Dipl.-Chem. Karl-Heinz Loebel
Director, Principal Consultant Regulatory Operations/Industry and Agency Liaisons, PharmaLex GmbH
Karl-Heinz is currently Director, Principal Consultant Regulatory Operations with PharmaLex GmbH, Germany – a consultancy and service provider in Drug Regulatory Affairs and Pharmacovigilance. As such he is advising and supporting Pharmaceutical Enterprises of all sizes and specialities in their efforts to obtain and maintain Marketing Authorisations for their products by means of electronic submissions.
After having obtained his Diploma as a Chemist at the Faculty of Natural Sciences at Heidelberg University, he spent several years in research and as a lecturer at the University’s departments for Pharmaceutical Technology and Biopharmacy, and at the Pharmaceutical Chemistry department, before he switched to a Biotech Start-up specialised in phytopharmaceuticals, where he was responsible for scientific as well as for administrative support.
Karl Heinz started his career in Regulatory Affairs when he entered PharmaLex in early 2005. Since then he has become a regular speaker and instructor on RA topics at international conferences, educational courses and DIA (Drug Information Association) meetings. He also
advises Pharmaceutical Companies on efficient electronic submission processes and implementation of ITand Regulatory Information Management Systems. His experiences with electronic submissions cover all global Regions where eCTD has been implemented, his regulatory and technical expertise covers the particularities of global Pharmaceutical Enterprises as well as those of SMEs and companies focussed on generics.
Since mid 2011 the submission of product related information to EMA’s XEVMPD-database has become an additional focus of his responsibilities and expertise and since May 2013 he is participating in the Agency’s workshops with industry to further develop XEVMPD towards ISO-IDMP Standards.
Karl-Heinz has been presenting on eCTD and CTD topics at various DIA educational training courses in the MENA region (Kingdom of Saudi-Arabia, Dubai and Egypt) in recent years.