About
Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars
| Date: | 25-Jul-12 to 25-Jul-12 |
| Location: | Online Webinar / California / United States |
| Category: | Education Conferences & Trade Fairs |
This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
Why Should You Attend:
On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics).
Why Should You Attend:
On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics).
Visitors
Who Will Benefit:
- Regulatory Affairs Professionals
-Managers
-Consultants
- Scientists
- Research Analysts
- State Policy Officials
- Regulatory Affairs Professionals
-Managers
-Consultants
- Scientists
- Research Analysts
- State Policy Officials
Exhibitors
Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He focuses his practice on the representation and counseling of clients in the food and drug industry, including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine; and medical devices.
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