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Maria-Jesus Alcaraz
Scientific administrator at EMA Manufacturing and Quality Compliance Service since February 2015
Before joining the EMA, Maria worked at the Spanish Medicines and Medical Devices Agency (AEMPS) Current main responsibilities are among others coordination of the JAP programme and oversight over the MRAs at EMA.
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Richard Bonner
Qualified Person, Chairman ECA, UK
Dick has been working with Eli Lilly and Company, UK, for many years and is currently Chairman ECA and Member of ECA’s Executive Board
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Dr Christopher Burgess
Qualified Person, Chaiman ECA Quality Control Interest Group, UK
Chris has been working in the pharmaceutical industry for many years and is currently among others Chairman of ECA’s Quality Control Interest Group, member of ECA´s Extended Board and member of ECA's Task Force on Data Integrity. |
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Klaus Eichmüller
Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Since 1996 he is working in the field of GMP Inspections of manufacturer of medicinal products and importers. He is Head of the Inspectorate for Drug Products, APIs, Blood Products and Tissues in Hesse. |
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Dr Matthias Heuermann
NRW Centre for Health (LZG.NRW), Münster, Germany
Since 1995 Dr Heuermann is involved in national and international GMP inspections with a focus on QC laboratories and QA systems. He is head of the Official Medicines Control Laboratory (OMCL) within the NRW Centre for Health of the federal state North Rhine-Westphalia
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Dr Afshin Hosseiny
Qualified Person, Chairman ECA GDP Interest Group, UK
Afshin looks back to many years with Glaxo Smith Kline in the UK and is Chairman of ECA's GDP Interest Group |
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Dr Andreas König
Quality König GmbH Germany
Andreas König is owner of Quality König GmbH and has practical experiences as Senior Vice President Corporate Quality & HSE at Director Manufacturing & Quality at Aenova Holding GmbH, Vice President Global Quality Operations Animal Health at Schering Plough, Global Quality Director at Intervet and Head of QC and QA at Fresenius Kabi.
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Oliver Küttner
Shire, Vienna, Austria
During the past years, he’s been working for Baxter and Baxalta in local and global Quality Management positions. Currently he is in charge of the Material Life Cycle Management for raw-, starting- and packaging Materials in EU and Asia at Shire.
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Johanna Linnolahti
Finnish Medicines Agency FIMEA, Finland
Johanna Linnolahti is a Senior Pharmaceutical Inspector at Fimea specialised in GDP. She is also Member of the ECA Authority Advisory Board which supports the GDP Group.
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Gert Moelgaard
Chairman ECA´s Working Group on Validation, Denmark
Gert Moelgaard has more than 25 years experience in the pharmaceutical and biotech industry, including several years of experience in process control, automation, computer systems validation and process validation as well as process engineering and consulting. Gert is Chairman of the ECA´s Working Group on Validation and member of ECA´s Extended Board. |
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Tracy Moore
Medicines and Healthcare Products Regulatory Agency, UK
Tracy is a GMDP Operations manager and Senior Inspector at the MHRA, joining in 2011 after 23 years in Industry. Tracy manages a team of GMDP inspectors and is part of the Agency‘s Data Integrity strategy and guidance drafting Group.
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Amelia Mutere
F. Hoffman La Roche, Basel Switzerland
Ms Mutere is head of Global Quality Inspection Management. She is responsible for Health Authority Inspections in the Roche Sites and CMOs. She also leads the Data Integrity Assurance Initiative Project at Pharma Technical.
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Dr Bernd Renger
Qualified Person, Immediate Past Chairman of the European QP Association, Germany
Bernd worked for many years in the pharmaceutical industry and is Immediate Past Chairman of the European QP Association (EQPA).
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Dr Franz Schönfeld
Regional GMP Inspectorate, Germany
Since 2007 he works for the centralised inspectorate for medicinal products of the government of upper Bavaria. He is head of the experts working group 7 for API’s and deputy head of the Radiopharmaceutical expert working group at ZLG.
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Dr Wolfgang Schumacher
Chairman ECA´s IT Compliance Group, Switzerland
He was till July 2017 Head of the department of Quality Computer Systems at F. Hoffmann-La Roche. He is currently Head of ECA´s IT Compliance Group, member of ECA´s Extended Board and member of ECA´s Task Force on Data Integrity.
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Lance Smallshaw
UCB Biopharma sprl, Belgium.
Lance Smallshaw is Global Director of Analytical Strategy for NBEs at UCB in Belgium and Member of ECA´s Executive Board.
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Alex Viehmann, FDA, USA
Alex Viehman is currently Chief (acting) – Quality Intelligence Branch at FDA/CDER/OPQ/OS
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