pharmacovigilance
Free Pharmacovigilance Webinar: Available to view now!
November 14, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Webinar, pharmacovigilance, primevigilance
Pharmafocus, alongside PrimeVigilance, hosted a webinar on 10 November and is now available to view for free.Throughout the webinar, PrimeVigilance …
Free Pharmacovigilance Webinar: Only one day left to register!
November 8, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharmacovigilance
There is only one more day to register for our free pharmacovigilance webinar on 10 November, in association with PrimeVigilance. …
Free Pharmacovigilance Webinar: Just two days left to register!
November 7, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Webinar, pharmacovigilance, primevigilance
There are only two more days to register for our free pharmacovigilance webinar on 10 November, in association with PrimeVigilance. …
FDA criticised for safety data flaws
January 18, 2016Sales and Marketing FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety
The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish …
Standardising the pharma benefit-risk assessment process
September 1, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, benefit-risk analysis, pharmacoepidemiology, pharmacovigilance
Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view …
EMA launches ‘black triangle’ post-marketing scheme
April 28, 2013Sales and Marketing EMA, Post-marketing surveillance, black triangle, pharmacovigilance
The European Medicines Agency has unveiled its new ‘black triangle’ post-marketing surveillance system, and the list of drugs that will …
Chat rooms used to check drug safety
October 12, 2012Medical Communications Chat rooms, pharmacovigilance
Social media chatter on blogs, tweets and online forums is to be analysed to see whether such comments can help …
Ethical dilemmas add to ‘critical weaknesses’ In FDA safety monitoring
August 25, 2012Sales and Marketing Avandia, Post-marketing surveillance, pharmacovigilance
Ethical challenges are central to continuing “critical weaknesses” in the FDA’s drug safety monitoring, according to a commentary by former …
Roche failed to investigate 80,000 safety incidents
June 25, 2012Manufacturing and Production, Sales and Marketing EMA, MHRA, Roche, pharmacovigilance
The European Medicines Agency is investigating Roche after ‘deficiencies’ in the manufacturer’s pharmacovigilance processes came to light. It has emerged …
Steve Mott joins DrugLogic
October 5, 2011Research and Development appointment, outcomes research, personalised medicine, pharmacovigilance, research and development
Former Datapharm Communications chief executive Steve Mott has been apppointed UK managing director by DrugLogic.The US firm develops analytical tools …
France cleans up regulation – and restricts pharma role
July 14, 2011Research and Development, Sales and Marketing France, Mediator, Servier, pharmacovigilance, research and development news
France has unveiled sweeping changes to how it regulates prescription medicines following the scandal surrounding Servier’s Médiator. Health minister Xavier …
EMA publishes details of new pharmacovigilance format
July 4, 2011Research and Development, Sales and Marketing EMA, pharmacovigilance
Pharma companies have been given the highly-specific electronic formats in which they will soon have to submit information on medicines …
Digital Pharma: Pharmacovigilance, the internet and social media
June 15, 2011Medical Communications, Research and Development, Sales and Marketing Digital Pharma blog, adverse event reporting, adverse events, pharmacovigilance
This week the ABPI released guidance on managing adverse events from social media and the internet in a document that …
EMA road map to prioritise pharmacovigilance
January 28, 2011Research and Development, Sales and Marketing EMA, European Medicines Agency, pharmacovigilance
The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely …
European medicines legislation and pharmacovigilance
October 20, 2010Research and Development NDA, pharmacovigilance, regulatory affairs
During the past decade, changes in European medicines legislation and guidelines have increased the scope and regulatory scrutiny of pharmacovigilance …
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