Live Online Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For online attendees, you will receive joining instructions.

 

Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Introductory Module 1

FREE to Attend | Live & Recorded

6 October 2023 | 1:00 PM (UK)

Delivered Online

Regulatory, guidance and standards for gathering medical device clinical evidence

• How does the regulation apply to gathering of clinical evidence
• What guidance and standard documents need to be followed when gathering clinical evidence
• Clinical evidence for different device classes and the procedures relative to each.
• What data, when, why, and how
• Clinical definitions and terminology

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Day 1

1 November 2023

Clinical Evaluation  – Part 1

• How to conduct a clinical evaluation
• The Clinical Evaluation plan contents and structure
• Conducting a literature search, the methodology
• Literature search protocols
• State of the Art literature review and analyses

Clinical Evaluation  – Part 2

• The Clinical Evaluation Report (CER)
• Equivalence and similar
• Benefit risk determination and meeting the general safety and performance requirements
• Learn to strategically maintain a CER post market with new data
• Practical guidance to incorporate post market surveillance with the CER
• Examining how regularly the CER should be updated
• Evaluating examples of what can trigger an update such as new claims or new clinical data
• Examining how the clinical evaluation links to the risk management plan
• Identify residual clinical risks and determine whether post-market clinical follow-up is required

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Day 2

2 November 2023

Clinical Investigations  – Part 1

• Overview of the relevant Directives and Guidance
• The requirement for clinical data for Class I, IIa and III
• Identify when a clinical investigation/trial is required
• Scientific opinion process and expert panels
• Clinical strategy for your device

Clinical Investigations  – Part 2

• Compliance with ISO 14155
• Development of a clinical investigation and essential documents including CIP, CRF, IB
• Incorporating risk management in your clinical investigation
• Optimising the study design
• Practical guidance for obtaining approvals for conducting clinical investigations including research ethics committees and competent authority

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Day 3

3 November 2023

Post market data collection  – Part 1

• Strategically implementing a post market clinical programme
• Examining the current requirements for PMCF studies
• Understanding the growing role of PMCF studies
• Discussing examples when a PMCF study is required for new claims or a line extension
• Practical guidance to strategically manage PMCF studies for existing products
• Linking PMCF studies back to the clinical evaluation
• Development of vigilance and corrective action plans
• The post market clinical follow up plan
• The post market clinical follow up report

Post market data collection  – Part 2

• Strategically implementing a post market surveillance system
• The post market surveillance plan
• The post market surveillance report
• Vigilance and adverse event reporting during regulatory and post market studies
• Discussing how the post market data relates to the clinical evaluation process

Other documents required for compliance

• The periodic safety update report
• The summary of safety and clinical performance
• The clinical development plan
• Ensuring your documents meet the regulatory requirements
• Notified body review of documents
• Resources available to keep up to date

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Janette Benaddi is a business mentor, international speaker/trainer and expert consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. In addition, she set up a very successful medical device CRO company in the late nineties which she later successfully sold to another large multinational organization in 2013. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical investigations/evaluations for the medical device industry, she has also provided training to Notified bodies on medical device studies as well as other medical companies. She is highly regarded as a medical device trainer with an exceptional ability to share her vast knowledge and expertise in an engaging manner.

 

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She has also received an honorary doctorate in Health Sciences form York St John’s University. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.