Welcome to IPAC-RS. We are an international association of innovator and generic companies that develop, manufacture or market orally inhaled and nasal drug products for local and systemic treatment of a variety of debilitating diseases such as asthma, chronic obstructive pulmonary disease and diabetes.

We are committed to advancing consensus-based, scientifically driven standards and regulations for these products, with the purpose of facilitating the availability of high-quality, safe, and efficacious drug products to patients.

Leachables and Extractables Handbook

The book, Leachables and Extractables Handbook: Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products has now been published. The book addresses safety and best practices related to leachables and extractables, as well as chapters on inorganic leachables and foreign particles. Also included are the protocols from the PQRI L&E work. Authors include IPAC-RS participants, regulators (FDA and Health Canada), and industry experts from outside of IPAC-RS.

The book is available at Wiley. Please share this link and information with your colleagues.

IPAC-RS Device Working Group Presentation at IBC Conference on Human Factors for Drug-Device Combination Products

The IPAC-RS Device Working Group will give a presentation at the upcoming IBC Human Factors for Drug-Device Combination Products conference to be held on May 14-15, 2013. This conference brings FDA representatives together with drug and device developers to address HF challenges specifically for developing drug-device combination products, such as: Regulatory Guidance and Standards on Human Factors Studies for Drug-Device Combination Products; How to Incorporate Human Factors Engineering into Development Programs; Understanding HF Methodologies, their Applications and Limitations. The program is tailored for both small molecule drug developers and biologics drug developers whose drug is combined with a device. IPAC-RS members can save 20% with Priority Code: B13502IPAC20.

Patient Concordance Presentation at 2013 ISAM Congress

Barbara Yawn, a member of the Patient Concordance Steering Committee, will give a presentation on the IPAC-RS Patient Concordance Initiative at the ISAM Congress on Sunday, April 7th. Her presentation will be a part of the fourth session, “Improving Patient Adherence/Compliance for Inhaled Therapies.”

IPAC-RS/UF Orlando Inhalation Conference: Approaches in International Regulation

On March 18-20, 2014, IPAC-RS and the University of Florida will host a public conference entitled "Orlando Inhalation Conference - Approaches in International Regulation" where industry, regulators and other interested parties will discuss best scientific and regulatory approaches for orally inhaled and nasal drug products. Click here for information on the 2014 IPAC-RS/UF Conference.

IPAC-RS/AAPS INTFG/USP/FDA Inhalation Workshop

On September 9-10, 2013, IPAC-RS/AAPS INTFG/USP/FDA will hold a public workshop entitled Inhaled Drug Products: Current Practices and the Future of In vitro Testing Technologies and Regulation. Click here for information on the 2013 Workshop.

IPAC-RS Webinars

The IPAC-RS OINDP Materials Working Group held a webinar series addressing aspects of materials quality and their publicly available Baseline Requirements for Materials used in OINDP. To access the presentations and audio from the earlier webinars see: OINDP Materials Webinars.

The IPAC-RS Device Working Group held an educational webinar about the use of human factors assessments in the development of OINDP on July 19. The webinar provided an opportunity to learn more about how human handling studies are integrated into device design, current regulatory expectations, and the 2011 FDA Draft Guidance on Human Factors. The audio and slide presentation from the webinar are available at: IPAC-RS Device Group

Our members include:

	3M
	AstraZeneca
	Boehringer Ingelheim
	Catalent
	Chiesi
	GlaxoSmithKline
	MannKind Corporation
	MAP Pharmaceuticals
	Merck & Co., Inc.
	Mylan
	Novartis
	Pfizer
	Sunovion
	Teva
	Vectura Ltd.
	Watson

In addition, the following suppliers of device components for orally inhaled and nasal drug products participate in the Supplier Quality Control Initiative of IPAC-RS:

	Aptar Pharma
	Medspray
	Rexam
	West