All times are to be considered in Belgian time, i.e. GMT+1 until 26/03/2023 (winter time).

1. Setting the scene : drug development in context 

Marc CZARKA

19-01-2023 14:00-17:00

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

Erik PRESENT

20-01-2023 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

24-01-2023 14:00-17:00

3.2 High Troughput Screening : setting-up of new functional assays, robustness, troughput and assays quality

Vincent DUPRIEZ

02-02-2023 14:00-17:00

3.3 Systems biology and translational research

Benjamin DIZIER

09-02-2023 14:00-17:00

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

Bruno JOSSO

10-02-2023 15:00-18:00

14-02-2023 15:00-18:00

16-02-2023 15:00-18:00

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

Bruno JOSSO et Sarah AMRANI

07-03-2023 15:00-18:00

All times are to be considered in Belgian time, i.e. GMT+1 UNTIL 26/03/2023 (winter time).

1. Non-clinical strategies and Study design 

Jean-Pierre VALENTIN

09-03-2023 14:00-17:00   

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 

14-03-2023 14:00-17:00  

2.2.2 The right dose for first-in-human administration

Denis GOSSEN   

17-03-2023 14:00-17:00

2.2.3 Toxicology testing (Part I)

– General toxicology for new chemical entities –  Annick CAUVIN 

– Genotoxicity – Helga GERETS 

23-03-2023 14:00-17:00

2.2.4 Toxicology testing (Part II)

– Preclinical safety: Secondary and safety pharmacology – Annie DELAUNOIS

– Safety evaluation of Biologicals – Annick CAUVIN

24-03-2023 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+2 FROM 26/03/2023 (summer time).

2.2.5 Genetic and genomic factors in drug development and response

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

30-03-2023 14:00-17:00

2.2.6 Novel approaches in investigative toxicology

Reiner CLASS

06-04-2023 14:00-17:00  

2.2.7 Computational Toxicology Methods for Prediction of Preclinical Safety Endpoints

Lennart ANGER

18-04-2023 14:00-15:30

3. Drug formulation 

2.3.1 Main aspects of Drug formulation & Concept of drug bioavailability

Jonathan GOOLE 

27-04-2023 14:00-17:00

2.3.2 Non-conventional dosage forms & Nanotechnologies for Drug delivery

Jonathan GOOLE

28-04-2023 14:00-17:00

4. Manufacturing  

2.4.1 Pharmaceutical technical development & Quality Management System

Luca PETRUCCI

23-05-2023 14:00-17:00

2.4.2 GMPs and required structures in manufacturing & Inspection-operating environment

Luca PETRUCCI

26-05-2023 14:00-17:00

5. Moving to First-in-Human studies

2.5.1 Ethics in the Pharmaceutical Industry

Ingrid KLINGMANN 

08-06-2023 14:00-17:00

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

Ingrid KLINGMANN 

09-06-2023 14:00-17:00

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

Hatice ALDEMIR 

16-06-2023 14:00-17:00

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

Nariné BARIRIAN 

21-09-2023 14:00-17:00

WORKSHOP (Assignment 2) : 3D Printing in Pharmaceutics

Hatice ALDEMIR & Jonathan GOOLE 

23-06-2023 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+2 UNTIL 29/10/2023 (summer time).

1. Early studies in patients

3.1.1  Pharmacokinetics : basic concepts and applications

Nariné BARIRIAN 

28-09-2023 14:00-17:00

3.1.2  Drug metabolism : drug-drug interaction studies

Nariné BARIRIAN

29-09-2023 13:30-16:30

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

03-10-2023 14:00-17:00

2. Clinical Trials Designs

3.2.1 Different types of clinical trials study designs

Nariné BARIRIAN

06-10-23 14:00-17:00

3.2.2 Randomisation modes

Giovanni BRIGANTI

12-10-23  14:00-17:00

3.2.3  Statistical aspects in the planning of clinical trials

Giovanni BRIGANTI

13-10-23  17:00-20:00

3.2.4 Innovative study designs

Giovanni BRIGANTI

24-10-23  17:00-19:00

3. Planning and managing clinical trials

3.3.1 GCP requirements and regulatory aspects

Ingrid KLINGMANN  

19-10-2023 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+1 FROM 29/10/2023 (winter time).

