Navigation Links
FDA's Lawrence Yu to Participate in Live Video Chat on Question-Based Review (QbR) for Generics on CPhI Pharma Evolution
Date:8/20/2013

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 21st 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
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Lawrence Livermore engineering team makes breakthrough in solar energy research
2. ViroPharma to Participate in Two December Healthcare Investor Conferences
3. Avanir Pharmaceuticals to Participate in Citi 2012 Global Health Care Conference
4. Medical Experts Who Participated in CSL Behrings Key Issues Dialogue Prefer Albumin for Fluid Management
5. Genomind to Participate in National Alliance on Mental Illness (NAMI) 2012 National Convention
6. Elsevier to Participate in SCOAP3 With the Journals Physics Letters B and Nuclear Physics B
7. Biosim Pharmaceuticals, Manufacturers of Generic ACTHAR, to Participate at Biotech Showcase 2013
8. Vermillion to Participate in Lazard Capital Markets 5th Annual Medical Technology Snowbird Conference on February 27, 2013
9. AVANIR Pharmaceuticals To participate in two conferences in March
10. P&P Optica Invited to Cambridge Innovation Centre for the Canadian Technology Accelerator Program, One of Eight Canadian Life Science Companies Chosen to Participate
11. ViroPharma To Participate In Two May Healthcare Investor Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... 2017 International research firm Parks Associates announced today ... the TMA 2017 Annual Meeting , October 11 in ... home security market and how smart safety and security products impact the ... Parks Associates: Smart Home Devices: ... "The residential security market has experienced ...
(Date:10/9/2017)... , Oct. 9, 2017  BioTech Holdings announced ... by which its ProCell stem cell therapy prevents ... ischemia.  The Company, demonstrated that treatment with ProCell ... limbs saved as compared to standard bone marrow ... HGF resulted in reduction of therapeutic effect.  ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... journal, Epilepsia, Brain Sentinel’s SPEAC® System which uses the surface electromyography (sEMG) ... tonic-clonic seizures (GTCS) using surface electromyography (sEMG). The prospective multicenter phase III ...
(Date:10/6/2017)... ... 06, 2017 , ... The HealthTech Venture Network (HTVN) is ... fourth annual Conference where founders, investors, innovative practitioners and collaborators are invited to ... showcasing early stage digital health and med tech companies. , This day-long event ...
Breaking Biology Technology:
(Date:10/4/2017)... Solutions, a global clinical research organization (CRO), announces the launch of ... 4, 2017. Shadow is designed to assist medical writers and biometrics ... the European Medicines Agency (EMA) in meeting the requirements for de-identifying ... ... ...
(Date:8/15/2017)... --  ivWatch LLC , a medical device company focused on improving ... of its ISO 13485 Certification, the global standard for medical device ... (ISO®). ... Monitoring device for the early detection of IV infiltrations. ... "This is an important milestone for ivWatch, as it ...
(Date:6/30/2017)... ARLINGTON, Va. , June 30, 2017 /PRNewswire-USNewswire/ ... a leading developer and supplier of face and ... the ATA Featured Product provider program. ... created an innovative way to monitor a driver,s ... benefit greatly from being able to detect fatigue ...
Breaking Biology News(10 mins):