Over two days you will learn the key aspects of RIM and the new IDMP standard such as training and user compliance, outsourcing and data/content management. Once completed you will have the necessary skills to plan, prepare and implement a strategy ready to meet IDMP deadlines.
With a dedicated day to each topic and practical elements on both days, this course will help you to get to grips with these key aspects of electronic submissions.
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.
Karl-Heinz Loebel is Head of Regulatory Operations at PharmaLex. Having finished his studies in Chemistry at Heidelberg University, Germany, he joined a Biotech startup company as a Scientific Advisor and a Management Executive for several years. In early 2005 he joined PharmaLex International and was recently promoted to Head of Regulatory Operations.
This course is relevant for anyone working with RIM or IDMP either directly or indirectly and may include people working in the following areas: