Navigation Links
Understand the Lessons Learned from the FDA QbD Pilot Programme - Case Study Merck Serono
Date:2/15/2012

LONDON, February 15, 2012 /PRNewswire/ --

Senior representatives from leading pharmaceutical companies including Roche Diagnostics, Lonza, Abbott, F. Hoffman-La-Roche LTD and Novartis MIT will meet at the Pharma Qbd Forum in Berlin, Germany on 24th-25th April 2012 to share their expert knowledge on how Quality by Design can be implemented in pharmaceutical development.

One of the main points of discussion will be the findings of the Merck Serono case study and how the lessons learned from this FDA Pilot Programme can shape the way for QbD projects in Europe and abroad. This session will be led by Pascal Valax, Group Head, Biotech Process Sciences, Merck Serono SA.

Speakers include:

  • Dr. John R Donaubauer, Director, Scientific Affairs Development Sciences Process R&D - Abbott
  • Dr.Richard Lakerveld, Associate - Novartis-MIT Center for Continuous Manufacturing
  • Serj Vartanian, Head of Global Quality Systems MBB - Baxter Healthcare Corporation
  • Dr. Gawayne Mahboubian-Jones, Program head - Excellence in Science and Design - Philip Morris International
  • Dr.Paul Stonestreet, Global Drug Substance Project Co-ordinator, Small Molecule Technical Development - F.Hoffman-La-Roche Ltd
  • Dr. Dirk Pamperin, VP R&D - Synthon Pharmaceuticals
  • Dr. Alessandro Butte, Head of DSP - Lonza
  • Sarah Mercier, Scientist USP - Crucell Holland BV
  • Dr. John Crowley, Head of Cell Culture Development - Lonza Biologics
  • Dr. Andreas Schneider, Vice President Life Science Alliances - Roche Diagnostics
  • Prof. Gary Montague, Professor of Bioprocess Control - Newcastle University
  • Dr. Mel Koch, Executive Director - CPAC Centre for Process and Analytical Control (University of Washington)
  • Prof. Mathieu Streefland, Professor Bioprocess Engineering - Wageningen University
  • Prof. Jose Cardoso de Menezes, Department of BioEngineering - Institute of Biotechnology & Bioengineering

Conference topics include:

  • Building quality earlier in the process
  • Improving process understanding
  • Successfully defining criticality
  • Defining continuous verification and the expanded change protocol
  • Lifecycle strategies for biopharmaceutical QbD
  • Implementing continuous manufacturing with QbD to reduce production timelines
  • Translating established development practice into QbD

To view the complete programme, speakers and topics visit http://www.pharmaqbdforum.com

For all press enquiries, email sarah.brzezicki@wtgevents.com or telephone +44(0)207-202-7727.



'/>"/>
SOURCE World Trade Group Conferences
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Amerigen Pharmaceuticals and VIWA Pharmaceutical Company Today Jointly Announce the Signing of a Memorandum of Understanding (MOU) Setting Out Their Intention to Establish a Joint Venture to Develop and Register a Range of Branded Generic Medicines
2. HIFU All Hype? Understanding This Non-FDA-Approved Prostate Cancer Treatment
3. Team AFib™ Unites Patient Advocacy Organizations to Elevate Understanding of Atrial Fibrillation and Stroke
4. Aeras and China National Biotech Group Sign Memorandum of Understanding for TB Vaccine R&D Collaboration
5. American Pain Foundation Launches New Educational Campaign, "Explain Your Pain," to Help Hispanic Americans Better Understand Chronic Pain and Pain Management
6. FDA Examines Ways to Improve Consumer Understanding of Prescription Drug Ads
7. Genoptix Enters Into Memorandum of Understanding Related to Class Action Lawsuits
8. Ground Breaking Findings on Understanding Cancer Published in the Current Issue of Science
9. Decision Resources Competitive Landscape Seminar Series: Biologics and Biosimilars on September 14, 2010 Will Help Pharmaceutical Companies Understand Market Opportunities for Biologics and Biosimilars
10. Information-Motivation-Behavioral Skills Analysis Advances Understanding of Barriers to Self-Monitoring of Blood Glucose
11. Results From Two Phase II Trials Add to Understanding of Ticagrelor (BRILINTA(TM)) and How it Works in the Body
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... AccuGenomics, Inc., a diagnostic company based in ... the company has provided an AccuKit to the HIV ... Chapel Hill and to Qura Therapeutics for evaluation in ... HIV reservoir and viral expression in human CD4+ T ... Center is a joint initiative between the University of ...
(Date:8/8/2017)... Aug. 8, 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), a ... reports its financial results for the second quarter ended ... the second quarter 2017 and to date: ... development programs for the Company,s lead project, BL-8040: ... study with BL-8040 as novel stem cell mobilization treatment ...
(Date:8/7/2017)... 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s largest ... June 30, 2017.  All comparisons, unless otherwise noted, are to ... Second Quarter 2017 Highlights include: ... an increase of 3.5% Total prescriptions dispensed ... of 7.5% versus 7.6% Gross profit ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... More than 20,000 pairs of ... Congo (DRC) thanks to an ambitious venture that conjoined the passions of an NBA ... support of the Liberty community. These shoes will save lives from the rampant infections ...
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today announces the launch ... lifestyles and highlighting the importance of proactive eye and ear health. The campaign ... latest innovations in hearing aid technology. , In this issue, the National ...
(Date:8/18/2017)... , ... August 18, 2017 , ... ... handling handheld devices. Through an educational webinar, they will present the line of ... chance to learn how easy you can automate everyday pipetting tasks. , Ideal ...
(Date:8/18/2017)... ... 2017 , ... Radabaugh & Associates, a family managed agency ... West Virginia, is embarking on a cooperative charity effort with the Chestnut Mountain ... Chestnut Mountain Ranch (CMR) is a Christ-centered boarding school for young men offering ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Brian Gifford Agency, an ... is campaigning in support of Campagna Academy in a charity drive to provide for ... Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization that has offered critical ...
Breaking Medicine News(10 mins):