Master Class.
Watch this space for the latest Master Classes from Pharmora.
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.
Unblinded Medical Review (UMR): what is it and when is it needed?
In this blog we explain what UMR means and why the Sponsors of clinical trials for investigational medicinal products might need it.
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.
Immunisation Masterclass (1) – Why Vaccinate?
August was National Immunisation Awareness Month. To highlight the importance of getting vaccinated, Pharmora has prepared a Masterclass series, discussing types of vaccines, why we need them, and the health implications of getting a jab. Read this first blog to understand the current vaccination scheme in the UK, and boost your general knowledge on immunisation!
The When, Why, What and How of HGR – Part 3
To celebrate the anniversary of the finalisation of the HGR Implementation Rules in China, we have published a series of blogs, covering the basis, history, recent changes and importance of HGR.
In this final blog of the series, we will describe the different types of licencing and explain how to save time navigating the steps involved in applying for an administrative licence for international clinical trials. Read on to learn more…
The When, Why, What and How of HGR – Part 2
To celebrate the first anniversary of finalisation of the HGR regulations we are exploring this important regulation and how it impacts on our work.
Part two of this HGR series explains how to identify which samples could fall under this regulation, how to determine whether you are defined as a “Foreign party” and describes the recent changes to the regulatory structure overseeing HGR. Read on to learn more…
The When, Why, What, and How of HGR – Part 1
To celebrate the anniversary of finalisation of this important regulation, we have created a series of blogs, exploring the HGR regulation in China, recent changes and how it impacts our work in clinical development. Read the first in our HGR series to find out more…
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