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.
Christine Hirt is Director of the Regulatory Competence Center at EXTEDO and is responsible for regulatory business consulting. 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.
What will you learn?
- Gain a complete overview of RIM and appreciate what systems are available on the market
- Learn how to successfully manage content by discovering tools to pull metadata
- Examine the importance of RIM systems linking key departments
- Fully understand the new ISO IDMP standard and how it impacts your organisation
- Learn how to apply a step by step strategic approach to prepare for IDMP
- Evaluating best practices for standardising and preparing data ready for IDMP
- As an SME you will gain useful tips and advice when approaching RIM and IDMP
- Discover how to outsource RIM and IDMP
- Examine how best to roll out training to ensure user compliance within large organisations with both RIM and IDMP
Who should attend?
This course is relevant for anyone working with RIM or IDMP either directly or indirectly and may include people working in the following areas:
- Regulatory Affairs
- Dossier & Document Management
- Data Management
- Electronic Submissions
Registration and details