Introduction to Regulatory Affairs in Drug Development Online

When developing new pharmaceuticals, the key to success is to ensure that all regulatory requirements are met throughout every stage of the research and development work. Doing it correctly from the beginning will save You time as well as money, which is often the difference between success and failure! This course targets an up-to-date overview of current regulations and how to ensure sufficient regulatory documentation in all phases of a drug’s development, with focus on the early phase.

During the live online course you will be able to ask questions via chat or orally.

Who should attend?

The course is primarily aimed at you who work at a small to medium sized research based pharmaceutical company and an need overall knowledge of Regulatory Affairs. You might work as project manager, project team member, innovator and entrepreneur, academic researcher, drug developer or as business manager who work in a pharmaceutical R&D company.

Learning objectives

You will get an overview of Regulatory Affairs and an understanding of the regulatory requirements that you encounter during drug development.

Course outline

The course is structured around lectures. Participants are given the opportunity to submit questions prior to the course starting date. From the program:

• The Innovation Office at the Medical Product Agency
• Terminology and Regulations
• Marketing Authorisation Application
• Regulatory Affairs in pharmaceutical drug development 
• Clinical trials – regulations and guidelines
• Product Life-Cycle Management

Instructors

The instructors are senior experts within their field. There are representatives both from Regulatory Affairs in the pharmaceutical industry as well as from the Swedish Medical Products Agency.

Time and venue

The course is held online via Läkemedelsakademin's virtual classrom in Zoom. The course starts at 09:00 and finishes at 17:00. All participants will have access to all recorded lectures for 1 month efter the course. A link of the recorded online course will be sent out a couple of days after the course. 

Participation fee and registration

The registration fee is 4.900 SEK until 23 Februari 2021 and thereafter 5.900 SEK. The fee includes access to all recorded lectures for 1 month, digital documentation and a certificate in digital format. All prices exclude VAT.

Other information

For information such as cancellation policy, participant list, GDPR – see “Registration Terms” to the right.