Biological and Clinical Evaluations Conference for Medical Devices - October 5-6th, 2021, Malmö
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Updated June 21, 2021 Biological and Clinical Evaluations Conference for Medical Devices - October 5-6th, 2021, Malmö a Key2Compliance® Continued Development Conference → Who is it for → Program, Day 1 - Biological evaluation → Program, Day 2 - Clinical Evaluation → Speakers → Conference facts Welcome 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 performance evaluations, 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).
Updated June 21, 2021
Program - Day 1 - Biological evaluation (Confirmed June 21st 2021)
Time Topic Speaker
08:00 Registration and breakfast -
08:30 Welcome Key2Compliance
Session 1: News and updates to ISO 10993
08:45 Updates of the ISO 10993 series (Biological Lars-Magnus Bjursten, Lund 20 min
evaluation of medical devices — Evaluation and University
testing within a risk management process) and
what to expect for the future
09:05 Safety is more than biocompatibility: MDR Paolo Pescio, Eurofins Biolab 30 min
general requirements and ISO 10993 series Italy
09:35 ISO 10993-18: Which extraction strategy might be Jan Peeters, Eurofins BioPharma 30 min
adequate for my medical device? Services Consulting Munich
10:05 After chemical characterization, do I still need Hana Hofman-Huether, H3 25 min
genotoxicity studies? Consulting Services
10:30 Coffee break
Session 2: Experience from industry, Notified Bodies and CROs
11:00 Biological Evaluation Submission's Common 25 min
Mistakes - Notified Body Experience
11:25 Chances and challenges of Chemical Elisabeth Mertl, OFI Technologie 25 min
characterization - a case study & Innovation GmbH
11:50 Managing uncertainty in the toxicological risk Ryan Paul Wheeldon, Baxter 25 min
assessment International Inc
12:15 Challenges to evaluate the biological safety of Lise Vanderkelen, Nelson Labs 25 min
reusable medical devices over their whole life-
cycle
12:40 Lunch
Session 3: 3R -Biocompatibility testing in vitro
13:30 In vitro skin irritation testing of medical devices Kristina Fant, RISE Research 20 min
Institutes of Sweden
13:50 Experience of using in vitro sensitization methods David Waeckerlin, Sonova 20 min
for medical devices
14:10 In vitro testing for endocrine disruptive properties Peter Behnisch, BioDetection 20 min
of medical device Systems
Session 4: More aspects on biological safety
14:30 Biocompatibility evaluation of breathing gas Lars-Magnus Bjursten, Lund 20 min
pathways in health care applications, proposed University
changes to the ISO 18562 series
14:50 Hemocompatibility assessment of devices with Crystal D’Silva, Baxter 20 min
circulating blood contact: Practical considerations International Inc
for experimental design and data interpretation
15:10 Methods for biological evaluation of drug-device Gaëlle Clermont, NAMSA 20 min
combination products
15.30 Coffee break
16:00 Panel/interactive discussion: 40 min
Making complex things easier – how can we optimize the synergies between the
biological and clinical evaluation?
16:40 Closing remarks 5 min
17:00 - The bar is open – mingle and food
Updated June 21, 2021
Program - Day 2 - Clinical evaluation (Confirmed June 21st 2021)
Time Topic Speaker
08:30 Breakfast
09:00 Welcome Maria Lindgren, K2C
Clinical evaluations, requirements & sufficient data
09:10 Clinical Data Requirements with the EU MDR – What is sufficient? Bassil Akra, CEO and Owner of
AKRA TEAM GmbH
09:40 Clinical evaluations- how to handle gaps in clinical data (TBD) Gianluca Colucci, Intertek
10:10 Coffee break
10: 40 Medical devices outside EU To be confirmed
Clinical investigations, news & updates
11.00 Updates ISO 14155 including approvals for clinical investigations Myriam, MD101
(TBD)
11.30 Bio break
11.40 Clinical trials/Investigator lead To be confirmed
12.10 PMCF- experience from collecting real life data (TBD) Christina Östberg Lloyd,
Pharmiva
12:45 Lunch
Experiences from manufacturers, lessons learned
13:30 Case study-class I Anna Sahlholm, Abilia
13.50 Case study- software David Hedfors, RaySearch
14.10 Case study- Emergency medicine Fredrik Arnwald, Jolife
14.30 Coffee break
Panel discussion and conclusion
14:50 Healthcare perspective/ Importance of patient safety To be confirmed
15.10 Panel discussion Speakers from the conference
15.50 Closing remarks Maria Lindgren,
Key2Compliance
16.00 End of conference
Stay tuned with the program - it will be constantly/continually updated!
