GMP - GLP - GCP

Dr. Hedwig Beernaert is involved in many research projects using chromatographic and spectroscopic techniques. He is an author and co-author of more than 100 peer review publications.

Hedwig is chairman of a steering group Mutual Joint Visit program European Union (1994-1998). (8 reports), a member of the OECD steering group Mutual Joint Visit program (1998-2009) (10 reports).

He is an Invited lecturer in GLP matter on national and international meetings, an Organisator of different GLP training courses and performed more than 200 GLP inspections, both domestically and overseas.

Dr. Beernaert is also an Invited professor at the University of Leuven for lectures about the application of the OECD GLP Principles in test sites.

As Vice-chairman of the Belgian Accreditation Board BELAC he performed many assessments in laboratory according to the criteria of the ISO standard ISO 17025, ISO 17043 (Proficiency testing), ISO 15189 (clinical laboratories). More than 150 assessments and reports (1994-2013).

He is a GLP consultant and organisator of several GLP training courses at different domestically and overseas (China) organizations

Member of the Food Section of the Royal Flemish Chemical Society. Organistor of several symposia; Advisor of EuroFIR. Technical advices concerning the EuroFIR quality system framework; Certified reviewer of peer-review articles in internationals Journals.

After completing a Bachelor of Science with specialization in microbiology/biotechnology, Ingrid van Klooster worked for several hospitals and medical centers before becoming a QA Inspector (and later QA Officer) at Wacker Biotech, where she worked for 12 years. More recently, she worked for Kiadis Pharma for over two years, managing teams with a main focus on Quality systems, managing consultants involved in different QA projects, etc.

Today, Ingrid is the owner of IvK Pharmaconsultancy. On the side, she is also working as a QA Manager for BioLyo Technologies, a start-up biotech company dedicated to the development of live micro-organisms to be used as vaccines or biotherapeutic, where she is working on the further development of the QMS and on setting up a GMP approved QC laboratory.

Ingrid has also been working as a Senior Training Specialist for Biotech Training Facility for over a year, developing customized training programs and providing training on various (GMP) topics.

Liesbeth Lemmens holds a bachelor’s degree in Nursing and obtained a master’s degree in Medico-Social Sciences at the Catholic University of Leuven. Her professional experience is a mix of 20 years working in clinical research, as a clinical trial coordinator, project manager and CRA (oncology, cardiology and IBD). In 2010, she started to work as an independent consultant for health care providers. Mrs. Lemmens is also key opinion leader in educating health care providers, clinical research associates, clinical trial assistants and (data) managers on different topics, such as: − ICH-GCP in daily practice − Audit and inspection readiness − Train the trainer − Time management in clinical research − Developments and therapies in oncology. She teaches in terms of the most-up-to-date knowledge delivered in an accessible and informative fashion, with constant updating of training materials. As a facilitator and moderator, she uses a wide range of skills and tools, from problem solving and decision making, to team and time management, coaching and communications.