£50 – £99

Global Medical Device & IVD Regulations: What You Need to Know

Event Information

Share this event

Date and Time

Location

Location

Hill Dickinson Law Firm

No. 1 St Paul's Square

Liverpool

L3 9SJ

United Kingdom

View Map

Refund Policy

Refund Policy

Refunds up to 7 days before event

Event description

Description

PLEASE NOTE: Multiple tickets are only available for members that have already secured a £70 ticket.
This ticket offer is not available to non-members
.


With the implementation dates for the new EU MDR and IVDR looming (May 2020 & May 2022 respectively), companies are having to get their heads around the implications of the new regulations, including the additional clinical evidence requirements and associated costs.

Furthermore, the EU regulations are only one of a number of different regulatory standards that life science companies need to navigate when selling products globally, with FDA becoming the first accreditation of choice for some new start-up companies. Whilst there are complexities posed by increasing regulation, there are of course opportunities offered through other initiatives, such as the emerging Medical Device Single Audit Program framework.

With so much change occurring in a short amount of time, there has been an overwhelming demand from our member companies for an event which allows companies to learn from each other, share experiences and knowledge they have gained in the practical implementation of global medical device and IVD regulations.

This event is designed to do just that: Providing real life experiences and offering a unique networking opportunity for CEOs and regulatory staff involved in the decision-making process around global medical device and IVD regulations.

See below for a full agenda and details of speakers and discussions.


New European Medical Device & IVD Regulations – how it’s actually working

Implementation of the Medical Device Regulation
BSI - Damon Williams, Business Development Manager (Medical Devices)
Implementation of the In-Vitro Diagnostic Regulation
BSI - Dr Erica Conway, Global Head of IVD

Challenges & Solutions

Clinical evidence – meeting the new requirements:
Medilink North of England - Tom Wright, Innovation & Commercialisation Manager

Technical evidence – its role in supporting regulatory compliance
Perfectus Biomed - Hannah Thomas - Operations Manager
NPL - Mark Hodnett, Commercial Engagement Leader

Practical company case studies:
Trio Healthcare – Stewart Lee, Technical Director
Abingdon Health - Marsha Leeman, QARA Director

Questions & Answer Session


-- LUNCH --


Brexit

DEAL / NO DEAL regulatory scenarios
Office of Life Sciences - Robert Reid, Senior Policy Manager

International regulatory opportunities

FDA: What you need to know
Stuart Gibson Associates – Stuart Gibson, Regulatory Consultant

Practical aspects of FDA accreditation and ongoing requirements
Paxman Coolers - Alexandra Sheldrake, Quality Systems Manager

Medical Device Single Audit Program - multiple overseas jurisdictions
BSI - Damon Williams, Business Development Manager (Medical Devices)

Overview regulatory requirements other major markets
Medilink North of England - Tom Elliott, Head of International

Questions & Answer Session


-- REFRESHMENTS --


Round Table discussions covering 6 different themes and an industry expert moderating each session.
Themes include: Clinical evidence | Technical evidence | EU regulatory approvals | FDA regulatory approvals | Other major global territories | Brexit


-- CLOSE --


PLEASE NOTE: Multiple tickets are only available for members that have already secured a £70 ticket.

This ticket offer is not available to non-members.

Share with friends

Date and Time

Location

Hill Dickinson Law Firm

No. 1 St Paul's Square

Liverpool

L3 9SJ

United Kingdom

View Map

Refund Policy

Refunds up to 7 days before event

Save This Event

Event Saved