- Dr. Klaus Menges
- Senior Expert in Regulatory Afairs and Electronic Submissions with NCA background
- BfArM, Germany
Klaus Menges is Authorized Representative at the Federal Institute for Medicinal Products and Medicinal Devices in Germany (BfArM) and National Representative of the eSUB CMB in the European Medicines Agency (EMA). Besides he is a Member of various Working Groups covering the eSubmission Process and Author of several Articles in pharmaceutical Publications. Klaus Menges is currently leading a BfArM project replacing an old database on products by an IDMP compatible database, contributing to the PharmNet.Bund portal, the German platform for medical products providing information to the general public, and services for pharmaceutical companies and regulators. Klaus represents BfArM in the eSubmission Change Management Board (eSub CMB) and is nominated expert in the ICH WG M8 on electronic submission.
- Karl-Heinz Loebel
- Director, Principal Consultant Regulatory Operations
- PharmaLex GmbH, Germany
Karl-Heinz is a highly experienced professional within regulatory operations with particular focus on e-documentation, particularly eCTD and the associated systems that support the ability to manage and be compliant with the connected regulations. Highlights include his involvement in a global capacity providing counseling and support on optimization of eCTD & IDMP compilation and his current position which has seen him involved in working groups on current ISO issues faced by Eudravigilance and Regulatory professionals.