IPAC-RS

Workstreams, Working Groups & Initiatives

General

General

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.

BA/BE, IVIC, Clinical

BA/BE, IVIC, Clinical

Workstream Objectives:

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

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

Our Working Groups

CMC & Product Development Test

CMC & Product Development Test

Workstream Objectives:

Monitor regulatory developments related to chemistry, manufacturing and controls (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.
 

Delivery Systems

Delivery Systems

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.
 

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