16 Oct 25
Welcome to tranScrip’s monthly newsletter where we share with you the latest news and views from across the organisation. This edition includes:
A Message from our Chief Commercial Officer
Dear Readers,
I’m delighted to welcome you to this month’s edition of the tranScrip newsletter. As ever, we’re excited to share insights and highlights from the past month, from navigating regulatory change at the EMA to shaping smarter approaches to commercialisation and market access. With healthcare innovation moving fast, getting the right support at the right time can make all the difference, whether you’re planning your next submission or preparing for launch.
We look forward to continuing the conversation with many of you at upcoming events.
Best regards,
Rob Fox, Chief Commercial Officer
Regulatory Insights: EMA transition to post-authorisation procedure management in IRIS
This year there have been big changes from the EMA, post-authorisation procedures (variations, MA transfers, PSURs & more) are now managed in IRIS, not via Eudralink. Submissions still go through the Gateway, but all communication is moving to IRIS.
To learn more about these changes, read the full article here > EMA transition to post-authorisation procedure management in IRIS
Commercialising a New Asset? 5 Essentials you Need to Get Right…
For biotech and mid-sized pharma companies, scientific innovation is just the beginning. The real challenge lies in turning that innovation into commercial success. From aligning early clinical decisions with market goals to building payer-centric value propositions and planning globally with local nuance, there are five essentials every company must get right. At tranScrip, we help clients embed commercial strategy early to maximise impact and avoid costly missteps.
Read article > Commercialising a New Asset? 5 Essentials You Need To Get Right
Webinar with BIA & MHRA on the Evolving Regulatory Landscape
tranScrip is delighted to be presenting with the MHRA in the upcoming BIA Regulatory and Access Community Connects webinar on 8th May, a vital discussion shaping the future of UK life sciences.
Roz Sutton, Senior Director, Regulatory Affairs, will be presenting on the role of the Regulatory Community in the UK Government Vision for Clinical Research Delivery and also joining a panel of industry leaders to explore the evolving regulatory landscape, the MHRA’s latest initiatives (including the relaunch of ILAP), and how we can collectively drive innovation and patient access in the UK.
Don’t miss the chance to engage with thought leaders, gain fresh perspectives, and be part of the conversation that will shape tomorrow’s regulatory ecosystem.
Register here > https://www.bioindustry.org/events/our-events/regulatory-and-access-community-connects.html
Upcoming Conferences and Events
Emma Bruce will be attending BIA’s Women in Biotech event in Edinburgh, a fantastic opportunity to connect, collaborate, and celebrate the achievements of women across the life sciences sector. As always, this event brings together inspiring leaders, meaningful conversations, and a strong sense of community.
If you’re also attending, we’d love to connect > contact us
Rob Fox, Ed Currie, and Emma Bruce will be attending ASCO 2025, one of the largest and most influential oncology meetings in the world. With cutting-edge science, breakthrough data, and global networking opportunities, it’s a key moment in the oncology calendar.
If you’re heading to Chicago, we’d love to schedule a meeting > contact us
Thank you for reading this month’s edition of tranScrip’s newsletter. Feel free to share your feedback in the comments.
To learn more about how we can support you, contact us.
Best regards, The tranScrip Team
Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.
