QbD
and PAT Sciences Network
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Background
QbD and PAT Sciences Network
Building quality into drug products should commence during the
early phases of research and development. Consideration and
implementation of the quality requirements for new medicines
at these early stages should facilitate effective process development
and robust large-scale manufacture. Process Analytical Technology
(PAT) should therefore play a crucial role in design, analysis,
and control of manufacturing processes based on timely in-process
measurements for integrated system approaches, innovative developments
and cutting edge scientific advances.
At the EUFEPS 2004 in Brussels – for which the overall
theme was New Safe Medicines: Towards Mechanistic Prediction
– there was a session devoted to Revolution in Science
Driving Process Analytical Technology. Those participating in
this session of two and a half days decided to create a European
Network on Process Analytical Technology Science to further
encourage, stimulate and initiate new approaches and interaction,
but also to promote education and training in the field. It
was concluded that both better understanding of chemical and
industrial processes and development of advanced instrumentation
and measurement tools were very much in demand. For a short
summary of the outcome of the EUFEPS 2004 Session, see the December
2005 (4/2005) issue of the EUFEPS
NewsLetter.
EUFEPS has agreed to provide a home for this emerging Network
as well as to facilitate communication including announcement
on the organization of PAT focused meetings and courses.
Current
EUFEPS QbD and PAT Sciences Network Steering Committee
Chair
• Staffan Folestad, AstraZeneca, Mölndal,
Sweden (staffan.folestad@astrazeneca.com)
Vice-chair
• Jukka Rantanen, Copenhagen University, Copenhagen,
Denmark (jtr@farma.ku.dk)
Secretary
• Thomas De Beer, Ghent University, Ghent, Belgium
(Thomas.DeBeer@UGent.be)
Members-at-large
• Buket Aksu, Santa Farma, Istanbul, Turkey (baksu@santafarma.com.tr)
• Joao Almedia Lopes, University of Porto, Porto,
Portugal (joaolopes@ff.up.pt)
• Marcel de Matas, University of Bradford, Bradford,
United Kingdom (m.dematas1@Bradford.ac.uk)
• Jarkko Ketolainen, University of Eastern Finland,
Kuopio, Finland (jarkko.ketolainen@uef.fi)
•Hans H. Lindén, EUFEPS Central Office, Stockholm,
Sweden (hans.linden@eufeps.org)
• Wim Oostra, Organon, part of Schering Plough, The
Netherlands (wim.oostra@spcorp.com)
•
Marco Weimer, Sanofi-Aventis, Frankfurt, Germany, (Marco.Weimer@sanofi-aventis.com)
From left to right: Buket Aksu, Gerd Kleinschmidt, Thomas De Beer, Jarkko Ketolainen, Joao Almeida Lopes, Staffan Folestad, Jukka Rantanen, Marcel de Matas, Hans Lindén.
Mission
The EUFEPS QbD and PAT Sciences Network has been established
to create and maintain a unique and effective forum to encourage
and improve collaboration, actively contribute to education
and training, and to promote innovation in relevant sciences
- all to power science based process understanding and Quality-by-Design
for medicines.
Objectives
of the EUFEPS QbD and PAT Sciences Network
The objectives of the EUFEPS QbD and PAT Sciences Network include:
-
To develop a network for academic, industrial and regulatory professionals in the various scientific fields underpinning PAT
-
To create a forum for sharing and discussing findings in cutting-edge research and establishing effective collaborations leading to innovation and better process understanding.
-
To bring scientists together, enabling active research debate, network development, scientific knowledge exchange and the initiation of collaborative projects
-
To promote and facilitate the advancement of fundamental underpinning science and process understanding
-
To contribute to education and training in the field as well as to foster hands-on implementation of systems approaches and emerging technology in pharmaceutical production processes
-
To educate and equip industrialists and regulators with requisite knowledge and cutting-edge process understanding, to facilitate the adoption and advancement of PAT science in the development and approval of new drug products
-
To promote and support collaborative research projects established from inter-academic, academic-industrial and public-private partnerships
Join
as Member of the EUFEPS QbD and PAT Sciences Network
All scientists involved in Process Analytical Technology (Process
Analytical Technology and underpinning sciences) are more than
welcome to become a member of the EUFEPS QbD and PAT Sciences
Network. You will be updated on all related activities including
the organization of courses and scientific meetings. To become
a member, please send an email to patnetwork@eufeps.org,
the EUFEPS QbD and PAT Sciences Network Secretary. Currently,
there is no additional fee, although EUFEPS has an ambition
to build the network from existing Members
of EUFEPS.
Presentations given at EUFEPS QbD and PAT Sciences Network Event
Link to presentations given during EuPAT 4, May 5-6, Kuopio (Finland): http://www.eufeps.org/spring10050506.html
PharmSciFair Sessions, June 8-12, 2009, Nice, France
- Challenges in Measurement System Development for Continuous Processes
- Continuous Processing the Factory of the Future
- Continuous Process for Solid Dosage Preparation
- Pharmaceutical Development and Manufacturing: Trends in Processing of Oral Solid Dose Forms
-
EuroPACT 2011, April 27-29, Glasgow, UK (information and link will follow in the near future)
- EuPAT 5, May 2012, Ghent, Belgium
Contact
The European Federation for Pharmaceutical Sciences –
EUFEPS
SE-175 72 Jarfalla (Stockholm) Sweden
Tel +46 8 7601050
Fax +46 8 4113217
Email secretariat@eufeps.org
EUFEPS QbD and PAT
Sciences Network Secretary
Thomas De Beer (PATnetwork@eufeps.org)
SE-175 72 Järfälla (Stockholm) Sweden
Tel +46 8 50582040 Fax +46 8 4113217 Email secretariat@eufeps.org
