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...
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...
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...
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...
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...
