The 2nd Symbioteq Biocompatibility
Medical Devices Conference 2017
in cooperation with Key2Compliance AB
Join us for Symbioteq Biocompatibility of Medical Devices Conference 2017 at the Elite Park Avenue Hotel, Gothenburg, Sweden.
Features a comprehensive program that faces the challenges in relation to biocompatibility today. An impressive list of national and international speakers from notified bodies, agencies, test houses and industry.
Mr. Henry Sibun, Henry Sibun Associates Ltd chairing the Conference day 1 and Dr Albrecht Poth, Dr. Knoell Consult GmbH, acting as Chairman 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 the biological safety of medical devices.
Some hot topics: the impact of the new MDR in relation to biocompatibility, update from the ISO 10993 standard series, learn more about animal tissue derivatives and wound healing, and not at least focus on requirements for Chinaand updates from US FDA. With speakers from Notified Body and exclusive from the China FDA and the US FDA.
This is an excellent opportunity to network with global Medical Devices Biocompatibility Professionals, share and discuss experience 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 experience and where you can also relax and enjoy the beautiful city of Gothenburg. We look forward to welcoming you to this not-to-be-missed event, Symbioteq Biocompatibility of Medical Devices Conference 2017 in Gothenburg.
Put 3-4 October 2017 in your diary and be sure to regularly visit the website for the latest updates.
Limited seats available, reserve your seat now!
Speakers and topics in the program:
- Global Harmonization.
Stephan Buttron, Principal Medical Research Manager Regulatory Affairs, NAMSA, Germany.
- A quarter-century with ISO 10993 -- from simply toxicology to risk-based evaluation, a personal view
Karl-Gustav Strid, PhD, Professor, Senior medical device expert, SP Certification (RISE), Sweden. Member of SIS/TC 340 and Swedish expert in ISO TC 194
FDA present their experiences following the publication their new guidance document
Jennifer Goode, Biocompatibility Program Advisor, FDA, US (Remote presentation)
- Update on the ISO 10993 standard series (what has happened since the last conference October 2014).
– Status and upcoming changes.
Albrecht Poth – PhD, Chairman ISO TC 194 and of the German National Mirror Committee, Convenor of ISO 10993-3, Senior Toxicologist, Business Unit Health Care – Business Development, Dr. Knoell Consult GmbH, Germany
- Notified Body perspective on biocompatibility, with the new Regulation in mind.
Notified body perspective on Biological Evaluations, including assessment of the impact of the new General Safety and Performance Requirements in the MDR (e.g. endocrine disruptors and quantitative restrictions) as well as discussion of the overlap between biocompatibility and clinical evaluation e.g. the assessment of equivalency and the pitfalls related therewith (toxicological equivalence, comparability of intended use, potential differences in patient population, etc.).
Dr. Julian Kirch, TÜV SÜD Product Service GmbH, Germany.
- Biocompatibility, risk management and the QMS
This presentation will give an overview of the risk based nature of managing biocompatibility and show how it can be effectively incorporated into different parts of the QMS. Topics covered include biocompatibility as part of the QMS and Risk Management processes, and feedback from a Notified Body perspective from auditing medical device companies and reviewing technical documentation.
Henry Sibun, Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for TÜV SÜD Product Service GmbH. UK
- Standardization – a powerful tool!
Lena Morgan, Project Manager, Reg Biomedical Scientist, Chair for Advisory Board for Health Standards (ABHS), CEN, Swedish Standards Institute.
- Global submission expectations regarding ISO 10993-1 – a manufacturer of active implantable devices’ perspective.
Gerhard Marini, MED-EL, Austria.
- Current development and future trend of ISO 10993 standards in China.
Director Chenghu Liu of the Biological evaluation department at China FDA-Shandong Quality Inspection Center For Medical Devices (one of the China FDA medical device testing centers and China TC 194 working group committee).
- When Drug meets Device - New challenges for Drug Stability and Material characterization of Combination products.
Key points: *Analytical testing for Combination products. How to approach? *New challenges for Drug stability especially for devices coated with drug products. *Impurities from the drug, the device or the combination?
*The importance of Chemical Characterization (ISO10993-18) and the impact on drug stability – leachables and their interaction with the drug product. *Case studies. The increasing use of and interest in innovative combination products – products combining a drug, device, and/or biologic – is raising significant challenges both for regulators and the industries they regulate.
