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DAY 2 - 13th Oct 202009:00-09:4545
mins
Let's Get Moving - PT Session
DAY 2 - 13th Oct 202010:00-10:1010
mins
Platform Tutorial
DAY 2 - 13th Oct 202010:20-10:3010
mins
Opening Remarks from Chair
DAY 2 - 13th Oct 202010:30-10:355
mins
EU Medical Device Regulation
Moderated by Richard Houlihan EudaMed.eu
DAY 2 - 13th Oct 202010:30-10:355
mins
临床评估和调查
由荷兰Qserve集团执行董事兼合伙人GERT BOS主持
- 哥特Bos-Executive Director & Partner,Qserve Group, The Netherlands
DAY 2 - 13th Oct 202010:30-10:355
mins
Post Market Surveillance and Vigilance
Moderated by FAYEZ ABOU HAMAD MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager at Terumo Europe N.V., Belgium
- Fayez Abou Hamad-MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager,Terumo Europe N.V., Belgium
DAY 2 - 13th Oct 202010:35-11:0025
mins
EU Medical Device Regulation
Smooth Operator: Implementing EO Requirements from the EU MDR
- Claire van den Nieuwenhof-EMEA Regulatory Affairs, Medical Products Division,W. L. Gore & Associates B.V
DAY 2 - 13th Oct 202010:35-11:0025
mins
临床评估和调查
DEEP DIVE CASE STUDY: Industry Feedback on the Clinical Module
- Shelley Jambresic-Clinical Research Manager & Science Writer,Geistlich制药公司
DAY 2 - 13th Oct 202010:35-11:0025
mins
Post Market Surveillance and Vigilance
NOTIFIED BODY FEEDBACK: Post Market Surveillance - How to Succeed in the First Year Under EU MDR
- 丹尼尔·博拉蒂-Product Conformity Assessment /Medical Devices Expert,IMQ
DAY 2 - 13th Oct 202011:05-11:3025
mins
EU Medical Device Regulation
Creating a Robust QMS System that can Successfully Process the EU MDR
- 丹尼尔·博拉蒂-Product Conformity Assessment /Medical Devices Expert,IMQ
DAY 2 - 13th Oct 202011:05-11:3025
mins
临床评估和调查
Sufficient Clinical Evidence for legacy devices under MDR
- 阿米·斯米尔斯韦特-Senior Director - Global Clinical Practice,Maetrics
DAY 2 - 13th Oct 202011:05-11:3025
mins
Post Market Surveillance and Vigilance
MANUFACTURER'S PERSPECTIVE: Interpreting Requirements for PMS Under the EU MDR
- Yaman Tunaboylu-Post Market Surveillance Manager,BioTronik AG
DAY 2 - 13th Oct 202011:30-12:1545
mins
Exhibition Networking Break
DAY 2 - 13th Oct 202012:15-12:4530
mins
Roundtable with BSI: The new UKCA and future UK regulation for Medical Devices and IVDs
- Jayanth Katta-Regulatory Lead,BSI UK Notified Body
DAY 2 - 13th Oct 202012:45-12:5510
mins
Taste of Dublin
DAY 2 - 13th Oct 202012:55-13:1520
mins
Exhibition Networking Break
DAY 2 - 13th Oct 202013:15-13:205
mins
EU Medical Device Regulation
Moderated by BASSIL AKRA CEO at QUNIQUE GmbH, Germany
DAY 2 - 13th Oct 202013:15-13:205
mins
临床评估和调查
Moderated by BASSIL AKRA CEO at QUNIQUE GmbH, Germany
DAY 2 - 13th Oct 202013:15-13:205
mins
Post Market Surveillance and Vigilance
Moderated by BASSIL AKRA CEO at QUNIQUE GmbH, Germany
DAY 2 - 13th Oct 202013:20-13:5030
mins
EU Medical Device Regulation
Feedback from European Commission: Notified Bodies Designation
- Mairead Finucane-Project Lead & Inspector for joint assessments of notified bodies (medical devices), DG Sante,European Commission
DAY 2 - 13th Oct 202013:20-13:5030
mins
临床评估和调查
Feedback from European Commission: Notified Bodies Designation
- Mairead Finucane-Project Lead & Inspector for joint assessments of notified bodies (medical devices), DG Sante,European Commission
DAY 2 - 13th Oct 202013:20-13:5030
mins
Post Market Surveillance and Vigilance
Feedback from European Commission: Notified Bodies Designation
- Mairead Finucane-Project Lead & Inspector for joint assessments of notified bodies (medical devices), DG Sante,European Commission
DAY 2 - 13th Oct 202013:55-14:4045
mins
EU Medical Device Regulation
NOTIFIED BODY PANEL DISCUSSION: EU MDR Pain Points
- Elaine Darcy-European Medical Device Operations Manager,NSAI
