Not activated for the a.y. 2023/2024
The First-level short specialisation degree in Legal and Regulatory Aspects of Medical Research wants to provide remote training to professionals, capable of ensuring suitable standards within the range of legal, regulatory, and contractual aspects of medical research in general, and clinical trials of medicines and clinical tests on medical devices in particular, with a potential positive impact in the sector, especially concerning non-profit research.
Modern clinical research involves the entire healthcare system to achieve the best health results. In order to ensure an efficient and effective planning and conditions for study protocols, healthcare professional legal figures and administrative positions should possess methodological, regulatory, legal, administrative and insurance skills.
The Short specialisation degree is the first educational reference on the subject, and therefore it stands out in the current educational system.
The First-level short specialisation degree in Legal and Regulatory Aspects of Medical Research provides training on the following macro-topics:
- Methodology of research and epidemiology, and organizational-ethical fundamentals
- Governing, public and private law, data protection
- Tax, fiscal and communication aspects
In order to contribute to the theoretical and practical, technical and methodological formation of specific professional figures, through the most advanced methodological, regulatory, legal, administrative and insurance skills in this sector.
The First-level short specialisation degree in Legal and Regulatory Aspects of Medical Research is addressed to professionals of the legal, administrative and healthcare sector, involved in the assessment of research project and in their planning.
Improving the appropriateness of the scientific and legal language promotes the ability to communicate with biostatistics, researchers or medical professionals in general, and also with supporting medical research figures.
Trained professionals may find a job placement in medical research support offices, in public or private hospital structures, pharmaceutical companies, and contract research organizations (CRO), as well as within the consultancy sector.
The First-level short specialisation degree in Legal and Regulatory Aspects of Medical Research provides in-depth training on the following topics:
METHODOLOGY OF RESEARCH AND EPIDEMIOLOGY, AND ORGANIZATIONAL-ETHICAL FUNDAMENTALS
- Research planning
- Main study plans
- Objectives and methods
- Profit vs non-profit research
- Project management
- Business plan
- Accounting aspects
- Ethics applied to research
- Good clinical practices
- Regulatory structures
- Medicine and device authorization process
- Statistical analysis and scope of a study
- Study protocol
- Epidemiology
GOVERNING, PUBLIC AND PRIVATE LAW, DATA PROTECTION
- Regional, national and community regulations applicable to medical research, regulatory bodies and competent authorities
- Liability
- Penalties
- Insurance profiles
- Contracts
- Regulation 231
- anti-money laundering
- Data collection platforms
- Cyber security
- Privacy roles
- Medical research GDPR
- Data protection agreement
- Information notice for data subjects
- Consent
- Data anonymization and pseudonymisation
- DPIA
TAX, FISCAL AND COMMUNICATION ASPECTS
- Study tax treatment
- VAT
- Third sector
- Promoting subjects
- Profit – non-profit
- Tax treatment
- Payments to experimentation centres
- Payments to subjects
- What sustainability means
- Sustainability governance in a medical study
- Sustainability communication tools
- Green washing
The First-level short specialisation degree in Legal and Regulatory Aspects of Medical Research is online, and it can be followed also by full-time workers, since it is provided on-demand through the Moodle multimedia platform of the University of Padua.
It includes modules between three and give week long. Each lesson week will include 4-hour long on-demand registrations and materials for individual study. At the end of each week, there will be homework, and, at the end of each module, two days of in-person meetings. At the end of the theoretical modules, there will be two options for hands-on activities (subject to availability):
- In-person traineeship
- Project work supervised by a tutor
The Short specialisation degree was designed for students and professionals who wish to combine other jobs and professionals with the need to qualify or further specialize.
There will be a frequent and user-friendly interaction between students and professors through the Moodle Forum.
The general ranking of merit for the academic year 2023/24 will be published on the Italian page of this First-level short specialisation degree according to the timing provided in the Call.
Information
FAQ
Pursuant to Article 24.6 of the Regulation for University Short specialisation degree, Postgraduate Course and Higher Education Courses, there is the option of supernumerary admission for University staff, to the extent of 10% of the maximum quantity of applicants that can be enrolled in each Short specialisation degree’s Course. The enrolment quota for the University administrative-technical staff (PTA) is equal to 20% of the quota provided for each Short specialisation degree’s Course.
PA and top grades (110 e Lode): Starting from academic year 2022/23, PA employees enrolling in our Short specialisation degree, will enjoy a 20% reduction on the registration fee. During the pre-enrolment process, there will be a specific question, “Are you an employee in an Italian Public Administration”, where you can enter this information.
No, there is no admission test. The assessment will be made based only on the titles.