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 Online Module

FREE to Attend | Live & Recorded

Delivered Online

Overview of biocompatibility

• An introduction to biocompatibility
• Biocompatibility vs biological safety

Day 1

Introduction to the course and overview of biocompatibility

Examining the ISO 10993 series

• ISO 10993 history and development
• ISO 10993 structure and content
• Relationship between regulatory standards

Regulatory aspects

• Examine the impact of the Medical device Regulation (MDR)
• Review the impact of Brexit

Biological evaluation process for a medical device

• Gap analysis of existing biocompatibility data
• Medical device categorization for biological risk assessment

Interactive group exercises are also included as part of the course to cement your knowledge on ISO 10993 and regulatory aspects of biological evaluations.

Day 2

Biocompatibility testing

• Endpoints to be addressed in a biological risk assessment
• GLP requirements
• Lab selection

Material characterisation

• Physical and Chemical characterisation
• Extractables and leachables testing – when and why?
• Use of QSAR

Assessment strategies

• Change Management
• Use of data sources to provide chemical information
• Literature searching to support safe use of materials

Global considerations for biocompatibility

• International requirements
  • Differences in in-vivo testing interpretations – US and Europe

Gas pathway devices

• Gas Pathway devices

Interactive group exercises are also included as part of the course to cement your knowledge on biocompatibility testing and assessment strategies.

Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a registered toxicologist and specialises in product safety assessment with over 30 years’ experience. He has published and presented widely in his expert field of genetic toxicology and in the wider area of safety assessment. Phillip has recently joined the BSI Ch/194 Committee to provide UK input to ISO/Tc 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices.

Janine Townsend

Janine is a Senior Safety Assessor with Chorley Consulting. She holds a MSc in Global aquatic biodiversity and a BSc in Molecular biology and biotechnology, both from the University of Hull. She has over 10 years of regulatory and product safety experience within FMCG and the Fragrance industry. She is an experienced project manager and is also our Quality Manager developing and maintaining our ISO 9001 quality management system. Janine brings to Chorley knowledge in the regulatory arena as well as toxicological data analysis skills for use in the risk assessment of medical devices.

Rona Middlemiss

Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen. Additionally, she has attended training courses on the Practical Application of Toxicology in Drug Development and also Personal Animal License Course, Modules 1-3. She spent her year industry with a multinational consumer healthcare and medical device manufacturer, gaining experience in the safety assessment of medical devices. She joins Chorley from a Scientist role with British American Tobacco where she honed her toxicology skills performing toxicological risk assessment for harm reduction products. Rona brings to Chorley experience gained with a healthcare medical device manufacturer as well toxicological risk assessment skills gained during her time with BAT.

During her time with Chorley, Rona has rapidly developed her skills in performing toxicological risk assessments of extractable and leachable data including the use of in silico tools for the prediction of toxicological effects. She has also developed her presentation skills, having presented a number of on-line training modules around various aspects of Biological Evaluation of Medical Devices.