IPAC-RS 2008 Conference
On September 22-24, 2008 IPAC-RS hosted its second open public conference entitled "Doing the Right Thing" in the Changing Culture of Design and Development of Inhalation and Nasal Drug Products: Science, Quality, and Patient-Focus where industry, regulators and other interested parties discussed best scientific and regulatory approaches for orally inhaled and nasal drug products.
The Conference program is posted here: Final Program.
The Conference Executive Summary is available here: Executive Summary
Click on the following links to access the slides from the Conference:
- Keynote Address: Future Opportunities in OINDP Development - Paul Huckle
- Lessons Learned from Other Industries - Overcoming Supplier-Manufacturer Challenges: Perspectives from Toyota North America and ArvinMeritor,LVS - Dennis Cuneo and Sherry Welsh
- QbD & Manufacturer-Supplier Partnerships - Barbara Falco and Jo Ward
- Case Study: Optimization of Cascade Impactor Methods - The AIM (Abbreviated Impactor Measurement) Concept - Jolyon Mitchell
- Lifecycle Approach to Specification Setting - Dave Christopher
- Patient Perspective: Suzanne Pattee (Cystic Fibrosis Foundation)
- Panel - Application of QbD to Clinical Trial Design for OINDP: Regulatory CMC & Clinical Perspectives
Moderator: Don Chambers
Panelists: Wally Adams, Badrul Chowdhury, Ken Furnkranz, Joseph Lim, Prasad Peri, Jun Zhang
- Clinical Relevance of Aerosol Quality Attributes: Exubera Case Study - Nancy Harper
- Moving Towards the Desired State - Roundtable: Regulatory and Industry Perspectives
Moderator: Andy Rignall
Panelists: Sabina Hoekstra-van den Bosch, Chuck Hoiberg, Rich Levy, Joseph Lim, Rik Lostritto, Reggie Saraceno, Terry Tougas
IPAC-RS 2008 Conference Poster Session
The Conference plenary sessions were supplemented by a scientific poster session that addressed a wide range of topics such as bioequivalence requirements for OINDP, optimized cascade impaction and other analytical methods, statistical design of experiments for device-drug combination products, extractables and leachables, and approaches to managing the supply chain.
Copies of the posters presented at the IPAC-RS 2008 Conference are available here: Posters.