Webinars

What do the recent FDA Guidances (Medical Product Communications That Are Consistent With the FDA-Required Labeling and Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities ) mean for historical OPDP/DDMAC enforcement and for your company’s risk profile?

Join OSR’s expert, in depth, webinar training program addressing the questions around the FDA Medical Product Communications That Are Consistent With the FDA-Required Labeling Consistent with FDA-Required Label and Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Guidance Documents, substantial evidence, and clinical trial design. This webinar will specifically focus on the following:

· Clinical trial design: multiplicity and multiple endpoints, inclusion and exclusion criteria, valid comparators, blinding and randomization, prospective specification, primary, secondary and exploratory endpoints, and study power

· Assessment of enforcement letters on promotional material making claims using the substantial evidence definition

· Relevance of enforcement letters issued before FDA’s Medical Product Communications That Are Consistent With the FDA-Required Labeling guidance (CFL)

· Case studies - using data in promotion applying the FDA Medical Product Communications That Are Consistent With the FDA-Required Labeling (CFL) guidance in contrast to the substantial evidence standard historically stated in enforcement letters

· Case studies - using data in health care economic information applying FDA’s Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities guidance.


$199 per Person

Reach out to info@OneSourceRegulatory.com for group rates (on-site & remote)!


Monday, November 4th, 2019

9AM Pacific/12NOON Eastern