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Speakers and Moderators of the Pre-Conference and the 8th GMP Conference

Speakers/Moderators of the 8th European GMP Conference

 

Ib Alstrup
GxP IT Medicines Inspector with the Danish Medicines Agency (DMA)
Ib Alstrup is a GxP IT Medicines Inspector with the Danish Medicines Agency. With a background as a software designer and tester, he has specific focus and large experience in inspection of validation and operation of computerised systems throughout the GLP, GCP, GMP, GDP and GVP areas. He is a co-writer of the new PIC/S guide on Data Integrity and holds a B.Sc. in Electronic Engineering.

  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.

  Dr Rainer Gnibl
GMP Inspector, District Government of Upper Bavaria, Germany
Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government and the EMA and performs GMP inspections worldwide. Before that, he was working for the Bavarian Ministry of Environment and Health. Rainer Gnibl also holds a lectureship at the University Erlangen-Nürnberg.

  Dr Afshin Hosseiny
Qualified Person, Chairman ECA Foundation, Chairman GDP Association, UK
Afshin looks back to many years with Glaxo Smith Kline in the UK and is Chairman of ECA´s GDP Interest Group and member of ECA´s Executive Board.

 

Dr Ulrich Kissel
Director Regulatory Affairs, ECA Foundation and Chairman, European QP Association
Ulrich Kissel is Qualified Person and Chairman of the Board of Directors of the European Qualified Person Association (EQPA). Previous to his current role he held leadership positions in Quality and Supply Chain and served for many years as QP for Roche.

  Gert Moelgaard
Chairman ECA Validation Group, 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.

 

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).

Mervi Saukkosaari  

Mervi Saukkosaari 
Senior Pharmaceutical Inspector, Head of Section, Finnish Medicines Agency (Fimea)
Mervi Saukkosaari, pharmacist by profession, is currently Senior Pharmaceutical Inspector at FIMEA. She has more than 20 years experience in the pharmaceutical industry (e.g. Scientist, Group and Project Manager in R &D and Consulting).

 

Dr Wolfgang Schumacher
Chairman ECA´s IT Compliance Group, Switzerland 
He was Head of the department of Quality Computer Systems at F. Hoffmann-La Roche until July 2017. 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.

 

 Matthew Scherer
FDA Office of International Programs - Europe Office
Assistant Health Attache and International Program and Policy Analyst.

 

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.

Speakers/Moderators of the Pre-Conference GMP for Cannabis

 

Dr Ingrid Walther
Pharma Consulting Walther, Germany
Dr Walther joined Fresenius AG in 1986 and was employed in various positions and has many years of experience in research and development, quality assurance/quality control and management of strategic projects. Since July 2009, she runs her own business as GMP compliance consultant, recently including many Cannabis Projects.

  Mag. Bernhard Föger
AGES (Austrian Agency for Health and Food Safety), Austria
Bernhard Föger is Head of the Institute for Sustainable Plant Production at AGES. The Institute is involved in public and in private activities concerning the sustainable production of plants. Amongst other things, Mr Föger is responsible for the Austrian (Federal) Cannabis production for Medicinal Cannabis.

  Dr Reinhard Kerker
GMP-Inspectorate, Germany
Dr Reinhard Kerker studied pharmacy at the University of Tuebingen and economics at the University of Hagen. He received a PhD in Pharmaceutical Technology at the University of Munich and has more than 25 years` experience in pharmaceutical industry in various positions (e.g. Quality Control, Manufacturing, Plant Manager and Managing Director). Since 2017 he is GMP Inspector at the Local Authority in Tuebingen.

  Savvas Koulouridas
Fagron, Netherlands
Savvas Koulouridas is Global Innovation Director of Fagron. He is leading the innovation and global marketing department of the company. He is a lawyer in profession and has also worked as a consultant on pharmaceutical law (GMP regulations and Pharmaceutical Contracts).

 

Silja du Mont
GDP/GCP -Inspectorate, Germany
Since 2010 Silja du Mont is working as GCP/GDP Inspector for medicinal products / medical devices at the district authority of Freiburg (Regierungspräsidium Freiburg). She is Head of the German GCP Inspectors Expert Group at ZLG, European Expert GCP IWG EMA and also responsible for Pharmacy Surveillance. 

  Dirk Ohlenforst (invited)
Bonn, Germany
Dirk Ohlenforst began his pharmaceutical career in the field of formulation development and clinical trials. He finally worked as Qualified Person according to § 14 AMG. He gained more than 10 years of experience in the field of legal trade in narcotic drugs there and in subsequent positions.