Investigator Training Resources
Resources
Welcome to Your Portal for Regulatory Information!
This web portal is an up-to-date repository of links from government, academic, and scientific institutions. Its goal is to provide an overview of regulatory information along with resources to help orient clinical research professionals in their approach to plan and conduct clinical trials in the United States, ultimately bringing bench discoveries to the patient’s bedside. This self-help tool is not meant to replace professional consultation.
Not sure where to begin? Watch the OpenRegSource tour video, or start with this page.
2025 APEC Foundational Principles of Medical Device Clinical Evidence and Risk Management
Day 1 | Focus on Clinical Assessments
Date and Time | Nov. 3 (U.S.) 3:00 PM – 8:00 PM PT
Nov. 4 7:00 AM – 12:00 PM Taipei (+1),
8:00 AM – 1:00 PM Seoul (+1) Learn about clinical evidence for devices, definitions and key concepts, clinical investigations, clinical evaluations, and clinical evidence for in vitro diagnostic devices (IVDs)
Day 2 | Optimizing Risk and Safety of Devices
Date and Time | Nov. 4 (U.S.) 3:00 PM – 8:00 PM PT
Nov. 5 (Asia) 7:00 AM – 12:00 PM Taipei (+1),
8:00 AM – 1:00 PM Seoul (+1) Learn about GHTF/IMDRF guidelines, adverse event reporting, ISO 14971:2019, IVDs, post-market surveillance, and pre-
market risk evaluation tools
Total Duration 10 hours (with breaks)
Location | Hosted Online via Zoom
51st International Musculoskeletal Biology Workshop
The 51st International Musculoskeletal Biology Workshop is almost here, but there is still time to register. The theme for this year’s workshop is: “Back to Basics: Bone Remodeling, Skeletal Cell Stimulation, and Mechanisms of MSK Disease Prevention.” The event provides a forum to identify problems in musculoskeletal disease and experimental approaches that provide solutions. Concepts debated at the workshop have had, and continue to have, a strong impact on the study of skeletal physiology and disorders. Don’t miss out on this important event.
Your virtual library on oral tissue regeneration
With each topic, you’ll receive a comprehensive scientific overview presented in three distinct formats: the Key Publication Interview, a Webinar featuring an expert in the field, and the Scientific Radar, offering a concise literature overview of the most relevant scientific publications.
The Next Regeneration Podcast – with Hatice Hasturk
Host modulation: a paradigm shift to enhance periodontal and bone regeneration.
Webinars on regulatory topics related to orphan drug designations.
NIH Concept to Clinic: Commercializing Innovation (C3i) Program
Education | Overview: The e-C3i course is a newly launched online entrepreneurial education platform aimed at teaching academic innovators methods to assess the commercial value of their biomedical technologies.
Eligibility: Investigators from a research institution with active NIH-funded research projects
Application Due Date: May 25, 2021
Eligibility: Investigators from a research institution or small business with active NIH-funded research projects
Application Due Date: July 26, 2021
Acceleration | Overview: The C3i Accell program provides product development and business support to assist academic innovators in accelerating the translation of their biomedical technologies.
Timeline: To be determined
Register here >
Global Tooth Regeneration Market Report, History and Forecast 2015-2026
The Regenerative Medicine Standards Landscape
This report provides a snapshot of the current landscape for regenerative medicine standards. It outlines existing and in-development standards, providing a reference that individual organizations can use to identify available standards to improve their operations.
Standards in Regenerative Medicine
Community Perspectives: Needed Standards in Regenerative Medicine report. The objective of the report is to outline standards needs identified by the community that could have the greatest benefit to the field and improve the safety and quality of regenerative medicine products.
Proceedings of NAS Cell Manufacturing Workshop
New FDA guidance documents on regenerative medicine therapies:
- Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
Osteology Research Guidelines: Online version of the book series, Osteology Guidelines for Oral & Maxillofacial Regeneration, where leading experts present their tried and tested study protocols and general aspects on preclinical and clinical research.
- Preclinical Models for Translational Research. Editors – Prof. William V. Giannobile and Prof. Myron Nevins
- Clinical Research. Editors – William V. Giannobile, Niklaus P. Lang and Maurizio S. Tonetti
Register now (free of charge) >
After you have register, go to the Osteology Research Guidelines.
Preclinical Animal Models for Temporomandibular Joint Tissue Engineering
- Periodontal Regeneration
- Peri-Implantitis
- Guided Bone Regeneration
- Soft Tissue Augmentation: Root Coverage
- Ridge Preservation