Join us for Symbioteq Biocompatibility of Medical Devices Conference 2019
at the Elite Park Avenue Hotel, Gothenburg, Sweden.
We would like to welcome you to Gothenburg and to the 3rd Symbioteq Biocompatibility of Medical Devices Conference. We are proud to present a two-day comprehensive conference program with international and national speakers. A biannual event not to be missed!
Director, Henry Sibun, Henry Sibun Associates Ltd, UK, chairing the Conference day 1 and Dr Arthur Brandwood, Brandwood CKC, all the way from Australia chairing the Conference day 2.
Together with good networking opportunities it will certainly be rewarding days in Gothenburg. The conference will enable you to understand the current and future requirements for ensuring biological safety of medical devices.
Some hot topics:
Regional differences in requirements, Biocompatibility requirements under the MDR, Update from the ISO 10993 standard series, and especially focus on in vitro methods and chemical characterization.
This is an excellent opportunity to network with global Medical Devices Biocompatibility Professionals, share and discuss experiences with colleagues and friends. Whether you work with R&D, QA or Regulatory this is a unique opportunity to learn more. Our primary ambition and focus is to offer you a multidisciplinary event to come together to learn and share experiences and where you can also relax and enjoy the beautiful city of Gothenburg.
On Monday evening, there will be an opportunity to meet and mingle with conference participants and organizers at the Pub Bishops Arms next to the hotel (at own cost) – your first networking opportunity to get in touch with colleagues, clients and friends.
We look forward to welcoming you to the 3rd Symbioteq Biocompatibility of Medical Devices Conference 2019.
Chairman day 1: Director, Henry Sibun, Henry Sibun Associates Ltd, UK.
Chairman day 2: Dr Arthur Brandwood, Brandwood CKC, Australia.
What’s cooking in TC 194 – recent changes and future plans for the ISO 10993 series. Dr Arthur Brandwood, Brandwood CKC, Australia. Head of Australian Delegation and TC 194 member since 1991.
Biocompatibility Requirements under the MDR. Henry Sibun, Director, Henry Sibun Associates Ltd, UK and External Notified Body Reviewer/Lead Auditor for TÜV SÜD Product Service GmbH, Germany. Description: This presentation will give an overview of the changes to biocompatibility requirements resulting from the introduction of the Medical Devices Regulation (EU) 2017/745 (the “MDR”) in Europe. It will also cover changes to the approach of Notified Bodies and discuss the steps to take to transition from MDD to MDR compliance.
Current challenges in submissions to notified body with regard to E/L data for biocompatibility and reprocessing validation Dr. Julian Kirch, TÜV SÜD Product Service GmbH, Germany.
Harmonisation under MDR: insights from an HAS consultant Paolo Pescio, ERT, HAS consultant, Senior Consultant and team leader, Eurofins Medical Device Testing, Italy.
Intro to Panel Discussion and Q&A – “Managing regional variation in a global industry”. Dr Arthur Brandwood, Brandwood CKC, Australia. Panelists: Henry Sibun, Paolo Pescio, Jia Liu, Leticia Filier.
Regional differences in biological evaluation requirements – Expectations from ANVISA/Brazil Letícia Barel Filier, Health Regulation Specialist, General Office of Medical Devices, Brazilian Health Regulatory Agency – ANVISA, Brazil. Description: This presentation will cover how medical devices are regulated in Brazil, what regulations predict the biocompatibility evaluation, the recent expectations from ANVISA regarding biocompatibility assessment (mainly focusing the evaluation within a risk management process) and the most frequent reasons for requesting, from the manufacturers, clarification on biocompatibility issues. Case study regarding the biocompatibility evaluation of a medical device will be included.
Safety evaluation for Innovation medical devices in China Dr Jia Liu, Biological Evaluation Department, NMPA-Shandong Quality Inspection Center For Medical Devices, China.
