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PHARMED - Post-Graduate programme in phramaceutical medicine & medicines development sciences

PHARMED - Post-Graduate programme in phramaceutical medicine & medicines development sciences

Accroche introductive

Post-graduate program in medicines development sciences.

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Call to actions

  • Intitulé du programme
    PHARMED - Post-Graduate programme in phramaceutical medicine & medicines development sciences
  • mnémonique du programme
    FC-704
  • Programme organisé par
    • Centre de Formation Continue en Santé et Sciences de la vie
    • Faculté de Médecine
  • Type de titre
    formation continue
  • Accessible en reprise d'études
    oui
  • Langues d'enseignement
    anglais
  • Durée de la formation
    longue (plus de 15 jours)
  • Campus
    Autre campus
  • Catégorie / Thématique
    Santé - Sciences biomédicales et pharmaceutiques
  • Complément
    Marie LEBACQ
    ULB HeLSci - BIOPS Training engineer

Détails

Informations générales

Type de titre

formation continue

Durée de la formation

longue (plus de 15 jours)

Langue(s) d'enseignement

anglais

Campus

Autre campus

Catégorie(s) - Thématique(s)

Santé - Sciences biomédicales et pharmaceutiques

Faculté(s) et université(s) organisatrice(s) Accessible en reprise d'études

oui

Visuel formation Pharmed ULB

Présentation

The PHARMED program is constituted by 6 distance learning modules covering the entire process of drug development from drug discovery to market access.

En journée

  • Each module is divided into several 3-hours courses that are given remotely via video conference in English, on Tuesday, Thursday or Friday afternoon.
  • The whole program is spread over 2 years with an average of 5 courses of three hours by month (from January to June and from September to December). The exact dates will be available later.

  • International program
  • Distance learning
  • A seventh elective module with a specific theme
  • The teaching team is composed of experts from various universities, regulatory authorities/agencies, CROs, pharmaceutical and biotechnology companies

Calendrier & inscriptions

Public ciblé

  • Intended for those who want to train for a future career in the pharmaceutical industry as well as for employees of biopharmaceutical companies who wish to complement or update their knowledge

Calendrier & inscriptions

Online registrations on https://pharmed.helsci.be

Next session : January 2021

Programme

Module 1 : Drug development with a focus on the changing health care environment  

1- Setting the scene : the context of drug development  

  • Overview and drivers of pharmaceutical innovation 
  • Specificities of the pharmaceutical market 
  • Changes in the healthcare environment 

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

  • Overview of the process of drug development 
  • How to achieve marketing approval and commercial excellence in a changing health care environment ?
  • Evolution from blockbuster to personalized medicine 
  • The rising importance of orphan drugs 
  • Patenting : basic criteria, issues in a changing health care environment and open-innovation 

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

  • Testing in animals : current use, ethical and regulatory aspects, limits ans alternative approachs  
  • Evolution of the methods used for drug screening 
  • High-Throughput-Screening (HTC) : Steps involved in setting-up of new functional assays 
  • HTC : Robustness, troughput and quality of assays 
  • System biology and principles of translational research 

4- Big data and personnalized medicine : How AI can potentially reinvent the drug design and development ?  

  • Concept of personalized medicine 
  • Patient selection 
  • AI for Clinical Trial design 
  • Big data, Robots and AI in Medecine and Healthcare
  • Impact on drug development and marketing
  • AI in Medecine 

Module 2 : From pre-clinical to First-in-Human studies  
 

1- Pre-clinical strategy and Study design 

  • GLP and Pre-clinical testing requirements 
  • Stages of development and registration  
  • Study protocol design  
  • Pre-clinical strategy : time and costs analysis 
  • Special population requirements and Regulatory Compliance 

2- Pre-clinical safety  : Principles of pharmacology and toxicology 

  • Drug metabolism, Pharmacokinetics (ADME) and Pharmacodynamics : basic concepts 
  • How to choose the dose for first in human administration ? 
  • Toxicology testing : general toxicology, genotoxicity, carcinogenicity
  • Genetic and genomic factors in drug development and drug response 
  • Novel approaches in investigative toxicology 
  • In silico toxicology methods : applications 

3- Drug formulation 

  • Main apsects of drug formulation 
  • Concept of drug bioavailability 
  • Non-conventional dosage forms : oral sustained release dosage forms, transdermal forms, injectable biodegradables microspheres, etc 
  • Nanotechnologies for drug delivery : potential and challenges 
  • 3D printing (drugs and medical devices) : what is possible to do now ? 

