PRA opens drug safety centre in Brazil

By Nick Taylor

- Last updated on GMT

Related tags: São paulo, United states

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

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 01-Mar-2020 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Related suppliers

Follow us

Products

View more

Webinars