• Sale!
    This course will help you to discover new definitions and types of trials as well as the main actors involved, specifically sponsor, investigator and subject. You will also learn about conditions, ethical principles, methods and the informed consent process and develop a better understanding of the new coordinated assessment. You will also gain key knowledge regarding substantial changes, temporary halt, and termination as well as adverse event reporting.
  • Sale!
    This course will help you develop a broader understanding of the new standard, ethical considerations and how to conduct a clinical trial from start to finish. You will also discover the new responsibilities of sponsor/CRO and principle investigator, and learn about safety and adverse events under the new standard.
  • Sale!
    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.
  • In this course you will get an overview of worldwide pharmacovigilance standards. Here we also talk about the main goals of pharmacovigilance in clinical research. In addition, we will shed the light on various ways how one can ensure the safest use of a drug and its compliance with the legal requirements on pharmacovigilance. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
  • In this course you will learn about all the MDR rules on medical device labelling, dwelling on the language, label content requirements, and updates according to data of the Post-market surveillance system.
  • The second part of New European UDI System Video Course is designed to help you discover UDI Implementation, Medical Device Registration, and functional specifications. This course also covers the data dictionary for UDI as well as the MDCG guidelines on UDI-DI and for special cases of device registration.
  • This Meditrial Video Course is designed to help you discover the FDA De Novo Classification Pathway and intended to provide De Novo requesters with transparency regarding the process of submission De Novo Classification request.
  • This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
  • In the Premarket Approval course we will provide regulatory information on the Premarket Approval process.
  • The Safer Technology Program Video Course is designed to help you discover STeP and how to navigate program principles and structure.

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