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Topic: Pharmacovigilance

The challenges of producing periodic benefit–risk evaluation reports
This article discusses the challenges of producing a periodic benefit–risk evaluation report (PBRER) from a writing perspective. It explains that by taking into consideration the most common pitfalls encountered by...
Author: Lisa Chamberlain James and Stephanie Millican
Journal: Regulatory Rapporteur
Date: Vol. 16, Issue 5, May 2019
Medical Writing
Regulatory submissions of non-interventional post-authorisation safety studies: Challenges for data interpretation and comparisons with clinical data
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be...
Author: James Visanji
Journal: Medical Writing, the journal of EMWA
Date: Vol. 26, No. 3, September 2107
The Pharmacovigilance Medical Writer: Medical Writer, Project Manager, Regulatory Expert
Pharmacovigilance is a critical element of drug development and marketing. The evaluation and monitoring of patient safety and a drug’s benefit/risk is a highly regulated global task, which is required...
Author: Sven Schirp and Lisa Chamberlain James
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2017
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Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
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...
Author: Massoud Toussi, Lisa Chamberlain James and Sir Alasdair Breckenridge
Journal: Medical Writing, the journal of EMWA
Date: Vol.24, No.2, June 2015
Good Pharmacovigilance Practices
June 18, 2015 | London, UK Trilogy hosted a discussion on the challenges posed by the guideline on good pharmacovigilance practices (GVP) with a special focus on Risk Management Plans...
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Strategic Medical Writing in the Post-Authorisation Phase
The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).
Author: Sarah Richardson
Journal: Medical Writing, The journal of EMWA
Date: Vol.23, No.4, December 2014