Regulatory expert named keynote speaker and panel chair for ‘key Scottish life sciences event’ this March
InnoScot Health’s regulatory expert will have a dual role as keynote speaker and panel chair during a new conference segment celebrating the 25th anniversary of Scotland’s Life Sciences Awards
The formal NHS Scotland partner's Head of Regulatory Affairs, Elaine Gemmell has been asked to present on one of the event’s key themes, ‘Regulatory Challenges faced by the Life Sciences industry’.
Following that, she will further chair a regulatory panel on that theme, delving into those challenges while foregrounding “the evolving regulatory landscape for life sciences companies, particularly in light of post-Brexit changes and US presidential appointments”.
Billed as “the key event in the Scottish life sciences calendar”, the conference will take place on Thursday 13 March in the Cambridge Suite of the DoubleTree Hilton Glasgow Central with Elaine speaking from 3.15pm.
The panel session is scheduled to commence at 3.45pm and will explore how companies can efficiently navigate multiple regulatory frameworks, manage compliance across regions, and adapt to the increasing complexity of global regulations.
The synopsis notes that “as of 2024, companies selling medicines and medical products in the UK must secure approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), while still navigating the European Medicines Agency (EMA) for EU markets.
“With approximately half of UK exports going to the EU, the dual approval process presents increased compliance challenges.”
The session will also see discussion around the need for life sciences companies expanding to global markets to comply with regulations from other regions, “further complicating regulatory pathways”.
Event organisers say that, thanks to the conference addition to the annual Life Sciences Awards, this year’s anniversary gathering will offer the ability to “dive into a series of insightful presentations and panel discussions, where industry leaders and experts will explore these critical topics in depth”.
Elaine said: “I’m delighted and grateful to have been given this opportunity to share regulatory insights within this exciting new conference format. Its addition is a fitting way to celebrate the Awards’ 25th anniversary as Scotland’s life sciences industry continues to thrive.
“I believe that ensuring regulatory know-how in order to effectively navigate often complex processes remains pivotal to that success and look forward to discussing further on 13 March.”
Mark Cook, Chair of Life Science Scotland Industrial Leadership Group, said: “For 25 years, Scotland’s Life Sciences Awards Dinner has highlighted Scotland’s ever-expanding footprint in life sciences. This event continues to celebrate the continued economic growth, medical research, and innovative contributions of the life sciences industry.
“This year, with a conference, the event will provide a platform for discussing research and development, finance and investment, regulatory reform to streamline approval processes, and collaboration between public and private sectors. These factors are central to the economic growth and healthcare improvements both in Scotland and globally via exports.”
The conference will begin at midday with a networking lunch, offering an opportunity for attendees to connect. The black-tie awards and dinner will be held in the hotel ballroom afterwards.
Complying with medical device regulation
InnoScot Health offers a skilled team of regulatory experts. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.
Consultancy, training and advice is available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices. We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.
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