11:10 a.m.
What Pharma Needs to Know About Avoiding The Risk of Non-Compliance In Social Media Marketing
Pharma marketing professionals keen on adopting social media technologies and campaigns designed to engage potential customers are under continuous pressure to do this in tandem with a strategy adhering to corporate compliance. In the absence of clear FDA guidelines, best practices are ever-evolving as pharma takes advantage of the ability to learn from the successes and failures of their competitors and peers.
- How can you avoid non-compliance and working with regulators to avoid and defend against an FDA warning letter
- Fashioning the appropriate response to FDA for:
- warning letters
- untitled letters
- Assessing the scope of the activity that has come under scrutiny
- looking at potential additional vulnerabilities
- Lessons in the pharmaceutical context that can assist in developing an internal process for future marketing materials
Chair:
Peter Pitts, President
Center for Medicine in the Public Interest & Former Associate Commissioner for External Relations, FDA
Manfred Fleschar, Former Associate Director - Regulatory Affairs Ad Promo/CMC
Astellas Pharma US, Inc.
Sonali P. Gunawardhana, Of Counsel, FDA Practice Group
Wiley Rein LLP
Preeti Pinto, Pharmaceutical Regulatory and Compliance Expert
Preeti Pinto and Associates |