Risk Management Questions? We’ve Got Answers

Risk Management Questions? We’ve Got Answers

Recently, Annette Stemhagen, DrPH, FISPE, Sr. Vice President, Safety, Epidemiology, Risk Management & Registries, met with PharmaVoice editor Taren Grom to discuss post-approval product safety. As part of the Editor’s Take video series, Dr. Stemhagen answered some critical questions. Here’s a preview of her comments.

When should a manufacturer start developing post-approval monitoring strategies?
It’s never too early to start thinking about identified and potential risks of the product, based on non-clinical data, other products in the class and the patient’s underlying disease.

How can early planning benefit a product’s long-term use?
Proactive planning during the pre-approval process can help a sponsor understand as much as possible how the clinical trial experience of a drug will differ from post-market use.

How do FDA post-marketing requirements add to product safety?
FDAAA gave the FDA more authority to require safety studies. UBC’s experience allows us to anticipate what the FDA might want and help the sponsor prepare.

What have you learned studying REMS programs?
Dr. Stemhagen is an industry-leading REMS expert, so you’ll want to hear for yourself the great information she shares, based on experience and insights. Click here to hear her full answers. For more REMS insights, click here to access our free whitepaper “100 REMS Programs and Counting – Top Lessons Learned.”

Dr. Stemhagen and her team offer safety, epidemiology, and risk management consulting services to guide products through regulatory mandates that can make or break successful commercialization strategies. Contact us if you have questions about post-approval product safety.