Introduction to Regulatory Affairs in R&D
6,200 kr
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.
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.
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. To register to the online course, please follow this link: https://www.lakemedelsakademin.se/produkt/introduction-to-regulatory-affairs-in-rd-2/?lang=en
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.
Coming events: Events in English
Date | Date | Event | Days | Location |
17 apr 2024 | apr 17 | 4th Swedish Medicinal Chemistry Symposium Stockholm | 2 | Stockholm |
22 may 2024 | may 22 | Trends in Metabolic Studies of Pharmaceutical Drugs Stockholm | 1 | Stockholm |
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
Introduction to Regulatory Affairs in R&D
Date: 2019-05-21
Venue: Wallingatan 26A
Town/City: Stockholm
Participation fee
Price: 4900 SEK
Early registration
Price: 6200 SEK
Late registration
Other info
500 SEK Utskrift av kursdokumentation
All prices are excl VAT.
Contact
Project administrator
Veronica Helzel
Project manager
Sandra Trost
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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