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:
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 at Apotekarsocieteten, Wallingatan 26A in Stockholm. Registration and breakfast starting at 8:30. The course starts at 09:00 and finishes at 17:00.
Participation fee and registration
The registration fee is 4.900 SEK until 21 April 2019 and thereafter 6.200 SEK. The fee includes digital documentation, certificate in digital format, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 500 SEK. All prices exclude VAT.
In order for us to offer all our participants the best possible service, please register your application no later than 72 hours before the start of the activity. When registering at short notice, please also contact the project administrator for the activity via email.
Participant list
We usually share a list of participants during the course. Many participants request these lists when taking our courses and we see networking as an important part of the professional development. With reference to this, we assume that our participants have an interest in us sharing the list and the lawfulness of processing the personal data is therefore the legitimate interest. The lists contain first and last name and organization. If you do not want your name and organization to be included in the participant list, please notify the project administrator at the time of registration or as soon as possible. If you have questions regarding the participant list, you are welcome to contact the responsible project administrator.
Inlägget Introduction to Regulatory Affairs in R&D dök först upp på Läkemedelsakademin.