Foundation for Pharma and Biotech Education

The Foundation Pharma & Biotech Education oversees the development of the Quality Management in Pharma and Biotech modules.

History

Biotechnology Studies Delft Leiden

In 1987, the Foundation “Biotechnology Studies Delft Leiden” (BSDL Foundation) was established as a collaborative initiative between Delft University of Technology and Leiden University.

The BSDL Foundation was initially established with a startup grant from the Ministry of Education and a subsidy from the European Social Fund (ESF). In consultation with the business community, these funds were used to set up two-year postgraduate programs for training biotechnology R&D specialists and design specialists for the industry and environmental sector. Additionally, short international courses (“Advanced Courses”) were developed on various areas of biotechnology and quality management for participants from industry, institutes, universities, and hospitals.

In 1997/1998, the “Training Course on Quality Management in Pharma and Biotech” (Q-course) was established in response to industry demand (including Centocor) and through the involvement of Professor Rob Verpoorte, who was a board member representing Leiden University at the BSDL Foundation at that time. Initially, the BSDL Foundation requested the Leiden Academic Centre for Drug Research (LACDR) to establish the course as it would be a better fit there than in Delft, but this was not possible at the time. Therefore, the BSDL Foundation eventually took on the responsibility.

In 1997/1998, the Q-course consisted of 8 modules, but this was considered excessive. From 2000/2001, 6 modules were offered, 5 modules in 2002/2003, and 4 modules from 2004 onwards. Currently the following modules are offered:

Module 1. The Role of the Qualified Person
Module 2. Quality Management in Drug Development
Module 3. Quality Management in Sterile Manufacturing
Module 4. Quality Management in Biopharmaceutical Manufacturing

The Foundation Pharma & Biotech Education oversees the development of the Q-Course modules.

Quality Management in Pharma and Biotech

The Quality Management in Pharma and Biotech course, first organized in 1987, has successfully given hundreds of (aspiring) Qualified Persons and other quality professionals a solid basis to fulfill their essential role in the pharmaceutical industry and hospital pharmacies.

“In the world of pharma, it's crucial for Qualified Persons to be hands-on: immerse in daily operations, conduct thorough GMP audits, build relationships with key functions, engage in validation planning, and always prioritize proactive quality management over reacting after the fact.”

Désireé Vendrig – Module Leader, during Module 1

The Quality Management in Pharma and Biotech program is designed for Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students. The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).

Bottles on a fill-finish line at a pharmaceutical manufacturing site — The Qualified Person is legally and ethically responsible for the released products. Module 1: the Role of the Qualified Person explores this responsibility in-depth.

Organization of Quality Management in Pharma and Biotech

The Foundation for Pharma and Biotech Education is primarily responsible for the development of the Q-course. It has outsourced the organization of the modules to PCS.

The Foundation is supported by the Advisory Board, the Exam Commission and two teams that focus on enhancement of the modules; the Curriculum and Didactic teams.