Basics of Regulatory Affairs
19,200 kr
5 - 7 Dec 2023 Stockholm/Online
Are You looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs gives a comprehensive picture and is a platform for Your further development in the area.
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”
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.
Learning objectives
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.
Course outline
The course days are structured around lectures and discussions – individually and in groups. From the program:
- Overview of European regulations
- 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
Instructors
All lecturers have long experience from Regulatory Affairs in the pharmaceutical industry and/or authority.
Elin Svensson-Wallin.................................Läkemedelsverket
Emelie Bergman Perland……………………..Läkemedelsverket
Helena Björkman.........................................Pharma Relations
Henrik Fant…………………………………………….Scientific Solutions
Ifeoma Asiegbu............................................Merck Sharp & Dohme (Sweden) AB
Jimmy Cedervall………………………................Läkemedelsverket
Mahsa Rezaei ...............................................Läkemedelsverket
Marianne Andersson..................................AstraZeneca R&D
Time and venue
The course is held 5 - 7 dec 2023 at Apotekarsocieteten, Wallingatan 26A in Stockholm.
The course is also available as an online live-streaming course. Those who choose to attend online will have access to all streamed lectures for 1 month after the course date. To register to the online course, please follow the link here.
Participation fee and registration
The registration fee is 17.000 SEK until 27th of October 2024 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.
Other information
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.
Coming events: Events in English
Date | Date | Event | Days | Location |
22 may 2024 | may 22 | Trends in Metabolic Studies of Pharmaceutical Drugs Stockholm | 1 | Stockholm |
30 may 2024 | may 30 | Regulatory Affairs 2024 Webinar and on-site | 1 | Webinar and on-site |
14 jun 2024 | jun 14 | Regulatory Affairs Academy Mingle Stockholm | 1 | Stockholm |
12 nov 2024 | nov 12 | 17th Symposium on Pharmacokinetics and Drug Metabolism Mölndal | 2 | Mölndal |
Details
Course
Basics of Regulatory Affairs
Date: 2023-12-05
End date: 2023-12-07
No. of days: 3
Venue: Biblioteket, Wallingatan 26 A, Apotekarsocieteten
Town/City: Stockholm
Participation fee
Price: 17000 SEK
Early registration
Price: 19200 SEK
Late registration
Other info
The fee includes digital documentation and certificate. The recorded lectures will be available one month after the live course for all participants.
All prices are excl VAT.
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043
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