Master's Degree in Advanced Therapies and Good Manufacturing Practices (GMP) for ATMPs

The Master’s Degree in Advanced Therapies and Good Manufacturing Practices (GMP) for ATMPs offers comprehensive training focused on understanding the development, manufacturing, and clinical application of advanced therapy medicinal products in highly regulated environments. The program covers both the scientific fundamentals of ATMPs and the quality, validation, and regulatory compliance requirements in this field.

Throughout the master’s program, students will gain a comprehensive overview of the life cycle of these therapies, from applied cell biology and GMP-compliant production to clinical development, pharmacovigilance, and technology transfer. In addition, the collaboration with Clínica CEMTRO and Amplicel provides a practical and specialized perspective linked to the actual manufacturing and quality control processes in advanced therapies.

• Understand the scientific foundations underlying advanced therapies and the different types of ATMPs.
• Be familiar with the regulatory framework applicable to advanced therapy medicinal products in national and international contexts.
• Master the principles of Good Manufacturing Practices (GMP) as applied to the production of ATMPs.
• Acquire skills in facility design, aseptic production, environmental control, and contamination prevention in GMP environments.
• Develop knowledge of quality management systems, documentation, audits, deviations, CAPA, and change control.
• Apply validation, qualification, and risk management strategies to advanced therapy manufacturing processes.
• Analyze production processes, in-process control, and batch release for advanced therapy medicinal products.
• Understand the phases of clinical development, documentation requirements, and pharmacovigilance specific to ATMPs.
• Gain a comprehensive overview of the life cycle of advanced therapies, from research and manufacturing to clinical application and technology transfer.
• Equip students to work in R&D, production, quality, and regulatory fields related to advanced therapy medicinal products.

• Graduates and professionals in Biology, Biotechnology, Pharmacy, Medicine, and related fields.

• Specialists seeking training in advanced therapies and GMP manufacturing.

• Professionals working in production, quality, validation, and regulation related to ATMPs.

MODULE 01: SCIENTIFIC FUNDAMENTALS OF ADVANCED THERAPIES

• Types of ATMPs: gene therapy, somatic cell therapy, and tissue-engineered products
• Applied cellular and molecular biology: culture, expansion, and differentiation
• Viral and non-viral vectors: design, production, and biological risk control
• Cryopreservation and cold chain
• Analytical assays: identity, purity, potency, sterility, and viability

MODULE 02: REGULATORY AND ETHICAL FRAMEWORK

• EC Regulation No. 1394/2007 on advanced therapy medicinal products
• EMA guidelines and their implementation in Member States
• National procedures: classification, authorization, and oversight by the AEMPS
• Ethical considerations: informed consent, use of human tissues, biobanks, and data protection under the GDPR
• Authorization of clinical trials with ATMPs: processing, documentation, and evaluation

MODULE 03: GOOD MANUFACTURING PRACTICES (GMP) FOR ATMPs

• General GMP principles applied to advanced therapies
• Design of GMP facilities: material and personnel flows, classified areas, airlock systems (SAS), HEPA filters, HVAC, environmental control, and monitoring
• Production under aseptic conditions: biological safety cabinets and sterile handling techniques
• Contamination control: cleaning, disinfection, disinfectant rotation, validation of the cleaning and decontamination process
• Control of raw materials, materials, and intermediate products
• Traceability and production documentation
• Biological waste management and biosafety

MODULE 04: QUALITY MANAGEMENT SYSTEM AND GMP CONTROL

• Structure of the pharmaceutical quality system
• Quality manual, SOPs, and records
• Management of deviations, OOS, and CAPA
• Change control and annual quality reviews
• Internal audits, inspections, and regulatory compliance

MODULE 05: VALIDATION AND RISK MANAGEMENT

• Types of validation: IQ, OQ, and PQ of facilities; processes; and analytical methods
• Cleaning and disinfection validation
• Risk assessment and management using FMEA in ATMP processes
• Determination and control of critical points: CCP and CQA
• Control strategy and validation documentation

MODULE 06: PRODUCTION AND PROCESS CONTROL

• Autologous and allogeneic production: flow design and scalability
• Upstream and downstream processes: cultivation, purification, formulation, and aseptic filling
• In-process controls and batch release
• Acceptance criteria and reference sample management
• GMP-compliant production in a hospital setting: models, advantages, and limitations

MODULE 07: CLINICAL DEVELOPMENT AND PHARMACOVIGILANCE

• Phases of clinical development for ATMPs
• Quality dossier for clinical trials
• Release requirements for clinical batches
• Post-treatment follow-up and specific pharmacovigilance for advanced therapies
• Risk management plan and long-term follow-up measures

MODULE 08: INNOVATION, TECHNOLOGY TRANSFER, AND MANAGEMENT

• Development and production models: hospital-based, academic, and industrial
• Intellectual property and patents in advanced therapies
• Entrepreneurship and public-private partnerships
• Economic evaluation and market access for advanced therapies