Giulia AURIEMMA | REGULATORY AFFAIRS AND INVESTIGATIONAL PHARMACEUTICAL PRODUCTS
Giulia AURIEMMA REGULATORY AFFAIRS AND INVESTIGATIONAL PHARMACEUTICAL PRODUCTS
| 0760400041 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY | |
| 2025/2026 |
| YEAR OF COURSE 5 | |
| YEAR OF DIDACTIC SYSTEM 2023 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| THE COURSE ALLOWS STUDENTS TO ACQUIRE KNOWLEDGE AND SKILLS ON THE REGULATORY SYSTEM AND ENVIRONMENT FOR THE EU CENTRALIZED OR NATIONAL PROCEDURES FOR DRUG MARKETING AUTHORIZATION COMPRISING ASSESSMENT OF DRUG QUALITY, SAFETY, AND EFFICACY. THE COURSE ALSO PROVIDES TOOLS FOR THE MANAGEMENT OF EXPERIMENTAL MEDICINES DURING CLINICAL TRIALS KNOWLEDGE AND UNDERSTANDING AT THE END OF THE COURSE, THE STUDENT WILL KNOW: - THE AUTHORIZATIONS, CONTROLS, AND ESSENTIAL DOCUMENTATION FOR THE PRODUCTION AND MARKETING OF MEDICINES - THE RELATIONSHIPS BETWEEN THE COMPETENT AUTHORITIES AND THE FUNCTIONAL AREAS OF THE MANUFACTURING COMPANY - THE MANAGEMENT OF INVESTIGATIONAL PRODUCTS WITHIN A CLINICAL TRIAL, WITH REGULATORY REFERENCES AND THE RESPONSIBILITIES OF SPONSORS, PROMOTERS, INVESTIGATORS, ETHICS COMMITTEES, AND HOSPITAL PHARMACISTS MAKING JUDGMENTS AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO APPLY THE KNOWLEDGE AND SKILLS ACQUIRED IN THE REGULATORY FIELD IN: - ALL PHASES OF THE DEVELOPMENT OF AN INDUSTRIAL MEDICINE - THE MANAGEMENT OF INVESTIGATIONAL MEDICINES DURING INDUSTRIAL AND CLINICAL SETTINGS |
| Prerequisites | |
|---|---|
| THE COURSE HAS NO SPECIFIC PREREQUISITES. HOWEVER, BASIC KNOWLEDGE RELATED TO THE FOLLOWING IS RECOMMENDED: - PREPARATION AND CONTROL OF INDUSTRIAL PHARMACEUTICAL PRODUCTS - CLINICAL TRIALS OF MEDICINES |
| Contents | |
|---|---|
| MODULE 1: REGULATORY AFFAIRS (32 TOTAL HOURS) 1. DEVELOPMENT OF AN INDUSTRIAL MEDICINAL PRODUCT (2 HOURS OF LECTURES) - ORGANIZATION OF A PHARMACEUTICAL INDUSTRY, PERSONNEL, AND KEY ROLES (PRODUCTION, QUALITY CONTROL, QUALITY ASSURANCE, PHARMACOVIGILANCE, REGULATORY AFFAIRS) - CONCEPTS OF QUALITY, SAFETY, AND EFFICACY - STAGES OF MEDICINAL PRODUCT DEVELOPMENT 2. MEDICINES FOR HUMAN USE: REGULATORY ASPECTS OF EU GOVERNANCE (20 HOURS OF LECTURES) - REGULATORY FRAMEWORK: EU PHARMACEUTICAL LEGISLATION AND ONGOING REFORMS - NATIONAL IMPLEMENTATION - EU AND NATIONAL REGULATORY AUTHORITIES - REGULATIONS RELATED TO: MARKETING AUTHORIZATION (AUTHORIZATION PROCEDURES - MA), MANUFACTURING, IMPORTATION, EXPORTATION, SUPPLY, DISTRIBUTION, PHARMACOVIGILANCE, CONTROL, AND USE OF MEDICINES FOR HUMAN USE 3. IN-DEPTH STUDY ON