Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

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

29 September | 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

22 November 2022

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

23 November 2022

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

24 November 2022

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.

Richard Young has over 30 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Keith Summerhayes has worked for major Pharmaceutical, Contract Research and Orthopaedic Medical Device Corporations, including Warner Lambert, Boehringer Ingelheim, Howmedica/Stryker & Zimmer.

Since leaving his role as Director International Clinical Affairs at Zimmer, keith has been successfully involved with several start-up medical device companies in the orthopaedic and spine world. He was responsible for strategic planning activities globally, evolving markets with regards to clinical studies, regulatory and quality assurance issues.

Keith started his consultancy as Managing Director and Clinical Affairs Consultant at Medical Device Clinical Regulatory & Quality Solutions Ltd (MDCRQ Solutions Ltd) and has worked with clients on a range of medical devices in Orthopaedics, Trauma, Cardiovascular, Gynaecology, amongst other exciting projects.