Section 3 – Production and compounding: Statement 3.4 Section 5 – Patient Safety and Quality Assurance: Statements 5.2, 5.11 Section 6 – Education and Research: Statements 6.1, 6.2, 6.3, 6.4, 6.5
A medicine, which is based on genes, cells or engineered tissues, meets the scientific criteria for defining Advanced Therapy Medicinal Products (ATMPs). New challenges are arising from differences in terms of donation, procurement, testing, clinical trials, and GMP requirements as compared to current active pharmaceutical ingredients (APIs). Therefore, novel analytical and technological equipment and methodologies rarely seen previously in hospital pharmacies will need to be installed, qualified, instructed and safely run. This might be feasible in the course of the general technical and electronical revolution in which the younger generations grow up. Nevertheless, adaptations to educational pharmacy curricula and specialisation must be implemented if supply and production of ATMPs are to be continued to be produced by hospital pharmacists instead of other professional such as physicians, biochemists or molecular biologists.
This seminar will outline the provisional future and importance of this class of medicines and how hospital pharmacists should manage it.
After the session, the participant should be able to:
• Describe the scope of ATMP regulations; • Outline the challenges for hospital pharmacists in general and for those practising in teaching and researching hospitals; • Make out opportunities and threats of this class of therapeutic products; • Identify opportunities and threats of this class of Therapeutics agents for their hospital; and • Anticipate future research and development as related to ATMPs.
Educational need addressed
Omics (genomics, proteomics,metabolomics, etc) as well as tissue engineering option e.g. for wound healing have been developed in recent years. For many pharmacists, there is a gap between the knowledge in times of his studies as compared to actual technologies translated from basic research into practice, and they need an update and upgrade of the scientific progress.