How to deal with risks in the pharmaceutical sector | Anika Staack
Summary :
In several sectors (transportation, flights, energy, insurance) clear risk assessment methods are given. In pharmacovigilance these methods are not defined. There is only high-level guidance available but no support on how to assess unknown risks and what might be acceptable. For example, DILI (drug-induced liver injuries) are a serious risk. Normally, only detected as a signal but not mentioned in standard Risk Management Plans. If it is detected as a signal, several patients have already experienced it. Wouldn’t proactive risk management be better? Koido M et al. found a quick gen test to check for the possibility of experiencing a DILI to a specific drug. It seems that gene tests might bring more light into the darkness of unknown risks. On the other hand, is the additional financial add-on worth the risk reduction? As there are no clear measurable benefit-risk methods provided in the guidelines, it is suggested to think about common risk registers and state-of-the-art technologies to ensure upfront risk detection before signals occur.
About Author :
Master of Science (Biology), currently working as EU-QPPV with 16-years’ of experience in clinical trial management, MedDRA coding, global regulatory reporting and intelligence, periodic report writing, risk management. Worked for pharmaceutical companies and CROs. Speaker for FORUM Institute and Salt&Light Biotech Institute via ARC-Traicoa.
