Reporting Requirements
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.
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
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.
How Paper and Electronic Source Data Meet ALCOA-C Principles
ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?
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.
Your Guide to sIRB Mandates
This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
5 Questions to Ask Your Sponsor for DCT Implementation
Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA
Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
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