Original presentation date: 17 April 2019

Overview

This webinar will give you sufficient understanding to classify new products and technologies containing human tissues or cells and to understand the impact of such products in a portfolio.

This webinar will cover:

• Classification of human cell and tissue-based products
• Borderline between ATMPs, combined ATMPs and medical devices
• Basic requirements for clinical use of human tissues
• The new Medical Devices Regulation (MDR): how devices incorporating human tissues will be regulated
• Impact of the MDR on companies and Notified Bodies

Learning objectives

After attending this webinar participants should be able to:

• Identify a product as an ATMP, combined ATMP or medical device
• Understand the requirements for medical devices used in combination with cell-based products
• Understand how human tissue requirements overlap with medicinal product (ATMP) and medical device legislation
• Appreciate the inclusion of human tissues within the new Medical Devices Regulation

Target audience

This webinar will appeal to those involved with strategic planning and due diligence for ATMPs, combined ATMPs and devices incorporating human tissues.
Listening to this webinar should give senior regulatory staff sufficient understanding to classify new products containing human tissues or cells and to understand the impact of such products in their portfolio.

Presenter 

Shaun Stapleton is currently Head of Regulatory Affairs at ReNeuron PLC, a UK based biotech company developing stem cell therapeutics in neurology, oncology and ophthalmology indications.

Having graduated in Biochemistry from Imperial College, London, Shaun began his career in research with the Imperial Cancer Research Fund, before moving into the pharmaceutical industry. He held positions of increasing responsibility in regulatory affairs at Sterling Winthrop, Eli Lilly and Boehringer Ingelheim before becoming Senior Director of Regulatory Affairs at Ipsen, where he managed regulatory input into development programmes globally, securing new product approvals internationally in the neurology, endocrinology and oncology therapeutic areas. These included new marketing approvals in the US and EU.

Following Ipsen, Shaun spent 8 years in regulatory consultancy at RRG (a Voisin Consulting Life Sciences Company) where he was a Director and Vice President of Regulatory Science. He supported clients on global development and registration projects, including extensive interaction with EU and US regulators.

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. 
Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.