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

17-10-2025 14h-17h 

3.2.2 Randomisation modes

Giovanni BRIGANTI

10-10-2025 14h-16h

3.2.3  Statistical aspects in the planning of clinical trials

Giovanni BRIGANTI

24-10-2025 14h-17h 

3.2.4 Innovative study designs

Giovanni BRIGANTI

31-10-2025 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-17h

3.3.4  Setting up a clinical trial (Part II)

Jonathan LETTANY 

14-11-2025 14h-17h

3.3.5  Monitoring safety in clinical trials and Drug development

Jonathan LETTANY 

18-11-2025 14h-17h

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

Xavier DRUART

09-01-2026 14h-17h

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

Xavier DRUART

23-01-2026 14h-15h30

2. Biostatistics : evaluating clinical data

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

Giovanni BRIGANTI 

20-01-2026 14h-17h

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

Giovanni BRIGANTI 

27-01-2026 14h-17h

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

Giovanni BRIGANTI

29-01-2026 14h-17h

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

Giovanni BRIGANTI

30-01-2026 14h-17h

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

Giovanni BRIGANTI 

06-02-2026 14h-17h

3. Evaluating safety data

4.3.1 Methods for the evaluation of safety data in clinical trials

Isabelle LAUGEL

03-03-2026 14h-17h

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

Isabelle LAUGEL

05-03-2026 14h-17h

4. Data interpretation and scientific writing

4.4.1 Different aspects of clinical study reports and conclusions in writing

Xavier DRUART

06-03-2026 14h-17h

4.4.2 Writing a paper for publication

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

Luise KALBE 

12-03-2026 14h-17h

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

Giovanni BRIGANTI

20-03-2026 14h-17h

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 

02-04-2026 14h-17h

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 

10-04-2026 14h-16h

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

Stéphane CALLEWAERT 

17-04-2026 14h-16h

5.1.4 Drug registration – Special issues (orphan products)

Tim LEEST

23-04-2026 14h-16h

2. Pharmacovigilance and Medical information

5.2.1  Back to basics in Pharmacovigilance

Marc CEUPPENS

12-05-2026 14h-17h

5.2.2  EU regulations and Guidelines in Pharmacovigilance

Marc CEUPPENS

19-05-2026 14h-17h

5.2.3 Everyday Pharmacovigilance

Marc CEUPPENS

22-05-2026 14h-17h

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

Nathalie LAMBOT   

29-05-2026 14h-17h

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

Marc CZARKA

02-06-2026 14h-17h

3. Pharmacoepidemiology

5.3.1 Principles of pharmacoepidemiology

Nicolas PRAET

12-06-2026 14h-17h

5.3.2  Study methods and data resources

Nicolas PRAET

16-06-2026 14h-17h

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

Nicolas PRAET

18-06-2026 14h-17h

WORKSHOP (Assignment 5) : Anticipating future regulatory challenges

Marc CZARKA & David FONTAINE   

23-06-2026 14h-17h

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 

17-09-2026 14h-17h

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

29-09-2026 14h-17h

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

6.3.1 Which new products are truly innovative ?

Marc Czarka

05-11-2026 14h-17h

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