RDD Europe 2005

'RDD Europe 2005 - A Regulatory and Analytical Symposium' was held at the Novotel Paris Tour Eiffel, Paris, France, May 25-27, 2005. Our first European conference, co-organized by Virginia Commonwealth University, RDD Online and Valois, was a huge success bringing together more than 300 scientists from around the world. We apologize to individuals on the waiting list who were unable to attend because we exceeded the meeting capacity.

Podium sessions generated intense discussion between the industrial, regulatory and academic scientists and managers in attendance and covered

• Current testing issues in nasal and pulmonary drug delivery
• Excipient and packaging qualification and control
• Global regulation of inhaled products

Podium sessions were augmented by more than 50 outstanding poster and exhibitor displays, and 10 workshop sessions. Manuscripts and abstracts of the presentations are available in hard copy or via electronic access if you were unable to attend in person because of our limited capacity.

A special thanks to the sponsors of RDD Europe 2005

3M Drug Delivery Systems, Aradigm Corporation, Astech Projects, Bang & Olufsen Medicom, Battelle, Bespak, Borculo Domo Ingredients, Cardinal Health, Chemic Laboratories, Copley Scientific, Covance, DTF- La Diffusion Technique Francaise, Drug Delivery Technology, Dupont Company, ERWEKA International AG, Ineos Fluor, Ing. Erich Pfeiffer GmbH, InnovaSystems & Next Breath, INyX Pharma Limited, JetPharma Group, Lancaster Laboratories, Malvern Instruments & Image Therm Engineering, Melbourn Scientific Limited, Micron Technologies, Novartis, Otsuka Pharmaceutical Co. Ltd. - ODPI Division, Oxford Lasers, Pamasol Willi Mader AG/DH Industries, Perlos Corporation, Pharmaceutical Profiles, PPD, Presspart, rap.ID Particle Systems GmbH, Respironics Respiratory Drug Delivery Division, sanofi-aventis, SI Associates, Solvay Fluor GmbH, Surface Measurement Systems, Team Consulting, Trudell Medical International, Valois, Vectura Limited, West Pharmaceutical Services.

PLENARY LECTURE

Platform Selection for Inhaled Drugs – Biological and Regulatory Merit of Different Approaches.
Peter R. Byron, Ph.D., Virginia Commonwealth University, Richmond, VA, USA.

CURRENT ISSUES IN INHALED AND NASAL DRUG PRODUCT TESTING

Replacing Cascade Impactors with Labor Saving Alternatives – Making the Methods Acceptable to the Regulators.
John K. Simons, Ph.D., 3M Drug Delivery Systems, St. Paul, MN, USA.

Cascade Impactor Mensuration: Deciding the Important Specifications.
Carole Evans, Ph.D., Cardinal Health, Research Triangle Park, NC, USA.

Analytical Testing of Nasal and Pulmonary Products using Patient-Derived Parameters – Realism vs Reproducibility.
Richard N. Dalby, Ph.D., University of Maryland, Baltimore, MD, USA.

In-Process Dosage Unit Assessments of Blend Uniformity – Is FDA’s Draft Guidance Applicable to Multidose Powder Inhalers?
Vidya Swaminathan, Ph.D., Pfizer, Groton, CT, USA.

EXCIPIENT AND PACKAGING QUALIFICATION, CHEMISTRY AND CONTROL

Qualifying Excipients for Inhaled Dosage Forms – Toxicological Essentials for the United States and Europe.
Jurgen Venitz, M.D., Ph.D., Virginia Commonwealth University, Richmond, VA, USA.

Absorption Enhancers for Nasal Sprays - Major Options and their Toxicological Characteristics.
Lisbeth Illum, Ph.D., IDentity, Nottingham, United Kingdom.

Amorphous Content Control – Feasible Test Methods and Specifications for Inhaled Drug Products.
Graham Buckton, Ph.D., University of London, London, United Kingdom.

Extractables & Leachables – The Regulatory Challenge of Qualifying Novel Inhaler Components.
Gordon E. Hansen, Ph.D., Boehringer Ingelheim, Ridgefield, CT, USA.

Device DMFs: What Satisfies the FDA?
David J. Howlett, B.A., PharmaDelivery Solutions, Norfolk, United Kingdom.

Application of FDA’s PAT Initiative to Respiratory Products – Improving Product Quality Through a New Regulatory Reward System.
David A. Radspinner, Ph.D., sanofi aventis, Kansas City, MO, USA.

GLOBAL REGULATION OF INHALED DRUG PRODUCTS

Quality by Design, Risk Management, and New Review Paradigms for Inhalation Drug Products.
Richard T. Lostritto, Ph.D., Food and Drug Administration, Rockville, MD, USA.

US Regulatory and Scientific Considerations for Approval of Generic Locally Acting Orally Inhaled and Nasal Drug Products.
Gur J. P. Singh, Ph.D., Food and Drug Administration, Rockville, MD, USA.

Setting Specifications for Inhalation and Nasal Products in the EU and the US: What specifically is the problem?
Stephen T. Horhota, Ph.D., Boehringer Ingelheim, Ridgefield, CT, USA.

Pharmaceutical Quality of Inhalation Drug Products:Harmonization between Canada and the European Union.
Marjolein Weda, M.Sc., National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.

EPAG’s Response to EU, US and Canadian Regulator Requirements for Inhaled Drug Products.
Steven C. Nichols, Ph.D., sanofi aventis, Holmes Chapel, UK.