Abstract
PHARMACEUTICAL MARKETS AND REGULATION
A joint project by AIFA and LUISS
Outline and timeline: a specialized course made by 8 lectures dedicated to the pharmaceutical sector. Each lecture will have a duration of ca. 1.30 h, divided into 2 modules of 45 min. The course will be held on-line during the first semester 2021, estimated starting point being the second week of March (tentative timeline: each Wednesday, 2-3.30 pm).
Organization: the course is organized by the Italian Medicines Agency (AIFA) as main content provider, and LUISS as general administrator and on-line manager.
Main contents: Introduction to the regulatory framework and economic landscape of the pharmaceutical sector, with an exposure to basic scientific knowledge needed for understanding pharmaceutical R&D (e.g. drugs classification, clinical trial design, new global public healthcare trends). Because of the ongoing Covid-19 pandemic and its related unprecedented drug R&D, the course will also cover emergency uses strategies from a regulatory perspective.
Target: a group of students from the ‘Mediterranean Program’ managed by LUISS (ca. 18 students from Jordan Syria, Palestine, and Malta, following an agreement with the University of Petra-UOP), plus a selec
Expected educational outcome: Participants will be provided with highly specific skills related to the pharmaceutical industry and its regulation, to be possibly applied both in the public and private sectors. With specific regards to the participants to the Mediterranean Program, it is expected they will empower their countries with a skilled public health approach and business understanding.
Study materials: slides of each lessons will be provided to participants, together with relevant literature.
Detailed course program
1. Public health, drugs, research: introduction Wednesday 17 March 2021 (h.2.00 pm)
1.A Public health and the pharma industry (welcome speech)
1.B Drugs, clinical trials, research ethics (N. Magrini)
2. Industrial landscapes 24 March 2021 (h.2.00 pm)
2.A Patents (L. Arnaudo)
2.B R&D scenarios and EU pharma strategy (L. Arnaudo)
3. Drugs regulatory models 7 April 2021 (h.2.00 pm)
3.A Regulatory pathways survey (F. Trotta)
3.B Conditional/emergency uses (N. Magrini)
4. Value for money and sustainability of the healthcare systems 14 April 2021 (h.2.00 pm)
4.A Clinical benefits analysis and prices (G. Traversa)
4.B Pricing and reimbursement strategies (G. Altamura)
5. Trends and frontiers I/II 21 April 2021 (h.2.00 pm)
5.A Orphan drugs: clinical values (E. Costa)
5.B Orphan drugs: legal rules and economics (A. Parziale)
6. Trends and frontiers II/II 28 April 2021 (h.2.00 pm)
6.A Plasma derivatives (F. Candura)
6.B Monoclonal antibodies and advanced therapies (C. Quintarelli)
7. Competition dynamics and rules 5 May 2021 (h.2.00 pm)
7.A Regulatory gaming (L. Arnaudo)
7.B Antitrust case-law (L. Arnaudo)
8. Global healthcare: critical issues and market re-organization 12 May 2021 (h.2.00 pm)
8.A Antimicrobial resistance (E. Tacconelli)
8.B Joint procurement (L. Arnaudo)