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

Ingrid KLINGMANN 

09-11-2023 14:00-16:00

3.3.3  Setting up a clinical trial (Part I)

Jonathan LETTANY 

10-11-2023 14:00-17:00

3.3.4  Setting up a clinical trial (Part II)

Jonathan LETTANY 

14-11-2023 14:00-17:00

3.3.5  Monitoring safety in clinical trials and Drug development

Jonathan LETTANY 

23-11-2023 14:00-17:00

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

Ingrid KLINGMANN 

24-11-2023 14:00-17:00

3.3.7  Patient centric approach in clinical resarch : Ethics, involvement and collaboration

P. MIQUEU 

Course postponed to 2024

3.3.9 Audits of clinical trials

Ingrid KLINGMANN

08-12-2023 14:00-17:00

4. Gathering data from clinical trials

3.4.1 Procedures for clinical data collection and data management

Marc ELSLEY

12-12-2023 14:00-17:00

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

Hatice ALDEMIR   

14-12-2023 14:00-17:00

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  

19-12-2023 14:00-17:00

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

21-12-2023 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+1 UNTIL31/03/2024 (winter time).

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 

16-01-2024 14:00-17:00

18-01-2024 14:00-17:00

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

Ludo HAAZEN

19-01-2024 14:00-17:00

2. Biostatistics : evaluating clinical data

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

Giovanni BRIGANTI 

23-01-2024 14:00-17:00

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

Giovanni BRIGANTI 

01-02-2024 14:00-17:00

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

Giovanni BRIGANTI

02-02-2024 14:00-17:00

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

Giovanni BRIGANTI

15-02-2024 14:00-17:00

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

Giovanni BRIGANTI 

16-02-2024 14:00-17:00

3. Evaluating safety data

4.3.1 Methods for the evaluation of safety data in clinical trials

Isabelle LAUGEL

20-02-2024 14:00-17:00

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

Isabelle LAUGEL

23-02-2024 14:00-17:00

4. Data interpretation and scientific writing

4.4.1 Different aspects of clinical study reports and conclusions in writing

Xavier DRUART

15-03-2024 14:00-17:00

4.4.2 Writing a paper for publication

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

Luise KALBE 

21-03-2024 14:00-17:00

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

Giovanni BRIGANTI

26-03-2024 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+2 FROM 01/04/2024 (summer time).

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 

11-04-2024 14:00-17:00

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 

12-04-2024 14:00-16:00

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

Stéphane CALLEWAERT 

16-04-2024 15:30-17:30

5.1.4 Drug registration – Special issues (orphan products)

Tim LEEST

19-04-2024 14:00-16:00

3. Pharmacoepidemiology

5.3.1 Principles of pharmacoepidemiology

Nicolas PRAET

16-05-2024 14:00-17:00

5.3.2  Study methods and data resources

Nicolas PRAET

23-05-2024 14:00-17:00

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

Nicolas PRAET

24-05-2024 14:00-17:00

2. Pharmacovigilance and Medical information

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

Nathalie LAMBOT   

28-05-2024 14:00-17:00

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

Marc CZARKA

30-05-2024 14:00-17:00

5.2.1  Back to basics in Pharmacovigilance

Marc CEUPPENS

04-06-2024 14:00-17:00

5.2.2  EU regulations and Guidelines in Pharmacovigilance

Marc CEUPPENS

07-06-2024 14:00-17:00

5.2.3 Everyday Pharmacovigilance

Marc CEUPPENS

14-06-2024 14:00-17:00

WORKSHOP (Assignment 5) : Anticipating future regulatory challenges

Marc CZARKA & Olivier FONTAINE   

27-06-2024 14:00-17:00

All times are to be considered in Belgian time, i.e. GMT+2 UNTIL 27/10/2024 (summer time).

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
12-09-2024 14:00-17:00

6.1.2 Interpreting cost-effectiveness – Patient reported outcomes

How the economic assessment affects market access ?

Hilde STEVENS

13-09-2024 14:00-17:00

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

Marc CZARKA 

19-09-2024 14:00-17:00

6.1.3 Real world data and Real world evidence

David FONTAINE & Joachim MORRENS 

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
01-10-2024 14:00-17:00  

6.2.2 Macroeconomic aspects

Olivier ETHGEN

6.2.3 Pharmaceutical marketing (I)

1. Pharma/Biotech : the Belgian environment

2. The role of the product manager

Yohan HEYLEN   

6.2.3 Pharmaceutical marketing (II)

1. Pharmaceutical life cycle management

2. Biotech vs Big Pharma : business models

3. Pharma future

Yohan HEYLEN   

6.2.4 Regulatory environment and market access in emerging markets

Hugues MALONNE   

All times are to be considered in Belgian time, i.e. GMT+1 FROM 27/10/2024 (winter time).

3. Innovation and improvment of health care

6.3.1 Which new products are truly innovative ?

Yves HORSMANS  

6.3.2 Health databases for innovation and improving health care ?

Yves HORSMANS  

3. WORKSHOP (Assignment 6)

Olivier ETHGEN  

Paul GILLARD