Speakers and Moderators
|Richard Bonner, Qualified Person, UK|
Richard has been working with Eli Lilly and Company, UK, for many years and is currently Chairman ECA.
|Dr Christopher Burgess, Qualified Person, 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
|Dr Klaus Eichmüller, Regional 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 of the German Federal State of Hesse.
|Dr Afshin Hosseiny, Qualified Person, UK|
Afshin looks back to many years with Glaxo Smith Kline in the UK and is Chairman of ECA´s GDP Interest Group.
|Dr Ajaz Hussain, Insight, Advice & Solutions, LLC, USA|
Dr Ajaz Hussain’s career at US FDA spanned 10 years; from 2000-2005 he served as the Deputy Director of the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER). Ajaz is now management consultant in the lifescience sector.
|Dr Jean-Denis Mallet, NNE Pharmaplan, France|
Jean-Denis was previously the Head of the Pharmaceutical and Cosmetics Inspection Department at the French Health Products Regulatory Agency (Afssaps) and is now working for NNE. He is an ECA Advisory Board Member.
|Gert Moelgaard, NNE Pharmaplan,Denmark |
Gert is Vice President at NNE Pharmaplan, Denmark and Co-Chair of the ECA Working Group on Validation
|Dr Bernd Renger, Qualified Person, Germany|
Bernd worked for many years in the pharmaceutical industry. Today, he is Immediate Past Chair of the European QP Association.
|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 APIs and deputy head of the Radiopharmaceutical expert working group.
|Dr Wolfgang Schumacher, F. Hoffmann-La Roche Ltd. , Switzerland|
Currently, he is Head of the department of Quality Computer Systems at F. Hoffmann-La Roche and a member of the ECA Advisory Board.
|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 Advisory Board.
|Dr Ingolf Stückrath, sanofi-aventis, Frankfurt, Germany|
The Six Sigma Black Belt Ingolf Stückrath is today responsible for a major insulin production facility in Frankfurt.
|Karthik Iyer, Food and Drug Administration (FDA), USA |
Karthik Iyer is Acting Branch Chief for the Quality Intelligence Branch in FDA/CDER/Office of Pharmaceutical Quality/Office of Surveillance/Division of Quality Intelligence, Risk Analysis and Modeling.
|Henny Koch, Qimp Management Systems B.V., The Netherlands|
Henny Koch is Managing Director at Qimp Management Systems B.V. During 36 years in pharmaceutical industry he held several positions in R&D, Manufacturing and Quality. His last position was Global Compliance Manager at MSD.
|Dr Andreas König, Aenova Group, Germany|
Dr Andreas Konig is Senior Vice President corporate Quality & HSE at Aenova-Group. Until 2009 he was Vice President Global Quality Operations Animal Health at Schering Plough. Before that he was head of QC and QA at Fresenius Kabi and later Global Quality Director at Intervet.
|Ian Jackson, BSc (Hons) MRSC MHRA, UK|
Ian Jackson joined the MHRA in August 2005 as a GMP Inspector. In 2008 he became an Operations Manager, with responsibility for a team of 10 GMP inspectors, and has recently been appointed as Unit Manager Inspectorate Risk, Control and Governance; a new role within the Inspection team, with responsibilities that include inspection planning and inspectorate training. Ian is also a Senior GMP Inspector and performs inspections both in the UK and overseas. Ian previously worked in the pharmaceutical industry for over 12 years in a variety of roles including Quality Control and Quality Assurance. Ian is also eligible to be named as a Qualified Person under directive 2001/83/EC. Industry experience has been mainly in non-sterile pharmaceutical manufacturing, with roles in Quality Control and Quality Assurance.
|Esther Martinez, EMA, London, UK|
Ms Martinez is a Scientific Administrator at the Compliance and Inspections department of the European Medicines Agency. She currently supports the work of the GMP/GDP Inspectors Working Group and European/ International collaboration activities in the area of GMP.