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How to Optimize Your sIRB Experience
Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.
Rare and Orphan Diseases in Regulated Development
In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.
Simple Strategies for Identifying Research Compliance Blind Spots
David Staley authored the article Simple Strategies for Identifying Research Compliance Blind Spots in Compliance Today.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.
Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software
Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.
Inspection Readiness: Before. During. After
This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
Growth Mode: Developing a Fit-for-Purpose QMS Model
Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.
Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success
Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.
Regulatory, Clinical, and Quality Considerations for Device Research
Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.
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