Module 1 — Pharmaceutical development, investigational medicinal products, technology transfer, Quality by Design and Quality Risk Management
Instructed by: Giuseppe Colombo (AFI – Associazione farmaceutici industria), Marco Oreste Adami (AFI – Associazione farmaceutici industria)
23–24 October 2026 | 12 hours
The module introduces pharmaceutical development, investigational medicinal products (IMPs), technology transfer from R&D to manufacturing, Quality by Design (QbD), Quality Risk Management (QRM), Design of Experiments and process validation, supported by practical examples.
Module 2 — GMP and fundamental processes of the Pharmaceutical Quality System
Instructed by: Alessandro Regola (AFI – Associazione farmaceutici industria)
30–31 October 2026 | 12 hours
Participants will examine GMP as applied to APIs and medicinal products, with a focus on Quality Risk Management, GMP documentation and Data Integrity. Practical sessions and exercises will connect regulatory principles with their operational application.
Module 3 — Formulation of parenteral and protein-based medicines
Instructed by: Giuseppe De Rosa (University of Naples Federico II)
2–4 November 2026 | 8 hours
This module covers the formulation of parenteral biotech products, including proteins, peptides and nucleic acids, together with the biological and physicochemical requirements of these products and an introduction to freeze-drying as a strategy for stabilizing biotech medicines.
Module 4 — Pharmaceutical freeze-drying
Instructed by: Giuseppe Colombo(AFI – Associazione farmaceutici industria), Marco Oreste Adami (AFI – Associazione farmaceutici industria)
6–7 November 2026 | 12 hours
The module explores the formulation, processes and equipment involved in pharmaceutical freeze-drying, including scale-up, technology transfer, process troubleshooting, equipment mapping and the physical principles underlying the process.
Module 5 — The manufacturing of RNA medicines
Instructed by: Giuseppina Salzano (Thermo Fisher Scientific)
19–20 November 2026 | 16 hours
The final module focuses on the development and scale-up of manufacturing processes for RNA-based medicines in sterile GMP production environments. Topics include pre-formulation, freeze-drying at R&D and industrial scale, manufacturing equipment and processes, and case studies addressing challenges that can arise on GMP production lines.