dr Kees Baggerman
Kees Baggerman, founder of Baggerman Farma Consult, began his career with a short period as an industrial pharmacist. He continued to work as a hospital pharmacist until 1987. In 1986 he obtained his Ph.D. degree at Leyden University for his thesis related to pharmaceutical technology. Next, he started his pioneering work as an independent consultant in the field of pharmaceutical production and regulatory affairs. Since that time he supported numerous companies with all kinds of regulatory and quality issues, got involved in a wide variety of developmental projects, ran various projects in over 30 hospital pharmacies, served for many years as an evaluation expert in various EU research programs, acted as secretary of a federation of pharmaceutical SME’s for over 10 years, and published over 30 articles and reports on various pharmaceutical issues and developments.
drs Wout Jan Louwaars
Wout Jan Louwaars, graduated as a pharmacist from the University of Utrecht in 1978. He began his career as an industrial pharmacist at the Central Military Pharmacy, before moving on to Chefaro International holding the position of Head of R&D and later Head of QA/QC. In 1996 he joined Baggerman Farma Consult and has since worked on projects aimed at the implementation of GMP/GDP, FDA/GcLP and ISO 9000/13485 for various pharmaceutical, chemical and medical device companies. He has also been responsible for a number of (European) regulatory projects for drugs, blood products and medical devices. He has been acting Qualified Person for a number of (bio)pharmaceutical companies in recent years.
drs Jens-Erik Vaessen
Jens-Erik Vaessen was engaged in a research project at the Analytical Department of Novo-Nordisk Denmark while being a pharmacy student at the University of Groningen. After his graduation in 1999 he started as a community pharmacist for a short period of time and then moved on to a phytopharmaceutical company. In 2000 he joined Baggerman Farma Consult and since he held various positions on regulatory affairs departments and in manufacturing plants as production pharmacist or Qualified Person. Other projects included the development and implementation of various quality systems (GDP, GMP) in several companies (food, cosmetics, pharmaceuticals). He also has been engaged in complex compliance projects in the area of the Code of Conduct for Pharmaceutical Advertising (CGR).
drs Chantal Vandierendonck
Chantal Vandierendonck completed her pharmacy study in 1991. She has worked for many years as an auditor in the Quality Assurance department of a Clinical Research Organization (CRO) and got very familiar with GCP, GMP, GDP and EN 540 systems. At the same time she was responsible for the storage and packaging of investigational medicinal products. She joined Baggerman Farma Consult in 2002 and acts as responsible pharmacist (QP) for several pharmaceutical distributors and packers. She also worked on projects regarding design and implementation of quality systems (GDP and GMP) as well as executing clinical research projects and various regulatory projects.
ir Maria van Acker
Maria van Acker studied food technology at Wageningen Agricultural University and graduated in 1991. After being a QA-manager in the food business for 5 years, she became lead-auditor at a certification and consultancy agency (BVQI) and performed audits on quality systems (ISO9001), food-safety (HACCP, BRC, IFS) and medical related systems (HKZ, NEN 46000) as well as in manufacturing and logistic services organisations .
In 2005 she switched to Sanquin, the national blood supply foundation in The Netherlands, to perform internal (ISO9001 and GMP) and supplier audits. In 2007 she joined Baggerman Farma Consult to do consultancy on quality related food-issues in pharmacy (e.g. supplements, vitamins) and GDP in logistic services. Besides this, she focusses on Regulatory Affairs.
ir Jasper Vink
Jasper Vink studied Physics at the Eindhoven University of Technology and graduated in 1991. Already during his study he started as a production operator with Cygne BV (acquired by GE Healthcare in 2004), manufacturer of various radiopharmaceuticals. He continued his career, working in Manufacturing, Quality Control, Regulatory Affairs, Quality Systems and EHS, before becoming Quality Assurance Manager of the site’s QA team (6 persons) in 2001. In this role he increased his experience of all aspects of Quality Systems, with focus on Aseptic Operations and Radiopharmaceuticals. In 2011 he moved to a global position, QA Training Manager, with the task of harmonising quality related training across 10+ sites and organisations worldwide.
In 2014, Jasper decided to make a career switch and he joined Baggerman Farma Consult, acting as a consultant with focus on Quality Systems and Regulatory Affairs.
