Monica Grekula, ERT (European Registered Toxicologist), MSc Applied Toxicology, MSc Pharma
Monica has over 25 years of experience in the field of medical devices, mainly within biological evaluations and toxicological risk assessments, all phases from a global perspective for class I – class III medical devices, as well as Combination Products. She has worked extensively with whole life-cycle risk management, setting up procedures and leading teams and has been involved in different development projects, both within pharma and medical devices.
Lina Burman, PhD in Polymer Technology with focus on evaluation of migration and degradation behavior of polymeric materials
Lina has 15 years of experience within the medical device industry, working mainly with biological evaluations and toxicological risk assessments, of which 10 years with focus on breathing gas pathway related devices as part of the development team. She’s been responsible for the evaluation of class I – class III devices for the EU and US markets. In addition, she’s experienced within clinical evaluations, environment related requirements, failure evaluations, chemical characterization, and QMS.
Training Objectives
By attending this training, you will develop a basic understanding of biocompatibility-related issues and requirements you can reduce the likelihood of:
- Time-consuming and costly mistakes when choosing materials;
- Having to re-do testing;
- Biocompatibility-related adverse events following material changes;
- Deviations related to material changes at audits; and
- Questions at filing to Notified Body and Authorities.
The course will improve your understanding of biocompatibility to:
- Ensure timely consideration of biocompatibility-related aspects during development;
- Facilitate discussions with those responsible for biological evaluation and test houses; and
- Ease reviewing of biocompatibility-related documentation for regulatory purposes or clinical evaluations.
The course also gives a good introduction to the area if you will be working with biological evaluations and you’re new to the field.
Training Content
Day 1:
- Definition and connection to other processes – risk management, clinical evaluation, quality system process (ISO 14971, ISO 14155, ISO 13485) and Design Development
- ISO 10993-1 general principles and process
- Endpoints of concern and product-specific hazards
- Information needed for biological evaluation, incl. choice of chemical information or chemical analysis
- Overview ISO 10993 remaining standards
- Changes that trigger update of evaluation and case studies
- Group exercise
Day 2:
- Basics to think about in material selection and dealing with suppliers
- Basics to think of when setting up tests with test house
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- Biological testing
- Chemical characterization
- Key points to be covered due to the EU MDR 2017/745 GSPR
- What Notified Bodies want to see
- Global aspects
Training Format
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend
This course is for beginners and basic needs – suitable for those of you who need a basic understanding, e.g. working as project managers, R&D engineers, regulatory managers, quality engineers, sustaining engineers, and/or involved in vigilance investigations and clinical evaluations, as well as beginners within biological evaluations.
Price
EUR 620 including course material and certificate