The process of collating, developing, submitting and managing a regulatory submission for approval is a complex project where masses of data must be collated and speed is critical. The electronic CTD (eCTD) has simplified the submission process speeding up your data through the approval process, saving you valuable resources and time. Although much simpler, the eCTD still handles large documents and must be led by professionals who are knowledgeable and competent to minimise delays.
Global regulatory agencies are committed to implementing the eCTD as standard so regulatory professionals must stay up-to-date with the latest regulations and trends. On completion of this 2-day course, you will understand how to organise applications in the correct electronic format and style ready for submission. You will also examine life cycle eCTD management to ensure you are capable of managing the submission post approval.
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.
Christine Hirt is a Managing Consultant and is responsible for regulatory business consulting at EXTEDO’s Regulatory Competence Center. She has more than 10 years of experience in the field of Regulatory Affairs and worked for several pharmaceutical companies, most recently as Head of Regulatory Affairs, before she joined EXTEDO.