post-graduate

outline

centre of excellence

PHARMED PROGRAMME 2016-2017

MODULE 1: INTRODUCTION TO MEDICINES DEVELOPMENT

  • Setting the scene : the context of drug development,  Marc Czarka (HM3A)
  • Planning the development of new medicinal products, Marc de Longueville (UCB Pharma)
  • Importance of intellectual property issues for the biopharmaceutical industry,  Jean-Marie Boeynaems (ULB)
  • New models for therapeutic innovation, Michel Goldman (ULB)
  • Drug development in the precision medicine era,  Jean-Marie Boeynaems (ULB)
  • Overview of the development of a medicinal product : the story of denosumab,  Hilde Vannerom, Jo Van der Veken & Hilde De Winter (Amgen)

 

Pre-module preparation : PharmaTrain e module

Introduction to Drug Development

 

MODULE 2 : DISCOVERY OF MEDICINES

  • Drug design,  François Dufrasne (ULB)
  • Ligand-receptor interactions, Michel Gillard (UCB Pharma)
  • High throughput screening using recombinant receptors,  Vincent Dupriez (Perkin-Elmer Life Sciences)
  • Testing new compounds in animals,  Aurore Colomar (UCB Pharma)

 

MODULE 3 : PRECLINICAL SAFETY

  • Non-clinical safety evaluation,  René Verloes (Tibotec)
  • Strategy for the evaluation of genetic toxicity,  N
  • Safety evaluation of anticancer drugs, biotechnology products and gene therapy agents, Philippe Detilleux (Sanofi)
  • Cardiac safety assessment in drug development,  Jean-Pierre Valentin (UCB Pharma)
  • Novel approaches in investigative toxicology, Stéphane Dhalluin (UCB Pharma)

 

Pre-module preparation : PharmaTrain e module

How to get it right – The scientific basis of formulating dose-response

 

MODULE 4: DRUG FORMULATION AND MANUFACTURING

  • Drug formulation, Jonathan Goole (ULB)
  • From pharmaceutical development to pharmaceutical manufacturing, N
  • Cell-based medicinal products, Enrico Bastianelli (Bone Therapeutics)


Pre-module preparation :

 

MODULE 5 : MOVING TO CLINICAL TRIALS : METHODOLOGICAL AND ETHICAL ASPECTS

  • Accelerating the move to clinical trials, Luc Tritsmans (J & J)
  • How to choose the dose for first in human administration, Luc Van Bortel (RUG)
  • Phase I studies : strategic importance and practical organisation, Pascal Ryckmans and Clarisse Lukuamusu (Pfizer) 
  • Vaccines development : from preclinical to clinical studies, Marie-Thérèse Martin (GSK Biologicals)
  • Introduction to Good Clinical Practice, Monique Podoor (Pharmakon)
  • Clinical trials in Europe : the regulatory framework and the role of the national competent authority, Anne Lenaers (FAMHP)
  • The role of ethics committees, André Herchuelz (ULB)
  • Differences in the ethics committee review process between EU member states, Ingrid Klingmann (EFGCP)

 

Pre-module preparation : PharmaTrain e modules

Introduction to ethical issues in clinical research

Introduction to Good Clinical Practice

 

MODULE 6 : CLINICAL TRIALS DESIGN AND PROTOCOL WRITING

  • Study designs, Christian Mélot (Erasme Hospital)
  • The study protocol, Ludo Haazen
  • Specificities of the clinical development plan of biologics, Marc de Longueville and Isabelle Campine (UCB Pharma)

 

Pre-module preparation :

 

MODULE 7 : ADVANCED BIOSTATISTICS

  • Common errors in statistics and how to avoid them, Viviane de Martelaer (ULB)
  • Statistical aspects in the planning of clinical trials, Viviane de Martelaer (ULB)
  • Critical reading of a scientific publication on biostatistics, Christian Mélot (Erasme Hospital)
  • Statistical analysis of complicated designs and multivariable analyses, Christian Mélot (Erasme Hospital)
  • Bayesian clinical trials, Christian Mélot (Erasme Hospital)
  • Meta-analysis, Viviane de Maertelaer ULB)

 

Pre-module preparation :

Reading of a scientific paper on biostatistics


MODULE 8 : ADVANCED PHARMACOKINETICS

  • Clinical pharmacokinetics, Christian de Mey (ACPS and University of Frankfurt)
  • Drug metabolism,  Flora Musuamba Tshinanu (UCL)
  • Bioequivalence,  Flora Musuamba Tshinanu (UCL)
  • Introduction to population pharmacokinetics, Flora Musuamba Tshinanu (UCL)

 

Pre-module preparation :

 

