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
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 access6.2.1 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 care6.3.1 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