Jasper is registered as a Qualified Person since 2004 and as a Radiation Protection Officer (Level 2) since 2000.
drs Maarten Bisseling
Maarten Bisseling graduated as a biologist in 2004 at the Radboud University of Nijmegen, with specializations in molecular and theoretical biology. He worked in the technical group of the Max Planck Institute of Psycholinguistics in Nijmegen until 2006. Subsequently, he has been working in the pharmacovigilance department of Synthon BV as a Pharmacovigilance Support officer and at MSD (formerly Organon BV) in Oss as a Safety Data Specialist. In 2015, he joined Baggerman Farma Consult, where he is primarily involved in the Pharmacovigilance activities.
dr Jacobine van Houts – Kuijlaars
Jacobine van Houts – Kuijlaars studied Biomedical Sciences at Utrecht University and graduated in 2010, with a specialization in neuroscience. She started her career as a research associate at the CNS Discovery department of Janssen – Pharmaceutical companies of Johnson and Johnson in Beerse (Belgium). In 2013 she started a PhD-project in the same department, in close collaboration with Hasselt University. Early 2017 she obtained her Ph. D degree at Hasselt University for her thesis on the use of human induced pluripotent stem cells for modelling neuro(patho)physiology. By the end of 2017 she joined Baggerman Farma Consult as a consultant, focusing on Regulatory Affairs.
drs Max Robben
Max Robben studied Biomedical Sciences at the VU Amsterdam. In his master he specialized in Psychophysiology as well as Science Communication, and graduated in 2010. Before entering the pharmaceutical industry he worked at the Verbeeten Institute in Tilburg in a temporary assignment to digitalize and bring structure to the patient files. Subsequently, he joined Amgen in 2011 in the role of drug safety officer. Within this role he assured compliance of the Dutch Amgen affiliate to the applicable pharmacovigilance legislations. During this period he also had a temporary assigment as medical information manager for the oncology portfolio. Within his PV role he gained experience in adverse event case handling, optimization of the case handling proces, screening of local literature, ensuring PV-compliance within many local commercial/clinical projects and PV-training of Amgen personell and external vendors. In 2018, he joined Baggerman Farma Consult, where he is primarily involved in the Pharmacovigilance activities.
drs Mariska de Meijer
Mariska de Meijer obtained her master’s degree in Pharmacy in 2010 at the University of Utrecht. She started her professional career in the pharmaceutical industry. During the first five years, she worked at the Regulatory Affairs and Medical Information department of a medium sized pharmaceutical company. She was in the frontline to successfully obtain a Marketing Authorization under the Well Established Use(WEU) article. She also performed a variety of other projects including regulatory dossier compilation, (pre-)clinical research projects, developing product information and employee training. Due to her pharmacy background she also became involved in quality assurance activities such as setting up document management systems, writing product quality reviews and drug stability reports. At a later stage, she was responsible for initiation and execution of named patient programs in the Netherlands. In 2018, she joined BFC as a consultant. She is involved in various projects concerning quality affairs and regulatory affairs.
drs Irene Goertz – Berson
Irene Goertz – Berson completed her pharmacy study in 2003. After her graduation she started as a community pharmacist but switched to the pharmaceutical industry in 2006. She joined MSD (former Organon), as a trainee production pharmacist. She was extensively trained in all aspects of the Pharmaceutical Quality Systems (GMP, GDP) for both sterile and non-sterile production. In 2009 she became production pharmacist at MSD in the Special Products Division (e.g. Nuvaring, Implanon) and afterwards at the hospital pharmacy (ZANOB) of the Jeroen Bosch Hospital. In that period she was responsible for the implementation of the quality guidelines and in the lead of building the Pharmaceutical Quality System (based on GMPz) of ZANOB. Furthermore, she was reponsible for the QA release of Medicinal Gases and Water for Dialyses within the hospital.
In 2014, Irene switched to a smaller company which produces veterinary medicines, where she combined regular QA and QP duties with drug-development, RA and auditing. After 3 years she developed herself further and started to work as QP at GE Healthcare, where she specialised herself in the manufacture and QP release of radiopharmaceuticals (123I and 18FDG). In September 2019 she joined Baggerman Farma Consult (BFC), where she is primarily involved in QA and QP related projects. These duties will be expanded with RA activities in the near future.