Medical and Regulatory Affairs

Europe’s New Trial Regulations: Quality VP to Address 2016 West and Wales Forum

DURHAM, N.C., April 05, 2016 – New European Union standards governing clinical research have significant implications for future drug trials. Nicky Dodsworth, Vice President, Quality Assurance, Risk & Compliance at Premier Research, will discuss these changes at the 2016 West and Wales Regional Forum on Innovation and Risk, April 21 in Milton Park, Oxfordshire, U.K.

In her EU Clinical Trial Regulation Update, Dodsworth will address key differences between the EU Clinical Trials Regulation, which took effect in 2014, and the Clinical Trials Directive it replaced. The update seeks to simplify and standardize study administration and reverse a decline in the number of European trials — down 25 percent from 2007 to 2011 — and make Europe more attractive to researchers.

Dodsworth also will talk about submitting applications using the EU portal and database and supporting dossier, the assessment and authorization process, and the latest timelines for implementation of the new regulation. The 30-minute presentation begins at 10:05 a.m.

About Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.