Class Biological Medicines

Many of the most innovative drugs are biological medicines. Therefore, an updated degree in the field of pharmacy/medicines should offer students the opportunity to deepen knowledge on this subject. Students should develop the following competences: - Characterization of biological medicines, production processes and administration specifics of these medicines - Pharmaceutical intervention in the area of biological medicines - Research, production, dispensation or hospital practice, relating with biological medicines - Characterization of biossimilar medicinal products - Identification of biological medicines marketing availability - Identification of the requirements of quality, safety and regulation in the approval of biological medicines

Not applicable

Introduction to biological medicines Particularities of biological medicines vs. synthetic medicines Production processes of innovative biological and biosimilar medicines Biosimilarity and its concepts: quality, non-clinical, clinical comparability and indication extrapolation Innovative biological and biosimilar medicines: substitution and interchangeability Innate and acquired immunogenicity. Pharmacovigilance of innovative biological and biosimilar medicines Types of biopharmaceuticals: monoclonal antibodies, vaccines, hormones, cytokines, enzymes, blood factors, therapeutic proteins, advanced therapy medicinal products Quality, safety and regulation relevant to centralised approval of biopharmaceuticals Biological medicinal products used in clinical practice in different pathologies and populations Advanced Therapy Medicines (ATMPs) Role of the pharmacist in biological therapeutics Clinical cases with practical application of the theoretical concepts taught

Learning includes the resolution of theoretical and practical cases in a real context, allowing the student to apply the acquired knowledge. The resolution of the same is accompanied by a clinical pharmacist with experience in the therapeutic area.

Crommelin, D., Sindelar, R., Meibohm, B. (2013) Pharmaceutical Biotechnology - Fundamentals and Applications, Springer (4th ed). Lima, N. e Mota, M. (2002) Biotecnologia - Fundamentos e Aplicações. Lisboa, Editorial Lidel. OKafor, N. (2007) Modern industrial microbiology and biotechnology. Enfield; Jersey. Plymouth: Science Publishers. Regulamento da Comissão 1085/2003 de 3/6, Anexo 1.