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ONLINE TRAINING: 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.
This online training is divided in 3 modules:
- Module 1 | 03 June 2020 from 11:00 am to 13:00 pm
- Module 2 | 10 June 2020 from 11:00 am to 13:00 pm
- Module 3 | 16 June 2020 from 11:00 am to 13:00 pm
Early Bird: € 540,00* (until 20 May 2020)
Ordinary: € 615,00*
Freelance - Academy - Public Administration**: € 324,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Wednesday, May 20, 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