When: 5 - 7 September 2022
Where: TOPRA Office, 3 Harbour Exchange, London, UK
Times: Day 1: 13:00 BST | Days 3: 15:30 BST
Also available as a virtual course, please click here for the virtual registration option
Course overview
The Masterclass will cover the following areas:
- 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.
- Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
A copy of the draft agenda 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. Current confirmed speakers include:
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: £1500 +VAT*
- Delegates: £1700 +VAT*
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: £1275+VAT*.
Please email us at meetings@topra.org for a discount code before making your booking.
*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.
By booking a place on this course you are agreeing to the training terms and conditions