The current state of ISO 10993-18; Chemical characterization of medical device materials within a risk management process Ted Heise, PhD; Vice President Regulatory and Clinical Services, MED Institute, US. Description: Dr. Heise will provide an overview of the chemical characterization process as well as its role in the overall biological evaluation process of 10993-1. He will outline the history of the document revision and project when the final standard is expected to be available. In addition, Dr. Heise will describe the key changes in the standard as compared to the previous version, and advise on expectations from regulators that have emerged during the revision process. Time permitting, lessons learned from previous chemical characterization work will be presented.
Chemical characterization for leachables of medical devices based on ISO 10993-18 Director Yong Shen, Chemical Department, NMPA-Shandong Quality Inspection Center For Medical Devices, China.
Sample preparation for biocompatibility tests DI Elisabeth Mertl, OFI Technology & Innovation GmbH, Austria.
Description: Extraction and sample preparation is regulated in the ISO 10993-12. This talk will present the influence of extraction parameters and sample preparation steps. Furthermore, the impact of personal interpretation will be discussed.
Challenges in chemical characterisation of medical devices based on substances: lesson learned from hyaluronic acid fillers Chiara Picotti, Senior Consultant and team leader, Eurofins Medical Device Testing, Italy.
Toxicology risk assessment of medical devices and proposed updates to ISO 10993-17 including the application of TTC values (TS 21726) Sherry P Parker, PhD, Senior Director of Regulatory Toxicology, WuXi AppTec, Lab Testing Division, US.
Application of QSAR in medical device safety assessments - how to mitigate risks of partially identified chemicals and those with limited experimental data. Philip Clay, Chorley Consulting Ltd. UK.
Predictive Toxicology: Using In Silico Systems Richard Williams, Chief Scientific Officer, Lhasa Limited, UK. Description: An overview of the development and application of the use of in silico systems for predictive toxicology, with a particular emphasis on the prediction of mutagenicity.
PK/TK/ADME and particles in Medical Device Biocompatibility
– When should we think about this? Gaëlle CLERMONT, Pharm D, PhD. Product Development Strategist, NAMSA, France. Description: There are references to these aspects in the MDR, and the ISO 10993-16 and FDA biocompatibility guidance aren’t exactly detailed. For medical devices PK/TK/ADME assessments are never going to be easy. This presentation will look at the background to these studies and what difficulties lay in store for medical devices looking at these endpoints. In addition, this presentation will also briefly discuss the GSPR 10.6 (particles) to determine when there may be possible risks linked to the size and the properties of particles following release into the patient/user.
Particles and (Avoiding) Kinetics Studies for Active Implants
– Case study from a manufacturer's perspective
Dr. Gerhard Marini, Sterilization and Biocompatibility, MED-EL, Austria. Description:ISO 10993-1:2018 does not provided clear guidance how to risk assess particles. Various other guidance documents deal with particles, some specifically for active implants. This presentation will provide an example how to address particles in the biocompatibility evaluation of active implants using these guidance documents. Since experimentally determining leachables release kinetics requires much effort, this presentation will also discuss what theoretical and bench-test concepts within ISO 10993-1:2018 can be used to avoid these kind of studies and still establish biocompatibility.
Drug-device compatibility- finding a perfect match Dr Ir Lise Vanderkelen, Department Head Pharma Services, Nelson Labs Europe, Belgium. Description:In this presentation, three parts of drug-device compatibility will be highlighted, with a focus on the “HOW”.
In-use stability testing methodologies for the assessment of drug, biological-device compatibility in an attempt to provide a reference for medical device manufacturers involved in the marketing of combined products.
Extractables and Leachables testing for drug-device combinations according to ISO 10993-18.
How is biocompatibility testing affected for drug-device combination?
ISO 18562 - Biocompatibility analysis of respiratory medical devices Dr Nikhil Sahotra, Materials Emission Specialist, Markes International Ltd, UK. Description: Updated regulation highlights the need for measuring chemicals released from materials in the air/gas stream. The regulation refers to ‘biocompatibility evaluation of breathing gas pathways in healthcare applications’ and is detailed in ISO 10993-1 (2018). Importantly, the standard cites ISO 18562, which has recently been recognised by the FDA (US Food and Drug Administration). ISO 18562-1 describes how risk from respiratory medical devices and its components should be evaluated. There are three tests associated with breathing gas pathways of medical devices listed in ISO 18562: particulate matter, volatile organic compounds (VOCs)and leachables. The talk will focus on sampling and analysis of volatile organic compounds released from respiratory medical devices.
