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PHARMED - Post-Graduate Programme in Pharmaceutical Medicine & Medicines Development Sciences

Programme Objectives

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

Programme's Added Value

• 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

Programme Details

General Information

• Title Type: Formation Continue
• Programme Duration: Long (more than 15 days)
• Learning Language(s): English
• Campus: Other Campus
• Category(ies) - Topic(s): Health - Biomedical and Pharmaceutical Sciences
• Open to Returning Students: Yes

Target Audience

• 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

Modules

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, and alternative approaches
   • Evolution of the methods used for drug screening
   • High-Throughput-Screening (HTC): Steps involved in setting-up of new functional assays
   • HTC: Robustness, throughput, and quality of assays
   • System biology and principles of translational research
4. Big Data and Personalized 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 Medicine and Healthcare
   • Impact on drug development and marketing
   • AI in Medicine

Module 2: From Pre-Clinical to First-in-Human Studies

1. Pre-Clinical 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 aspects 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 modeling 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
   • Different types of clinical trials: study designs
   • Randomisation modes
   • Statistical aspects in the planning of clinical trials (choice of the endpoints, hypothesis, Alpha and Beta risks, sample size calculation)
   • Innovative study designs
3. Planning and Managing Clinical Trials
   • Regulatory aspects throughout 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 contract 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 personalized 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 clinical trial protocol
   • Role of the Investigator Drug Brochure (IDB)
   • Regulatory codes and guidance for authoring the IDB
2. Clinical Data Evaluation
   • Statistical methods used in clinical research
   • Common errors in statistics and how to 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 resources
   • Interpretation of pharmacoepidemiological data
   • Role of the pharmacoepidemiology in the lifecycle of a medicine

Module 6: Health Economics 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 Healthcare
   • Which new products are really innovative?
   • Health databases for innovation and improving healthcare

Elective Modules

• Biologics, Vaccines, ATMPs, Medical Advices: How Do They Differ from Conventional Drugs?
  1. Specificities of the Clinical Development of
  2. Medical Advices: Overview from Manufacturer to Patient
  3. Advanced Therapy Medicinal Products (ATMPs)
  4. Development Challenges: From Preclinical to Clinical Studies