Zobrazeno 1 - 10 of 15 pro vyhledávání: '"Lisa Chamberlain-James"'
1
The Lay Protocol Synopsis: Requirements and feasibility
Autor: Lisa Chamberlain James
Publikováno v: Medical Writing. 32:34-36
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::30c4e441d26eeea8eed5024923ac2f7a
https://doi.org/10.56012/dwxn7122
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2
The Future of Medical Writing: A Panel of One
Autor: Lisa Chamberlain James
Publikováno v: AMWA Journal. 37
Of all the points in the evolution of the medical writing profession, I believe we are at the pinnacle of what promises to be the most exciting and biggest paradigm shift in medical writers’ roles and responsibilities. With an accompanying leap in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::21589839375c90ff6e40fdb7692aec51
https://doi.org/10.55752/amwa.2022.210
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3
Value of Medical Writing: The Regulator’s Perspective
Autor: Julia Cooper, Lisa Chamberlain James, Joan Affleck, Brian Bass, Julia Forjanic Klapproth, Dylan Harris
Publikováno v: AMWA Journal. 36
In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s pers
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::08576585d0f065ba4e9a5a644105ec47
https://doi.org/10.55752/amwa.2021.83
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4
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Autor: Lisa Chamberlain James
Publikováno v: Medical Writing. 24:195-199
There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced significa
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c6795846ac34ae4cb52aa79691fd3d3f
https://doi.org/10.1179/2047480615z.000000000322
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6
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
Autor: Massoud Toussi, Sir Alasdair Breckenridge, Lisa Chamberlain James
Publikováno v: Medical Writing. 24:77-81
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 repor
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e978e35aa19a71d6d7232eb9327d6305
https://doi.org/10.1179/2047480615z.000000000289
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