Using specific case studies, this talk will present the challenges that Toxikon has overcome in drug stability studies as well as well in material characterization of drug/device products from a practical, analytical and regulatory point of view.
Dr. Ir.Lise Vanderkelen, Department Head Pharma Services, Toxikon Europe nv, Belgium.
- The ISO 18562 series “Biocompatibility of breathing gas pathways in healthcare applications” is now released - what does it contain and why?
The ISO 18562 standard series has been developed to cover evaluation of Biocompatibility of breathing gas pathways, a route of exposure not properly covered by the ISO 10993 standard series. The presentation will cover the identified hazards and methods presented in the standard together with background information about the methods and TTC values. The talk will cover concerns when including the subpopulation neonate in the standard and how the TTC values were discussed to be used for this patient group.
Lina Burman, PhD, Consultant, Symbioteq, Sweden.
- Hemocompatibility ISO 10993-4, with industry examples from a global perspective.
Barbara Musi, PhD, Principal Research Scientist, R&D and Innovation, Baxter Healthcare Corporation.
- Are the current medical device extraction procedures sufficient for genetic toxicity hazard identification?
Extracts prepared according to ISO 10993-12 are used in several genetic toxicity test systems to identify potential hazards. The adequacy of the various extraction procedures allowed in ISO 10993-3 is still being debated. The concern is that these extraction procedures may not be adequate for hazard identification. A comparison of literature data made to determine if the extract concentrations were sufficient to induce a mutagenic response at the lowest positive doses induced by various mutagenic chemicals will be presented. In addition, results from 104 Non-Volatile-Residue tests analyzed to determine the cumulative frequency of non-volatile residues at 6 targeted dose-concentrations (0.001% to 10%). The results were used to determine how often known mutagens could be detected using current ISO 10993-12 extraction procedures.
Robert Przygoda, PhD, Johnson & Johnson, USA.
- Wound healing – specific considerations.
Co-chair: Andy Makin, Scientific Director, Director of Business Development and Sales. CiToxLAB Scantox A/S, Denmark.
- Presentation on non-clinical wound-healing studies.
Trine Starostka, DVM, Study Director, Toxicology Science, CiToxLAB, Denmark.
- Open discussion led by, Andy Makin. CiToxLAB Scantox A/S – what challenges are the industry facing today? Focus on devices within the category wound-healing.
- Presentation on non-clinical wound-healing studies.
- Sterilization and Microbiology, impact on biological safety? Sterilization area in general and reprocessing of reusable instruments.
Dr. Hana Hofman-Hüther, Head of Consulting, Toxicologist, Eurofins Professional Scientific Services, Germany.
- Development of an in-vitro testing battery to assess biocompatibility of medical devices.
DI Elisabeth Mertl, OFI Technology & Innovation GmbH, Austria
- Chemical characterization, extraction/leaching conditions and biological testing in relation to the TTC concept (Threshold of Toxicological Concern).
Duopresentation. Ulrika Carlander, PhD, Senior Consultant, SoundAdvice AB and Lars Magnus Bjursten, MD, PhD, Professor Bioimplant Research, Lund University. Sweden.
- Toxicological Risk Assessment of medical devices based on extractable and leachable data – Lessons learned.
The presentation will provide information on the general approach to conduct a toxicological risk assessment. This will include data generation, evaluation of data quality, setting of exposure limits, benefit evaluation. The presentation will also highlight approaches to evaluate substances with limited toxicological data as well as unknown chemical substances (e.g. in silico methods and TTC-concept). Real-life examples will be presented for different exposure routes (inhalation, dermal, intraveneous).
Dr. Anja Rämisch. European Certified Toxicologist, Dr. Knoell Consult GmbH, Germany.
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.
If you are interested in Exhibitor or Sponsor opportunities, please send an email to: firstname.lastname@example.org
Monica Grekula and the Symbioteq Conference Team
SIS invites delegates from Swedish companies attending the Symbioteq conference to participate for free at the next SIS / TK 340 meeting in Gothenburg on October 5th, place and time TBD.
To get further information contact: email@example.com
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Deadline for registration: 29 September, 2017
Specified in the agenda
Day 1: 09.00 - 17.45
Day 2: 08.15 - 16.30
Price (excl. local VAT 25%):
SEK 11 900 (€ 1260 / USD 1320) incl. conference notes, lunches and refreshments.
Conference dinner, 3 Oct:
SEK 750 (€ 80 / USD 83) excl. 25% VAT
Dresscode is casual.
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.
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.
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 course 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.