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The needs assessment component of a continuing medical education grant proposal document describes why a specific programme should be developed. Medical writers frequently play a central role in producing the needs assessment as an important first…
There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and…
Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…
Dear Medical Writers It is time for me to give you another brief update on the activities of the EMWA Executive Committee (EC) and our plans for 2013, as well as a short preview on the spring conference in Manchester. The autumn conference…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Doughnut economics provides a new framework for sustainable development, by balancing the ecological boundaries of the planet with the social boundaries of humanity. The framework provides a valuable opportunity for the healthcare industry to…
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…
Medical writers are increasingly likely to come across patient apps in their work, and we describe here the background and use of two apps for assessing patient-reported outcome (PRO). Systematic collection of PRO data via patient apps has been…
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
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