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   

25-06-2024 14:00-17:00

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   

6.1.2 Interpreting cost-effectiveness – Patient reported outcomes

How the economic assessment affects market access ?

Hilde STEVENS   

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

Marc CZARKA   

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  

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   

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