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Clara Fargo
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Device Safety And Vigilance (English)
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4 hours
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Device Safety And Vigilance (English)
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About
An introduction to the principles of adverse event reporting and risk assessment as applied to medical devices in the US, Europe, and other key international markets. The US has the most developed device vigilance processes but the course also summarizes the situation in Europe, Australia, Canada and Japan too. With coverage of risk assessment, AE report types, causality and event types, this course is designed to give a solid grounding in all key aspects of vigilance within this +$300 billion sector.
The Device Safety and Vigilance course gives you a good understanding of the basic principles of vigilance and risk analysis – the course covers the history of device vigilance & safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management. Keeping devices on the market without interruption becomes more essential with soaring development costs. Successful navigation of adverse event reporting, trend analysis and risk assessment are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on device vigilance and safety.
Course Benefits
Fully compliant
This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)
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