Regulatory Harmonization Institute, Inc. Company Profile

05:57 EST 11th December 2018 | BioPortfolio

Regulatory Harmonization Institute, Inc. (RHI) is a non-profit association dedicated to global harmonization of regulatory requirements with a mission to influence the development and introduction of meaningful therapies to patients across the globe. RHI will advance global harmonization of regulatory requirements for medicines and devices intended for human use, enabling greater delivery of meaningful new therapies to all patient populations.

News Articles [779 Associated News Articles listed on BioPortfolio]

FDA proposes standardization of generics standards

The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (I...

US Regulatory Reads, May 2018: Embracing Harmonization, Maturity Models And More

Talk from US FDA officials last month about using the ISO 13485 quality standard to replace all or parts of...   

Individual pathways for development of complex generics

The downside of having clear regulatory standards for approval of pharmaceuticals, according to Rodrigo Cristofoletti from Brazil’s Health Surveillance Agency (Agência Nacional de Vigilância Sanit...

The EU HTA Harmonization Initiative: What is the Significance to Manufacturers of the New Directive?

Comparative clinical benefit assessments are at the core of Health Technology Assessments (HTAs) in Europe. HTAs are a multi-disciplinary process considering input and evidence from medical, social, a...

#jobs #lifescience National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH): Director, Office of Regulatory Affairs

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: National Institute of Allergy and Infectious Diseases (NIAID), National Insti...

PDA-Funded Study on Post-Approval Changes Published by The Economist Intelligence Unit

Intelligence report analyzes link between post-approval change regulations and drug shortages BETHESDA, Md. (PRWEB) June 19, 2018 PDA today announced the availability of "Medicine and vaccine sh...

Older melanoma patients have better response to immune checkpoint blockade therapy

(The Wistar Institute) Patient age correlates with response to immunotherapy in melanoma and depleting regulatory T cells in young patients may have a therapeutic potential to enhance response in youn...

Higher Level of Oversight Results in Greater Harmonization of Imaging Protocols

Radiology practices with collaborative, consensus-based decision-making and conflict resolution processes can lead to greater standardization.

Drugs and Medications [92 Associated Drugs and Medications listed on BioPortfolio]

Sodium chloride injection usp, 0.9% [Taro Pharmaceuticals U.S.A., Inc.]

Sodium Chloride Injection USP, 0.9%

Sterile water [Hospira, Inc.]

Sterile Water For Injection, USP

Sodium chloride [Hospira, Inc.]


Sodium chloride [General Injectables & Vaccines, Inc]

0.9% Sodium Chloride 0.9% Injection, USP Single Dose vial

Sodium chloride [Hospira, Inc.]

0.9% Sodium Chloride Injection, USP

PubMed Articles [1019 Associated PubMed Articles listed on BioPortfolio]

ICH: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products.

Eight years ago this journal published "The Value and Benefits of the International Conference on Harmonization to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health" to mar...

Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence.

The Global Bioequivalence Harmonization Initiative (GBHI) was launched by the Network on Bioavailability and Biopharmaceutics (BABP) under the auspices of European Federation for Pharmaceutical Scienc...

Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?

Drug regulatory agencies around the world have implemented programs to expedite drug development and review for promising new products for serious diseases. These programs are all intended to minimize...

Data Harmonization for a Molecularly Driven Health System.

Data commons have emerged as the best current method for enabling data aggregation across multiple projects and multiple data sources. Good data harmonization techniques are critical to maintain quali...

Approaches for creating comparable measures of alcohol use symptoms: Harmonization with eight studies of criminal justice populations.

With increasing data archives comprised of studies with similar measurement, optimal methods for data harmonization and measurement scoring are a pressing need. We compare three methods for harmonizin...

Clinical Trials [1132 Associated Clinical Trials listed on BioPortfolio]

The Differential Effects of 3 Different Immunosuppressive

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive the...

T-Regulatory Cells in Amyotrophic Lateral Sclerosis

This is an open-label pilot study to determine the safety and tolerability of infusions of autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4 subje...

Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group

Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17

Assessing the Induction of Long-term Immune Regulation Following Treatment With Lemtrada® (Alemtuzumab).

In this study the investigators wish to test the hypothesis that treatment with Lemtrada is associated with alterations in immune homeostasis in favor of multiple regulatory leukocyte popu...

Messages for Increasing Dairy Consumption

Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the recommended number of milk and milk product servings (≤2 servings per day). Given the wide range o...

Companies [1994 Associated Companies listed on BioPortfolio]

Regulatory Harmonization Institute, Inc.

Regulatory Harmonization Institute, Inc. (RHI) is a non-profit association dedicated to global harmonization of regulatory requirements with a mission to influence the development...

Regulatory Harmonization Institute

Regulatory Harmonization Institute, Inc. (RHI) is a non-profit association dedicated to global harmonization of regulatory requirements with a mission to influence the development...

Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Phase Forward’s products and services have been utilized in o...

Phase Forward Incorporated

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Phase Forward's products and services have been utilized in over 1...

Critical Path Institute (C-Path)

The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Scien...

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