ABOUT
The International Pharmaceutical Aerosol Consortium on Regulation & Science has been the leading global voice of the orally inhaled and nasal drug products (OINDP) industry for more than 20 years. Through joint research, benchmarking, collecting and analyzing data, and developing best practices, IPAC-RS advances and supports science-based regulatory approaches for OINDP, to ensure their availability, safety, efficacy and quality. IPAC-RS works collaboratively across the industry and with external experts from regulatory agencies, standard-setting bodies, academia, pharmacopeias, healthcare providers, patient groups, and other stakeholders. IPAC-RS members are based around the world, and its activities are global, with region-specific projects in North and South America, Europe, and Asia. IPAC-RS shares its findings with the larger scientific and regulatory community through publications, online tutorials, in-person training courses, webinars, and conferences.
IPAC-RS offers two membership categories to serve the needs of the OINDP community:
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Full Membership: Full membership includes innovator and generic companies that develop, manufacture or contract to manufacture OINDPs for local and systemic treatment of a variety of debilitating diseases such as asthma, chronic obstructive pulmonary disease and diabetes.
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Associate Membership: IPAC-RS also offers an associate membership category for corporations that (1) develop or manufacture components and/or devices for OINDPs; (2) provide scientific or technical services relating to development and manufacture of OINDPs; or (3) are eligible for full membership but have annual revenues of less than seventy-five million US dollars.
IPAC-RS membership is at the company rather than individual participant level. Accordingly, members and associate members can leverage IPAC-RS with unlimited participation from interested colleagues.
IPAC-RS represents the interests of its members to international authorities and standard-setting bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, the Brazilian Health Regulatory Agency (Anvisa), National Medical Products Administration (NMPA), the United States Pharmacopeia (USP), the International Conference on Harmonization (ICH), the International Organization for Standardization (ISO), and regulatory agencies in other world regions. IPAC-RS also collaborates with trade associations and academic researchers around the globe.
MEMBER COMPANIES
MEMBERS
ASSOCIATE MEMBERS
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invoX Belgium N.V.
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Koura, Orbia’s Fluor & Energy Materials Business Group
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Nemera
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PPD
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Proveris Scientific Corporation
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RxPack
Benefits of Membership
Participation in IPAC-RS affords a variety of benefits to member companies including opportunities to shape the scientific and regulatory environment and tools to stay informed.
Shape the Scientific and Regulatory Environment
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Address technical issues drawing on the data and expertise of the industry
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Interact with industry leaders to develop and promote best scientific approaches
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Participate in confidential surveys and benchmarking exercises
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Identify, assess, and address emerging issues early
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Contribute to the shaping of business and regulatory environment
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Meaningfully interact with regulatory agencies and other key stakeholders such as PQRI, ISO, EPAG, USP, EP, EFPIA and others in a non-product specific context
Stay Informed
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Be informed and influential in a variety of areas, especially chemistry manufacturing and controls (CMC) of OINDPs
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Access technical reports, slides, data summaries and other internal IPAC-RS documents
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Access all IPAC-RS training courses, workshops, webinars, and internal events such as expert roundtables
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Stay up-to-date on current regulatory requirements worldwide through discussions in IPAC-RS working groups and bi-monthly newsletters