The master’s program comprises 10 modules, 9 focusing on specific aspects of the pharmaceutical industry and 1 devoted to the professional development. These modules are meticulously designed to cover a wide range of topics, including sector regulations and state of the art of the pharmaceutical industry.

The program excellently balances its technical core with soft skills training to prepare a 360 degrees professional. It will be delivered in English to ensure that participants are well-prepared for the global nature of the pharmaceutical industry.

The modules that build the master’s structure are the following ones including duration and main content:

• Pharmaceutical sector overarching view
  • Types of companies in the pharma sector
  • Organization of pharmaceutical companies
  • Professional profiles in the pharmaceutical industry
  • Business Development, Marketing, department functions,
  • Regulatory, Medical Affairs, Manufacturing, Quality Control,
  • Quality Assurance, Finances, etc
  • Pharmaceutical technology introduction
  • Qualified Person responsibilities
  • Legal qualifications and licenses
  • Traceability and distribution
  • Medicines advertising/publicity regulations
  • Export and importation of medicines
  • End of module practical exercise
• Pharmaceutical Quality System
  • Good Manufacturing Practices regulation
  • Laboratory authorization by health authorities
    inspection
  • ICH Q8. Pharmaceutical Development & Quality by
    Design
  • ICH Q9. Risk Management
  • ICH Q10. Pharmaceutical Quality System.
  • ISO 9001 Quality System
  • Personnel training and job descriptions.
  • Documental Management
  • Deviations, out of specifications and corrective/
    preventive actions system
  • Complaints handling and batch recall management
  • Quality audits and suppliers qualification
  • Quality Continuous Improvement
  • Good Distribution Practices
  • End of module practical exercise
• Quality Control
  • Good Laboratory Practices
  • Laboratory areas design
  • Pharmacopeias
  • Retention and reference samples
  • Investigation of out of specification results
  • Stability studies
  • Environmental control
  • Microbiological laboratory
  • End of module practical exercise
• Industrial Processes
  • Manufacturing facilities design
  • Facilities and equipment qualification
  • Utilities qualification
  • Manufacturing process validation
  • Instrument calibrations
  • Computer systems validation
  • Solid forms manufacturing principles
  • Liquid and semi-solid forms manufacturing principles
  • Sterile manufacturing principles
  • Cleaning validation
  • Statistical Process Control
  • Production Direction
  • Integrated Production Planning
  • End of module practical exercise
• Health Authorities relationship
  • European Medicines Agency (EMA). Responsibilities and
    organization
  • Spanish Medicines and Medical Devices Agency
    (AEMPS)
  • United States Food and Drug Administration. Responsibilities and organization
• Regulatory Affairs
  • Regulatory dossiers historic evolution
  • Common Technical Documents (eCTD)
  • Regional information in eCTD module 1
  • Quality information in eCTD module 3
  • Preclinical studies in eCTD module 4
  • Clinical trials in eCTD module 5
  • European medicines register system.
  • Veterinary products
  • Post-marketing activities
  • Cosmetic products informative expedients and
    cosmetovigilance
  • Medical Devices and Combination Products
  • Commercialization and advertisement of medical
    devices.
  • Dietary products
  • End of module practical exercise
• Medicines Safety and pharmacovigilance
  • Pharmacovigilance regulation
  • Safety in Clinical Trials
  • Side effects surveillance and reporting
  • Aggregate reports (PSUR, ACO, DSUR)
  • Veterinary pharmacovigilance
  • End of module practical exercise
• Clinical Investigation
  • Clinical Trials and Good Clinical Practices
  • Design of Clinical Trials
  • Clinical Trials monitoring
  • Administrative management of Clinical Trials
  • Activities and responsibilities of Medical Affairs
  • End of module practical exercise
• Market Access and Pharmaeconomy
  • Pricing
  • Functions and responsibilities of Market Access
  • Market Access strategy
  • Economical assessment of health interventions
  • Therapeutic market positioning
  • Market Access planning
  • Administrations relationship
  • End of module practical exercise
• Professional Development
  • Personal Branding
  • Communication skills
  • Teamwork, collaboration and time management
  • Creativity and problem solving