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Learn the
Regulatory Processes for All Aspects of
Product Development and
Management
FDA
receives a large number of combination products for review as technological
advances continue to merge product types. Because combination products involve
components that would normally be regulated under different types of regulatory
pathways, and frequently by different FDA Centers, they often raise difficult
policy, regulatory, and review management challenges.
This 90-minute webinar will cover topics from what kind of product you have,
to how it’s assigned, to application development and review, as well as the
premarket steps for combination products. Case studies and scenarios will bring
these steps together.
Presenters:
• Kathy
Lee, Lead Interdisciplinary Scientist; Division of Therapeutic
Proteins/OBP/OPS/CDER,
FDA
• Hina M.
Pinto, Regulatory Advisor, CDRH,
FDA
Who Should Attend?
Pharmaceutical, academic and government senior-level
professionals and decision-makers involved in: |
• Drug Research and
Development •
Medical
Device and
Diagnostics
• Regulatory
Affairs |
• Clinical Research
•
Development of Drug/Device Combinations
and Companion
Diagnostics |
Next Week's Webinar:
A
Closer Look at FDASIA Provisions to Promote Biomedical Innovation
April
30 | 12:30-2:00PM ET
The Food and Drug Administration Safety and Innovation Act (FDASIA) includes
a number of significant new provisions to promote the development and
availability of safe, effective, and innovative therapies. This webinar will
discuss these provisions as well as the user fees from industry to fund reviews
of innovator drugs, medical devices, generic drugs and biosimilars.
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May 23 | 10:00AM-12:00PM ET
May 30 | 1:00-2:30PM
ET
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Almost Half of the Sites Recruited by Trial Planners End
up Enrolling Less than Two Patients
Connecting
the Right Sites to Promising Trials: The Role of Web-based Feasibility
Assessment
May 22 | 10:00-11:30AM ET
Selection of the right sites for a promising clinical trial is the most
relevant step in the planning process for subsequent successful study conduct. A
number of obstacles stand in the way of efficient implementation of this
process.
This webinar will address common weaknesses in the established process of
feasibility assessments and site selection, from the point of view of both trial
planners and research centers. You will learn relevant key performance
indicators (KPIs) and how to address them, global country selection strategies,
and better management of site feasibility assessment by improving the efficiency
of information exchange between sites and trial planners.
Stay
Up-To-Date with DIA
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