All times are to be considered in Belgian time, i.e. GMT+1 until 29/03/2025 (winter time).

1. Setting the scene : drug development in context 

Marc CZARKA

16-01-2025 14:00-17:00

2. Integrated product development : from discovery phase to market authorization

Erik PRESENT

17-01-2025 14:00-17:00

3. Drug screening : from animals to recombinant proteins and translational research 

3.1 Animal testing : current use, ethical and regulatory aspects, limitations and alternative approaches

Remi ROSIERE

21-01-2025 14:00-17:00

3.2 Drug Discovery with a focus on target-drug interactions & screening assays

Céline VERMEIREN

23-01-2025 14:00-17:00

3.3 Systems biology and translational research

Benjamin DIZIER

30-01-2025 14:00-17:00

4. Big Data and personalized medicine : can AI reinvent drug design and development?

Bruno JOSSO

31-01-2025 14:00-17:00

07-02-2025 14:00-17:00

14-02-2025 14:00-17:00

WORKSHOP (Assignment 1) : Big data, AI and healthcare environment

Bruno JOSSO et Sarah AMRANI

11-03-2025 14:00-17:00

1. Non-clinical strategies and Study design 

Jean-Pierre VALENTIN

18-03-2025 14h-17h

2. Pre-clinical safety  : Principles of pharmacology and toxicology 

2.2.1 Non-clinical testing for chemical and biological compounds, including Pharmacology (ADME)

Denis GOSSEN 

03-04-2025 14h-17h

2.2.2 The right dose for first-in-human administration

Denis GOSSEN   

08-04-2025 14h-17h

2.2.3 Toxicology testing (Part I)

– Genotoxicity an phototoxicity – Helga GERETS 

28-03-2025 14h-17h

2.2.4 Toxicology testing (Part II)

– General toxicology for new chemical entities –  Annick CAUVIN 

01-04-2025 14h-16h

2.2.5 Toxicology testing (Part III)

– Preclinical safety: Secondary and safety pharmacology – Annie DELAUNOIS

– Safety evaluation of Biologicals – Annick CAUVIN

04-04-2025 14h-17h  

All times are to be considered in Belgian time, i.e. GMT+2 FROM 29/03/2025 (summer time).

2.2.6 Genetic and genomic factors in drug development and response

James STALEY, Olga GIANNAKOPOULOU, Bram VAN DE SANDE & Martin ARMSTRONG 

17-04-2025 14h-17h

2.2.7 Novel approaches in investigative toxicology

Leandro ROYER

11-04-2025 14h-17h

2.2.8 Computational Toxicology Methods for Prediction of Preclinical Safety Endpoints

Marie Ledecq

18-04-2025 14h-17h

3. Drug formulation 

2.3.1 Main aspects of Drug formulation & Concept of drug bioavailability

Jonathan GOOLE 

22-04-2025 14h-17h

2.3.2 Non-conventional dosage forms & Nanotechnologies for Drug delivery

Jonathan GOOLE

24-04-2025 14h-17h

4. Manufacturing  

2.4.1 Pharmaceutical development of drug substance and drug product, including biological medicines and advanced therapies

Luca PETRUCCI

15-05-2025 14h-17h

2.4.2 Technical pharmaceutical development : formulations, primary packaging, delivery systems

Luca PETRUCCI

16-05-2025 14h-16h

2.4.3 GMPs and the department/system structures necessary for development and manufacturing

Luca PETRUCCI

23-05-2025 14h-17h

5. Moving to First-in-Human studies

2.5.1 Ethics in the Pharmaceutical Industry

Ingrid KLINGMANN 

06-06-2025 14h-17h 

2.5.2 Requirements, ethics and regulations for first-in-Human studies

Ingrid KLINGMANN 

12-06-2025 14h-17h 

2.5.3 Strategic importance, design and practical organization of Phase I studies

Nariné BARIRIAN 

13-06-2025 14h-17h

2.5.4 Accelerating the move to clinical trials (computer assisted modelling on the way of proof of concept)

Hatice ALDEMIR 

19-06-2025 14h-17h

WORKSHOP (Assignment 2) : 3D Printing in Pharmaceutics

Hatice ALDEMIR & Jonathan GOOLE 

26-06-2025 14h-17h

1. Early studies in patients

3.1.1  Pharmacokinetics : basic concepts and applications

Nariné BARIRIAN 

25-09-2025 14h-17h

3.1.2  Drug metabolism : drug-drug interaction studies

Nariné BARIRIAN

26-09-2025 14h-17h

3.1.3  Special PK topics : Multiple dose PK, Influence of hepatic and renal impairments on drug PK, bioavailability and bioequivalence, PK/PD analysis

