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4. EUROPA i Trial Clinici, le nuove regole, cosa cambia e come prepararsi
Medical Device RevolutionDuration: Unlimited
Cost: 99 USD
Meditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
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- COURSE DESCRIPTION
COURSE DESCRIPTION
Il corso è dedicato:
- ai professionisti che lavorano nel settore della ricerca clinica e che vogliano acquisire maggiori competenze nel settore del medical device
- ai professionisti che già lavorano nel settore del medical device e che vogliano comprendere come impostare una sperimentazione clinica con medical device
- ai neofiti che hanno già una idea di come funziona la ricerca clinica
Programma:
Il corso prevede 10 lezioni (2 ore di lezione dalle 17:00 alle 19:00):
Ecco i titoli delle sessioni programmate:
28 Settembre - Storia dei Medical Device, capire la classificazione e il mercato;
1 Ottobre - Dispositivi Medici: regolamenti globali, roadmap to market;
5 Ottobre - EUROPA - Regolamento per i dispositivi medici: panoramica e punti critici per le CRO;
8 Ottobre - EUROPA - I trial clinici: le nuove regole, cosa cambia e come prepararsi;
15 Ottobre - ISO 14155: Fondamenti, Disegno e pianificazione dello studio, la documentazione;
22 Ottobre - ISO 14155: Conduzione dello studio dalla A alla Z;
29 Ottobre - ISO 14155: Il monitoraggio per i Medical Device in pratica;
05 Novembre - DIGITAL HEALTH: Sistemi elettronici eCRF/ePro, Data Management, Cyber-security;
12 Novembre - ITALIA: Normative e Procedure di approvazione, report di sicurezza;
19 Novembre - PRIVACY, GDPR e Medical Device.
Perché iscriversi?
Grazie a questo corso acquisirai tutte le nozioni necessarie e gli ultimissimi aggiornamenti per poter lavorare su sperimentazioni cliniche con i medical device.
Preparati alla rivoluzione del medical device!
- MEET THE MEDITRIAL EXPERTS
MEET THE MEDITRIAL EXPERTS
Dr. Monica Tocchi MD, PhD
Founder, Chief Medical Officer
Monica Tocchi, MD, PhD, is a cardiologist, medical director of Meditrial, clinical investigator and medical device regulation expert. Dr Tocchi has been contributing for 15 years to the development of international ISO standards for the Italian National Standards Association.
In her own words she "founded Meditrial because I saw an opportunity to help create more effective collaboration between the medical community, the healthcare industry and regulators. Ultimately, the quality of patient care depends not only on the doctor-patient connection, but on countless other relationships and joint efforts that exist behind the scenes to synergically enable medical progress."
Rossella Mercuri
Director EU Clinical Operations
As Director of Business Development and Marketing, CRO Business at at Meditrial, Ms. Rossella Mercuri is responsible for maintaining successful relationships with key opinion leaders and is actively involved in managing clinical projects, as well as clinical site staff and the Ethical Committees of the Hospital centers. She coordinates the trials and ensures efficient progression in line with agreed timeframes by proactively identifying and resolving issues together with sponsor management.
"Every day, we take part in the development of new health technologies to help our clients accelerate the delivery of safe and effective therapeutics to patients. Our dedicated teams engage quickly to deliver reliable service and are always responsive to customer's needs. We embrace your goals, timelines and major milestones as our own."
Alessia Nuciari
Director of Education
Mrs. Alessia Nuciari provides legal advice and is an export in Quality Management system and has actively contributed to the creation of Meditrial's SOPs. At Meditrial, she is responsible for the interpretation of policies, procedures, regulations, issues relating to contractual functions and administration of resources. In addition, she is involved in the recruitment and management of the Human Resources and has recently been coordinating the Meditrial Academy, Meditrial's e-learning Platform.
"Meditrial has grown so much in recent years that it is hardly recognizable from the company I remember. It is very exciting for me to know that I contributed in building the structure of such a fast-growing Company."
Zsuzsanna Lödi
Director of Clinical Affairs
As Director of Clinical Affairs, Zsuzsanna LÅdi has established a successful track record in the clinical project management of large multicenter studies across Europe. She is highly regarded by Meditrial customers who appreciate her ability to provide precise and timely services, excellent communication skills and experience in coordinating the team to meet even the tightest deadlines.
"I believe that ensuring the success of the Company's projects and guaranteeing that effective operational plans are in place for each situation, maintaining the harmony of the Team, are the keywords for achieving my goals." - Resources to learn more
Resources to learn more