Regulatory investigations: could your product end up under the regulator's microscope? | Health Check Winter/Spring Series

Sodium valproate, opioid products and hip implants are just some recent examples of products that have attracted regulatory investigation. An increased focus on patient safety, combined with a greater abundance of patient data and a shifting regulatory landscape in the EU and UK have all combined to drive up the agenda the prospect of investigations into the safety performance of life sciences products.

We will examine:

• The implications of the MHRA's new focus on "risk proportionate regulation"
• Mitigating the side-effects of regulatory scrutiny: product recalls, personal injury litigation risk, negative PR
• Pre-empting common questions from regulators