Before any new medical product can be made available to patients, it needs to demonstrate that it complies with the requirements set out by the relevant regulatory bodies in the territories where the product will be made available. The purpose of these requirements is to ensure, as far as is possible, that a product is safe to use and that it performs in the manner the manufacturer says it does.
Meeting the requirements of the regulators is a significant undertaking and as a result dictates much of the downstream development process for healthcare technologies. The novel nature of research means that there will not always be a clearly defined regulatory pathway for novel technologies. By considering potential pathways and engaging with regulators early you can identify how your technology might fit with existing pathways and if it doesn’t fit, it will enable you to work with the regulators to develop an appropriate pathway. Furthermore, the external landscape Brexit and forthcoming changes in regulation, also have additive implications developing new products.
So how do you go about getting the right advice and from who? We’ve got a diverse array of regulatory experts coming along to share their knowledge and be questioned by the audience with burning issues to solve.
By attending our event, you will:
- Understand about forthcoming changes in the regulatory environment
- Hear from regulatory experts in both Pharma and Medtech
- Discover what support the region offers
- Lear from companies who have worked innovatively with the regulators to accelerate new product development
- Engage in a panel debate on ways to improve your regulatory approach
- Network with likeminded businesses
We recommend this event for CEO’s, Directors, Managers, and Leaders of:
- Innovation
- Marketing
- R & D
- Product Development
- Business Development/New Business Development
Confirmed Speakers
- Keynote NICE developments and direction of travel, Peter Barry, Consultant Clinical Advisor for NICE and chair of the guideline committee
- Isabel Teare, Senior legal adviser, Life Sciences, Technology, Healthtech, Mills & Reeve and Event Chair
- Neil Ebenezer, Medtech and Genomics Specialist, Department for International Trade
- Vishal Thakker, Head of UK Approved Body and Senior Regulatory Lead BSI
- Tim Bubb, Technical Director, IMed Consultancy
- Tina Amini, TA Medtech & Combination Products Consulting
- Jonathan Ripley, Consulting Services Director, IMed Consultancy
- Bryan Lister, Health Technology & Regulatory Consultant – Medical Devices, InViva Healthcare Management
Followed by
- Panel Session
- Lunch and networking
- Round Table exploring “Why is life sciences flourishing in the region, and what is required to accelerate the sector”
Confirmed Exhibitors
- Clear Insurance Management
- Smallfry
- TBAT
- Nottingham Trent University
- PHC Europe BV
- Medilink Midlands
- Guardtech Group
- IMed Consultancy
- Department of Business and Trade
- Blum Health
- Claric Legal Services
- BSI
- Loughborough College
- SMC
- Inventya
- Weiss technik
- InViva Healthcare Management
- Innovate Edge
Life Sciences Round table 7th Nov Charnwood Campus
Booking is now open for our round table “Why is life sciences flourishing in the region, and what is required to accelerate the sector”
This event will take place at 2pm after the Regulatory Event. Please book this separately to the regulatory event as numbers are limited.
https://www.eventbrite.co.uk/e/life-sciences-round-table-tickets-705939874167?aff=oddtdtcreator
Life Sciences Survey
Would you like your say but can’t make the Round Table. We have created a short survey of four questions to help us identify why life sciences are flourishing in the region and what is missing. Please follow the link, your responses are valuable to helping make our region more successful.