Fusion Pharma Limited

Wishing friends and colleagues a very Merry Christmas!

We're #hiring a new Regulatory Affairs Consultant in United Kingdom. Apply today or share this post with your network.

We are recruiting again! If you are motivated, energetic and have a positive attitude, we want you to join our team - please see details and apply here: https://lnkd.in/exruuVK7

We are holding a joint webinar with ADAMAS Consulting in January, sign up here: https://lnkd.in/evFn8XPw

Over the past year, #FusionPharma has been exploring how the Windsor Framework affects Regulatory activities through several of our Fusion webinars and articles. In this latest edition of Fusion Connect, Dr Lorraine Sammut Marsh discusses how Pharmacovigilance (PV) activities will be impacted. #MHRA #WindsorFrameworkPharma #Pharmacovigilance

Time is nearly up for transitioning studies from the EU CTD to the EU CTR!   According to the #EMA, there a still a large number of active studies not yet transitioned. Any ongoing studies not transitioned by 30-Jan-25 will be considered non-compliant and in breach of the CTR. Consequently, sponsors could be subject to corrective measures and penalties and subject to civil and criminal liability.   If you have any ongoing studies beyond 30-Jan-25 that have not been transitioned yet, please get in touch asap to see if we can help. #ClinicalTrials #CTD #CTR

Did you know that #FusionPharma has extensive Regulatory experience in herbal medicines?  You can find out more about the ways in which we can help you here - https://lnkd.in/eKiSQRym #HerbalMedicines #RegulatoryHerbals #RegulatoryAffairs

In this latest edition of #FusionConnect, Sophie Milden explains the MHRA's new pipeline planning process and its potential impact on Regulatory submissions. Read the full article below to discover how this initiative could streamline approvals, improve resource allocation, and support faster patient access. #MHRA #RegulatoryAffairs #RegulatoryPharma

If you haven't already registered, sign up here for your place on next weeks Windsor Framework Webinar - https://lnkd.in/ehkrk74g

A major component of the EU CTR is to improve the accessibility of clinical trial information to all stakeholders.   The full public section of Clinical Trials Information System (CTIS) is now live and all new studies approved via CTR that fall within the transparency guidelines will have study information published on CTIS.   If you need support with understanding the CTIS transparency requirements; types of studies to be published, timing of publication, documents to be published, information that can be removed, how to remove sensitive information, get in touch. #ClinicalTrials #CTR #CTIS #EUCTR