We are pleased to announce that OneSource Regulatory has joined ProPharma Group.
More webinars coming soon!
Reach out to info@OneSourceRegulatory.com for group rates (on-site & remote)!
Join OSR’s expert, in-depth, webinar training program which will address key topics related to advertising and promotion for accelerated approval products. This webinar will address the following learning objectives:
Interactive Case Study: What do you do when you have an upcoming product approval with two (2) indications – one is accelerated approval and the other is a full approval? Join the discussion on this topic, including participant polling questions.
Presented by Nicol George, Pharm.D., R.Ph., Executive Director, Regulatory & Medical Review Services - OneSource Regulatory
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.
Explore MyIndago's newest solution - MyIndago HAD with OneSource Regulatory's Co-Founders Tracy D. Rockney, JD and Robert Merrill. JD! MyIndago HAD is a subscription search solution for Health Authority Decisions where you can find answers that help to inform your drug development strategy. MyIndago HAD contains FDA Drug Approval Packages. Come see what it's all about!
Presented by OneSource Regulatory Co-Founders & Managing Partners Tracy Rockney, JD and Robert Merrill, JD