Expert Details

Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM

Expert ID: 731813 Belgium

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Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the compliance with GCP and all relevant regulatory, ethical and scientific requirements at a variety of organizations involved in pharmaceutical research and development (R&D), i.e. sponsors, CROs, vendors, labs and investigator sites. She performed inspections in such diverse regions as Europe (EU and non-EU countries), Asia, and USA.

As an independent consultant she supports her clients by evaluating the GCP compliance of their systems, e.g. Quality Management Systems (QMS), organizations, sites and facilities, as well as documents. She also helps them in identifying areas of potential improvement, and developing improvement strategies, for example CAPAs. She performs "mock-inspections" as preparation for regulatory authority statutory surveillance or pre-approval inspections, or as part of "Inspection readiness" program. She also supports her clients in identifying, reporting and remedying GCP issues, so called "serious breaches", as required by MHRA.

Expert has over 13 years of professional experience in clinical research and development. She has a great wealth of operational experience having worked for a CRO and a global pharmaceutical company. She led the clinical trial team which was responsible for the first successful marketing authorization application of a biosimilar (Omnitrop). Expert provided her operational expertise in the development and implementation of different clinical development programs. She was also involved in the development and implementation of clinical trial protocols and amendments, Case Report Forms (CRF) and informed consent forms/documents in different indications. Furthermore she was also involved in several statistical (interim) analyses of clinical trials, and the preparation and writing of Clinical Study Reports according to ICH E3.


Expert has studied the history, theory and current methodologies of quality management during her postgraduate studies of Total Quality Management. She has several years of practical experience in developing and implementing quality management systems that she gained at a pharmaceutical company and at BfArM’s GCP Inspections Unit.

As an independent consultant, expert applies her knowledge and experience by developing and implementing QMS for her clients. In case of an already established QMS, she can perform a gap assessment and help to identify the necessary changes and improvements. Furthermore, she supports the quality assurance efforts of her clients. She performs following types of audits: routine audits in the context of a clinical trial, for cause audits, pre-inspection audits, system related audits, service provider & vendor qualification audits, clinical document (protocol, informed consent documents, Trial Master Files (TMF), Clinical Study Reports, etc.) audits. The audits can be performed at clinical trial sites, CROs, service provider facilities and client’s facilities. She also supports her clients in developing and implementing audit programs.

Expert has several years of professional experience in the pharmaceutical industry. She can provide clients with a combination of operational experience (having worked for a CRO and a global pharmaceutical company) and regulatory expertise (6 years as a GCP inspector). It enables Expert to provide her clients with a unique insight in regulatory requirements in this highly regulated industry while ensuring that the advice provided is pragmatic. She is familiar with the European clinical trial authorization (CTA) procedure, the central authorization procedure (CAP) at the EMA, and the national marketing authorization procedures (DCP, MRP, national). She disposes of an established network within industry and regulatory authorities (Europe and USA).

Furthermore, expert is an active member of the Drug Information Association (DIA), and member of the Core Committee of DIA GCP&QA Community. She is very much interested in the improvement of regulations and the quality of clinical trials and she is convinced that this can be achieved only in good coordination across the industry sectors. Therefore she has been involved in a DIA working group which resulted in the recent publication of a position paper on “The Life Cycle and Management of Protocol Deviations”. As training and knowledge sharing are also topics she is enthusiastic about, she volunteered as member of the Task Force that supported the development of the “GxP Training Guidelines” published by IAoCR.


Education

Year Degree Subject Institution
Year: 1999 Degree: MSc Subject: Biology Institution: Heinrich-Heine-Universitaet Duesseldorf, Germany
Year: 2013 Degree: Certificate Subject: Total Quality Management Institution: Technische Universität Kaiserslautern, Germany

Work History

Years Employer Title Department Responsibilities
Years: 2012 to Present Employer: Undisclosed Title: Managing Director Department: Responsibilities:
Years: 2005 to 2011 Employer: BfArM - Federal Institute for Drugs and Medical Devices, Bonn, Germany Title: GCP inspector Department: Clinical Trials and GCP Inspections Unit Responsibilities: She led and conducted global GCP inspections in the context of national and EMA marketing authorisation procedures. She participated in the pilot EMA-FDA GCP initiative and led an EMA GCP Inspectors subgroup responsible for the revision of the EU GCP inspection procedures. She further participated in the development and implementation of a quality management system for BfArM’s GCP Inspections Unit, and provided trainings related to ICH-GCP as well as to quality assurance on a national and international level (e.g. EMA, DIA, IFAPP, etc)
Years: 2003 to 2005 Employer: Sandoz GmbH, Biopharmaceuticals, Vienna, Austria Title: Clinical Operations Manager Department: Responsibilities: She led the clinical trial team which was responsible for the first successful marketing authorisation application of a biosimilar (Omnitrop). Furthermore she contributed to the development and implementation of a quality management system in the newly established Clinical Development department.
Years: 2000 to 2003 Employer: Omnicare Clinical Research, Schwalbach, Germany Title: Senior Clinical Research Associate Department: Responsibilities:

Government Experience

Years Agency Role Description
Years: 2005 to 2011 Agency: BfArM - Federal Institute for Drugs and Medical Devices, Germany Role: GCP Inspector Description: She led and conducted global GCP inspections in the context of national and EMA marketing authorisation procedures. She led an EMA GCP Inspectors subgroup responsible for the revision of the EU GCP inspection procedures. She participated in the Pilot EMA-FDA GCP initiative.

Career Accomplishments

Associations / Societies
DIA: member of the GCP & QA Community; member of the Working Group for the Position Paper on Protocol Deviations
Professional Appointments
Core Committee member of the DIA GCP & QA Community;
Task force member for the “GxP Training Guidelines”, International Academy of Clinical Research (IAoCR)
Publications and Patents Summary
Expert has 3 publications

Language Skills

Language Proficiency
German Native
Polish Native
English Business fluency
French Intermediate

Fields of Expertise

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