Summary Regulatory Sciences in Biomedicine | KU Leuven | 2025/26

REGULATORY SCIENCES IN
BIOMEDICINE
1. INTRODUCTION

THE AIM OF RESEARCHERS

 Scientific validation
 Testing in patients
o Can we test it directly in patients?
o Who needs to approve this?
o What about stored biological samples?
o What about patient data?
 Clinical use
 AI tool validation
 Decision-support in clinic
 Fast translation into practice

The regulatory framework:
 Ethical approval by ethics committee
 Use of human biological material via biobank law
 Data protection & privacy (GDPR)
 In vitro diagnostics regulation (IVDR & MDR)
 Reimbursement & access (RIZIV or national health insurance)
 Clinical validation & performance with clinical trials
 Cybersecurity & software safety following ISO 27001
 Liability & legal compliance
 Post-market surveillance & updates by real-world performance monitoring
 User training & transparency

From the very first experiment, you are already operating within a regulatory landscape
→ Regulatory science is not a final step, it runs alongside your research from the
beginning
→ If you think too late about it, the innovation might not reach patients or reach
them too late

STAKEHOLDERS

Researchers have an important position in the translation of findings from the lab to the
clinic
→ They identify molecules & their targets & try to identify the pathways in which
they interact with each other
→ They will have to work together with all the stakeholders in the field
→ Academic, clinical or translational researchers
→ Work at universities or research institutions

The industry’s job is to translate what is found in the lab in a larger scale in order to bring
it to the market
→ They can scale up the production of a molecule

1

, → The industry consists of the manufacturers
→ Can also include researchers

The regulatory authorities will look at how & whether the research is conducted according
to the ethical rules
→ Did the researchers ask permission?
→ Are they doing tests according to the correct standards?

Patient organisations & society use the treatments & medications available on the market
(= users)
→ They need to be involved in the process early on to decide what is really needed
from the industry

Health care professionals (HCPs) are involved in the care of patients
→ Will decide which medications to give to their patients a lot of the time
→ Dual roles: can be researchers at the same time
→ Work in hospitals or private entities

Universities take care of education & research
→ Research coordination office (DOC) helps researchers set up a protocol, finding
funding,…

The industry leads to valorisation (= the process of creating economic or societal value
from knowledge, research, or technology)
→ Technology transfer office helps researchers when they want to protect their
findings via patents

Hospitals & patients are protected by the clinical trial centre (CTC)
→ Research needs to pass through this office before it can be approved

The ethics committee is an independent organization
→ Not linked to a specific hospital or university


ETHICS COMMITTEES
SMEC = social & societal ethics committee
→ Social, behavioural & non-medical human research
→ Not legally recognized

EC research at UZ or KU Leuven for medical-scientific & clinical research involving
humans

EC Care for ethical aspects of patient care & use of donated human biological materials
→ Ex. A girl is being ventilated in the hospital. The doctors decide there’s nothing left
they can do, so want to stop the ventilation against her parents’ will.

ECD = ethical committee for animal experimentation
→ Explain how much pain the animals will be in
→ Explain how you will euthanise them
→ Justify why you need x amount of animals


2

,3

, EC DMM = ethical committee on dual use, military use & misuse
→ Ex. You do a clinical trial & you collaborate with some universities in China. DMM
will look at it & say you aren’t allowed to work with one of the universities because
they know they are involved in taking transplant organs from people that are in
prison.

OBC = education & support committee
→ Support & ethical guidance for master’s theses

PRET = privacy & ethics team
→ Data protection, privacy review & compliance support
→ Looking at GDPR tools


REGULATORY AUTHORITIES
National level:
 FAMHP = federal agency for medicines & health products
 FAGG = federaal agentschap voor geneesmiddelen & gezondheidsproducten

European level:
 EMA = European medicines agency
o Central evaluation
o Authorization of medicines
 European commission
o EU legislation
o Health policy
o Organize funding programmes
 HMA = heads of medicines agencies
o EU network of national authorities
 EDQM = European directorate for the quality of medicines & healthcare
o Quality standards
 ECDC = European centre for disease prevention & control

International level: WHO


PAYERS
National public payer like RIZIV or INAMI
→ Main national health insurance institution
→ Sets reimbursement rules for therapies, medicines & medical procedures
→ Evaluates cost-effectiveness & clinical benefit

Sickness funds (= mutualiteiten)
→ Administer health coverage for citizens
→ Collect contributions & reimburse care according to INAMI or RIZIV regulations
→ Serve as the link between patients & national reimbursement system

Private insurance companies
→ Complementary or supplementary coverage
→ Limited role in standard therapies

4