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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 10: Special Regulatory Considerations for Development

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

Special Protocol Assessment
Special Development Pathways

Expedited Programs for Serious Conditions
Background and Subpart E
Concepts for Expedited Programs
Expedited Programs

Fast Track
Breakthrough Therapy Designation (BTD)
Regenerative Medicine Advanced Therapy (RMAT)
Accelerated Approval
Qualified Infectious Disease Product (QIDP)
Priority Review

Orphan Products
Priority Review Vouchers

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