1. Setting the scene : the context of drug development 

Marc Czarka

12-01-2021 13:30-16:30

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

Peter Hendrickx

14-01-2021 13:30-16:30

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

3.1 Testing in animals : current use, ethical and regulatory aspects, limits and alternative approachs

Remi Rosière

15-01-2021 13:30-16:30

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

Vincent Dupriez

28-01-2021 14:00-17:00

3.3 Systems biology and translational research

Benjamin Dizier

29-01-2021 14:00-17:00

4. Big Data and personnalized medecine : How AI can potentially reinvent the drug design and development ?

Bruno Josso

23-02-2021 14:00-17:00

02-03-2021 14:00-17:00

04-03-2021 14:00-17:00

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

Bruno Josso et David Gruson

12-03-2021 14:00-17:00

1. Pre-clinical strategy and Study design 

Jean-Pierre VALENTIN   23/03/2021  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   26/03/2021  14:00-17:00

2.2.2 How to choose the dose for first in human administration ?

Denis GOSSEN    30/03/2021  14:00-17:00

2.2.3 Toxicology testing (Part I)

Annick CAUVIN & Helga GERETS   01/04/2021  14:00-17:00

2.2.4 Toxicology testing (Part II)

Annie DELAUNOIS & Annick CAUVIN  02/04/2021  14:00-17:00

2.2.5 Genetic and genomic factors in drug development and response

Csilla SIPEKI, James STALEY, Ciara VANGJELI & Martin ARMSTRONG    20/04/2021  14:00-17:00

2.2.6 Novel approaches in investigative toxicology

Reiner CLASS   23/04/2021   14:00-17:00

2.2.7 In silico/Computational toxicology

Lennart ANGER   27/04/2021   14:00-17:00

3. Drug formulation 

2.3.1 Main aspects of Drug formulation & Concept of drug bioavailability

Jonathan GOOLE   30/04/2021   14:00-17:00

2.3.2 Non-conventional dosage forms & Nanotechnologies for Drug delivery

Jonathan GOOLE   04/05/2021   14:00-17:00

4. Manufacturing  

2.4.1 Pharmaceutical technical development & Quality Management System

Christophe ALLARD   27/05/2021   14:00-17:00

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

Christophe ALLARD   28/05/2021   14:00-17:00

5. Moving to First-in-Human studies

2.5.1 Ethics in the Pharmaceutical Industry

Ingrid KLINGMANN   10/06/2021   14:00-17:00

2.5.2 Requirements, ethics and regulations of First-in-Human studies

Ingrid KLINGMANN   11/06/2021   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   15/06/2021   14:00-17:00

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

Nariné BARIRIAN  18/06/2021   14:00-17:00

WORKSHOP (Assignment 2) : 3D Printing in Pharmaceutics

Hatice ALDEMIR & Jonathan GOOLE  24/06/2021   14:00-17:00

1. Early studies in patients

3.1.1  Pharmacokinetics : basic concepts and applications

Nariné BARIRIAN   09/09/2021  14:00-17:00

3.1.2  Drug metabolism : drug-drug interaction studies

Nariné BARIRIAN   10/09/2021  14:00-17:00

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   23/09/2021  14:00-17:00

3.1.4  Clinical Pharmacokinetics : ADME, linkage between pharmacokinetic and Pharmacodynamic data, contribution of simulated data and modelling to Clinical Pharmacokinetic

Ioannis LOISIOS-KONSTANTINIDIS   05/10/2021  14:00-17:00

2. Clinical Trials Designs

3.2.1 Different types of clinical trials study designs

Hakim DEHBI   07/10/2021  14:00-17:00

3.2.2 Randomisation modes

Hakim DEHBI   08/10/2021  14:00-16:00

3.2.3  Statistical aspects in the planning of clinical trials

Hakim DEHBI  12/10/2021  14:00-17:00

3.2.4 Innovative study designs

Hakim DEHBI  14/10/2021  14:00-16:00

3. Planning and managing clinical trials

3.3.1 GCP requirements and regulatory aspects

Ingrid KLINGMANN   21/10/2021  14:00-17:00

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

Ingrid KLINGMANN  28/10/2021  14:00-17:00

3.3.3  Set-up of clinical trials (Part I)

Sophie JAMIN  29/10/2021  14:00-17:00

3.3.4  Set-up of clinical trials (Part II)

Sophie JAMIN  09/11/2021  14:00-17:00

3.3.5  Monitoring safety in clinical trials and Drug development

Sophie JAMIN  16/11/2021  14:00-17:00

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

Ingrid KLINGMANN  18/11/2021  14:00-17:00

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

P. MIQUEU   16/12/2021  14:00-17:00   !!! NEW DATE

3.3.8 Outsourcing clinical trials and managing contracts

Nicolas LEROY  03/12/2021  14:00-17:00  !!! TO BE RESCEDULED

3.3.9 Audits of clinical trials

Ingrid KLINGMANN  30/11/2021  13:30-16:30  !!! NEW TIME

4. Gathering data from clinical trials

3.4.1 Procedures for clinical data collection and data management

Marc ELSLEY   09/12/2021  14:00-17:00

3.4.2 Patient adherence and persistence in trials

Hatice ALDEMIR   14/12/2021  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   17/12/2021  14:00-17:00