MODULE 9 : CONDUCT OF CLINICAL TRIALS

  • Set-up of a clinical trial, Marc de Longueville (UCB Pharma), Els Van Mierlo (PPD) & Simonne Breemans (PPD)
  • Monitoring and closure of a study, Els Van Mierlo (PPD) & Simonne Breemans (PPD)
  • Management of the investigational product, Yves Geysels (Quintiles)
  • Patient adherence and persistence in trials and practice, Bernard Vrijens (Aardex)
  • Outsourcing of clinical trials and contract management, Rachel Emerson

 

Pre-module preparation :

MODULE 10 : CLINICAL TRIALS REPORTING AND AUDITING

  • Data interpretation and writing the study report, Marc de Longueville & Isabelle Campine (UCB Pharma)
  • Clinical research and the art of scientific writing, Anne Hepburn (4Clinics)
  • Audits of clinical trials, Kristel Van de Voorde (BMS)
  • Quality, compliance and risk management in R&D, Eckart Schwarz (GSK)
  • Clinical trials in developing countries –challenges and opportunities, Eckart Schwarz (GSK)
  • Specificities of investigator-initiated trials : the EORTC example, Denis Lacombe (EORTC)
  • Specific aspects of the conduct of clinical trials involving biologics, Marc de Longueville (UCB Pharma)

 

Pre-module preparation :

MODULE 11 : PHARMACOVIGILANCE

  • Basic concepts in pharmacoepidemiology, Robert Vander Stichele (RUG)
  • Drug utilisation studies, effectiveness research and risk minimisation studies, Robert Vander Stichele (RUG)
  • European organisation of pharmacovigilance, Caroline Dumas (Vigilex)
  • Pharmacovigilance  in daily practice, Caroline Dumas (Vigilex)

 

Pre-module preparation :

 

MODULE 12 : REGULATORY AFFAIRS

  • Drug registration : European and international environment, Stéphane Callewaert (GSK Biologicals)
  • Preparation of a new drug application, Anne Hepburn (4Clinics)
  • Clinical trials in children and the Paediatric Regulation, Daniel Brasseur (FAMHP)
  • Orphan medicinal products, André Lhoir (FAMHP)
  • Decentralised & Mutual Recognition procedures, regulation of generics, Els Verschaeren (FAMHP)
  • Specific regulatory aspects of biologics, Alan Fauconnier (FAMHP)
  • Regulation of medical devices, Augustin Coppée (FAMHP)

 

Pre-module preparation : Pharmatrain e module

Introduction to the registration of medicinal products

MODULE 13 : MEDICAL AFFAIRS

  • Organisation of the medical department, Dirk Vander Mijnsbrugge (Pfizer)
  • Communication with health practitioners, Michèle Sangeleer (Eli Lilly)
  • Summary of product characteristics and user package leaflets, Robert Vander Stichele (RUG)
  • Ethics in the pharmaceutical industry, Marc Czarka (HM3A)
  • Market access, Guy Vandenhoven (HEPHS-ISEK)  
  • Medical affairs 2020 and beyond: from patient centricity to patients support programmes, Mathias Schifflers (Abbott products)

 

Pre-module preparation :

MODULE 14 : HEALTH ECONOMIC ANALYSIS

  • Methods used in health economics, Dominique Dubois (PVS)
  • QALYs : measurement and scoring, Dominique Dubois (PVS)
  • Health economics reporting standards, Dominique Dubois (PVS)
  • Patient reported outcomes, Guy Vandenhoven (HEPHS-ISEK)
  • A case study in health economics of advanced therapies, Dominique Dubois (PVS)

 

Pre-module preparation : Pharmatrain e module

Introduction to health economics

MODULE 15 : MARKETING OF MEDICINAL PRODUCTS

  • Marketing in the pharmaceutical industry :  life cycle management of a medicinal product, Direct to Consumer & how to create a brand for a drug, Johan Heylen (Ablynx)
  • Managing teams to reach optimal results, Hughes Malonne (ULB)

 

Pre-module preparation : Pharmatrain e module

 

MODULE 16 : SPECIFICITIES AND EVOLUTION OF THE BIOPHARMACEUTICAL MARKET

  • Macroeconomic aspects, Alain de Wever (ULB)
  • Patents on medicinal products, William Bird (Patentive)  
  • Pricing & reimbursement of medicinal products, Marc Czarka (HM3A)
  • Access to innovative medicinal products, Alain Dupont (VUB) 
  • Emerging markets : challenges and opportunities, Gil Carrasquinho  (Novartis)
  • Key challenges and trends in today’s pharmaceutical market, Romain Seffer (PwC)

 

Pre-module preparation :