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
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:
85% had applied content during the course to their role
£1,595 + 20% VAT = £1,914
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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