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Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
In this post-truth era we live in, the validity of facts from climate change and evolution to the shape of the earth and even vaccine safety is challenged by misinformation. As scientists,we should make greater efforts to engage with the public and…
Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…
Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…
Bad Pharma is the latest book by the well-known anti-quackery campaigner Ben Goldacre, and attempts to explain to us that medicine is broken. Despite the title, he criticises not only the pharmaceutical industry, but also regulators, doctors,…
The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…
An Introduction to Pharmac - ovigilance is a compelling read and one that both new and experienced medical writers will find useful for providing a suc - cinct, yet thorough, overview of today’s current drug safety requirements. Patrick Waller and…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
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