WORKSHOP (Assignment 3) : Blockchain in Clinical trials

Olivier SIMON & Christophe VAN HUFFEL   21/12/2021 14:00-17:00

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   18/01/2022  14:00-17:00

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

Ludo HAAZEN   20/01/2022  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   27/01/2022  14:00-17:00

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

Giovanni BRIGANTI   28/01/2022  14:00-17:00

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

                   Giovanni BRIGANTI   03/02/2022  14:00-17:00

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

   Giovanni BRIGANTI   10/02/2022  14:00-17:00

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

Giovanni BRIGANTI   11/02/2022  14:00-17:00

3. Evaluating safety data

4.3.1 Methods for the evaluation of safety data in clinical trials

Isabelle LAUGEL  17/02/2022  14:00-17:00

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

Isabelle LAUGEL   18/02/2022  14:00-17:00

4. Data interpretation and scientific writing

4.4.1 Different aspects of clinical study reports and conclusions in writing

           Preparing review documents for regulatory submissions

Luise KALBE   15/03/2022  14:00-17:00

4.4.2 Writing a paper for publication

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

Luise KALBE   17/03/2022  14:00-17:00

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

            Giovanni BRIGANTI  29/03/2022 14:00-17:00

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   19/04/2022  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   26/04/2022  14:00-16:00

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

Stéphane CALLEWAERT   28/04/2022  14:00-16:00

5.1.4 Drug registration – Special issues (orphan products)

Tim LEEST  29/04/2022  14:00-16:00

2. Pharmacovigilance and Medical information

5.2.1  Back to basics in Pharmacovigilance

Karin HARDT   06/05/2022  14:00-17:00

5.2.2  EU regulations and Guidelines in Pharmacovigilance

Karin HARDT   12/05/2022  14:00-17:00

5.2.3 Everyday Pharmacovigilance

Karin HARDT   13/05/2022  14:00-17:00

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

Nathalie LAMBOT   31/05/2022  14:00-17:00

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

Marc CZARKA  02/06/2022  14:00-17:00

3. Pharmacoepidemiology

5.3.1 Principles of pharmacoepidemiology

Nicolas PRAET
09/06/2022  14:00-17:00

5.2.2  Study methods and data resources

Nicolas PRAET   16/06/2022  14:00-17:00

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

Nicolas PRAET   21/06/2022  14:00-17:00

WORKSHOP (Assignment 5) : Anticipating future regulatory challenges

Marc CZARKA & Olivier FONTAINE   23/06/2022 14:00-17:00

6.1.1 Health economics assessment of medicinal products :

Study quality concept and methods used to assess quality

Health technology assessment

Hilde STEVENS   08/09/2022  14:00-17:00

6.1.2 Interpreting cost-effectiveness – Patient reported outcomes

How the economic assessment affects market access ?

Hilde STEVENS   09/09/2022  14:00-17:00

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

Marc CZARKA   13/09/2022  14:00-17:00

6.1.4 Real world data and Real world evidence

David FONTAINE & Joachim MORRENS   20/09/2022  14:00-17:00

6.2.1 Ethical and legal aspects

Marc CZARKA   29/09/2022  14:00-17:00

6.2.2 Macroeconomic aspects

Olivier ETHGEN   30/09/2022  14:00-17:00

6.2.3 Regulatory environment and market access in emerging markets

Hugues MALONNE   06/10/2022  14:00-17:00

6.2.4 Pharmaceutical marketing (I)

1. Pharma/Biotech : the Belgian environment

2. The role of the product manager

Yohan HEYLEN   07/10/2022  14:00-16:00

6.2.4 Pharmaceutical marketing (II)

1. Pharmaceutical life cycle management

2. Biotech vs Big Pharma : business models

3. Pharma future

Yohan HEYLEN   11/10/2022  14:00-16:00

6.3.1 Which new products are truly innovative ?

TBC   20/10/2022  14:00-17:00

6.3.2 Health databases for innovation and improving health care

TBC   25/10/2022  14:00-17:00

TBC   27/10/2022  14:00-17:00