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The Northern Powerhouse, which includes the cities of Manchester, Leeds, Liverpool, Sheffield, Hull and Newcastle, accounts for a large proportion of UK life sciences exports with more than 1,000 life sciences and healthcare businesses. This makes up one of the largest life sciences clusters in Europe with a combined turnover of £10.8 billion. Due to its importance in the Northern Powerhouse, we are supporting businesses from the Health and Life Sciences industry as part of the levelling up agenda.
We are pleased to be hosting some exciting events over the coming months, including a must-attend Regulatory Symposium featuring 10 key industry speakers over two days, an International Market Programme focusing on doing business in specific regions and a full-day event focusing on the impact of the EU transition and considerations for the sector.
See our events programme below and book your place for the upcoming Regulatory Symposium. We will be adding more events as they are confirmed.
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Regulatory Symposium
The changes being made to the Medical Device Regulations (MDR) and Medical Device Directive (MDD) affect all Health and Life Sciences companies, presenting a challenge for businesses across the region.
Examples of changes affecting MDR that companies will need to be aware of include:
- Vigilance and Post market Surveillance
- Role of Economic Operators and Person Responsible for Regulatory Compliance
- Scope and Classification of Product
- Changes affecting Notified Bodies
- Unique Device Identification (UDI)/ Implant Card
- Summary of Safety and Clinical Performance
- Clinical Evaluation / Post market Clinical Follow-up, Clinical Investigations
To prepare you and your business, we are bringing together 10 renowned specialists in their disciplines to guide you through the changes and provide answers to the key questions in this two-day event.
This is an unmissable event for businesses in the Health and Life Sciences sector. View the programme below and book your free place now.
Session 1 with Richard Hall and David Ashworth
Monday 19 October, 10:00 - 12:00
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10:00 - 10:45 |
CE mark certification: “The Gateway into Europe and Beyond” UKCA mark: “What it Means and How is it Used?” Richard Hall – QMS Consultancy Ltd |
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10:45 - 11:30 |
The Medical Device Regulation (MDR): “Implications, Technical Documentation and Requirements” David Ashworth – Flintloque Management Systems Ltd |
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11:30 - 12:00 |
Discussion Panel Richard Hall – QMS Consultancy Ltd David Ashworth – Flintloque Management Systems Ltd |
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Session 2 with Bryan Lister, Jane Oglesby and Alistair Clarke
Monday 19 October, 14:00 - 16:00
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14:00 - 14:30 |
Understanding Device Classification Under the MDR: “When is a Device a Medical Device?” Bryan Lister – InViva Healthcare Management |
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14:30 - 15:00 |
Implementing a Quality System (ISO13485): “Pitfalls and Audit Preparation” Jane Oglesby – Oglesby MDS Ltd |
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15:00 - 15:30 |
Risk Management: “How Do We Identify and Mitigate Risk?” Alistair Clarke – Weaver Technical Solutions Ltd |
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15:30 - 16:00 |
Discussion Panel Bryan Lister – InViva Healthcare Management Jane Oglesby – Oglesby MDS Ltd Alistair Clarke – Weaver Technical Solutions Ltd |
Session 3 with Patrick Trotter, David Small and Monir El Azzouzi
Wednesday 21 October, 10:00 - 12:00
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10:00 - 10:30 |
Commercial Drivers for Adoption and Relationships to Clinical Evidence (CER): “NHS Access and CER Process” Patrick Trotter – Medilink Regulatory |
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10:30 - 11:00 |
Post Market Surveillance – PMS, PSUR and PMCF: “Complaint Investigation, Trends and User Experience” David Small – Patient Guard Ltd |
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11:00 - 11:30 |
Functions and Responsibilities of Notified Bodies, Manufacturers, Distributors, Importers and Qualified Persons: “Who’s Who - Roles and Responsibilities” Monir El Azzouzi – Easy Medical Device GmbH |
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11:30 - 12:00 |
Discussion Panel Patrick Trotter – Medilink Regulatory David Small – Patient Guard Ltd Monir El Azzouzi – Easy Medical Device GmbH |
Session 4 with Peter Brady and Ash Ramzan
Wednesday 21 October, 14:00 - 16:00
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14:00 - 14:45 |
The Regulation of Health Applications and Software and Medical Devices: “Digital Health Regulation” Peter Brady – UOVO Technologies Ltd |
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14:45 - 15:30 |
Introduction to In Vitro Diagnostic Regulation: “IVDR Introduction” Ash Ramzan – Woodley Bioreg Ltd |
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15:30 - 16:00 |
Discussion Panel Peter Brady – UOVO Technologies Ltd Ash Ramzan – Woodley Bioreg Ltd |
On registering you will be able to select which event/s you wish to attend.
On registering for these events, we will be collecting personal information as part of our registration process. This information will be processed and shared within the Department for International Trade (DIT) and with selected third parties for purposes connected with DIT performing a task in the public interest or to fulfil an official function and the task or function has a clear basis in law. This information will be shared with Leeds Digital Festival for its marketing and analytical purposes only, and Leeds Digital Festival will not share the information with any other organisation. DIT takes your privacy very seriously. Your personal data shall be processed according to the Department for International Trade’s Fair Processing Notice available here. Enterprise Growth Solutions, in partnership with the Department for International Trade, is delivering the contract for the European Regional Development Fund (ERDF), which provides £7.1 million of support for first time, but also experienced exporters as part of the Exporting for Growth Programme.
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International Market Programme
Middle East Market Briefing
Tuesday 3 November, 10:00 - 11:45
In this briefing for companies in the Health and Life Sciences industry, DIT representatives from markets within the region will share their insights on exporting to the Middle East. There will also be a case study from one of our Northern Powerhouse Export Champions who is successfully exporting to the region. More details to follow; book your place now.
Further events and details coming soon.
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Speakers
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Discover how you can grow your business
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