International Pharmaceutical Aerosol Consortium on Regulation & Science

The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is an international association that seeks to advance the science, and especially the regulatory science, of orally inhaled and nasal drug products (OINDPs) by collecting and analyzing data, and conducting joint research and development projects. Representing the OINDP industry since 2000, IPAC-RS aims to build consensus and contribute to effective regulations and standards by sharing the results of its research through conferences, technical journals, webinars, and discussions with regulatory bodies.
IPAC-RS Roundtable Webinar Series 2021
 

Starting in 2020, IPAC-RS organized a number of roundtables with thought leaders to discuss key regulatory and scientific topics in respiratory products.  Continuing that practice, in 2021, IPAC-RS launched a new series focusing on drug-device combination products with digital components, and digital-health opportunities and challenges more broadly.  

 

Recordings from the first webinars are available here

What is a Digital Biomarker and Why Is It Important? 

Beyond Usability/Human Factors for Digital Healthcare

Digital Devices:  Manufacturing and Design Considerations

Business Case for Digital Devices 

Digital Devices:  Regulatory Challenges and Considerations
 

Respiratory Drug Delivery and IPAC-RS are collaborating again to develop a jointly organized session on Thursday, May 5, 2022 that will address Regulatory, Science and Technology Innovations Enabling Novel and Improved OINDP Design, Development and Manufacturing. The podium presentations will be supplemented with subsequent in-depth roundtables (delivered online after RDD 2022).

The session will be moderated by Jennifer Wylie (Merck) and Vijay Sethuraman (Genentech).   Presentations topics and speakers include:

  • Patient Centric Design:  Paul Upham (Genentech)

  • Sustainability:  Richard Henderson (GlaxoSmithKline)

  • Regulatory Evolution:  Prasad Peri (Teva)

  • Advanced Data Analytics:  Will Ganley (Nanopharm)

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News and Events

January 2022

IPAC-RS is pleased to announce the release of the 2022-2024 IPAC-RS Strategic Plan.  IPAC-RS is and will remain the leading technical resource and advocate of the global OINDP industry.  We encourage you to view the Plan and we look forward to collaborating with all OINDP industry stakeholders in the new year!  We extend a special thanks to the IPAC-RS Board for their leadership in connection with the development of this plan. 
 

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March 2022

Read the IPAC-RS 2021 Year in Review to learn more about IPAC-RS's achievements and the benefits of membership.   
The report highlights the impressive work IPAC-RS accomplished in 2021.  
 
 

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April 2022
 

IPAC-RS Summary of Global Regulatory Developments 2021

 

 IPAC-RS engages actively in reviewing and commenting on regulatory developments around the world, and works collaboratively with all stakeholders to improve science-based regulations affecting orally inhaled and intranasal pharmaceutical products.  IPAC-RS prepared a summary of relevant global regulatory developments in 2021.   

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