Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

Select category
Search this blog

Biosimilars and Pharmacovigilance: 5 Key Challenges

Posted on April 7th, 2016 by in Pharmacovigilance

The first biosimilar (Zarxio [filgrastim-sndz]) was approved in the US in March 2015, launching what some refer to as a “milestone in the maturity of medical biotechnology.”1 (more…)

Data Transparency in Pharmacovigilance: European regulators give increased access to adverse drug reactions

Posted on March 16th, 2016 by in Pharma R&D

On 17 December 2015, the European Medicines Agency (EMA) adopted the revised policy on access to Eudravigilance. According to the press release, the EMA will give increased access to reports of adverse reactions (more…)

PV Poll: Processing of EMA MLM Data

Posted on March 16th, 2016 by in Pharmacovigilance

Over the past few months, we have posted blog entries about the EMA Medical Literature Monitoring (MLM) program, including a review of the EMA Annual Update and impressions of the launch phase closure report. (more…)

Validation: The importance of search formulas in Literature Monitoring

Posted on February 29th, 2016 by in Pharmacovigilance

A reasonable number of Market Authorization Holders (MAHs) have no ready answer to justify why they use a specific search formula for each specific product when Audit or Inspection time comes: (more…)

  1. 1
  2. 10
  3. 11
  4. 12
  5. 13
  6. 14