Regulators and Industry Experts to Present Reports of Latest EMEA/EFPIA Development at ISPE Conference
ISPE will host industry regulators and experts at its upcoming Strasbourg Conference and report on key findings from the landmark European Medicines Agency (EMEA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) Quality by Design (QbD) Application workshop.
Tampa, FL, August 22, 2009 --(PR.com)-- ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, will host industry regulators and experts at its upcoming Strasbourg Conference and report on key findings from the landmark European Medicines Agency (EMEA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) Quality by Design (QbD) Application workshop.
Attendees at ISPE’s Strasbourg Conference — being held 28 September through 1 October, 2009 at the Palais des Congrès — will be able to hear the latest news about the proposed ICH training program from members of the ICH Implementation Working Group. Attendees will also hear regulator and industry feedback from the previous day’s EMEA/EFPIA workshop where industry representatives will present case studies and exchange views on QbD implementation with European assessors and EU inspectors.
A summary of the EMEA/EFPIA workshop, as well as the lessons learned from the case studies, will be presented during ISPE’s “PQLI - Global Realization and Implementation of the ICH Quality Vision” session in Strasbourg. Attendees will also gain a greater understanding of QbD’s impact on the European Pharmacopoeia, receive a status report on the progression of the Q11 guideline on Development and Manufacture of Drug Substances through EFPIA’s Mock S2 and — through a series of presentations and break-out sessions — discuss how ISPE’s Product Quality Lifecycle Implementation® PQLI® initiative can assist in the application of QbD to development and manufacturing, as well as how it can improve overall business performance.
In addition, ISPE and INTERPHEX have organized a tabletop vendor exhibition and a variety of networking receptions that will allow exhibit attendees to engage and network with fellow seminar delegates, vendors, colleagues, and like-minded professionals from around the world. Siemens is the recognized host sponsor of the conference, exhibition, and receptions. For information about exhibit hall and sponsorship opportunities, contact Christine Sainvil at +32 2 743 4422 or at christine.sainvil@associationhq.com.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
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Attendees at ISPE’s Strasbourg Conference — being held 28 September through 1 October, 2009 at the Palais des Congrès — will be able to hear the latest news about the proposed ICH training program from members of the ICH Implementation Working Group. Attendees will also hear regulator and industry feedback from the previous day’s EMEA/EFPIA workshop where industry representatives will present case studies and exchange views on QbD implementation with European assessors and EU inspectors.
A summary of the EMEA/EFPIA workshop, as well as the lessons learned from the case studies, will be presented during ISPE’s “PQLI - Global Realization and Implementation of the ICH Quality Vision” session in Strasbourg. Attendees will also gain a greater understanding of QbD’s impact on the European Pharmacopoeia, receive a status report on the progression of the Q11 guideline on Development and Manufacture of Drug Substances through EFPIA’s Mock S2 and — through a series of presentations and break-out sessions — discuss how ISPE’s Product Quality Lifecycle Implementation® PQLI® initiative can assist in the application of QbD to development and manufacturing, as well as how it can improve overall business performance.
In addition, ISPE and INTERPHEX have organized a tabletop vendor exhibition and a variety of networking receptions that will allow exhibit attendees to engage and network with fellow seminar delegates, vendors, colleagues, and like-minded professionals from around the world. Siemens is the recognized host sponsor of the conference, exhibition, and receptions. For information about exhibit hall and sponsorship opportunities, contact Christine Sainvil at +32 2 743 4422 or at christine.sainvil@associationhq.com.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
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Contact
ISPE
Marni Schribman
813-960-2105
www.ISPE.org
Marni Schribman
813-960-2105
www.ISPE.org
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