This 5-week online course participants learn and practise the Question-Based Clinical Development (QBCD) approach to develop novel medical interventions. This method, based on the Real Options Theory, is common in various industries, but it is still rarely used in the biomedical sector. Dealing with similar huge investments, a high degree of uncertainty and large scale economic risks, this theory is particularly suitable to design a rational and efficient pathway for the development of a novel medical intervention. Estimating costs, risks and the value of the research project, and determining a suitable path for development with this approach, transcends and can be applied to any type of medical intervention. The course takes approximately 5 hours of study per week and thus can be combined with a busy work and private life.
Learning objectives of this course are:
recognize the advantages and disadvantages of using the Net Present Value (NPV) method vs Question-Based approach;
formulate the most important scientific questions to answer during the development process;
identify the uncertainties associated with answering these questions; and
estimate the costs associated with the development process and the potential revenues following successful development.
The online course can be taken as a stand-alone course and is completed with an online exam. Participants who wish to increase their network and gain further experience are invited to join the two consecutive on-campus courses in Leiden. The 4-day on-campus course, held at Castle Oud-Poelgeest in Oegstgeest (near Leiden), gives participants the opportunity to work on advanced teaching cases in small interdisciplinary groups. The teaching cases are based on real research project in industry and invited speakers from industry join the “What really happened” sessions to share their decision making process during the development of the products. Immediately following the on-campus course, the 5-day on-campus extended course, held at Centre for Human Drug Research (CHDR) at Leiden Bio Science Park, allows participants to develop their own idea into a clinical trial proposal with guidance of a mentor. The best clinical protocol with with a registered drug written during the extended course can win a ZonMw grant of € 500,000
The online and on-campus courses have been accredited by KNMG and participants with Dutch BIG registration can receive up to 40 point.
Paul Janssen Futurelab Leiden (PJFL), a new initiative of LUMC, is an international blended learning program (online and on-campus) for entrepreneurial biomedical professionals. With our courses, we try to inspire and engage participants by using a repertoire of educational tools such as animations, infographics, articles, videos, quizzes, tools, and teaching cases based on real events.
Non-profit organizations receive 25% discount.
Scholarships are available.
(twice yearly, exact dates to be announced on PJFL website)
On-campus course at Castle Oud-Poelgeest: https://www.pauljanssenfuturelab.eu/product/clinical-development-on-campus/
On-campus extended course at CHDR: https://www.pauljanssenfuturelab.eu/product/clinical-development-on-campus-extended/
Scholarship information: https://www.pauljanssenfuturelab.eu/about/scholarships-and-grants/
Subtype: Individuele patiëntenzorg