Thoughts.
Watch this space for the latest News, Top Tips, Blogs and Master Classes from Pharmora.
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Our latest thinking
News
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…
World Patient Safety Day
Celebrating the World Patient Safety Day, Pharmora has prepared a blog reflecting on how we contribute to Patient Safety. Read more about the work we have done!
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
Pharmora at World Drug Safety Congress – Europe
Hear from Pharmora Limited’s Stephanie Jones and Ian Pinches as they discuss the benefits of attending the World Drug Safety Congress 2024 and what they do at Pharmora Limited
Anti-Microbial Resistance: what does this mean?
Anti-microbial resistance is a rising problem in medicine and healthcare, but what exactly is it? Read on for a brief history of anti-microbial science, the rise of anti-microbial resistance and what this means for us in the future.
Prostate Cancer and Men’s Health
Following on from Men’s Health Week and Urology Awareness Month, Pharmora discovered some interesting news about the changing landscape in the treatment of Prostate cancer and men’s health developments…
Case Studies
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!
Case Studies – Providing an Entire Safety Department
Pharmora provided an entire safety department to set up safety processes and monitoring over a 6-year period leading to successful global product approvals.
Master Class
Pharmora RMP Masterclass (3) Updates to EMA guidance on RMMs
On 11th September there was an EMA webinar to launch the updates to GVP Module XVI on Risk Minimisation Measures and its Addendum II. Read on for a summary of the key updates…
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!
Pharmora RMP Masterclass (1): History of RMP legislation in different regions.
The Risk Management Plan (RMP) is a detailed description of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Read on to find out how this important document differs across the world.
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