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Evaluation ViewAttendees 8

Preconference Workshop

Devices (includes Medical Devices and In Vitro Diagnostics)

Communication Toolkit for a Successful Regulatory Compliance Strategy

Monday, October 2, 2023
8:30 AM – 4:00 PM EDT
Location/Room: 510A
Additional Registration Fee Advanced Level
Defining and maintaining a strategy for regulatory compliance which is a part of the manufacturer’s QMS, as requested by both MDR and IVDR, is now considered to be a major challenge for MD Regulatory Affairs Professionals.
While the RAP is a key person when it comes to strategy for regulatory compliance, all the functions of the company are likely to collaborate in the choices which are made to determine it, implement it and develop it. It is therefore necessary to support the interactions between all the involved parties with an efficient communication. For instance, it is important to translate the regulatory context in the language of business. It is a way to change your management's approach from regulations as a cost center to regulations as an opportunity center. To help regulatory professionals, overcome this challenge.
The workshop will address how strategic management tools can be used to develop your strategy for regulatory compliance and which communication tools are the most appropriate through the following milestones:
• Fundamentals of business strategic management
• Implementation in the MDR/IVDR context
• Communication tools based on real situations


Workshop Agenda (Subject to Change)

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome

8:30 - 9:00 am
Workshop Introduction

Presenters:
Corinne Delorme
Vincent Casteras
Florianne Torset Bonfillou

9:00 - 9:45 am
Fundamentals of business strategic management

Presenters:
Vincent Casteras

9:45 - 10:30 am
MDR/IVDR context: Strategy for regulatory compliance is an essential part of business strategy

Presenters:
Corinne Delorme
Vincent Casteras

10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

11:00 am - 12:00 pm
Attendees work groups: Where am I in the alignment between the company's strategy and the strategy for regulatory compliance?

Presenters:
Corinne Delorme
Vincent Casteras
Florianne Torset Bonfillou

12:00 - 12:30 pm
Introduction of communication tools

Presenters:
Corinne Delorme
Vincent Casteras

12:30 - 1:30 pm
All Workshop Registrants: Lunch

1:30 - 2:30 pm
Attendees work groups: Person-to-person communication (language – media) based on real situations

Presenters:
Corinne Delorme
Vincent Casteras
Florianne Torset Bonfillou

2:30 - 2:45 pm
Quick break

2:45 - 3:45 pm
Attendees work groups: Communication through business tools based on real situations

Presenters:
Corinne Delorme
Vincent Casteras
Florianne Torset Bonfillou

3:45 - 4:00 pm
Wrap-up & closing remarks

Presenters:
Vincent Casteras
Corinne Delorme

Learning Objectives:

  • Build a successful medical device strategy for regulatory compliance using strategic management tools
  • Integrate the strategy for regulatory compliance within the global business strategy of the company
  • Choose the communication methods most adapted to one’s interlocutors to onboard them for the implementation of the strategy for regulatory compliance