Hello Colorado RAPS,
If you've not already seen the event for Monday in your email, we are pleased to present a Colorado Chapter Webcast: Expedited Development, Review & Innovation Incentives for the US Market.
Description
Expedited pathways, designed to provide drugs to patients sooner, are being used more often. These "express lanes" are open to products containing both significant benefit over available therapies and filling an unmet need.
This presentation will examine the opportunities and incentives available to sponsors to expedite the development and approval specifically of drugs and biologics, with a focus on the United States.
The topics covered will include:
- FDA programs to accelerate development and approval of drugs and biologics for serious and unmet need
- Approval statistics for expedited programs
- Priority Review Vouchers - history and use
- Exclusivity incentives
A Q&A session will be provided at the end.
This event encourages knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Learning Level: Basic-Intermediate
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections.
Featured Speakers:
Linda Bowen, MSc., RAC, FRAPS, Head of Regulatory Policy and Intelligence, Seattle Genetics
If you've not already, please regiser here:
https://www.raps.org/events/colorado-chapter-webcast-expedited-development-review--innovation-incentives-for-the-us-market
Looking forward to seeing you there!
Colorado Chapter Leadership
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Lindsey Summers, MBA
Director, Pharmaceutical Consulting Division Green Key Resources, LLC
President-Elect, AMWA Rocky Mountain Chapter
Communications Manager, RAPS Colorado Chapter
Denver, CO
Direct: 720.543.8692
Mobile: 303.437.0391
lsummers@greenkeyllc.comwww.linkedin.com/in/lindseysummershttp://www.greenkeyllc.com/ph/Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Clinical Development / Medical Affairs & Monitoring / Epidemiology / Health Outcomes
Ecosystem: Pharma-Life Sciences/Healthcare/Accounting-Finance/Info Tech/HR-Office Support
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