- Martin Witte-Global Director, Active Implantable and Cardiovascular Devices,TÜV SÜD
- Yvonne Ndefo-Chief Clinical Evaluator,NSAI
- 丹尼尔·博拉蒂-Product Conformity Assessment /Medical Devices Expert,IMQ
- Bart Mersseman-Certification and Business Enhancement. Global Medical Devices Certification Manager Notified Body,SGS, Belgium
- Jayanth Katta-Regulatory Lead,BSI UK Notified Body
DAY 2 - 13th Oct 202013:55-14:4045
mins
临床评估和调查
NOTIFIED BODY PANEL DISCUSSION: EU MDR Pain Points
- Elaine Darcy-European Medical Device Operations Manager,NSAI
- Martin Witte-Global Director, Active Implantable and Cardiovascular Devices,TÜV SÜD
- Yvonne Ndefo-Chief Clinical Evaluator,NSAI
- 丹尼尔·博拉蒂-Product Conformity Assessment /Medical Devices Expert,IMQ
- Bart Mersseman-Certification and Business Enhancement. Global Medical Devices Certification Manager Notified Body,SGS, Belgium
- Jayanth Katta-Regulatory Lead,BSI UK Notified Body
DAY 2 - 13th Oct 202013:55-14:4045
mins
Post Market Surveillance and Vigilance
NOTIFIED BODY PANEL DISCUSSION: EU MDR Pain Points
- Elaine Darcy-European Medical Device Operations Manager,NSAI
- Martin Witte-Global Director, Active Implantable and Cardiovascular Devices,TÜV SÜD
- Yvonne Ndefo-Chief Clinical Evaluator,NSAI
- 丹尼尔·博拉蒂-Product Conformity Assessment /Medical Devices Expert,IMQ
- Bart Mersseman-Certification and Business Enhancement. Global Medical Devices Certification Manager Notified Body,SGS, Belgium
- Jayanth Katta-Regulatory Lead,BSI UK Notified Body
DAY 2 - 13th Oct 202014:50-15:0010
mins
Tech Tour: Cactus
DAY 2 - 13th Oct 202015:05-15:1510
mins
Tech Tour: Maetrics
DAY 2 - 13th Oct 202015:20-15:3010
mins
Tech Tour: Thera-Business
DAY 2 - 13th Oct 202015:30-15:4010
mins
Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
DAY 2 - 13th Oct 202015:40-15:455
mins
EU Medical Device Regulation
Moderated by JEFFREY CYR Global Director, Regulatory Affairs at Sirtex Medical Inc
DAY 2 - 13th Oct 202015:40-15:455
mins
临床评估和调查
Moderated by MELANIE CRYSTAL Sr. Manager, Clinical Affairs | Clinical Evidence and Compliance Respiratory, Gastrointestinal, & Informatics at Medtronic
DAY 2 - 13th Oct 202015:40-15:455
mins
Post Market Surveillance and Vigilance
Moderated by FAYEZ ABOU HAMAD MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager at Terumo Europe N.V., Belgium
DAY 2 - 13th Oct 202015:45-16:1025
mins
EU Medical Device Regulation
EUDAMED UPDATE: Status and Future Timelines of Implementation of the EUDAMED Database
- Richard Houlihan-CEO,EudaMed.eu
DAY 2 - 13th Oct 202015:45-16:1025
mins
临床评估和调查
Optimal Use of Scientific Literature to Ease Your Path to EU MDR Compliance
- Dr. Isabella Steffensen-President,Thera-Business
DAY 2 - 13th Oct 202015:45-16:1025
mins
Post Market Surveillance and Vigilance
Streamlining the post-market surveillance planning for biomedical literature
- Carlos Rodriguez Delrio,Elsevier
DAY 2 - 13th Oct 202016:15-16:4025
mins
EU Medical Device Regulation
Implementing a UDI System to Meet EU MDR and Global Requirements
- Kristopher Williams-Associate Director, Engineering Services MDR Core Team,Zimmer Biomet, USA
DAY 2 - 13th Oct 202016:15-16:4025
mins
临床评估和调查
Developing a Strategic Outlook on Clinical Evaluation Plans
- Juliana Witte-临床评估经理,Institut Straumann AG
DAY 2 - 13th Oct 202016:15-16:4025
mins
Post Market Surveillance and Vigilance
Creating a Robust Post Market Surveillance Plan Under the EU MDR
- Philippe Auclair-Senior Director, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory,Abbott
DAY 2 - 13th Oct 202016:45-17:1025
mins
临床评估和调查
Update on ISO/TR 24971 Guidance Document
- Jahan Azizi-Special Projects Manager,Healthmark Industries
DAY 2 - 13th Oct 202017:10-18:1060
mins
Speed Networking
DAY 2 - 13th Oct 202018:10-18:155
mins
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