Early Bird discounts:
Register early to save € 500 for the Individual ticket, € 600 per person for 2-3 Delegates, € 700 per person for 4+ delegates from the same company until 16 April 2021.
Medical Device Regulations Summit 2020 is focusing on EU MDR and IVDR overview, appropriate challenges and strategies for their overcome; company, team and portfolio preparation to new regulations; technical documentation, labelling and clinical data adoption; risk management and quality management systems updates; compliance strategies; Unique Device Identification (UDI) system implementation; medical devices traceability and devices classification.
07:30 Registration and Welcome Coffee
08:00 Opening Address from the Chairman
08:10 Implementation of the MDR and effect on Combination Products.
Mark A. Chipperfield, M.Sc, B.Eng.(Hons), AMIMechE, MTOPRA,
Company Director and Principal Consultant, Corvus Device, Holmes Chapel, United Kingdom
08:50 Speed Networking
09:30 To Be Announced
10:10 Morning coffee and networking break
10:40 Reserved for a GlaxoSmithKline RESERVED
11:20 To Be Announced
12:00 Business lunch
13:00 Reserved for a Gold or Silver Sponsor AVAILABLE
13:30 Updating the QMS to MDR.
14:10 Reserved for a Booth or Bronze Sponsor AVAILABLE
14:30 Afternoon coffee and networking break
15:00 Relation between manufacturers and Notified Bodies
15:40 Workshop: Risk Management.
16:40 EU MDR Vigilance System – EU Vigilance Decision Tree and Optimal Set Up.
17:20 Roundtable Discussion
18:10 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 EUDAMED, the Database of Medical Devices. Current implementation status and future developments
EUDAMED, the European Medical Device Database of Medical Devices is one of the most significant changes introduced by the new European Medical Device Regulations on Medical Devices (MDR) and In Vitro Diagnostics Medical Devices (IVDR). As the core of the new regulatory system of MDR and IVDR, a lot of resources and efforts have already been spent by the EU Commission and different stakeholders to design, build, validate and further develop the database. This presentation will analyze the current status of EUDAMED and future improvements of one of the most challenging European Initiatives ever introduced in the medical device sector.
09:20 To Be Announced
10:00 Morning coffee and networking break
10:30 Reserved for a Speaking Sponsor AVAILABLE
10:50 Workshop - EU MDR Post Market Surveillance – Requirements and Lessons Learned.
11:50 Business lunch
12:50 Reserved for a Zimmer Biomet RESERVED
13:30 To Be Announced
14:10 Afternoon coffee and networking break
14:40 Biocompatibility testing to meet the requirements of the EU Medical Device Regulation.
15:20 Case Study #6 AVAILABLE
16:00 Q & A
16:20 Chairman’s closing remarks and end of summit
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
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Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - Others