4- Manufacturing  

  • Pharmaceutical technical development : formulations, primary packaging, delivery system 
  • Quality Management System, Quality by design and Process Analytical Technologies 
  • GMPs and Required structures of departments/systems in development and manufacturing 
  • EMA and FDA agencies and inspection-operating environment for product development and manufacturing (concept of inspection readiness)  

 5- Moving to First-in-Human studies 

  • Ethics in the Pharmaceutical Industry 
  • Requirements, ethics and regulations of First-in-Human studies 
  • Accelerating the move to clinical trials (possibilities and opportunities of computer assisted modelling on the way of proof of concept) 
  • Strategic importance and practical organization of Phase I studies (responsibilities, planning and activities) 

Module 3 :Clinical studies : Planning, managing and collecting data 

1- Early studies in patients 

  • Dose-finding studies 
  • Proof of mechanism studies 
  • Bioequivalence testing 
  • Clinical Pharmacokinetics and Pharmacodynamics
  • Confirmatory clinical development plan 

2- Clinical trials Designs 

  • Different types of clinical trials : study designs 
  • Randomisation modes 
  • Statistical aspects in the planning of clinical trials (choice of the enpoints, hypothesis, Alpha and Beta risks, sample size calculation) 
  • Innovative study designs 

3- Planning and managing clinical trials 

  • Regulatory aspects troughout the product development cycle (GCP requirements) 
  • Set-up of clinical trial 
  • Monitoring safety in clinical trials and Drug Development 
  • Development Risk Management Plans – The challenges 
  • Risk-based and remote monitoring in clinical trials 
  • Patient centric approach : Direct-to-patients trials and logistics
  • Outsourcing of clinical trials and contrat management 
  • Audits in clinical trials : Key feature of audits and inspections, keys to preparing for and effectively managing inspection, roles and expectations of key personnel, differences between inspections from various authorities 

4- Collecting clinical trials data 

  • Clinical trial data collection and data management 
  • Patient adherence and persistence in trials (uptake of mobile health, e-tools, big data analysis and personnalized medicine) 

5- Blockchain in Clinical trials 

  • Hope or reality ? 
  • Cases for blockchain application in clinical trials 
  • Barriers and challenges yet to be resolved 

Module 4 : Data Evaluation and Biostatistics

1- Clinical trial protocol and Investigator drug brochure (IDB)  

  • Clinical trial protocol : a key document 
  • Reading and understanding a clinicial trial protocol 
  • Role of the Ivestigator Drug Brochure (IDB) 
  • Regulatory codes and guidance for authoring the IDB 

2- Biostatistics : Clinical data Evaluation 

  • Statistical methods used in clinical research 
  • Common errors in statistics and how avoid them 
  • Critical reading of a scientific publication on biostatistics 
  • Understanding the crisis around the p-value : Statistical methods for the 21st century 

3- Safety data Evaluation  

  • Methods for the evaluation of Safety Data in clinical trials
  • Background and implementation of Development Safety Update Reports (DSUR) 
  • Data Safety Monitoring boards 

4- Data Interpretation and Scientific writing 

  • Different aspects of the Clinical study report : data and conclusions on paper 
  • Preparation of review documents for regulatory submissions 
  • Writing a manuscript for publication 
  • Submission to a peer-review journal, dealing with the reviewer’s comments 

Module 5 : Registration and Pharmacovigilance 

1- Drug Registration : European procedures and International environment 

  • Overview of the regulatory environment and medicines registration in the EU 
  • Comparison with the US FDA requirements and Japanese authorities 
  • Comparison with requirements in international and emerging-markets 
  • The Common Technical Document (CTD) format 
  • Special issues : orphan products 
  • Understanding defects in the application and improving the chances of approval 
  • Collaborate with the FDA to facilitate innovation 

2- Pharmacovigilance & Medical information

  • Back to basics in Pharmacovigilance 
  • EU regulations and Guidelines in Pharmacovigilance 
  • Pharmacovigilance in daily practice 
  • Overview of Patient Support ProgramS (PSPS)
  • Recent trends in Pharmacovigilance 
  • Medical information : communication with health practitioners 
  • Summary of products characteristics and user package leaflet 

3- Pharmacoepidemiology 

  • Principles of pharmacoepidemiology 
  • Study methods and data ressources 
  • Interpretation of pharmacoepidemiological data 
  • Role of the pharmacoepidemiology in the lifecycle of a medicine 

Module 6 : Health Economic and Biopharmaceutical market

1- Principles and practical applications of health economics 

  • Health Economic Evaluation of medicinal products : concept of study quality and the methods used to assess quality 
  • Health technology assessment 
  • Interpretation of the cost-effectiveness plane 
  • Impact of the economic evaluation in the field of market access 
  • Pricing and reimbursement of medicinal products (overview, issues and challenges in EU) 
  • Patient reported outcomes – Real world data and Real world evidence 

2- Market access  

  • Ethical and legal aspects 
  • Macroeconomic aspects 
  • Medical affairs, regulatory environment and market access in emerging markets 
  • Pharmaceutical marketing : lifecycle of a medicinal product, trademark, business model 

3- Innovation and improvement of health care 

  • Which new products are really innovative ? 
  • Health data bases for innovation and improving health care 

Elective modules

Biologics, Vaccines, ATMPs, Medical advices : how do they differ from conventional drugs ?

  1. Specificities of the clinical development of Biologics
  2. Medical advices : Overview from manufacturer to patient
  3. Advanced Therapy Medicinal Products (ATMPs)
  4. Vaccines development challenges : from preclinical to clinical studies