SCHEDULEs

Discover schedules for 6 modules!

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

    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   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

    2. Market access

    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

    3. Innovation and improvment of health care

    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

    3. WORKSHOP (Assignment 6)

    TBC   27/10/2022  14:00-17:00