Presentations Now Posted!​

The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) will be collecting and submitting comments from its members on the revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) products – Quality Considerations.

The Cascade Impaction Working Group presented CI Testing of Passive DPIs: Best Practices and Relevance to Patient Use –An IPAC-RS Viewpoint at RDD (2018)

IPAC-RS has released a new Cascade Impaction Tutorial Module "Performance Evaluation of Efficient Data Analysis: EDA vs. Grouped Stages."

The revised and updated paper from the Population Bioequivalence WG, “Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers.” has been accepted for publication in AAPS PharmSciTech.

The International Pharmaceutical Aerosol Consortium congratulates the Montreal Protocol Parties on 30 years of progress in ozone healing.

IPAC-RS has submitted comments on USP the Stimulus Article “Proposals for Data Interpretation in the Context of Determination of Aerodynamic Particle Size Distribution Profile for Orally Inhaled Products.”

IPAC-RS has submitted comments to EMA on two recent concept papers.

The Cascade Impaction WG’s paper about results of the second IPAC-RS experiment on discriminating ability of AIM and EDA has been published by AAPS PharmSciTech.

The final program and presentations from the workshop on June 3, 2017 are now available.

IPAC—RS has submitted comments to EMA on the “Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product”.

View IPAC-RS comments on the FDA draft guidance Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.

IPAC-RS has updated Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) to reflect the 2017 regulatory landscape.

Read about recent additions to the IPAC-RS Member Webinar Series.

An Inhalation article about the Cascade Impaction online tutorials is available here. Thank you to all who have contributed to the Cascade Impaction Online Tutorials.

View the newest Cascade Impaction Tutorial on Efficient Data Analysis (EDA)

Don’t forget to register for the free IPAC-RS webinar on PS 9000:2016 Pharmaceutical Packaging Materials for Medicinal Products (GMP) Update Standard

IPAC-RS has submitted comments to MHRA on the draft “Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products.”

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.

The GRRO China and Materials Working Groups are leading the consolidation and submission of IPAC-RS comments on the CNPPA guideline for elastomeric components for drug products (including inhalation products).

The IPAC-RS Human Factors Subgroup is leading the preparation of IPAC-RS Comments on the draft MHRA Guidance Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products.

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.

Presentations are now available from the IPAC-RS Symposium.

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.