TIZIANA ESPOSITO | TECHNOLOGY AND REGULATION OF ANIMAL HEALTHCARE PRODUCTS
TIZIANA ESPOSITO TECHNOLOGY AND REGULATION OF ANIMAL HEALTHCARE PRODUCTS
cod. 0712300019
TECHNOLOGY AND REGULATION OF ANIMAL HEALTHCARE PRODUCTS
| 0712300019 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF6 | |
| PHARMACEUTICALS AND NUTRACEUTICALS FOR ANIMALS | |
| 2024/2025 |
| OBBLIGATORIO | |
| YEAR OF COURSE 3 | |
| YEAR OF DIDACTIC SYSTEM 2022 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| The teaching aims at acquiring knowledge on: -Technological role of the excipients in products promoting health and well-being of animals intended for systemic or topical application -Italian and EU Regulations of different types of products -Advanced formulation technologies for the development of feed supplements, nutraceuticals, phytotherapic animal products. At the end of the course the student will be able to: Select the most suitable raw materials and techniques for the production of a healthcare product, with nutraceutical, phytotherapeutic or feed supplement value. Proper use the core elements of the regulatory system regarding production and marketing of animal health products. |
| Prerequisites | |
|---|---|
| STUDENTS MUST HAVE PASSED ALL THE EXAMS OF THE FIRST YEAR OF THE COURSE, AS REQUIRED BY THE EDUCATIONAL REGULATIONS. |
| Contents | |
|---|---|
| 1.ANIMAL WELFARE AND REGULATIONS: DEFINITION AND MEASUREMENT OF ANIMAL WELFARE. NATIONAL AND EU REGULATIONS. MAIN REGULATORY BODIES. (4 HOURS OF LESSONS) 2.EXCIPIENTS IN VETERINARY PRODUCTS: DEFINITION AND ROLE OF EXCIPIENTS, TYPES AND CHARACTERISTICS, INTERACTIONS WITH ACTIVE INGREDIENTS, FORMULATION TECHNIQUES. (8 HOURS OF LESSONS) 3.DISTINCTION BETWEEN VETERINARY DRUGS (REGULATION (EU) 201/6), FEED MATERIALS, FEED ADDITIVES, AND BIOCIDES (EU RECOMMENDATIONS 2011/25): (4 HOURS OF LESSONS) 4.ANALYSIS OF DIFFERENCES BETWEEN COMPLEMENTARY, MEDICATED (REGULATION (EU) 2019/6), AND NUTRITIONALLY SPECIFIC FEEDS (REGULATION (EU) 2020/354): FORMS OF ADMINISTRATION, PRODUCTION TECHNOLOGIES, AND LABELLING. (8 HOURS OF LESSONS) 5.ORGANIC ANIMAL FEED: PRODUCTION, LABELLING, AND REGULATION (REGULATION (EU) 2018/848). (4 HOURS OF LESSONS) 6.HERBAL PRODUCTS FOR ANIMALS: DEVELOPMENT, TECHNOLOGICAL APPROACH, AND LEGISLATION. (2 HOURS OF LESSONS) 7.CASE STUDIES ON HEALTH PRODUCTS: ANALYSIS OF PRACTICAL CASES USING HEALTH PRODUCTS AND FUNCTIONAL INGREDIENTS. (6 HOURS OF LESSONS) 8.COSMETIC PRODUCTS FOR ANIMALS: MORPHOLOGY AND PHYSIOLOGY OF THE SKIN AND COAT. INGREDIENTS, COSMETIC FORMS, AND TECHNOLOGIES. RELEVANT REGULATIONS (1272/2008 CLP AND 1906/2007 REACH). (6 HOURS OF LESSONS) 9.REGULATIONS ON ANIMAL HEALTH PRODUCTS: PRODUCTION, MARKETING, DISTRIBUTION, REGISTRATION, AUTHORIZATION, AND SURVEILLANCE; RESPONSIBILITIES AND OBLIGATIONS OF PRODUCERS, DISTRIBUTORS, AND USERS; PROTOCOLS FOR EVALUATING SAFETY AND EFFICACY. (6 HOURS OF LESSONS) |
| Teaching Methods | |
|---|---|
| THE COURSE WILL BE STRUCTURED WITH LECTURES (45 HOURS), AND SEMINARS WITH INDUSTRY EXPERTS (3 HOURS). |
| Verification of learning | |
|---|---|
| THE ACHIEVEMENT OF THE EDUCATIONAL OBJECTIVES WILL BE VERIFIED THROUGH A WRITTEN TEST AND AN ORAL TEST, THE OVERALL EVALUATION OF WHICH WILL BE EXPRESSED IN THIRTY THE WRITTEN EXAM CONSISTS OF 4 OPEN-ENDED QUESTIONS, EACH WITH A MAXIMUM SCORE OF 4 POINTS, AND 14 MULTIPLE-CHOICE QUESTIONS. THE ORAL PART OF THE EXAM COMPRISES A DISCUSSION OF THE WRITTEN ASSIGNMENT AND AN ORAL TEST WITH A MAXIMUM DURATION OF 20 MINUTES. THE EVALUATION IS ON A SCALE OF THIRTY (30/30). THE MINIMUM PASSING GRADE (18/30) WILL BE AWARDED TO STUDENTS WHO DEMONSTRATE A FRAGMENTED KNOWLEDGE OF THEORETICAL CONTENT AND A LIMITED ABILITY TO APPLY IT IN THE STUDY CONTEXT. THE HIGHEST GRADE (30/30) WILL BE GIVEN TO STUDENTS WHO DEMONSTRATE AN UNDERSTANDING OF METHODOLOGIES AND TOOLS AND A SIGNIFICANT ABILITY TO APPLY THEM IN THE STUDY CONTEXT. HONOURS (CUM LAUDE) WILL BE AWARDED TO STUDENTS WHO SHOW A MASTERY OF TECHNICAL-SCIENTIFIC LANGUAGE AND METHODOLOGIES, CAPABLE OF CRITICALLY CONNECTING ALL STUDY CONTEXTS AND APPLYING THE ACQUIRED CONCEPTS. |
| Texts | |
|---|---|
| SLIDES PRESENTED DURING LESSONS CURRENT NATIONAL AND EUROPEAN LEGISLATION REGULATING DIFFERENT PRODUCTS, AVAILABLE ON THE OFFICIAL WEBSITES OF ITALY (MINISTRY OF HEALTH) AND THE EUROPEAN UNION (EUROPEAN COMMISSION) |
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