Special Protocol Assessments - Webinar CD/Transcript

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Special Protocol Assessments: Decoding FDA’s SPA Program and Revised Guidance

When should you consider pursuing an SPA? If you do, how long will it take?

How has the revised guidance changed the process?

Join Alexander Varond — Associate at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors.

After attending this 90-minute session you will:

  • Understand how and when to optimally utilize SPAs to get feedback from the FDA on clinical trial design and maximize the chance that your trials will be successful.
  • Determine the circumstance when FDA might rescind your SPA agreement.
  • Address the critical issue of whether your SPAs will have an impact on your ability to market and promote your products.
  • Understand the deadlines established by FDA for submitting an SPA and how to avoid delays and lengthy negotiations in the process.
  • Know exactly what content FDA to be included in your SPA to avoid receiving an unfortunate “No Agreement Letter” from the agency.
  • Understand the important changes in the animal rule efficacy protocols to support approval under Part 314, Subpart I, and part 601, Subpart H for drug and biological products.

Order today for a thorough understanding of the FDA’s SPA process and its benefits.

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Alexander Varond, Associate, Hyman, Phelps & McNamara
Alexander Varond works on medical device and drug development, advertising and promotion and enforcement issues. He counsels clients on development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution and patent and exclusivity issues. Mr. Varond also supports ongoing litigation efforts and performs due diligence for corporate transactions.