Nariné BARIRIAN

30-09-2025 14h-17h   

2. Clinical Trials Designs

3.2.1 Different types of clinical trials study designs

Nariné BARIRIAN

07-10-2025 14h-17h 

3.2.2 Randomisation modes

Giovanni BRIGANTI

09-10-2025 14h-16h

3.2.3  Statistical aspects in the planning of clinical trials

Giovanni BRIGANTI

10-10-2025 14h-17h 

3.2.4 Innovative study designs

Giovanni BRIGANTI

16-10-2025 14h-16h  

3. Planning and managing clinical trials

3.3.1 GCP requirements and regulatory aspects

Ingrid KLINGMANN  

All times are to be considered in Belgian time, i.e. GMT+1 FROM 25/10/2025 (winter time).

04-11-2025 14h-17h   

3.3.2 Confirmatory Clinical Development Plan and Target Product Profile (TTP)

Ingrid KLINGMANN 

06-11-2025 14h-16h   

3.3.3  Setting up a clinical trial (Part I)

Jonathan LETTANY 

13-11-2025 14h-16h

3.3.4  Setting up a clinical trial (Part II)

Jonathan LETTANY 

14-11-2025 14h-16h

3.3.5  Monitoring safety in clinical trials and Drug development

Jonathan LETTANY 

18-11-2025 14h-16h

3.3.6 Development Risk Management Plan & Risk-based and remote monitoring in clinical trials

Ingrid KLINGMANN 

21-11-2025 14h-17h   

3.3.7 Outsourcing clinical trials and managing contracts

Olivier SIMON

27-11-2025 14h-17h 

3.3.8 Audits of clinical trials

Ingrid KLINGMANN

28-11-2025 14h-17h 

4. Gathering data from clinical trials

3.4.1 Procedures for clinical data collection and data management

Marc ELSLEY

02-12-2025 14h-17h

3.4.2 Patient adherence and persistence in trials : uptake of mobile health, e-tools, big data analysis and personnalized medicine

TBC 05-12-2025 14h-17h

5. Blockchain in Clinical trials

Science-fiction or science-fact ?

Cases for blockchain applications in clinical trials

Barriers and challenges yet to be overcome

Olivier SIMON, Christophe VAN HUFFEL & Ingrid VAN ROMPAEY  

09-12-2025 14h-17h

WORKSHOP (Assignment 3) : How and Why Blockchain and Distributed Ledger Technologies (DLTs) are new disruptive approaches in the Clinical Trials Industry ?

Olivier SIMON & Christophe VAN HUFFEL

18-12-2025 14h-17h

Upcoming dates

Module 4 courses will take place between January 2026 and March 2026 – detailed timetable available from 15/11/2025

