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Day One - EST/EDT (Eastern Daylight, GMT-4)
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Day One - EST/EDT (Eastern Daylight, GMT-4)
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Day 1 - 24th October
08:30 - 08:45
Welcoming Remarks
08:45 - 09:15
Legal Background of Product Complaints
- Mika Reinikainen - Managing Director, Abnovo Ltd., UK
09:15 - 09:45
Panel Discussion: Auditing Procedure from Notified Body, Regulatory and Manufacturer Point of View
- Marta Carnielli - IVD Technical Officer, TÜV SÜD Product Service GmbH, Germany
- Mairead Finucane - Health & Food Safety Directorate General (DG SANTE), Directorate F – Health and food audits and analysis Unit, European Commission, Ireland
09:45 - 10:15
Coffee Break & Networking
10:15 - 10:45
The Ombudsman Process: Product versus Process Complaints
- Erica Katherine - ORA Ombudsman, Office of the Associate Commissioner, Office of Regulatory Affairs, U.S. Food and Drug Administration, USA
10:45 - 11:15
Rise of Social Media Use for Complaint Making
- Sharon Perez - Vice President, Global Medical Safety, Novocure, USA
11:15 - 11:45
Coffee Break & Networking
11:45 - 12:15
GDPR and How to Keep the User Anonymized
- Sharon Perez - Vice President, Global Medical Safety, Novocure, USA
12:15 - 12:45
Economic Operators Perspective; How they Handle and Report Complaints
- Deborah Ann Cenci - A.V.P of Regulatory Affairs, Quality and Compliance, Global Consulting Firm, USA
12:45 - 13:00
End of Day & Networking on the Platform
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