Conference Day 1

8:30 AM - 8:50 AM Registration and Welcome Coffee

8:50 AM - 9:00 AM Pharma IQ Welcome

9:00 AM - 9:10 AM Chairman's Opening Address

· Analyse the application of a Risk Based Device Classification System
· Utilise the existing UDI regulatory framework to enhance compliance of evaluations
· Discuss the role of the new Medical Device Coordination Group

Raymond Nistor-Gallo

Senior Medical Safety Officer / Global Patient Safety
Baxter Medical Products

9:50 AM - 10:30 AM Interpreting the New MDR and Regulatory Changes

Michel Marboeuf, Senior Director Regulatory Affairs and Quality - Europe, Stryker
· Prepare for the new changes to your regulatory pathway with a MDR update
· Discuss an implementation timeline of regulatory changes for new device developments, ongoing device developments and legacy devices
· Understand the requirements – what do you need to do from an ongoing regulatory and compliance perspective?

Michel Marboeuf

Senior Director Regulatory Affairs and Quality - Europe

10:30 AM - 11:00 AM Morning Coffee Break

11:00 AM - 11:45 AM Interactive Round Tables

1.Managing the Med-Dev Regulatory Changes
Luc Verhees, VP of Global Clinical Affairs, LivaNova

2.Implementing Design Controls Throughout Your Clinical Evaluation

3.Managing Your Supplier Relationships – How to Integrate External Services Into Your Team Management
Bolette Nordby, Director Medical Devices Global Quality Assurance, Ferring Pharmaceutical

4.Training Ongoing Compliance in Your Clinical Development Teams

11:45 AM - 12:30 PM Preparing Your Pathway: Key Differences Between MEDDEV 2.7/1 Rev. 3 and 4

Tobias Schreiegg, Director of Quality and Regulatory Affairs Management, Siemens Healthcare
· Map out the cascade of activities in line with MEDDEV 4
· Consider the macro factors to the MDR – what are the drivers to this
· Understand the full picture: Clinical Lifecycle Management under the new MDR
· Ensure an appropriate level of clinical data according to IMDRF for Software as a Medical Device

Tobias Schreiegg

Director of Quality and Regulatory Affairs Management
Siemens Healthcare

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:10 PM Optimise Your Documentation Strategy for Clinical Development

Brian Shoemaker, Ph.D., Principal Consultant, Shoebar Associates
  • Analyze the concerns around more stringent documentation requirements
  • Build an effective quality management framework
  • Understand the impact of increased transparency and vigilance
reporting requirements

Brian Shoemaker, Ph.D.

Principal Consultant
Shoebar Associates

2:10 PM - 2:50 PM MDSAP Audit Pathway Preparation

• Understand the MDSAP program’s goal to leverage regulatory resources to manage an efficient and sustainable single audit program focused on the oversight of medical device manufacturers
• Discover the impact of a MDSAP audit as a means of streamlining your device compliance for five different medical device markets
• Evaluate the value of a MDSAP audit for your organisation – what are the advantages and potential disadvantages?

2:50 PM - 3:30 PM Building your Regulatory Strategy from Scratch – Understanding the Challenges of a Small Size Medical Device Company

Mark Moynihan, Quality & Regulatory Affairs Manager, PMD Solutions
· Starting from scratch – create a process map for your regulatory strategy
· Analyse the balance between innovation and compliance to ensure a proactive regulatory strategy formation
· Align your device development timeline and broader company strategy to your regulatory framework

Mark Moynihan

Quality & Regulatory Affairs Manager
PMD Solutions

3:30 PM - 4:00 PM Afternoon Coffee Break

4:00 PM - 4:40 PM Global Standards in Clinical Approval Pathways

Tania Snioch, Director, Healthcare, GS1
- Understand the role of unique global identification
- Analyse learnings from other parts of healthcare
- Discuss the opportunities and challenges inherent to standardisation

Tania Snioch

Director, Healthcare

4:40 PM - 5:20 PM Panel Discussion: Creating a Pro-Active Medical Device Compliance Framework

· Highlight practical approaches to design control and design change to determine best practice for future trial management
· Balance the importance of audit preparedness and inspection readiness while minimising the burden and paperwork for your clinical team
· Put in place a flexible risk management structure to support your clinical evaluation process and device development
· Discuss the trial of the future – what would an ideal trial look like from a regulatory and agility point of view?

5:20 PM - 5:30 PM Chairman's Summary and Close of Day 1