Patient injured because of event described in black box warning: Company still liable, long established FDA approved warnings not sufficient...

Patient injured on generic drug: innovator company could be liable for inadequate warnings...

FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.

This audio conference covers:

• How failure mode & fault tree-type hazard analysis can be applied to labeling development
• How quantitative risk/frequency assessment can effectively communicate and lower risks
• Why developing an explicit FDA record on risk & label decisions is essential
• How adding label engineering methods to the product design space can solve critical risk & regulatory challenges

About the speaker:

Gary Gamerman, MS, JD, is president of Seraphim Life Sciences Consulting, and also a former FDA reviewer and life sciences attorney with 20 years of experience in product research, development, regulatory and liability management, and as an operating executive. He has been involved developing, implementing and accessing labeling engineering and risk management strategies for a wide range of drug and device products for companies, investors and foundations.

Who should attend?

• Regulatory Affairs
• Medical Affairs
• Labeling Managers
• Marketing
• Senior Management
• Risk Management
• Legal Counsel

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.