This course will give participants an in-depth knowledge of the purpose and responsibilities of a regulatory affairs department. Participants will gain the ability to have a qualified engagement with their regulatory business partner’s, with a comprehensive understanding of their core processes and objectives. The course is organized to provide an overall understanding of the main functions and business processes of regulatory affairs. It will explain the crucial role of the regulatory affairs department in a pharmaceutical company including its many stakeholders. In addition, the course will discuss the elements of a product submission and how this is developed and maintained throughout the lifespan of the drug product. It will walk through the submission and approval process and explain the complexity of launching and marketing drugs in a global environment.The Regulatory Affairs course is targeted at employees who are new to the pharma industry and work with or within Regulatory Affairs. The duration of the course is 1 day and it can be carried out at NNIT premises or at customer site.
After this course, participants can expand on their knowledge by attending the following courses:
Understanding Clinical Development and Clinical Systems
Regulatory Processes and Systems
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 Affairs" 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 course "Regulatory Processes and Systems" the total price will be DKK 8500 per participant. The price will be subject to change depending on the requirements of your organization.