About the Webinar:
US-FDA published new regulations on Competitive Generic Therapy in March 2020 for generic companies- a new pathway defined by FDA to designate drug with inadequate generic competition as CGT. This regulation is imposed to support timely access of high quality affordable generic medicines which have limited market and difficult to develop. This act provides companies with a 180- day exclusivity, different from 180-day patent challenge exclusivity, for the first approved applicant of a drug with a CGT designation.
When: May 14th 2020
Register for our upcoming webinar to learn more about:
- Regulatory framework and expectations from regulators for generic companies
- Procedure for application for CGT
- Applicability of exclusivity and how will it affect the generic companies
- How this marketing exclusivity works?
- FDA’s partnership with industry under this program.
About the speaker:
Mona holds master’s degree in Pharmaceutics (Formulation Development) and has around 16 years of experience in Regulatory Affairs (US, Canada, EU, Russia and CIS countries) and regulatory compliance across drug products (solid orals and sterile) and medical devices. Mona has contributed in formulating regulatory strategies, technical reviews along with guidance during the development & scale up stages, regulatory intelligence, due diligence reviews, facility compliance audits and has also expertise in compilation of regulatory execution documents and dossiers.
She brings in a lot of expertise and regulatory knowledge from her previous organizations such as Sentiss Pharma Pvt Ltd, Ranbaxy Laboratories Limited, Wyeth Pharmaceuticals (USA), Merck (USA), and Dr Reddy’s Laboratories.