Electronic Document Management and Regulatory Information Management.
This course will provide a solid understanding of the key systems that support the main regulatory business processes. The course will enable participants to engage in proficient and competent collaboration with business partners in the regulatory domain. Focus will be on two of the main disciplines in regulatory affairs; the management and submission of documents and the management of regulatory registration of products. Key systems for these processes are Electronic Document Management System (EDMS) and Regulatory Information Management System (RIMS). The course will discuss these systems both from a business and a technology side. New regulations and technology trends affecting this area will also be included in the course.The Regulatory Processes and Systems course is mainly targeted at employees who interact with Regulatory Affairs and their systems, such as technical support staff or IT project members, as well as Regulatory Affairs managers who want to know more about IT systems in RA. It is recommended that participants have completed the course "Regulatory Affairs" or have some prior knowledge of the regulatory affairs domain. The duration of the course is 1 day and it can take place at NNIT premises or at customer site.RegistrationIf you are interested in attending this course, you can request to be contacted by one of our instructors in order to schedule your participation and adjust to any special requirements that you might have. Please fill out your contact details below and choose "Regulatory Processes and Systems" in the course dropdown menu. We will then get in touch with you as soon as possible. The price for participating in this course is DKK 4500 per participant. If taken in conjunction with the Regulatory Affairs course, the total price will be DKK 8500 per participant. The price will be subject to change depending on the requirements of your organization.