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:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... 2016  Consumers have taken a more active ... more emphasis on patient outcomes. ... the pharmaceutical industry have evolved beyond just providing ... are focusing on becoming more patient-oriented across their ... services that improve health. ...
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Comfort ... the American Cancer Society and the Road To Recovery® program to drive cancer patients ... seniors and other adults to ensure the highest quality of life and ongoing independence. ...
Breaking Medicine News(10 mins):