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General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation
A training for understanding the impact of GDPR in clinical trials both at local and international level
The EU's General Data Protection Regulation (GDPR) is the most important change in the management of privacy in the last 20 years.
The GDPR radically changes the way personal data are handled in any area, including health care and clinical trials. Pharmaceutical, biomedical and medical device companies have to restructure their personal data management systems to ensure compliance with the GDPR as well as the collection, storage, and use of personal data.
It is therefore essential for companies acquiring the necessary skills to perform what is needed to implement GDPR in scientific research. The application of the GDPR in clinical trials and scientific research must be done to guarantee the company's effectiveness and competitiveness. This is a complex but not impossible challenge. This training course on GDPR in clinical trials and scientific research aims to provide the basic tools to deal with this challenge.
Analysis and understanding of the applicable legislation on the management of personal data (GDPR):
- The European and Italian legislation: Regulation (EU) 2016/679 and local regulations
- Administrative, criminal, civil and insurance sanctions
- The lawfulness of treatment and legal bases in clinical trials, scientific research and in pharmacovigilance
- Data integrity, security, privacy by design and by default
- Minimisation and purpose of personal data processing (data re-use, biological samples, and administrative database)
- Treatment register
- Roles in data processing (Sponsors, CROs, Centers, Laboratories, Monitors, etc.): Data Processor, Data Protection Authority (DPA) appointments and instructions
- Extra EU data transfer: Limits and conditions
- Data Protection Impact Assessment
- Data Privacy Officer (DPO)
- Qualifications and checks on suppliers
- The future: certifications and codes of conduct
Clinical research and health database:
- Specific regulations regarding data processing in clinical trials
- Definition of genetic data
- Prior consent
- Simplified information
- Research on populations of patients with mental incapacity
- Retrospective research
- Genetic retrospective research
The course will be in Italian
Freelancer, Senior Partner of Miari-Preite Law Firm in Reggio Emilia. Legal adviser in clinical research and health law, with specific know-how on personal data protection in epidemiological studies and in the management of clinical databases in health care. DPO in clinical-health companies. She has published several disclosures, including articles for the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC), on this topic.
Pharmaceutical, biomedical and medical device companies, CROs, Healthcare companies and hospitals, IRCCS, Nursing Homes, Laboratories, PMA Centers, Scientific Associations, Foundations, Non Profit Organizations, Freelancers and Consultants operating in the clinical-health field along with professionals who collect or manage data regulated by the GDPR in clinical trials and scientific research.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 790,00* (until 18 February 2020)
Ordinary: € 905,00*
Freelance - Academy - Public Administration**: € 485,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, February 18, 2020
At the end of the training, you will be able to
Maturing skills and competences to GDPR in scientific research
Implement and manage tools needed to comply with the requirements of GDPR in clinical trials