1. Clinical Trial Protocol and Investigator Drug Brochure (IDB)

4.1.1  Clinical trial protocol : a key document – Reading & understanding clinical trial protocols

Ludo HAAZEN 

TBC

TBC

4.1.2  Role of the nvestigator Drug Brochure (IDB) – Regulatory codes and guidance for authoring the IDB

Ludo HAAZEN

TBC

2. Biostatistics : evaluating clinical data

4.2.1  Statistical methods in clinical research (Part I) : Probability distributions and descriptive statistics

Giovanni BRIGANTI 

TBC

4.2.2  Statistical methods in clinical research (Part II) : Statistical models

Giovanni BRIGANTI 

TBC

4.2.3 Statistical methods in clinical research (Part III) : Inferential statistics

Giovanni BRIGANTI

TBC

4.2.4 Statistical methods in clinical research (Part IV) : Epidemiological methods

Giovanni BRIGANTI

TBC

4.2.5  Statistical methods in clinical research (Part V) : Principles of machine learning

Giovanni BRIGANTI 

TBC

3. Evaluating safety data

4.3.1 Methods for the evaluation of safety data in clinical trials

Isabelle LAUGEL

TBC

4.2.2  Background and implementation of Development Safety Update Reports (DSUR) & Data Safety Monitoring Boards (DSMB)

Isabelle LAUGEL

TBC

4. Data interpretation and scientific writing

4.4.1 Different aspects of clinical study reports and conclusions in writing

Xavier DRUART

TBC

4.4.2 Writing a paper for publication

Submitting to peer-reviewed journal, handling the reviewers’ comments

Luise KALBE 

TBC

WORKSHOP (Assignment 4) : Critical reading of a scientific paper on Biostatistics

Giovanni BRIGANTI

TBC

Upcoming dates

Module 5 courses will take place between March 2026 and June 2026 – detailed timetable available from 15/01/2026

1. Drug registration

5.1.1 Drug registration : European procedures and the international environment (I)

Overview of the regulatory environment and medicine registration in the EU

Stéphane CALLEWAERT 

TBC

5.1.2 Drug registration : European procedures and international environment (II)

Comparison with requirements under the US FDA and Japanese authorities

Comparison with requirements in international and emerging markets

Stéphane CALLEWAERT 

TBC

5.1.3 Preparation of a new drug application – The Common Technical Document (CTD)

Stéphane CALLEWAERT 

TBC

5.1.4 Drug registration – Special issues (orphan products)

Tim LEEST

TBC

3. Pharmacoepidemiology

5.3.1 Principles of pharmacoepidemiology

Nicolas PRAET

TBC

5.3.2  Study methods and data resources

Nicolas PRAET

TBC

5.3.3  Interpretating pharmacoepidemiological data – Role of pharmacoepidemiology in a medicinal product’s lifecycle

Nicolas PRAET

TBC

2. Pharmacovigilance and Medical information

5.2.4 Overview of Patient Support ProgramS (PSPS) – Recent trends in Pharmacovigilance

Nathalie LAMBOT   

TBC

5.2.5  Medical information : communicating with healthcare practitioners – Summary of product characteristics and user package leaflet

Marc CZARKA

TBC

5.2.1  Back to basics in Pharmacovigilance

Marc CEUPPENS

TBC

5.2.2  EU regulations and Guidelines in Pharmacovigilance

Marc CEUPPENS

TBC

5.2.3 Everyday Pharmacovigilance

Marc CEUPPENS

TBC

WORKSHOP (Assignment 5) : Anticipating future regulatory challenges

Marc CZARKA & Olivier FONTAINE   

TBC

Upcoming dates

Module 6 courses will take place between September 2026 and November 2026 – detailed timetable available from 15/06/2026

1. Principles and practical applications of health Economics

6.1.1 Health economics assessment of medicinal products :

Study quality concept and methods used to assess quality

Health technology assessment

Hilde STEVENS

TBC

6.1.2 Interpreting cost-effectiveness – Patient reported outcomes

How the economic assessment affects market access ?

Hilde STEVENS

TBC

6.1.3 Pricing and social security coverage of medicinal products (overview, issues and challenges in EU)

Marc CZARKA 

TBC

6.1.4 Real world data and Real world evidence

David FONTAINE & Joachim MORRENS 

TBC

2. Market access

6.2.1 Ethical and legal aspects & Pricing and social security coverage of medicinal products (overview, issues and challenges in EU)

Marc CZARKA

TBC  

6.2.2 Macroeconomic aspects

Olivier ETHGEN

TBC

6.2.3 Regulatory environment and market access in emerging markets

Hugues MALONNE

TBC

6.2.4 Pharmaceutical marketing (I)

1. Pharma/Biotech : the Belgian environment

2. The role of the product manager

Johan HEYLEN

TBC

6.2.5 Pharmaceutical marketing (II)

1. Pharmaceutical life cycle management

2. Biotech vs Big Pharma : business models

3. Pharma future

Johan HEYLEN   

TBC

All times are to be considered in Belgian time, i.e. GMT+1 FROM 25/10/2026 (winter time).

3. WORKSHOP (Assignment 6)

Olivier ETHGEN

TBC

Paul GILLARD