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Understanding Clinical Evaluations, Investigations and Post Market Clinical Studies

PTI
Course summary
2 days
English
City of London
Professional Training

Course description

The newly finalised Medical Device Regulation will mean significant changes to clinical evidence with more clinical data being required for riskier device products.

Day One (Clinical Evaluations) will focus on clinical evaluation reports and will provide you with a comprehensive understanding of literature reviews, proving equivalence, medical writing and managing CER's throughout the life-cycle of a product.

Day Two (Clinical Investigations and Post Market Clinical Studies) will examine the requirements and design protocols of clinical investigations for new devices with case study examples. This day will also cover post-market clinical studies for existing products and will look at the impact of the new Regulation.

Suitability - Who should attend?

This course is aimed at professionals who are responsible for or involved in clinical evaluations and investigations in industry, consultancy, agencies, notified bodies and within CRO’s and include the following departments and job titles:

  • Regulatory affairs
  • Clinical development
  • Medical writing
  • Quality
  • Engineers
  • Scientists

Training Course Content

  • Practical guidance for constructing a clinical evaluation report (CER) with medical writing advice
  • Review tips to show equivalence and conduct a literature review with case study examples
  • Discuss and evaluate the impact of the new Regulation on clinical evaluations and investigations to ensure you remain compliant and can manage the transition smoothly
  • Examine how the clinical evaluation report is linked to post-market surveillance and the risk management plan
  • Assess post-market clinical studies for existing products and examine how requirements will change with the new Regulation

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Expenses

£1,595 + 20% VAT = £1,914

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 4 reviews

Regulatory Affairs Specialist, Greatbatch Medical
(5)
The course material was very comprehensive with a good mix of information on regulations and guidance and practical advice on how to comply. I enjoyed the informal atmosphere!
Q&R Post-Market Surveillance, Philips
(5)
I chose this course to get an overall knowledge about clinical evaluations and really enjoyed the exchange of ideas with the course leader. A lot of information was shared!
Clinical Project Scientist, JRI Orthopaedics
(5)
I chose this course as I wanted to learn how to write more effective clinical evaluation reports. The run-through of a template CER was particularly useful.
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Reviews
Course rating
(5.0)
Based on 4 reviews
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