RELEVANT TOPICS DISCUSSED BY THE EUROPEAN COMMISSION AND PUBLISHED ON THE OFFICIAL WEBSITE (2 HOURS OF LECTURES + 4 HOURS OF PROJECT ACTIVITIES IN CLASS) 4. IN-DEPTH SEMINARS WITH REGULATORY AFFAIRS EXPERTS FROM VARIOUS PHARMACEUTICAL COMPANIES PRESENT IN THE NATIONAL TERRITORY (4 HOURS OF LECTURES) MODULE 2: INVESTIGATIONAL PHARMACEUTICAL PRODUCTS (16 TOTAL HOURS) 5. EUROPEAN REGULATIONS ON CLINICAL TRIALS: PURPOSES, ESSENTIAL ELEMENTS, IMPLEMENTATION (12 HOURS OF LECTURES) - REGULATORY DEVELOPMENTS (DIRECTIVES, REGULATIONS, ETC.) - THE CLINICAL TRIALS INFORMATION SYSTEMS (CTIS) - ROLE OF SPONSORS, PROMOTERS, INVESTIGATORS, ETHICS COMMITTEES, AND HOSPITAL PHARMACISTS - PROCEDURES FOR CLINICAL TRIAL AUTHORIZATION - LOW-INTERVENTION CLINICAL TRIALS - MANAGEMENT OF A CLINICAL TRIAL: GUIDELINES FOR INITIATION, CONDUCT, COMPLETION, TEMPORARY HALT, AND EARLY TERMINATION AS PROVIDED BY EUDRALEX VOLUME 10 - PROTECTION OF SUBJECTS AND INFORMED CONSENT - EMA GUIDELINES ON TRANSPARENCY IN CLINICAL TRIALS - IMPLEMENTATION OF EUROPEAN REGULATIONS AT THE NATIONAL LEVEL - CLINICAL TRIALS AND SANCTIONS 6. SEMINARS WITH CLINICAL TRIAL EXPERTS (4 HOURS) COURSE CONTENTS MODULE 1: REGULATORY AFFAIRS (32 TOTAL HOURS) 1. DEVELOPMENT OF AN INDUSTRIAL MEDICINAL PRODUCT (2 HOURS OF LECTURES) - ORGANIZATION OF A PHARMACEUTICAL INDUSTRY, PERSONNEL, AND KEY ROLES (PRODUCTION, QUALITY CONTROL, QUALITY ASSURANCE, PHARMACOVIGILANCE, REGULATORY AFFAIRS) - CONCEPTS OF QUALITY, SAFETY, AND EFFICACY - STAGES OF MEDICINAL PRODUCT DEVELOPMENT 2. MEDICINES FOR HUMAN USE: REGULATORY ASPECTS OF EU GOVERNANCE (20 HOURS OF LECTURES) - REGULATORY FRAMEWORK: EU PHARMACEUTICAL LEGISLATION AND ONGOING REFORMS - NATIONAL IMPLEMENTATION - EU AND NATIONAL REGULATORY AUTHORITIES - REGULATIONS RELATED TO: MARKETING AUTHORIZATION (AUTHORIZATION PROCEDURES - MA), MANUFACTURING, IMPORTATION, EXPORTATION, SUPPLY, DISTRIBUTION, PHARMACOVIGILANCE, CONTROL, AND USE OF MEDICINES FOR HUMAN USE 3. IN-DEPTH STUDY ON RELEVANT TOPICS DISCUSSED BY THE EUROPEAN COMMISSION AND PUBLISHED ON THE OFFICIAL WEBSITE (2 HOURS OF LECTURES + 4 HOURS OF PROJECT ACTIVITIES IN CLASS) 4. IN-DEPTH SEMINARS WITH REGULATORY AFFAIRS EXPERTS FROM VARIOUS PHARMACEUTICAL COMPANIES PRESENT IN THE NATIONAL TERRITORY (4 HOURS OF LECTURES) MODULE 2: INVESTIGATIONAL PHARMACEUTICAL PRODUCTS (16 TOTAL HOURS) 5. EUROPEAN REGULATIONS ON CLINICAL TRIALS: PURPOSES, ESSENTIAL ELEMENTS, IMPLEMENTATION (12 HOURS OF LECTURES) - REGULATORY DEVELOPMENTS (DIRECTIVES, REGULATIONS, ETC.) - THE CLINICAL TRIALS INFORMATION