Speakers

David Abraham
QRS-Associates, UK
Principal Consultant and Director at QRS-Associates Ltd with extensive experience in both business and Quality Management. Chairman of the ECA GMP-Auditor Association Board of Directors.

Ian Holloway
Form. MHRA, UK
Consultant and former GMP/GDP/GCP inspector and Head of the Defective Medicines Report Centre at MHRA. Member of the ECA GMP-Auditor Association Board of Directors.

Dr Felix Kern
Merck, Germany
Associate Director and Head of Compliance Launch and Technology Center. Member of the ECA GMP-Auditor Association Board of Directors.

Ágnes Kis
form. GMP-Inspector at OGYÉI, Hungary
Compliance Consultant
Before starting to work as a consultant, Ágnes Kis worked as GMP-Auditor at Roche and Novartis. Before her industrial career, Ágnes Kis was Senior GMP/GDP Inspector for the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) and expert member in various working groups at EMA, PIC/S and the European Commission. Ágnes is a member of the new ECA Working Group for GMP-Auditors.

Dr Hanneke Later-Nijland
Genome Lawyers, The Netherlands
Lawyer and pharmacist, specialised in EU and national regulatory life sciences law. Former inspector for Clinical Trials and Pharmacovigilance with the Dutch Inspectorate for Healthcare (IGJ).

Markus Roemer
comes compliance services, Germany
Consultant, Auditor, Speaker and Trainer

Beatriz Sanchez
Kyowa Kirin, USA
Senior Director, Global Head GMP/GDP/GQP Audit with 10+ years QP & RP Experience in the EU.

Thomas Højsholm Schmidt
CSL Behring, Switzerland
Associated Director and Corporate Lead Auditor in Global Quality Systems & Compliance at CSL Behring AG located in Switzerland. Before that, 12 years at LEO Pharma A/S in Denmark as GMP domain expert and GMP Lead Auditor. Member of the ECA GMP-Auditor Association Board of Directors.

Dr Ingrid Walther
Pharma Consulting Walther, Germany
Independent consultant with many years of professional experience in R&D, QA/QC, auditing and management of strategic projects. Member of the ECA GMP-Auditor Association Board of Directors.