Post marketing safety: the industry’s key concern

I have been re-reviewing the drug safety survey results which have again proved interesting reading. Its a great way for us to keep up with what is happening in the industry as it allows safety colleagues to anonymously provide insight (and have a grumble) about the challenges of working in this sector. This survey shows clear patterns from the respondents as to where they see the biggest challenges/bottlenecks/hurdles in drug safety.

I have found that if you ask someone who works in the drug safety sector what challenges face them on a day to day basis, the list can be endless, whether they are strategic level challenges in the way management approach and prioritise safety, or day to day struggles stemming from man power and time lines. There are many hurdles in the industry but I wanted to highlight what our feedback is showing is one of the most significant.

I asked survey respondents to rate (from highly critical to not important) a number of drug safety factors on how they see their affect on the industry. The factors were quite broad in their scope but addressed safety throughout the lifecycle of a drug, from pre clinical, clinical through to post clinical themes as well as infrastructure and operational hurdles.

The feedback leant towards post marketing safety as the stage that presents most hurdles. Specifically risk management and communication (73% of respondents selected these as highly relevant), post authorisation safety (76%) and the stand out challenge was signal detection and reporting (82%). These elements of pharmacovgilance are where the size and scope of managing the data and responding to it get significantly bigger so its understandable that this is at the forefront of the industry's mind. Do you agree with this feedback or is there an alternative area of drug safety that you feel is more of a significant challenge on a day to day basis?

Respondent break down:

54% pharma, 15% biotech, 27% CRO, remaining government, NGO, Re gulatory agencies.

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