SYSTEMS (CTIS) - ROLE OF SPONSORS, PROMOTERS, INVESTIGATORS, ETHICS COMMITTEES, AND HOSPITAL PHARMACISTS - PROCEDURES FOR CLINICAL TRIAL AUTHORIZATION - LOW-INTERVENTION CLINICAL TRIALS - MANAGEMENT OF A CLINICAL TRIAL: GUIDELINES FOR INITIATION, CONDUCT, COMPLETION, TEMPORARY HALT, AND EARLY TERMINATION AS PROVIDED BY EUDRALEX VOLUME 10 - PROTECTION OF SUBJECTS AND INFORMED CONSENT - EMA GUIDELINES ON TRANSPARENCY IN CLINICAL TRIALS - IMPLEMENTATION OF EUROPEAN REGULATIONS AT THE NATIONAL LEVEL - CLINICAL TRIALS AND SANCTIONS 6. SEMINARS WITH CLINICAL TRIAL EXPERTS (4 HOURS) |
| Teaching Methods | |
|---|---|
| THE 6-CREDIT COURSE (48 HOURS) WILL INCLUDE 36 HOURS OF LECTURES COVERING THE TOPICS AS DESCRIBED, 4 HOURS OF IN-CLASS PRACTICE WITH STUDY OR WORK GROUPS RELATED TO THE MENTIONED TOPICS, AND 8 HOURS OF SEMINARS AND INTERACTION WITH THE TEACHER AND/OR EXPERTS IN THE FIELD. ATTENDANCE IS MANDATORY FOR AT LEAST 75% OF THE TOTAL COURSE HOURS. ATTENDANCE WILL BE RECORDED USING THE EASYBADGE AUTOMATIC SYSTEM PROVIDED BY THE UNIVERSITY. |
| Verification of learning | |
|---|---|
| STUDENT LEARNING WILL BE ASSESSED THROUGH BOTH A WRITTEN AND AN ORAL EXAM, WITH EVALUATION EXPRESSED IN THIRTIETHS. TO TAKE THE ORAL EXAM, STUDENTS MUST FIRST PASS THE WRITTEN EXAM WITH A MINIMUM MARK OF 18/30. THE WRITTEN EXAM WILL CONSIST OF 20 QUESTIONS AND LAST A MAXIMUM OF 90 MINUTES, AIMED AT EVALUATING KNOWLEDGE AND SKILLS. THE ORAL EXAM WILL EVALUATE THEORETICAL KNOWLEDGE, AUTONOMY OF ANALYSIS, AND THE ABILITY TO APPLY THE CONCEPTS TO PRACTICAL SCENARIOS. THE FINAL EVALUATION WILL BE THE AVERAGE OF THE PARTIAL GRADES. STUDENTS WHO DEMONSTRATE ONLY A FRAGMENTARY KNOWLEDGE AND A LIMITED CAPACITY TO APPLY THE CONCEPTS WILL RECEIVE A MINIMUM MARK OF 18/30. STUDENTS WHO DEMONSTRATE A COMPLETE KNOWLEDGE OF THE METHODOLOGIES AND A NOTABLE ABILITY TO APPLY THE CONCEPTS WILL RECEIVE A MAXIMUM MARK OF 30/30. THE HIGHEST PRAISE WILL BE RESERVED FOR THOSE STUDENTS WHO DEMONSTRATE A SIGNIFICANT MASTERY OF THE METHODOLOGIES AND A HIGH ABILITY TO APPLY THE CONCEPTS. |
| Texts | |
|---|---|
| - EU LEGISLATION – EUDRALEX (LINK HTTP://EC.EUROPA.EU/HEALTH/DOCUMENTS/EUDRALEX/INDEX_EN.HTM) - ELEMENTI DI SCIENZE REGOLATORIE DEL FARMACO - SICUREZZA , EFFICACIA E QUALITÀ DEI PRODOTTI FARMACEUTICI” DI CAMMARATA, PANI. - LEGISLAZIONE FARMACEUTICA DI: PAOLA MINGHETTI. DECIMA EDIZIONE. CEA CASA EDITRICE AMBROSIANA, 2021 |
| More Information | |
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| NONE |
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