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Last updated on April 24, 2014 at 1:21 EDT

FDA’s Lawrence Yu to Participate in Live Video Chat on Question-Based Review (QbR) for Generics on CPhI Pharma Evolution

August 20, 2013

NEW YORK, Aug. 20, 2013 /PRNewswire/ — On Thursday, August 22, at 10:00 a.m. ET, FDA’s Lawrence Yu, PhD, will take part in an hour-long video chat on CPhI Pharma Evolution, to discuss the QbR process and address pharma professionals’ questions on the initiative and what it means for generic drug manufacturers.

The FDA’s Question-Based Review process for generic drugs brings more modern principles from the FDA’s cGMPs for the 21(st) century initiative into CMC evaluations for ANDAs. The process was developed to ensure that what is most critical to final product quality is prioritized in generic drug development, and brings more of the science-based approach found in NDA review to ANDAs. It also aims to have generic manufacturers demonstrate more effective and efficient manufacturing and scale-up approaches, and to integrate the fundamental principles of pharmaceutical QbD into their drug development programs.

Yu, who was instrumental in developing the QbD process, was formerly Director of Science in the FDA’s Office of Generic Drugs, is now Acting Deputy Director of its Office of Pharmaceutical Science, and oversees the FDA’s Office of New Drug Quality Assessment, Office of Generic Drug Quality Assessment, Office of Biotechnology Products, and Office of Testing and Research.

For more information and to participate in the live video chat, click here: http://www.pharmaevolution.com/video-stream.asp?section_id=3043&doc_id=560782

Contact
Amy Averbook
Sr. Marketing Director
UBM DeusM
(917) 743-2693
averbook@deusm.com

About UBM DeusM
UBM DeusM (www.deusm.com) is an integrated marketing services company owned by UBM plc, targeting the fastest growing segment of the online publishing industry: business social media. The company is led by Managing Director Stephen Saunders, Min’s Marketer of the Year 2010. He and the other UBM DeusM principals have built and delivered more than 45 successful sites and online communities over the last two years. UBM DeusM’s service is based on a unique platform, called Community in a Box (CiaB), which employs a structured system of proven B2B Web publishing best-practices, combined with a breakthrough integrated multimedia publishing platform (“n-Server”) to enable marketers to quickly and profitably set up specialized communities for their target customers.

About CPhI
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, China, India, Japan, Southeast Asia, Russia, Istanbul and South America co-located with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com and hosts a global community with news and analysis at PharmaEvolution.com.

About UBM plc
UBM plc is a leading global business media company. We inform markets and bring the world’s buyers and sellers together at events, online, in print and provide them with the information they need to do business successfully. We focus on serving professional commercial communities, from doctors to game developers, from journalists to jewelry traders, from farmers to pharmacists around the world. Our 6,000 staff in more than 30 countries are organized into specialist teams that serve these communities, helping them to do business and their markets to work effectively and efficiently. For more information, go to www.ubm.com.

SOURCE CPhI Pharma Evolution


Source: PR Newswire