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
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
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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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