Biological and Clinical Evaluations Conference for Medical Devices
a Key2Compliance® Continued Development Conference - October 5-6, Malmö, Sweden
You are hereby invited to participate in a medical device regulatory conference: An international conference on medical device pre- and post-market strategies for biological evaluation, material characterisation and clinical evaluation and investigations. It is an opportunity to broaden your understanding and expand your professional network!
The conference supersedes the previous conferences – Symbioteq Biocompatibility of Medical Devices – now organised by Key2Compliance®, a Symbioteq company. The conference has a new format which we hope will suit your medical device needs and is designed to be valuable for both specialists and beginners. You will get the opportunity to hear the latest news from professionals within the fields of biocompatibility, clinical evaluations and investigations.
Who is it for
The conference is intended for professionals working with product safety, as material specialist, within material characterization, biological evaluation, or clinical investigations, post-market-clinical follow-up activities or clinical and, design and development, process development or Quality Assurance/Regulatory Affairs.
By attending this conference you will understand the intent of the regulators better and get a clear view of the path towards compliant technical documentation. Our speakers will represent both regulatory advisors, Notified Bodies, and the industry as well as other stakeholders (test labs, CROs and more).
Updates on ISO 10993 and ISO 18562 Prof. Lars-Magnus Bjursten at Lunds University, Convener ISO TC121/SC3/WG13 (ISO 18562 series), Chairman for the Swedish mirror committees for ISO TC 150 (surgical implants) and ISO TC 194 (ISO 10993 series)
Safety is more than biocompatibility: MDR generals requirements and ISO 10993 series Paolo Pescio, ERT, Senior Scientific Director Medical Devices, EurofinsBiolab
ISO 10993-18: Which extraction strategy might be adequate for my medical device? Jan Peeters, Senior Consulting Specialist, Eurofins BioPharma Services Consulting Munich, Germany, member of the ISO/TC 194 WG 1, 2, 11, 14, 15, ISO TC 172 SC07 WG 7, ISO/TC 198/WG 7
After chemical characterization, do I still need genotoxicity studies? Dr. Hana Hofman-Huether, Founder of H3 Consulting Services, Convener of WG 6, ISO/TC 194 (ISO 10993-3)
Session 2: Experience from industry, Notified Bodies and CROs
Biological Evaluation Submission’s Common Mistakes – Notified Body Experience
Chances and challenges of Chemical characterization – a case study Dr. Elisabeth Mertl, OFI, Österreichisches Forschungsinstitut für Chemie und Technik
Managing uncertainty in the toxicological risk assessment Dr. Ryan Paul Wheeldon, Manager, Research and Development at Baxter International Inc. member of the ISO/TC 194 WG 6 and WG 11
Challenges to evaluate the biological safety of reusable medical devices over their whole life-cycle Dr. Lise Vanderkelen, Nelson Labs
Session 3: 3R -Biocompatibility testing in vitro
In vitro skin irritation testing of medical devices Dr. Kristina Fant, RISE Research Institutes of Sweden
In-vitro skin sensitization tests in the biological evaluation David Waeckerlin, Sonova
In-vitro testing for endocrine disruptive properties of medical devices Dr. Peter Behnisch, BioDetection Systems
Session 4: More aspects on biological safety
Biocompatibility evaluation of breathing gas pathways in health care applications, proposed changes to the ISO 18562 series Prof. Lars-Magnus Bjursten at Lunds University
Hemocompatibility assessment of devices with circulating blood contact: Practical considerations for experimental design and data interpretation Dr. Crystal D’Silva, Research Scientist, Biocompatibility lead for Baxter’s Acute Renal and Nutrition product portfolio, Life Sciences & Operations, Baxter, Member of the ISO/TC 194 WG 5, 9, 12, & 15
Methods for biological evaluation of drug-device combination products. Dr. Gaëlle Clermont, Senior Product Development Strategist, NAMSA
Panel/interactive discussion: Making complex things easier – how can we optimize the synergies between the biological and clinical evaluation?
Day 2 – Clinical evaluations
Session 5: Clinical evaluations, requirements & sufficient data
Clinical Data Requirements with the EU MDR – What is sufficient? Dr. Bassil Akra, CEO and Owner of AKRA TEAM GmbH
Clinical evaluations- how to handle gaps in clinical data Gianluca Colucci, Intertek
Updates ISO 14155 including approvals for clinical investigations MD101 Consulting
Clinical trials/Investigator lead TBD
PMCF- experience from collecting real life data Christina Östberg Lloyd, CEO, Pharmiva AB
Session 7: Experiences from manufacturers, lessons learned
Case study – Class I Anna Sahlholm, Medical Science Liaison & Product Owner at Abilia
Case study – Software David Hedfors, RaySearch
Case study- Emergency medicine Fredrik Arnwald, Director of Clinical Affairs at Stryker
Session 8: Panel discussion and conclusion
Healthcare perspective/ Importance of patient safety TBD
Panel discussion Speakers from conference
Stay tuned with the program – It will be constantly/continually updated!
October 5-6th, 2021
St Gertrud Conference in Malmö, Sweden.
Directions to hotels and conference will be provided after registration and posted on the web site
Not included in the fee and suggested nearby hotels with special fee for conference guest will be provided after registration and posted on the web site
Evening the 5th after last session all guests are invited to a networking get-together where refreshments and drinks (alcoholic/non-alcoholic) will be served
Early-bird until August 4th: 890 Euro (appr equal to 8 945 SEK or 6 650 DKK )
Full price from August 5th: 990 EUR (appr equal to 9 950 SEK or 7 400 DKK )
Discount: 3 persons or more 10% if registered and invoiced together.
The fee includes full participation at conference, get-together mingle and electronic copies of conference notes.