Postapproval Safety Considerations Start Now

UBC provides expertise on pre- and postapproval risk management strategies

Postapproval Safety Considerations Start Now

Once a medical product is taken out of a highly controlled clinical environment and is made available through physicians to their patients, additional risks and unknown safety issues may become apparent. Therefore, proactive risk management should begin early in product development. This pre-marketing timeframe offers opportunities to:

  • Develop the product's safety profile and identify risks
  • Identify special subgroups at greater risk
  • Quantify benefits (including unique benefits)
  • Understand populations to be included in clinical trials
  • Understand how the target population may differ from randomized control trial patients
  • Design and evaluate risk management interventions

Pre-approval risk management activities help a manufacturer understand, as much as possible, how the clinical trial experience of a drug will differ from the postmarket use, thus providing key insights for strategies to ensure patient safety in the post-approval period.

Gretchen Dieck, PhD, Vice President, Safety, Epidemiology,  Registries and Risk Management, provides a helpful overview on planning ahead for patient safety in the post-approval period.  Her article is online now at PharmaPhorum.