Informazioni di Developing Medicinal Products | DidatticaWEB

Generali:

Dipartimento: Scienze Matematiche, Fisiche E Naturali
Settore Ministeriale: BIO/14
Codice di verbalizzazione: 8067951
Metodi di insegnamento: Frontale
Metodi di valutazione: Orale
Prerequisiti: For an effective comprehension of the course contents the student is expected to know the basic principles of pharmacology/pharmacokinetics/pharmaceutics/clinical pharmacy and therapeutics. During the lectures, the teacher will always provide the student with enough background infor
Obiettivi: LEARNING OUTCOMES: Provide an understanding of the regulatory framework in the EU and the strategies to develop innovative (advanced and personalized) medicinal products that are of good quality, safe and effective to reach the EU market without failures. Awareness also of other regulatory models in the UK, United States, Canada, Japan and Australia will be provided. The course will provide a comprehensive introduction into medicines and how they are regulated. Students will be able to understand the entire process from pre-submission to what happens after authorisation for a product. During the life cycle of products the marketing authorisation dossier is changed and the changes are subject to regulatory processes. KNOWLEDGE AND UNDERSTANDING: Study Unit Aims: �� To understand the EU regulatory system and its stakeholders; �� To understand the structure of EMA/EU network and its role; �� To appreciate strategic regulatory aspects of global regulatory affairs; �� To appreciate Clinical development programs to support a marketing authorisation; �� To develop an appreciation of regulatory aspects of regulatory strategy for all products (including ATMPs and personalized orphan medicines) regulated by EMA and the NCAs. APPLYING KNOWLEDGE AND UNDERSTANDING: By the end of the program the individual will be able to: - Appreciate requirements in drug regulation; - Understand the legal framework and the roles of major players in regulation. MAKING JUDGEMENTS: The Common Technical Document (CTD) is an internationally agreed format for preparing applications to be submitted to regulatory authorities in the three ICH regions of Europe, the United States and Japan. This unit of study also provides an introduction to the structure and format of the CTD and how it is designed to save time and resources and to facilitate reporting and regulatory reporting. Students will have the necessary ability to deal with the validation of a CTD paper. COMMUNICATION SKILLS: By the end of the course the individual will be able to: Navigate through the regulatory requirements of the EU (from legislation to EMA guidelines) LEARNING SKILLS: At the end of the course the individual will be able to: Understand the structure of the human quality dossier and the relevance of the documents for the assessment Develop understand manufacturing of active substances with principles of process development and its documentation Foundational knowledge on international guidelines and respective legislation on MAA considering ICH members and in particular EU, USA, Japan Foundation knowledge on ICH with leading role in stablishing the eCTD structure and other ICH guidelines related to product development and marketing authorisation application Understanding the interplay between regulation and innovation Understanding the requirements and critical factors for the clinical development of medicinal products including clinical development phases I-IV

Didattica:

A.A.: 2025/2026
Canale: UNICO
Crediti: 6

Classe virtuale:

Nome classe: BORG-8067951-DEVELOPING_MEDICINAL_PRODUCTS_1
Link Microsoft Teams: Link
Docente: BORG JOHN JOSEPH