Filing new submissions is a time consuming, laborious task for both industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.
Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in the correct electronic format and style from the onset.
Having finished his degree in Chemistry at Heidelberg University, Germany, Karl-Heinz Loebel joined a Biotech startup company as Scientific Advisor and Management Executive for several years. In early 2005 he joined PharmaLex International and was recently promoted to Head of Regulatory Operations.
Silke Nolkemper studied pharmacy and holds a PhD in Pharmaceutical Biology from the University of Heidelberg, Germany. She has more than 7 years’ experience as Regulatory Affairs Manager in the pharmaceutical industry spending time at PharmaLex, Sandoz/HEXAL and finally Extedo where she is responsible for the implementation of regulatory updates regarding eSubmission (eCTD, NeeS, eCopy, VNeeS, ASMF, DMF).