Medical Writing Medical Writing in Oncology Regulatory Writing
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Volume 21, Issue 1 - Medical Writing in Oncology

Regulatory Writing

Abstract

At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According to this document, there are three strategic areas where much of their effort will be spent in the coming years: addressing public health needs, facilitating access to medicines, and optimizing the safe and rational use of medicines. As a follow-up to the road map, the EMA has published a document explaining how it will go about achieving its goals in each of the strategic areas mentioned above.2 Interestingly, there is the candid recognition that we are living through a difficult economic situation, and this will have an impact on the availability of resources and the achievement of the stated goals. Below, I discuss a couple of aspects that most caught my eye.

References

  1. Road map to 2015: The European Medicines Agency's contribution to science, medicines and health. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf
  2. Implementing the European Medicines Agency's Road map to 2015: The Agency's contribution to Science, Medicines, Health ‘From Vision to Reality’. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/10/WC500115960.pdf
  3. Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, et al. Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov 2011;10:495–506.
  4. Neu HC. The crisis in antibiotic resistance. Science 1992;257:1064–73.

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About the Medical Writing Journal
Oncology and medical writers
Message from the President
The war on cancer – What is the enemy, and are we winning?
Medical writing for cancer trials and submissions
Developing a treatment for ovarian cancer
The evolving landscape of medical education in oncology
Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs
Identifying appropriate journals in which to publish original research on vaccines against human infectious diseases
New myths about English
From researcher in Europe to medical writer in India
Imaging techniques in oncology
Is cancer preventable? A literature review
A rising tide: Hospitals and social media
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
Good Writing Practice
Out On Our Own
Translation Section

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  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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