pharmacovigilance

Showing 15 posts of 33 posts found.

Free Pharmacovigilance Webinar: Available to view now!

November 14, 2016
Business 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 …

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Free Pharmacovigilance Webinar: Only one day left to register!

November 8, 2016
Business 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. …

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Free Pharmacovigilance Webinar: Just two days left to register!

November 7, 2016
Business 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. …

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FDA criticised for safety data flaws

January 18, 2016
Sales 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 …

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Standardising the pharma benefit-risk assessment process

September 1, 2015
Manufacturing 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, 2013
Sales 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, 2012
Medical 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, 2012
Sales 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 …

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Roche failed to investigate 80,000 safety incidents

June 25, 2012
Manufacturing 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 …

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Steve Mott joins DrugLogic

October 5, 2011
Research 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, 2011
Research 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, 2011
Research 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 …

ABPI social media internet guidelines

Digital Pharma: Pharmacovigilance, the internet and social media

June 15, 2011
Medical 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, 2011
Research 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, 2010
Research 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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