We are delighted to see your interest in Freyr’s Webinar Series (FWS). The webinar on, “Competitive Generic Therapies (CGT) – FDA Requirements” is scheduled on November 4, 2020.
What Is It All About?
It is all about Competitive Generic Therapies (CGT). What are they and what are the FDA’s latest requirements for them? What is the criteria for CGT designation? How and when can companies request for expedited development and review of CGT? How can companies adopt plans or strategies to avoid forfeiting of CGT exclusivity by the FDA? We presume, as a Generic drugs developer and as a market enthusiast you would like to know more such details about CGT. To address them all, Freyr brings you an informative webinar on:
Competitive Generic Therapies (CGT)
November 4, 2020
Duration – 50 Minutes
Join the Webinar at your Convenient Time.
Nandakumar Reddy Gollapalli
(Presenter of the Session)
General Manager – Global Regulatory Affairs
Nandakumar Gollapalli leads Freyr Regulatory Affairs Services portfolio. Nanda carries 16+ years of experience in end-to-end Regulatory strategic and registration activities Drug Products and Active Pharmaceutical Ingredients (APIs) for all major Health Authorities. Nanda has extensive experience in registration and life cycle management of Generic drug products.
During the webinar, the presenter, Nandakumar Reddy Gollapalli (General Manager – Global Regulatory Affairs) will discuss about:
- Introduction to Competitive Generic Therapies (CGT)
- CGT – Why & Necessity
- Criteria and Timelines for CGT Designation
- Contents of Request for CGT Designation
- Expedited Development and Review – Key Considerations
- CGT Exclusivity
- CGT exclusivity Vs 180-day Patent Challenge Exclusivity
- Notification to FDA of First Commercial Marketing
- Benefits to Industry
Given the keynotes and with due respect to your busy schedule, we really look forward to seeing you in the webinar. Register now. Stay informed. Stay compliant. Stay safe.