Course Description:
As the U.S. market, the largest commercial market for pharmaceutical and biologic drugs, focuses on stabilizing its supply chain of essential medicines and faces pressure on healthcare costs, there is a need for low-cost, high-quality drug therapies as well as a diversified source of supply.
This webinar will address the most important steps in a roadmap to bring biosimilar, generic, and complex generic drugs through U.S. FDA filings and into the U.S. market.
Portfolio Analysis
Which products to pursue for U.S. market entry; volume; pricing, regulatory risk, intellectual property (IP)
Quality Management Maturity (QMM)
Understanding CDER’s quality assurance framework and practices; capability gap analysis; regulatory dossier preparation
Regulatory Submission
How to interface with the U.S. FDA; Reference Listed Drug (RLD), Therapeutic Equivalence (TE), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA); inspection readiness
Commercial Readiness
A review of material requirements planning (MRP), policies and procedures, forecasting, governance, licensing, distribution, channel strategy
Who should participate:
Drug developers, drug manufacturing, pharmaceutical manufacturing, QA/QC professionals, portfolio managers, RA/ Regulatory operations, Quality managers, scientists, engineers, CDMOs / CROs, CMO/CTO/CEO
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.
The live version of this recording took place on September 25, 2024.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker:
Sireesha Yadlapalli
CEO Pharmatech Associates
MBA, Indian School of Business
BA, economics, Rutgers University
Bikash Chatterjee
President, CSO, Pharmatech Associates
B.Sc. chemical engineering, UC San Diego
BA, biochemistry, UC San Diego