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. By doing it correctly from the beginning you will save time as well as money and this is often the difference between success and failure. This course is for you who need an up-to-date overview of current regulations and how you can ensure sufficient regulatory documentation in all phases of a drug’s development with focus on the early phase.
Who should attend
The course is primarily aimed at you who work at a small to medium sized research based pharmaceutical company and 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 as online and live streaming. The course starts at 09:00 and finishes at 17:00. The course is also available as online live-streaming course. Those who choose to attend online will have access to all streamed lectures for 1 month. If you want to register to the physical course, please follow this link: https://www.lakemedelsakademin.se/produkt/introduction-to-ra-in-drug-development/
Participation fee and registration
The registration fee is 5.100 SEK until 11 Sep 2020 and thereafter 6.500 SEK. The fee includes access to all streamed 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.
Inlägget Introduction to RA in Drug Development Online dök först upp på Läkemedelsakademin.