Medical Writing Careers in medical writing Regulatory Public Disclosure

Volume 28, Issue 1 - Careers in medical writing

Regulatory Public Disclosure

Abstract

EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to October 2017, EMA’s report provides information on the total number of docu ments published, the amount of commerc - ially confidential information (CCI) redacted and the anonymisation techniques used.

References

  1. RPD SIG members’ page Available from: https://www.emwa.org/members/ special-interest-groups/regulatorypublic- disclosure-sig/
  2. “Anonymizing Health Data: Case Studies and Methods to Get You Started” by Khaled El Emam and Luk Arbuckle, ISBN number 978- 1-449-36307-9, is available as an eBook. Précis: “Updated as of August 2014, this practical book will demonstrate proven methods for anonymizing health data to help your organization share meaningful datasets, without exposing patient identity. Leading experts Khaled El Emam and Luk Arbuckle walk you through a risk-based methodology, using case studies from their efforts to de-identify hundreds of datasets.”
  3. “Guide to the De-identification of Personal Health Information” by Khaled El Emam, ISBN number 978-1-4665-7906-4, is available as an eBook. Précis: “Offering compelling practical and legal reasons why de-identification should be one of the main approaches to protecting patients’ privacy, the Guide to the De- Identification of Personal Health Information outlines a proven, riskbased methodology for the deidentification of sensitive health information. It situates and contextualizes this risk-based methodology and provides a general overview of its steps.”

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Careers in medical writing
President’s Message
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Educating the medical writer: A 5-year update
Cheeky medical writers: Transitioning from academia to medical writing
Making the leap: My move from academia to medical writing
From bench to pen: Life as a new medical writer
The grass is always greener on the other side
Pharmaceutical writer or CRO writer – choosing the right path
Career shift: Employment to freelancing
Medical writing and medical translation – two crossing paths
Career opportunities in medical device writing: Employee and freelance perspectives
Career shifts – surviving a change in geography
Grant writing and editing
1000 words in 1 picture
Medical writing at the management level
Thriving (and not just surviving) in a VUCA healthcare industry
Elevate your medical writing team to success
Clinical trial disclosure landscape and awareness in Japan
News from the EMA
Regulatory Matters
Gained in Translation
In the Bookstores
Medical Devices
Journal Watch
Veterinary Medical Writing
Good Writing Practice
Medical Communication
Regulatory Public Disclosure
Out on Our Own
Vignettes - Life After Medical Writing

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