Well its been a busy few days for all involved in World Drug Safety Congress Americas this week in Boston. There have been some great presentations and interesting discussion on developments in pharmacovigilance, clinical safety and risk management.
A great way to gage how the industry is performing and what it is finding challenging is to listen to the questions and discussions in the conference room.
So what's been discussed over the past week? Here are some of the key topics that people in the room have spoken about:
- INDUSTRY CHALLENGE: The current lack of participation by physicians in the debates on benefit-risk
- PATIENT BENEFIT RISK: When patients want certain drugs which improve quality of life but may have certain risks (eg. 1 in 10000), these are therefore considered risky by regulators. Why should they be denied these products?
- TRANSPARENCY: Should drug safety information be made transparent? Eg. What happens in some very rare vaccine cases
- TECHNOLOGY:Â Rational use of tools – more focus on new drugs, new indications and new populations – and how can technology help this?
- SPECIAL POULATIONS: The risk benefit profile for pregnant patients – where the only risk can be to the developing baby
- SIGNAL DETECTION: Identifying signals on an ongoing basis for PSUR updates and the problems particularly with high volume drugs
- EU LEGISLATION CHALLENGE: After all the buzz on âharmonisation' in drug safety, the new EU legislation is considered by some to only demonstrate the major problems with this. The legislation was driven by lawyers and politicians, who some suggested don't understand the difficulties in its implementation -i.e. waves of modules being published – how is a team meant to plan a strategy when only parts come out at a time!! In saying that the modules are considered to be well written and clear.
- EU LEGISLATION BENEFITS: The positives from the new EU legislation is definitely the single point of reporting to Eudravigilance. Regulations dictate that member states can not impose additional reporting requirements on MAH.