Dr. Debbie Elke

Dr. Elke Debie, Ph.D.
Manager, CMC Regulatory Affairs
Janssen Pharmaceuticals

Dr. Elke Debie earned a Ph.D. in Chemistry from the University of Gent. She did her Ph.D. thesis on Vibrational Circular Dichroism (VCD), an analytical technique to determine the absolute configuration of chiral molecules in solution. She did a post-doctoral assignment as a visiting scientist at BioTools in the USA, prior to joining Janssen Pharmaceutica in Beerse in 2010.

Dr. Debie is currently working in the Global Chemistry, Manufacturing and Controls Regulatory Affairs (CMCRA) department providing regulatory strategy for projects that transfer from the development through the commercial registration phases. In addition to her project-related responsibilities, she represents CMCRA in discussions related to ASAP initiatives. She is also a member of the International Consortium of Innovation and Quality (IQ consortium), a technically-focused organization of pharmaceutical and biotechnology companies that provides a forum for exchange of ideas within and across technical disciplines. Within the IQ, she is part of the cross-company pharmaceutical regulatory sub-team which discusses the strategies for use of risk-based stability procedures in regulatory filings.