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FALLS CHURCH, Va., Oct. 25, 2018 /PRNewswire-PRWeb/ -- FDA's New Biosimilars Plan: CBER's New Policy and the Impact on Pharmaceutical Stakeholders **An FDAnews Webinar** Nov. 7, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/biosimilarsplan
To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market.
The FDA's Biosimilars Action Plan lays out how the agency is modernizing regulatory policies, accommodating new scientific tools to better enable comparison between biosimilars and reference products, and potentially reducing the need for clinical studies.
FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what drugmakers need to know: what the FDA is thinking, where the industry is heading, and how to gain competitive advantage. Here are just a few of the specifics to be covered:
Meet the Presenter: Nitisha Pyndiah Ph.D. is a consultant with HartmannWillner where she provides Biotech Consulting Services to clients, including strategic support for development of biological, biotechnologica, and biosimilar products from preclinical development through the entire product lifecycle.
Who Will Benefit:
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/biosimilarsplan By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDANEWS
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To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market.
The FDA's Biosimilars Action Plan lays out how the agency is modernizing regulatory policies, accommodating new scientific tools to better enable comparison between biosimilars and reference products, and potentially reducing the need for clinical studies.
FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what drugmakers need to know: what the FDA is thinking, where the industry is heading, and how to gain competitive advantage. Here are just a few of the specifics to be covered:
- The key elements of the Biosimilars Action Plan — including balancing innovation and competition
- Interchangeability vs. biosimilarity — understanding the differences under the BPCI Act
- The development and implementation of new FDA review tools (i.e.: standardized review templates tailored to marketing applications for biosimilar and interchangeable products)
- Enhancements to the Purple Book, including more information about approved biological products
- The significance of the BsUFA II fees
Meet the Presenter: Nitisha Pyndiah Ph.D. is a consultant with HartmannWillner where she provides Biotech Consulting Services to clients, including strategic support for development of biological, biotechnologica, and biosimilar products from preclinical development through the entire product lifecycle.
Who Will Benefit:
- Executive suite
- Strategic planners
- Regulatory affairs
- QA/QR/QC
- Manufacturing executives
- R&D
- Marketing/sales
- Legal counsel
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/biosimilarsplan By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDANEWS
