Information Day and Interactive Hands-on Workshop on The New European Medical Device Regulation: Change Management

This event will provide insight to the essential changes of the New Medical Device Regulation, such as the role of notified bodies and requirements in clinical and post-market requirements.

アジェンダ

Day 1 2016年11月29日 (火)

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 9:00 AM

INTRODUCTION

9:00 AM — 10:30 AM

SESSION 1: Highlights of the New Medical Device Regulation

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

SESSION 2: Changed Role for Notified Bodies under the New Medical Device Regulation and Implications for manufacturers

12:30 PM — 1:30 PM

LUNCH BREAK

1:30 PM — 3:00 PM

SESSION 3: Changes in pre- and post-market clinical requirements in the New Medical Device Regulation

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 5:00 PM

WORKSHOP 1: Gap Assessment, Portfolio Management and Planning the Implementation of Dossier and QMS Changes

5:00 PM — 5:30 PM

Q&A

5:30 PM — 6:30 PM

NETWORKING RECEPTION

Day 2 2016年11月30日 (水)

8:00 AM — 9:30 AM

SESSION 4: Changes in vigilance and post-market requirements in the New Medical Device Regulation

9:30 AM — 10:00 AM

COFFEE BREAK

10:00 AM — 11:30 AM

WORKSHOP 2: Post Marketing Clinical Follow-Up and Post Marketing Medical Device Studies

11:30 AM — 12:30 PM

SANDWICH LUNCH

12:30 PM — 2:00 PM

WORKSHOP 3: Post-Market – Activities after First Placing the Product in the Market – Transforming Fulfilment of Legal Requirements into Benefit for Actors

1:00 PM — 2:00 PM

Q&A. RECAP OF WRKSHOPS & GENERAL FEEDBACK

Information Day and Interactive Hands-on Workshop on The New European Medical Device Regulation: Change Management

アジェンダ

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