Program

Discover detailed program for 6 modules!

Content

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 criteriaissues 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 
  • High Troughput Screening : setting-up of new functional assays, robustness, troughput and quality of assays
  • Systems biology and 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 

 

Learning outcomes

At the end of this module, the student should be able to outline the : 

1- Principal steps in drug development 

2- Specificities of the current changing heath care environment 

3- Principal steps and innovations in drug screening 

4- Principles of translational research and personnalized medecine 

5- Would-be contribution of Artificial Intelligence in drug design and development  

Content

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 

  •  Non-clinical testing for chemical and biological compounds, including pharmacology (ADME)
  • 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) 

     

    Learning outcomes

    At the end of this module, the student should be able to outline the : 

    1- Principles of pre-clinical strategy 

    2- Requirements, ethics and regulation of pre-clinical and First-in-Human studies 

    3- Basic concepts of pre-clinical pharmacology and toxicology 

    4- Main aspects of drug formulation and innovations in this area 

    5- Pharmaceutical technical development 

    6- Requirements and regulations in drug manufacturing 

    7- Planning and practical organization of Phase I studies 

    Content

    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 

       

      Learning outcomes

      At the end of this module, the student should be able to outline the : 

      1- Main aspects of early studies in patients and their impact on the drug development plan 

        2- Design of various types of clinical studies ans statistical aspects of these designs 

        3- Key issues involved in a conduct of a clinical study in terms of Good Clinical Practice (GCP) 

        4- Main safety aspects in clinical trials and drug development 

        5- Principles and tools of data collection 

        6- Key steps and methods in data management 

        7- Applications of Blockchain in clinical trials 

      Content

      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 

               

              Learning outcomes

              At the end of this module, the student should be able to outline the : 

              1- Development of a clinical trial protocol and the role of the Investigator Drug Brochure (IDB) 

              2- Evaluation and interpretation of clinical trial results in a scientific publication 

              3- Main statistical methods used in clinical data analysis and understand the current challenges aroud the p-value 

              4- Main aspects of the Clinical Study Report and the documents for regulatory submission 

              Content

              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 

                 

                Learning outcomes

                At the end of this module, the student should be able to outline the : 

                1- General principles of medicinesregulation (pre- and post- approval) 

                2- Principles of pharmacovigilance and medical information 

                3- Role of Pharmacoepidemiology in the lifecycle of a medecine 

                Content

                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 

                     

                    Learning outcomes

                    At the end of this module, the student should be able to outline the : 

                    1- Principles and practical applications of health economics and Health Technology Assessment within the healthcare marketplace 

                    2- Ethical and legal aspects of market introduction of a drug 

                    3- Specificities of a really innovative product 

                    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