Basics of Regulatory Affairs
Are You looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs in English is back! Previous participants say:
”The course gave a perfect overview of all areas that concern RA”
"The possibility to follow the course online, worked really well”
”Nice and dedicated lecturers with extensive experience and expertise in their respective areas”
Are You looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs in English is back!
Previous participants say:
Who should attend?
This course is perfect if You are new in Your role within Regulatory Affairs and need an overview of current regulations, processes and documentation. It also suits You who hold more experience within the Regulatory Affiars field and are looking to update or confirm Your knowledge. In addition, it's an opportunity to exchange experience and best practises with colleagues regarding e.g. practical application of current regulations and guidelines.
The course gives a comprehensive picture of Regulatory Affairs. After the course, you will have a broad knowledge of Regulatory Affairs and a platform for further development in the area.
The course days are structured around lectures and discussions – individually and in groups. From the program:
- The authority role
- Regulatory Affairs role in pharmaceutical development
- Development phases, from selection of substance to market authorisation approval
- Approval Procedure Product life-cycle management
- Variations and line extensions
- Market authorisation application: structure and content
- Product information
- Practical application and discussions
All lecturers have long experience from Regulatory Affairs in the pharmaceutical industry and/or authority.
Lecturers, in alphabetical order:
Henrik Fant………………………………………….Scientific Solutions
Ifeoma Asiegbu..........................................Merck Sharp & Dohme (Sweden) AB
Marianne Andersson................................ AstraZeneca R&D
Time and venue
The course is held 7-9th of November 2023 at Apotekarsocieteten, Wallingatan 26A in Stockholm.
Schedule will be announced later.
Participation fee and registration
The registration fee is 17.000 SEK until 6th of October 2023 and thereafter 19.200 SEK. The fee includes digital documentation and certificate, 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 quality, please register your application no later than 72 hours before the start of the activity. At short notice, please contact the project administrator for the activity via email. For information such as cancellation policy, participant list, GDPR etc – see “Registration Terms” to the right.
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Basics of Regulatory Affairs
End date: 2023-11-09
No. of days: 3
Price: 17000 SEK
Price: 19200 SEK
The fee includes digital documentation and certificate.
All prices are excl VAT.
i Stockholm AB
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11