www.gmp-conference.org

Speakers and Moderators of the European GMP & GDP Forum

Ib Alstrup  

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   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.

Cheryl Chia   Cheryl Chia
Lotus Phoenix Consulting, Netherlands
Cheryl Chia is Consultant for GMP and GDP compliance in the pharmaceutical supply chain.

Prabjeet Dulai   Prabjeet Dulai
GDP & Quality Matters, UK
Prabjeet Dulai is a Consultant at GDP & Quality Matters Ltd. Before working as a consultant she was the RP and Senior Supply Chain Pharmacist for the UK Ministry of Defence, and prior to this worked as a Pharmacist within the NHS/private hospital sector, retail and pharmaceutical industry.

  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.

Jochen Heinzel   Jochen Heinzel
F. Hoffmann-La Roche, Switzerland
Jochen Heinzel is Global Quality Manager Supply Chain & Affiliate Quality EMEA Region.

Dr Afshin Hosseiny   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.

Saddam Huq   Saddam Huq
GlaxoSmithKline, U.K
Saddam Huq is Senior Manager Quality for Distribution & Cold Chain Management Vaccines, Quality Assurance Shared Services.

Dr Ulrich Kissel  

Dr Ulrich Kissel
Chairman European QP Association
Ulrich Kissel is Qualified Person and Chairman 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   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.

Helga Peters   Helga Peters
Switzerland
Helga Peters held various positions in the Diagnostic and Pharmaceutical Industry. During the past years, she’s been working for F. Hoffmann-La Roche Ltd in Global Quality Inspection Management where she is providing training, strategies and support during Health Authority Inspections. She is now self-employed.

Axel Radke   Axel Radke
Trust Expertenservice, Germany
Axel Radke is Responsible Person and technical expert for investigations of issues in the storage and transport of pharmaceuticals.

Jonathan Riley   Jonathan Riley
Astellas Pharma Europe Ltd
Jonathan Riley is a QA professional with over 18 years quality management experience including GMP, GDP, GLP and GCP in contract research, pharmaceuticals, clinical trials and chemicals manufacturing.

Dr Bernd Renger  

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).

Maria Sekamwa   Maria Sekamwa
Surgipharm, Uganda
Maria Sekamwa is Assistant Warehouse Manager and Qualified Person for Pharmacovigilance.

Dr Franz Schönfeld   Dr Franz Schönfeld
District Government of Upper Franconia, Germany
Dr Franz Schönfeld is a GMP and GDP inspector at the local inspectorate for medicinal products and active substances of the District Government of Upper Franconia. He is head of the expert working group for APIs at the Central Authority of the Federal States for Health Protection.

Dr Wolfgang Schumacher  

Dr Wolfgang Schumacher
Chairman ECA Data Integrity & IT Compliance Group , Switzerland
He was til July 2017 Head of the department of Quality Computer Systems at F. Hoffmann-La Roche. He is currently Head of the ECA Data Integrity & IT Compliance Group, member of the ECA Foundation’s Extended Board and member of ECA´s Task Force on Data Integrity.

Lance Smallshaw  

Lance Smallshaw
UCB Biopharma sprl, Chairman ECA Cannabis Group, Belgium

Lance Smallshaw is Global Director of Analytical Strategy for NBEs at UCB in Belgium and member of the ECA Foundation’s Executive Board.

Dr Ingrid Walther   Dr Ingrid Walther
Pharma Consulting Walther, Former Head of the Business Unit iv Drugs, Fresenius
Dr Walther was employed in various positions and has long years of experience in the fields of research and development, quality assurance/quality control, and the management of strategic projects and as head of a Business Unit Validation and GMP Compliance. Since July 2009 she runs her own business as consultant. She was Head of ECA´s adhoc task force commenting the Annex 1 revision.