FDAnews Announces — Special Protocol Assessments: Decoding FDA’s SPA Program and Revised Guidance Webinar, Oct. 26, 2016

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How should manufacturers use SPAs to get feedback from the FDA on clinical trial design? Join Alexander Varond — Associate at Hyman, Phelps & McNamara — on Oct. 26 for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors.

Special Protocol Assessments:
Decoding FDA’s SPA Program and Revised Guidance
**An FDAnews Webinar**
Oct. 26, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/special-protocol-assessments-pr

How should manufacturers use SPAs to get feedback from the FDA on clinical trial design?

How they can avoid getting a “No Agreement Letter” from the FDA after submitting a SPA?

Join Alexander Varond — Associate at Hyman, Phelps & McNamara — on Oct. 26 for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors.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 webinar manufacturers will:

  •     Understand how and when to optimally utilize SPAs to get feedback from the FDA on clinical trial design and maximize the chance that their trials will be successful.
  •     Determine the circumstances when FDA might rescind your SPA agreement.
  •     Address the critical issue of whether your SPAs will have an impact on the ability to market and promote 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.

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

Meet the Presenter:
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.

Who Will Benefit:

  •     Medical Affairs Officers
  •     Director of Clinical Operations
  •     Regulatory Affairs Professionals
  •     Director of Clinical Trial Regulatory Management
  •     Clinical Trial Information Disclosure Directors
  •     Global Clinical Safety and Pharmacovigilance Officers

Webinar Details:
Special Protocol Assessments:
Decoding FDA’s SPA Program and Revised Guidance
Oct. 26, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/special-protocol-assessments-pr

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://info.fdanews.com/special-protocol-assessments-pr
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.

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Michelle Butler
FDANEWS
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