Course overview

• European Regulatory requirements for PMS, including recalls and vigilance
• Responsibility for PMS: Competent Authorities, Notified Bodies, manufacturers and other economic operators
• Other Regulatory requirements – e.g. US MDRs
• Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
• Key elements of pro-active PMS including PMS system and PMS plan
• Role of the person responsible for regulatory compliance in PMS
• Tailoring PMS systems to specific products, including drug device combinations and IVDs
• Requirements of EN ISO13485, Quality Management Systems standard
• Feedback of PMS data into the PMS plan, risk management, clinical evaluation, summary of safety and clinical performance, labelling and so on
• PMS reports and periodic safety update reports (PSUR’s)
• Vigilance including incidents, serious incidents, field safety corrective actions,periodic summary reports and trend reports
• The electronic system on vigilance and PMS including public access
• Exchange of information: PMS databases e.g. MAUDE and EUDAMED

Benefits to delegates

• Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
• Be able to make recommendations and vigilance procedures
• Demonstrate the ability to critically analyse the legal requirements relating to surveillance and vigilance
• Critically appraise and evaluate communications from competent authorities, notified bodies, economic operators and other stakeholders relating to the conduct of surveillance and vigilance.
• Critically evaluate the requirements and guidance for post-market market surveillance
• Critically evaluate the requirements and guidance and vigilance
• Possess a systematic understanding and critical awareness of the European requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

A draft programme can be downloaded here.

Speakers

TOPRA Masterclasses are developed and delivered by a faculty  of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

This course is suitable for

• Students of the TOPRA MSc programme
• Delegates from the regulatory affairs industry who wish to develop their knowledge of the post market surveillance and vigilance for medical devices
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing

Standard

• TOPRA MSc students: £1,545 +VAT*
• Delegates: £1,785 +VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

• Those working for regulatory agencies, government agencies or academic institutions: £1,338.75 +VAT*
• Those working for charities, patient groups or in full-time education: £892.50 +VAT*

*VAT, if applicable, is charged at the rate of 20%.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.