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Understanding Clinical EvaluationsPTI
The new Medical Device Regulation, published in 2017 and due to be fully implemented in 2020, will result in significant changes to clinical evidence, with more clinical data being required for device products.
This 4 module course will focus on clinical evaluation reports and will provide you with a comprehensive understanding of literature reviews, proving equivalence, and managing Clinical Evaluation Reports throughout the life-cycle of a product.
Suitability - Who should attend?
This course is aimed at professionals who are responsible for or involved in clinical evaluations in industry, consultancy, agencies, notified bodies and within CRO’s and may come from the following departments:
- Regulatory affairs
- Clinical development
- Medical writing
Training Course Content
- Practical guidance for constructing a clinical evaluation report (CER)
- Discuss and evaluate the impact of the new Regulation on clinical evaluations to ensure you remain compliant and can manage the transition smoothly
- Understand how to assess and analyse clinical data
- Examine how the clinical evaluation report is linked to post market surveillance and the risk management plan
- Comprehend the use of Clinical Evaluation throughout the product lifecycle
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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