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Watch this space for the latest News, Top Tips, Blogs and Master Classes from Pharmora.
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News
Pharmora’s Sparkling Prize Draw
At our most recent conference, Pharmora once again held our Prize Draw for a bottle of fizz! And the winner was …
Urology Awareness Month 2024
This September is Urology Awareness Month, an event which highlights the wide range of conditions and the incorrect assumptions that people can have of these urological conditions. Read on to find out more about the event…
Big Butterfly Count Blog
This year, to improve our mental health here at Pharmora, we took part in the Big Butterfly Count. This is an initiative which benefits not only people’s stress levels, but also our understanding of biodiversity – read on to find out more…
Top Tips
Pharmora RMP Masterclass (2): RMP Development Process -TOP TIPS
In this blog our CMO, Dr Stephanie Jones, provides detailed guidance on how to save time and effort and produce high quality risk management plans. Read on to find out more!
IDMC Tips to Help You Prepare
An Independent Data Monitoring Committee (IDMC) is a group of experts contracted to review data during a clinical trial. The members are individuals with ‘extensive clinical experience’ (Sartor et al, 2015) in that area of research, and they are independent of the Sponsor conducting the trial.
Top Tips for CSR Safety Narratives
Whether you are working with an external service provider or creating them in-house the safety narratives always cause a great deal of work right at the end of the study. This can be the busiest period when the team needs to focus on generating key messages for the completed study report (CSR) and potentially a marketing authorisation application.
Blog Posts
The Windsor Framework
Urgent reminder of the Windsor Framework: the deadline is approaching! This is especially important for all medicines manufacturers with a current PLNI and PLGB licence. They need to urgently to cancel their PLNI to be automatically converted to a UK licence. Read on to find out more…
The importance of reporting adverse events
Have you ever experienced an adverse event after taking a medication? Did you tell a healthcare professional about it? Would you know how to report it? Read on to find out why it is important to report!
What is the summary of product characteristics and how does it help me?
The theme for #medsafetyweek2024 is “The importance of using medicines correctly to prevent side effects”. In order to do this we need some information on correct use. Where do we find this? Read on to find out!
Case Studies
Unblinded Medical Review (UMR): How does it work in Pharmora?
In a follow up to the blog outlining what unblinded medical review (UMR) means and why it might be needed, this case study from one of the UMR team explains how Pharmora can support with UMR of clinical trial data.
Case Studies – Unexpected Signal Evaluations
Pharmora helped to meet a tight deadline for submitting an application for marketing approval by reviewing multiple signals to support the safety profile.
Case Studies – How Safety Saved a Study
Pharmora safety monitors conducted a signal evaluation that saved a clinical trial from disaster. Read on to find out how!
Master Class
Immunisation Masterclass (2)
Continuing the Immunisation Masterclass series, our second blog revolves around the topic of oral vaccines. Read on to learn more about what oral vaccines are, what are they used for, their mechanism of action, and clinical trials of oral vaccines.
Introduction to HIV and patient outcomes – Masterclass 1
In the first blog of this Master Class series, we will discuss the basics of HIV, including some of the history of its discovery and how it links to AIDS.
Unblinded Medical Review (UMR): How does it work in Pharmora?
In a follow up to the blog outlining what unblinded medical review (UMR) means and why it might be needed, this case study from one of the UMR team explains how Pharmora can support with UMR of clinical trial data.
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