policy document, and to the EMA regarding the OINDP quality guideline and OIP BE guideline.

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IPAC-RS/RDD 2016 Symposium Outcomes

The Symposium brought together scientists, academia, and regulators from around the world to discuss important topics related to the development of inhaled pharmaceuticals. The well-planned program drew over 165 attendees from 16 countries.

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Device Working Group Comments to FDA

The Device Working Group has submitted comments on the FDA Draft Guidance, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.

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