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ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry


3/8/2013 9:07:57 AM

(TAMPA, FLORIDA, USA, 07 March 2013) – ISPE announced today that it will hold its first-ever conference focused on benchmarking and advancing the development of Quality by Design (QbD) in the biopharmaceutical industry. The two-day event, taking place 10 – 11 April 2013 in San Francisco, Calif. USA, will feature workshops and discussions on the industry’s progress since the introduction of A-Mab and steps for further adoption of QbD principles. The conference is endorsed by CASSS, a not-for-profit 501(c)(6) professional scientific society made up of over 4,000 industry, academic and public sector professionals.

“Quality by Design is a critical issue for the industry, with companies and global regulatory authorities working to help the industry adopt QbD practices,” said Nancy Berg, ISPE President and CEO. “As the global pharmaceutical association representing the entire pharmaceutical lifecycle, ISPE will bring together top QbD experts to discuss how planning and controlling product evolution can lead to superior quality, better resource use and increased business effectiveness.” The State of Quality by Design in the Biopharmaceutical Industry Conference will offer in-depth case studies, lessons learned and best practices in implementing QbD. Pfizer’s Roger Nosal, Vice President, Global Chemistry, Manufacturing and Controls (GCMC), will present a plenary address titled “Carpe Opportunite: Regulatory Experience with Implementation of QbD, An Industry Perspective.” Mr. Nosal has an extensive history of leading advanced technology dialog among industry and regulators.

Speakers and delegates from Abbott, Amgen, Eli Lilly, Genentech, MedImmune, Merck, Pfizer, Roche and more will explore challenges and solutions with industry and regulatory experts and peers in workshops on design space, control strategies, successful dossiers and lifecycle management. The content of these workshops will be infused with attendees’ pre-conference input, resulting in discussions specifically tailored to audience concerns. After the event, aggregate workshop results will be compiled and re-structured to produce a set of proposed QbD solutions that will be carried forward to US and European health authorities.

More information on The State of Quality by Design in the Biopharmaceutical Industry Conference, including complete education details and registration information, is available at www.ISPE.org/2013QbDConference. To watch a video about this conference, visit http://youtu.be/xXFquN6A6OA.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.

For more information contact:

Danielle Hould

ISPE Communications Manager

Tel: +1-813-960-2105, ext. 277

email: dhould@ispe.org

www.ISPE.org



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