Medical Writing Public Disclosure Out on Our Own
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Volume 27, Issue 2 - Public Disclosure

Out on Our Own

References

  1. AMWA-EMWA-ISMPP Joint Position Statement: the Role of Professional Medical Writers. Med Writ. 2017;26(1):7–8.
  2. Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Comission Decision 2010/227/EU. Official Journal of the European Union. 2017 [cited 2018 April 11] Available from: Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746
  3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 1998 [cited 11APR2018]. Available from: Available from: http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:31998L0079
  4. The White House, Office of the Press Sceretary. FACT SHEET: President Obama's Precision Medicine Initiative. 2015 [press release; cited 2018 April 09]. Available from: Available from: https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative
  5. Concept paper on predictive biomarkerbased assay development in the the context of drug development and lifecycle. European Medicines Agency. 2017 [cited 2018 April 09]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/07/WC500232420.pdf
  6. Eppinger E, Halecker, B., Hölzle, K., Kamprath, M. Dienstleistungspotenziale und Geschäftsmodelle in der Personalisierten Medizin: Springer; 2015.

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Articles

Editorial
President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Clarity and Openness in Reporting: E3-based (CORE) Reference
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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