title: Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop.
abstract: This article reports on discussions at the 2015 workshop cosponsored by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and the International Society for Aerosols in Medicine (ISAM), entitled "Regulatory and Patient Considerations for Inhalation Device Design, Development and Use." Key topics addressed at the workshop and presented here include patient-focused device design for orally inhaled products (OIPs), instructions for use (IFU), human factors, regulatory considerations in the United States and Europe, development of generic inhalers, quality-by-design, and change management of OIP devices. Workshop participants also identified several areas for further consideration and emphasized the need for increased focus on the patient to create therapeutic products (inclusive of device design, IFU, education, training) that support adherence with an individual patient's treatment regimen. Advances in patient-centric product development will require engagement and collaboration by industry, regulators, patients, physicians, and other stakeholders. The article includes summaries of presented talks as well as of panel and audience discussions.
authors.affiliation: 1 Hôpital Cochin, AP-HP and University Paris Descartes (EA2511) , Sorbonne Paris Cité, Paris, France .
authors.forename: Nicolas
authors.initials: N
authors.lastname: Roche
authors.affiliation: 2 Ventaleon GmbH , Gemünden, Germany .
authors.forename: Gerhard
authors.initials: G
authors.lastname: Scheuch
authors.affiliation: 3 Philips Respironics , Tangmere, West Sussex, United Kingdom .
authors.forename: John N
authors.initials: JN
authors.lastname: Pritchard
authors.affiliation: 4 Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) , Bonn, Germany .
authors.forename: Cornelia
authors.initials: C
authors.lastname: Nopitsch-Mai
authors.affiliation: 5 US Food and Drug Administration, Center for Devices and Radiological Health , Silver Spring, Maryland.
authors.forename: Deepika A
authors.initials: DA
authors.lastname: Lakhani
authors.affiliation: 6 US Food and Drug Administration, Center for Drug Evaluation and Research , Silver Spring, Maryland.
authors.forename: Bhawana
authors.initials: B
authors.lastname: Saluja
authors.affiliation: 7 Medicines and Healthcare Products Regulatory Agency , London, United Kingdom .
authors.forename: Janine
authors.initials: J
authors.lastname: Jamieson
authors.affiliation: 8 GlaxoSmithKline , Ware, Hertfordshire, United Kingdom .
authors.forename: Andrew
authors.initials: A
authors.lastname: Dundon
authors.affiliation: 9 Mylan , Dublin, Ireland .
authors.forename: Roisin
authors.initials: R
authors.lastname: Wallace
authors.affiliation: 10 GlaxoSmtithKline, Research Triangle Park , North Carolina.
authors.forename: Susan
authors.initials: S
authors.lastname: Holmes
authors.affiliation: 11 Aradigm , Hayward, California.
authors.forename: David
authors.initials: D
authors.lastname: Cipolla
authors.affiliation: 12 Department of Medicine, McMaster University , Hamilton, Canada .
authors.forename: Myrna B
authors.initials: MB
authors.lastname: Dolovich
authors.affiliation: 13 Teva , West Chester, Pennsylvania.
authors.forename: Samir A
authors.initials: SA
authors.lastname: Shah
authors.affiliation: 14 Drinker Biddle & Reath LLP , Washington, District of Columbia.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Lyapustina
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D004867:Equipment Design; D005060:Europe; D006801:Humans; D062307:Medical Device Legislation; D009330:Nebulizers and Vaporizers; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D014481:United States
chemical_list: D000336:Aerosols; D004364:Pharmaceutical Preparations
keywords: DPI; MDI; apps; device; generic inhaler; human factors; instructions for use; patient; regulatory; smart technology; telehealth