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Clinical Investigations And Post Market Clinical Studies - Online Academy

Course summary
5 weeks
Online courses
Professional Training

Course description

Clinical Investigations And Post Market Clinical Studies - Online Academy

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.

Suitability - Who should attend?

This course is suitable for professionals working with clinical investigations in industry, consultancy, agencies, notified bodies and within CROs, including:

  • Regulatory affairs professionals
  • Clinical development professionals
  • Medical writers
  • Quality professionals
  • Engineers
  • Scientists

Outcome / Qualification etc.

  • Understand protocol and regulation around Clinical Investigation planning and conduct
  • Assess post market clinical studies for existing products and examine how requirements will change with the new Regulation
  • Consider key factors in study design
  • Investigate PMCF study design and how to implement PMCF

Training Course Content

  • Module 1: Introduction to Clinical Investigations
  • Module 2: ISO 14155
  • Module 3:  Study Design
  • Module 4:  Gaining Regulatory Approval
  • Module 5:  Post-Market Clinical Follow-Up

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


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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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Average rating 5

Based on 1 reviews

Clinical Trial Leader, Institut Straumann AG
I really enjoyed the course and especially that the course leader was able to offer key details during the presentations!
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