Beate Roder, Ph.D.

Beate, a Senior Director of Clinical Trial Regulatory Services, manages a team of more than 100 staff members in Central and Eastern Europe. As a partnership leader, she has set-up global CTA Hubs that manage regulatory submissions for 400+ clinical trials in more than 70 countries, as well as an oncology development program of 6 compounds in phase II/III stage with 50+ countries (Europe, the Americas, Asia/Pacific, Middle East, and Africa).

Work experience

Beate has more than 22 years of experience in the pharmaceutical industry as well as in CROs in the areas of site monitoring, study management, and regulatory affairs. This includes more than 15 years of experience in coordinating regulatory agency applications for large global study programs, providing regulatory consultancy and establishing strategies for effective study start-up, deficiency letter response and amendment submissions. In addition, Beate has been a strategic leader for several Regulatory Partnerships. Besides her scientific background gained in the fields of molecular neurobiology and immunology, Beate’s expertise includes an in-depth knowledge of ICH/GCP guidelines, as well as European and national laws related to all regulatory aspects in clinical trials (including gene therapy trials). Beate has shared her expertise by presenting at DIA meetings on “Gene Therapy Trials in the EU” and on “CTA requirements in Europe”.

Education

Beate received her Master of Science degree in Immunology from Ruhr-Universität in Bochum, Germany. She also completed her Ph.D. in molecular neurobiology from Ruhr-Universität.