Session: "In vitro methods, progress and hurdles…"Co-chair Rose-Marie Jenvert, PhD, Senzagen, Sweden.
Cytotoxicity testing - An overview and current aspects of cytotoxicity testing including some basics and suggestions on way forward when the cytotest fails Nick Edwards, PhD, Senior Biosafety Specialist, Ambu A/S, Denmark. Description: Main test methods briefly (qualitative USP elution test, quantitative NRU, MTT, etc. and testing extracts vs. direct contact vs. agar overlay) and highlight that they measure different aspects of toxicity. Also describe the mechanisms for ‘false’ positives: closed in vitro system vs. more dynamic in vivo system with ADME, non-physiological conditions, surface-active agents, effects on the measurement system that are separate from cytotoxicity, etc.)
In vitro irritation testing for Medical Devices, ISO 10993-23
Kelly Coleman, PhD, DABT, ERT, RAC, Distinguished Toxicologist, Medtronic PLC, US. Description: Round Robin for in vitro irritation testing, results and MDDT submission (regulatory acceptance), ISO 10993-23.
In vitro skin sensitization testing for Medical Devices, ISO 10993-10 Rose-Marie Jenvert PhD, Product Manager, SenzaGen, Sweden. Description: In vitro methods available today. AOP and key events for sensitization. Up-dates from ISO/TC 194 WG8, ISO 10993-10.
Regulatory acceptance of new in vitro methods. Dr. Hana Hofman-Hüther, Head of Scientific Consulting Services Munich, Eurofins Professional Scientific Services GmbH, Germany. Description: Regulatory acceptance of in vitro methods today, challenges and way forward to build confidence for new methods.
Case studies including in vitro assays Dr. Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Eurofins Biopharma Product Testing Munich GmbH, Germany. Description: This presentation will give examples, case studies were in vitro assays have been used in customer projects for the endpoints cytotoxicity, irritation and sensitization.
Panel Discussion and Q&A: “In vitro methods i.e. techniques for cytotoxicity, irritation and skin sensitization”
led by Rose-Marie Jenvert. Panelists: Nick Edwards, Kelly Coleman, Hana Hofman- Hüther and Helge Gehrke.
at Elite Park Avenue Hotel, Oct 1st
Entertainment: Once again, our appreciated Gothia Show Chorus
Who should attend:
The conference gives you the opportunity for learning the latest news within biocompatibility together with excellent networking, being a specialist or beginner within biocompatibility/toxicology? Product safety, material specialist, within material characterization, for those of you in development, production, process development or Quality Assurance/Regulatory Affairs, we are sure you will have a rewarding few days in Gothenburg.
Due to tax/VAT regulations within the EU (for seminars/conferences/courses), the conference fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the conference fee.
Discounts: For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 5%
4 or more 10%
Quantity discounts cannot be combined with other discounts or offers and does not apply to the dinner fee.
We do not offer or practice any general company discounts without commitments and/or written agreements.
Cancellation policy for Conferences: Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before conference start are subjected to a service charge of 150 € (Euro)/registered conference day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the conference, or failure to cancel or "no-show", will be charged in full.Cancellation of conferences:
The conference may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 35 days prior the conference start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another event for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled conference. If you need to book flights way ahead (+30 days prior the conference) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.
Hint going from Copenhagen to Gothenburg
- Travel by train More info
There is a direct train leaving every hour ( at 42 minutes past the hour) from Copenhagen airport to Gothenburg (Göteborg in the time table and wending machines). Tickets for this train are available at the airport lobby to the train in vending machines marked "Öresundståg". There is no bonus to buy first class ticket. The train takes about 3 hours 20 minutes. Note that the train may split half way with the front part always with destination Gothenburg. With a seat on the left hand side, you will be able to see some of the coast line. At the website, www.sj.se, you have all information.