Training
Introduction to Pharmaceutical Medicine
Tjeerd Korver has developed a specific module for medical students as an introduction to pharmaceutical medicine. Using contraception as an example, the module covers the topics of medical need, health economics, sociological aspects, scientific background, pros and cons of available methods, defining benefit-risk balance, as well as the rules and regulations governing drug development in humans. The module is also suitable for drug development professionals in the pharmaceutical industry and is also available for the level of high school/college students.
Overview of the Drug Development Process
Clinical development is a complex process. The flow of any parameter measured involves first recording ("the source"), transfer to case report forms and entry into the study database, followed by one or more validation cycles, ultimately resulting in a "locked" study database. The locked study database constitutes the basis of statistical processing and analysis, the results of which are described in the clinical study report. Data from various studies are summarized in integrated summary documents, that are the building blocks of registration dossiers. These process involve many disciplines and data flows, which need to be tightly controlled. An overview of these processes with emphasis on the critical controls has been developed to provide a basis for professionals in drug development.
Drug Development Simulation
Tjeerd Korver has been involved in trainings directed at developing knowledge and skills in the field of drug development, according to the concept of "learning by simulation". In these intense 4-day trainings participants are divided over (competitive) multidisciplinary drug development teams that will select a (virtual) preclinical drug development candidate and be responsible for subsequent development into a registrable and marketable product. The course is shaped according to real life and deals with both project managerial and scientific aspects of the process. As such it includes defining proof of concept criteria and target product profile; design, planning, budgetting and execution of the development program; interpretation of results and follow-up actions. The occurrence of unexpected incidents and scheduled and unscheduled face-to-face meetings with internal management and regulatory bodies allow for a realistic experience.
Good Clinical Practice
Tjeerd Korver has authored standard operating procedures and document templates to support drug development. He developed corresponding in-house trainings for clinical trial staff, focussing on the principles and "spirit" of Good Clinical Practice (GCP), with the ultimate goal to ensure full adherence.