Updated June 21, 2021
Speakers (in alphabetic order)
Prof. Lars-
Dr. Bassil Magnus
Akra Bjursten
CEO and Owner of AKRA TEAM GmbH Professor at Lunds University, Convener
Clinical Data Requirements with the EU ISO TC121/SC3/WG13 (ISO 18562 series),
MDR – What is sufficient? Chairman for the Swedish mirror
committees for ISO TC 150 (surgical
implants) and
ISO TC 194 (ISO 10993 series)
Updates on ISO 10993 and ISO 18562
Fredrik
Arnwald
Director of Clinical Affairs at Stryker
Experiences from clinical trials in emergency Dr. Gaëlle
medicine Clermont
Senior Product Development Strategist,
NAMSA.
Methods for biological evaluation of drug-
device combination products
Dr. Peter
Behnisch
Director, BioDetection Systems BDS
In-vitro testing for endocrine disruptive
properties of medical devices
Updated June 21, 2021
Dr. Hana
Dr. Crystal Hofman-
D’Silva Huether
Research Scientist, Biocompatibility lead Founder of H3 Consulting Services,
for Baxter’s Acute Renal and Nutrition Convener of WG 6, ISO/TC 194 (ISO
product portfolio, Life Sciences & 10993-3).
Operations, Baxter, Member of the ISO/TC After chemical characterization, do I still
194 WG 5, 9, 12, & 15. need genotoxicity studies?
Hemocompatibility assessment of devices
with circulating blood contact: Practical
considerations for experimental design and
data interpretation
Dr. Elisabeth
Mertl
OFI, Österreichisches Forschungsinstitut
Dr. Kristina für Chemie und Technik
Fant Chances and challenges of Chemical
characterization - a case study
RISE Research Institutes of Sweden
In vitro skin irritation testing of medical
devices
Jan
Peeters
David Senior Consulting Specialist, Eurofins
Hedfors BioPharma Services Consulting Munich,
Germany, member of the ISO/TC 194 WG
Quality and Regulatory Affairs director, 1, 2, 11, 14, 15, ISO TC 172 SC07 WG 7,
RaySearch Laboratories AB ISO/TC 198/WG 7.
Case study- software ISO 10993-18: Which extraction strategy
might be adequate for my medical device?
Updated June 21, 2021
Paolo Dr. Lise
Pescio Vanderkelen
ERT, Senior Scientific Director Medical Nelson Labs
Devices, Eurofins Biolab Challenges to evaluate the biological safety
Safety is more than biocompatibility: of reusable medical devices over their whole
MDR general requirements and ISO 10993 life-cycle
series.
Dr. Ryan Paul
Anna Wheeldon
Sahlholm
Manager, Research and Development at
Medical Science Liaison & Product Owner Baxter International Inc. member of the
at Abilia ISO/TC 194 WG 6 and WG 11.
Setting up a process for clinical data Managing uncertainty in the toxicological
generation according to MDR - building on risk assessment.
existing knowledge and relations.
Christina
Östberg
Lloyd
David
Waeckerlin CEO Pharmiva AB, MD, specialist in
gynecology and obstetrics
Sonova The clinical dvelopment journey for
Experience of using in vitro sensitization Pharmivas products
methods for medical devices
Updated June 21, 2021 Conference facts Date October 5-6th, 2021 Location/Venue St Gertrud Conference in Malmö, Sweden. Directions to hotels and conference will be provided after registration and posted on the web site: key2compliance.com/product/biological-and-clinical-evaluations-for-medical-devices/ Accommodation 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. Conference mingle 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. Conference fee 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. Note: 25 % local VAT will be added
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