PhRMA Transitions Management of its Benefit–Risk Action Team - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

PhRMA Transitions Management of its Benefit–Risk Action Team


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it will transition the management of its benefit–risk action team (BRAT) to the Centre for Innovation in Regulatory Science (CIRS), according to a press release. CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. This transition is being made to further the program’s technical development and broaden input from the scientific community.

The BRAT framework is a structured framework and methodology for benefit–risk assessment that has been developed over the last six years. In 2011, a voluntary pilot program was conducted among PhRMA member companies to gain practical industry experience with the framework, process, and tools and to help facilitate adoption of a more structured approach to benefit–risk assessment by industry and regulators. According to PhRMA’s press release, progress beyond a pilot program will require increased stakeholder input, improved incorporation of pilot program results, and further development of benefit–risk assessment principles.

To that end, CIRS will incorporate the BRAT Framework into its new Unified Methodologies for Benefit–Risk Assessment (UMBRA) initiative. The goal of UMBRA is to improve benefit–risk assessments during the drug development and regulatory approval process and increase the transparency, predictability, and consistency with which benefit–risk assessments are conducted. UMBRA will be expanded to incorporate the BRAT Framework and other CIRS benefit–risk activities, which have focused on the development of an internationally accepted approach for the systematic, routine, and standardized documentation of decision making in the benefit–risk assessment of medicines.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here