Medical and Regulatory Affairs

Regulation of Orphan Drugs: May 19 Webinar Offers Important Insights

PHILADELPHIA, MAY 1, 2015 — Premier Research will examine regulatory challenges unique to orphan drug research at a free webinar on Tuesday, May 19.

Join Nach Dave and Carol Huntington of Premier Research for Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape. The hour-long event, beginning at 11am EDT, 4pm BST, and 5pm CEST, is aimed at researchers and pharma companies tackling some of the 7,000 rare diseases identified by the National Institutes of Health.

More orphan drug studies are underway today than at any time in history. Each has its own maze of regulatory challenges, and these can differ greatly by geographic market. Register now for new insights into how therapies for rare diseases find their way to market, and how regulatory nuances can affect development of these products. We’ll identify how these pathways differ in the United States and Europe and where they are similar, and review current guidance documents, possible loopholes, and strategies you might not have thought about.

Nach Dave is Director of Regulatory Affairs at Premier Research, a leading contract research organization that serves the needs of biotechnology, pharmaceutical, and medical device companies worldwide. Carol Huntington is Premier Research’s Associate Director for Regulatory Affairs–Europe. Together, they’ll explore legal tools and incentives that have stimulated growth in rare disease drugs, examine the obstacles developers can encounter, and consider opportunities to achieve greater success.

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. 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 such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.