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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here