IN-VITRO DIAGNOSTICS
DIRECTIVE
(IVDD)

IN-VITRO DIAGNOSTICS DIRECTIVE (IVDD)

IN-VITRO DIAGNOSTICS
DIRECTIVE
(IVDD)

Including Practical Exercises and Workgroup
Sessions

Including Practical Exercises and Workgroup Sessions

Including Practical Exercises and Workgroup
Sessions

Conference Date: 02 Feb 2012
Conference Ref: N2-8212
Fee: £575 + VAT
Venue: The Rembrandt Hotel, London

Benefits of Attending:-

Understand the IVD Directive
Prepare for Future Changes to the IVD Directive
Take Away Techniques on Conformity with the Essential Requirements
Gain Essential Information on Supplier Control
Apply the Principles in Practical Exercises and Workshop Sessions

INTRODUCTION

This seminar will clarify the requirements applicable for IVDs and will look at the future proposed changes to the Directive and the implications for industry. It will also highlight the important issues regarding supplier control and validation.

Practical workshop exercises throughout the day will help consolidate the information provided.

WHO SHOULD ATTEND

Regulatory Affairs Personnel
Quality Assurance Professionals
Those responsible for OriginalEquipment Manufacturer (OEM) / Subcontractor control of IVD's

24 * AVOIDING PITFALLS IN PATENT KNOW HOW LICENCES AND R&D COLLABORATIONS

27 * DEALING WITH DIFFICULT PEOPLE
* REGULATORY AFFAIRS FOR SUPPORT STAFF ~ PART 1

28 * EFFECTIVE PERFORMANCE MANAGEMENT
* REGULATORY AFFAIRS FOR SUPPORT STAFF ~ PART 2
* PHARMACEUTICAL REGULATORY AFFAIRS IN: RUSSIA, BELARUS & UKRAINE

29 * INTRODUCTION TO POST MARKETING SURVEILLANCE AND MEDICAL DEVICE VIGILANCE SYSTEM