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Gene Therapy Insights

Viewing all entries for: gene therapy

  • Insights
    • Insights Archive
      • gene therapy
Doctor Patient Talking using Tablet Whitepapers

The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

Read More about The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
guidance documentation Blog Posts

Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

Read More about Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
Portrait Of Young Man Wit Face Mask News & Events

[Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials

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Genetic Engineering And Gene Manipulation Concept Blog Posts

Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials

Read More about Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials
man working at computer News & Events

[Webinar] IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market

Read More about [Webinar] IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market
Businesswoman reviews documents at desk Ask the Experts

As a sponsor, does my HGT clinical trial require IBC approval at all sites?

Read More about As a sponsor, does my HGT clinical trial require IBC approval at all sites?
Scientist in laboratory filling pipette. Ask the Experts

Does Human Gene Transfer research at my site require IBC approval?

Read More about Does Human Gene Transfer research at my site require IBC approval?
person thinking yes Ask the Experts

How should we handle financial conflicts of interest in FDA-regulated clinical trials?

Read More about How should we handle financial conflicts of interest in FDA-regulated clinical trials?
DNA strand Whitepapers

Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know

Read More about Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know
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