Regulatory Information Management (RIM) software is vital in an industry where vast amounts of regulatory information must be gathered from multiple departments, then submitted to the regulatory agency for approval. When an organisation has many products RIM becomes even more crucial to regulatory operations and requires strategic planning. Identification of Medicinal Products (IDMP) was designed in response to demand for harmonised specifications for medicinal products. Currently the identification of medicinal products is dependent on the country and company but changes to this under the new IDMP standards are imminent.
Over two days you will learn the key aspects of RIM and the new IDMP standards 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 get to grips with the 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: