PRA opens drug safety centre in Brazil

By Nick Taylor

- Last updated on GMT

PRA International has opened a drug safety centre in São Paulo, Brazil, expanding its presence in Latin America and bringing its array of services to a new market.

From the centre PRA will provide services support clients activities including assistance with US Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy (REMS) and annual safety reporting.

PRA already provides these services from its sites in Charlottesville, Virginia, US and Mannheim, Germany but the company regards the opening of the Brazil centre as an important step in expanding its global footprint.

Sabine Richter, PRA’s vice president of safety and risk management, said: “The opening of the São Paulo drug safety centre enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardised drug safety services globally, by growing and strengthening our overall safety team​.

This new centre will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally​.”

The centre is staffed with drug safety professionals and has already commenced activities, with the team drawing on expertise from other groups in PRA, such as “analysis & reporting” and “late phase services”.

This follows the model of the exiting facilities in Germany and the US, which in 2008 did more than 18,000 individual safety reports, five data integration and pooled analysis projects and contributed to three approvals by the FDA.

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Related suppliers

Follow us

Products

View more

Webinars