To improve patient safety the Medical Device Regulation (MDR) puts a greater emphasis on clinical data to provide evidence of safety, especially for riskier products. As a result more clinical data is required by manufacturers, which in turn means more clinical investigations must be undertaken to generate the data.
But what is required to perform a trial?
What requirements must you follow?
How should the study be designed?
This 5 module course will examine the requirements and design protocols of clinical investigations for new devices with case study examples. You will learn also about post-market clinical follow-up studies for existing products and will look at the impact of the new Regulation.
If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing Jessica.Purnell@informa.com and we will arrange this for you as soon as possible.
Victoria Cavendish is a highly skilled Clinical Affairs Specialist with an extensive understanding of the associated Quality and Regulatory landscape gained over 15 years within academia, medical device manufacturing companies, and Clinical Research Organisations. Victoria has held senior positions at various medical device companies such as Premier Research, Reckitt Benckiser and Novartis Pharma AG managing successful clinical teams.
This course is aimed at professionals who are involved with clinical investigations in industry, consultancy, agencies, notified bodies and within CROs and include the following departments and job titles:
MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
I really enjoyed the course and especially that the course leader was able to offer key details during the presentations!
Once you have registered and made the full payment, you will be given login details to access the course.