FDAnews Announces — Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process Webinar, June 23, 2015
Falls Church, VA (PRWEB) May 28, 2015 -- Success Strategies for Biosimilars Approval:
A Roadmap to the 351(k) Application Process
**FDAnews Webinar**
June 23, 2015 — 11:00 a.m. – 12:30 p.m. EDT
[http://www.fdanews.com/BiosimilarsApproval
On June 23, 2015, FDAnews is offering the combined knowledge and expertise of two leading intellectual property attorneys from the international law firm Duane Morris in the webinar Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process.
Firm partner Kevin Nelson and Associate Dr. Patrick Gallagher will show how to use the FDA’s guidance and prior decisions to greatly improve the chances of getting 351(k) biosimilar applications approved — the first time.
They'll give attendees candid "what to do — and how to do it" advice, such as identifying the supporting clinical data that must be include in filings to gain approval quickly. And the right way to apply the FDA’s latest recommendations for demonstrating that a proposed product is “highly similar” to a reference.
They'll also explain details manufacturers must understand about 4 critical topics from the recent FDA guidances:
1. How to establish a step-wise approach to product development — the way the FDA prefers
2. The agency's “totality of evidence” methodology for assessing 351(k) applications
3. Using foreign reference products and the need for bridge studies
4. How analytics should be designed for pharmacokinetics and pharmacodynamics
In just 90 minutes, attendees will increase their specific knowledge of unclear key areas of the application and approval process that they need to know to get on the fast track to approval:
• Understanding the application pathway, including the statutory requirements for an approvable application
• How the FDA’s thinking on the clinical requirements for showing biosimilarity has evolved with the 2015 guidance
• Key takeaways from FDA’s latest guidances and FAQs
• 7 'must-do' steps (all based on the new guidances) for preparing an application
• How to successfully work with the FDA’s Biological Product Development Program (BPDP)
Meet the Presenters:
Kevin Nelson is a partner in the Intellectual Property Practice Group of the international law firm, Duane Morris LLP. For 14 years, he has represented generics companies exclusively in Hatch-Waxman litigation and related matters. Mr. Nelson has been lead trial counsel and has argued before the Court of Appeals for the Federal Circuit.
Dr. Patrick Gallagher is an associate in the Intellectual Property Practice Group of Duane Morris. He has been involved in all aspects of Hatch-Waxman practice, including advising on Abbreviated New Drug Application filings, development of noninfringement and invalidity arguments for FDA-required notice letters, and in every phase of litigation through trial and appeal to the Federal Circuit Court of Appeals.
Who Will Benefit:
• Clinical project specialists
• Product lifecycle specialists
• Pharmacokineticists/clinical pharmacologists
• Medical affairs
• Clinical data management and statistics personnel
• R&D staff
• Regulatory affairs professionals
• Submission and approval specialists
• Executive management
• IP/general/corporate counsel
• Consultants/service providers
Webinar Details:
Success Strategies for Biosimilars Approval:
A Roadmap to the 351(k) Application Process
**FDAnews Webinar**
June 23, 2015 — 11:00 a.m. – 12:30 p.m. EDT
[http://www.fdanews.com/BiosimilarsApproval
Tuition:
$287 per site
Easy Ways to Register:
Online: [http://www.fdanews.com/BiosimilarsApproval
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.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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