PRACTICAL EXERCISE 1work through case studies to determine the best PMS strategies with specific emphasis on data collection and use of internet
PRACTICAL EXERCISE 2Using vigilance data to determine which cases require reporting and when they should be reported
PRACTICAL EXERCISE 3Practical cases of what can go wrong in the eyes of Notified Bodies and Competent Authorities are discussed as well as practical crisis management
PRACTICAL EXERCISE 4A simulated exercise using a real life scenario – PMS, vigilance and enforcement. Delegates will assume the roles of the manufacturer, CA, NB and the user
As a medical device or IVD manufacturer, it is imperative to ensure you are employing up-to-date procedures for post market surveillance to guarantee regulatory compliance and avoid product recall. This course will provide you with the latest updates on regulations for medical device and IVD PMS and vigilance, clarifying any grey areas to outline your responsibilities as the manufacturer.
Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to build successful PMS strategies and understand the latest requirements and technologies for reporting vigilance.
This course will provide the knowledge you need to overcome every day problems and enhance performance, ensuring you are employing the most appropriate PMS strategies for your products.
This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:
• Regulatory Affairs
• International Regulatory Affairs
• Safety specialists
• Compliance Managers
• Quality Assurance
• Quality Compliance
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
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