INITIATIVES

Global Regulatory Review and Outreach Workstream

Workstream Objectives

  • Stay abreast of regulatory developments for OINDPs in countries with well-established regulatory systems.

  • Understand requirements for OINDPs in emerging markets, such as China and Brazil.

  • Initiate outreach to regulatory agencies, pharmacopeias and other standard-setting bodies worldwide as appropriate.

  • Collaborate with other trade groups on issues relevant for OINDPs.

Working Groups

Bioavailability (BA), Bioequivalence (BE), In-Vitro/In-Vivo Correlations (IVIVC) Workstream

Workstream Objectives

  • Monitor, evaluate and, as appropriate, engage in discussions related to research and regulatory recommendations for BA, BE, IVIVC clinical inputs for Quality-by-Design (QbD) and similar topics.

  • Stay abreast of research, and as appropriate collaborate with other organizations pursuing clinical topics for OINDPs.

Working Groups

Chemistry, Manufacturing and Controls (CMC) & Product Development Test Workstream

Workstream Objectives

  • Monitor regulatory developments related to CMC and product development requirements.

  • Assess and respond to regulatory developments as appropriate.

  • Develop improved approaches, “best industry practices” and other recommendations for CMC and product development tests, such as delivered dose uniformity, aerodynamic particle sizing, material characterization and others.

Working Groups

Delivery Systems Workstream

Workstream Objectives

  • Study industry practices and regulatory developments related to OINDP devices and device-patient interface.

  • Develop and promulgate recommendations for OINDP industry, device manufacturers, regulators, health-care providers, patients and other potential stakeholders.

  • Coordinate with other IPAC-RS activities and seek potential synergies in areas of mutual interest.

Working Groups

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