Lex van Loosbroek
Lex van Loosbroek is a pharmacist by education (MScPharm) and given his experience in the pharmaceutical industry, eligible as Qualified Person. During his employment in industry for about 8 years, he held several positions in Quality Control and Manufacturing at EU and FDA approved companies.
He then joined the Dutch Medicines Inspectorate for nearly 10 years as a GMP inspector. At the Inspectorate he held the position of senior GMP inspector specialized in sterile and biological manufacturing. During his career as a GMP
inspector, he performed many inspections of pharmaceutical companies, mainly in the Netherlands but also a significant number in the USA.
Lex started his own independent consultancy firm in 2002 and now advises pharmaceutical companies on quality and GMP-related issues, performs audits and organizes seminars and training courses. Having worked for a long time in the regulatory environment and having actively contributed to European legislation and guidelines, Lex is an expert on current regulatory and GMP requirements in Europe. He has a special interest in the regulatory expectations concerning the responsibilities of the Qualified Person.
Since starting his consultancy firm, Lex has built up an impressive track record of successful projects with both international and local companies. In the course of these projects, companies have benefited from his combination of hands-on and regulatory experience.
Inge Helsper is a pharmacist by education (MScPharm) and given her more than 15 years experience in the pharmaceutical industry and allied healthcare business, eligible as Qualified Person. Inge’s career started in 1988 in the pharmaceutical industry at Centocor, Leiden, the Netherlands, a biotech company. In 1993 she joined the national Blood Institute (now named Sanquin) where she held various QA positions with increasing responsibilities. As of 2005, Inge holds a certificate in organizational sciences from the Sioo institute in Utrecht, the Netherlands.
In 2005 Inge joined Van Loosbroek Farma Consult as senior consultant. Since then she has worked for several clients in various projects, e.g. as interim-Qualified Person for both sterile and non-sterile products, and as QA consultant to set-up and streamline quality management systems. Since becoming a consultant Inge has had significant successes in helping organisations to achieve regulatory GMP compliance and business benefits. Further, she has gained a deep
understanding of aseptic processing and an insight in quality management systems. With her interest in management and leadership skills she is strong in coaching persons effectively.