Welcome. If you're a registered user, please log-in. If not, please sign-up.

        CPD

..
Practical Exercises

PRACTICAL EXERCISE 1

work through case studies to determine the best PMS strategies with specific emphasis on data collection and use of internet

PRACTICAL EXERCISE 2

Using vigilance data to determine which cases require reporting and when they should be reported

PRACTICAL EXERCISE 3

Practical 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 4

A simulated exercise using a real life  scenario – PMS, vigilance and enforcement. Delegates will assume the roles of the manufacturer, CA, NB and the user
Your Course Leader
..

Successful Medical Device & IVD Post Market Surveillance and Vigilance Reporting

Course Objectives

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.

Why you should attend

  • Ensure compliance and avoid product recall
  • Develop effective processes for monitoring risk
  • Prepare for the overhaul of the Medical Device Directive
  • Gain perspective on global developments for PMS and Vigilance

Who Should Attend?

This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:

• Vigilance
• Regulatory Affairs
• International Regulatory Affairs
• Safety specialists
• Compliance Managers
• Quality Assurance
• Quality Compliance

Other Events That Will Interest You

Regulatory Affairs in Latin America for Medical Devices

04 Dec 2014 - 05 Dec 2014
Radisson Blu Edwardian Grafton


Introduction to Regulatory Affairs for Medical Devices

17 Sep 2014 - 18 Sep 2014
Radisson Blu Edwardian Grafton


Dates and Venues

15 Oct 2014 - 16 Oct 2014

Radisson Blu Edwardian Grafton

twitter 

LinkedIN

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 

Media Partners

scrip, business intelligence, pti, pti global, pti europe, european regulatory affairs, regulatory affairs

 

clinica, advanced regulatory affairs for medical devices, regulatory affairs, medical devices, pti global, pti, pti europe