Dairine Dempsey

CEO & co-founder at Open Orphan DAC

Dr. Dairine Dempsey is the CEO/CMO & a co-founder of Open Orphan DAC, a Dublin-based EU pharmaceutical company specialised in bringing orphan drugs to EU patients.

Dairine has over 15 years experience in the pharmaceutical industry including almost 10 years in the national regulatory authority for medicines (now the Health products Regulatory Authority).

She previously held the role of Vice President ,Strategic Regulatory Affairs at ICON plc, a global clinical research organisation running clinical trials and providing a variety of pharmaceutical services to the medicines and medical device industries worldwide.

From 2009 to early 2015 Dairíne worked as a pharmaceutical consultant with The Compliance Group with responsibility for pre- and post-marketing regulatory affairs and pharmacovigilance.

During that time she led the establishment of the pharmaceutical products regulatory authority in Bahrain. Dairine holds a PhD and a pharmacy degree from Trinity College Dublin.


Title: Overview of the regulatory Landscape for Biologics and Biosimilars

  • A summary of the global regulations for biologics and biosimilars
  • Similarities and differences between the key geographies
  • Challenges and opportunities in biologics and biosimilar licencing