Sponsor: Our Diamond and Gold Sponsors
Moderator: Richard N. Dalby, Ph.D.

From Q2 to QbD: The Influence of Formulation Changes on Metered Dose Inhaler Performance 
Jay T. Holt, Ph.D.
Cirrus Pharmaceuticals, A Kemwell Company, Durham, North Carolina, USA

Mimicking the APSD from pMDIs: Can it be Done and is it Sufficient to Declare Bioequivalence? 
Paul M. Young, Ph.D.
Woolcock Institute of Medical Research and University of Sydney,
Sydney, Australia

Improving Pulmonary Drug Delivery in Capsule Inhaler Systems: Optimizing Capsules Based on Formulation-Capsule-Device Interactions 
Sven Stegemann, Ph.D.
Capsugel, Bornem, Belgium

Beyond Asia: Designing Combitide Starhaler for Western Markets
Duncan Bishop, B.Sc.
Cambridge Consultants, Cambridge, United Kingdom

Sponsor: Aptar Pharma
Moderator: Gerallt Williams, Ph.D.

The following companies each sponsored 60-minute interactive presentations on new technologies and services related to nasal and pulmonary drug delivery. Meeting participants selected and attended THREE of these sessions, on their Registration Form.

Amcor
A Comprehensive Approach to the Packaging of Powders Used in OINDP Devices

Copley Scientific
In Vitro Bioequivalence Testing and Improving IVIVCs for Inhaled Generics

Harro Höfliger
Get It Right: 100% In-line Verification of Dosed Mass in Pre-metered Powder Inhalation Products

InnovaSystems 
Modern Principles of Developing Actuation Methods for Characterization of Nasal Sprays

Malvern Instruments / Next Breath
Use of Advanced Instrumentation for Characterizing Inhalation Drug Products from Deformulation to ANDA Submission

Presspart
It's Time to Count - A Review of End of Life Indication Devices

Sponsor: Our Diamond and Gold Sponsors
Moderator: Daniela Traini, Ph.D.

Access to Inhaled Therapy in India: Availability, Price and Affordability of Asthma Medicines 
Anita Kotwani, Ph.D.
V.P. Chest Institute, University of Delhi, New Delhi, India

Under-Engineering a DPI Device for Tuberculosis Treatment: Facilitating Access to Inhaled Therapies Among Disadvantaged Groups in India
Amit Misra, Ph.D.
CSIR - Central Drug Research Institute, Lucknow, India

Inhaler Device Options in Emerging Markets: Innovation, Improvization and Evolution 
Jaideep A. Gogtay, M.D.
Cipla, Mumbai, India

Sponsor: Our Diamond and Gold Sponsors
Moderator: Sai Chamarthy, Ph.D.

Managing the Supply Chain for Inhaled Products in the Regulated Marketplace
Brent Donovan, Ph.D.
Merck, Summit, New Jersey, USA

Qualifying Container-Closure Systems for OINDPs:
Current and Future Regulatory Expectations 
Julie D. Suman, Ph.D.
Next Breath, Baltimore, Maryland, USA

Quality by Design, In-Process Testing and End Product Testing
Joanne Peart, Ph.D.
Virginia Commonwealth University, Richmond, Virginia, USA

Sponsor: Our Diamond and Gold Sponsors
Moderator: Gur Jai Pal Singh, Ph.D.

1:30 p.m.

Inhalers and Intellectual Property in India:
The Outlook based on Recent Judgments
Saya Choudhary Kapur, LL.B.
Singh and Singh, New Delhi, India

2:00 p.m.

Regulatory Pathways, Development Challenges and Market Access for Inhaled Products in China
Shuguang Hou, Ph.D.
Sichuan Purity Pharmaceutical Technology, Chengdu, China

2:30 p.m.

Refreshments, Scientific Poster Session & Technology Exhibition

3:00 p.m.

Developing Inhalation Products to Satisfy Global Markets with Different Regional Requirements - Special Considerations for Asia
Geraldine Venthoye, Ph.D.
SkyePharma, Muttenz, Switzerland

3:30 p.m.

Jumping Legal Hurdles with the US FDA:
The Generic Inhaler Challenge
Kurt Karst, J.D.
Hyman, Phelps & McNamara, Washington DC, USA

4:00 p.m.

PANEL DISCUSSION:
IP Protection and Product Quality in Developing Markets
Chairman: Richard N. Dalby, Ph.D.
School of Pharmacy, University of Maryland, Baltimore, Maryland, USA