Regulatory documentation, content and format guide
8,700 kr
May 7, 2025 Stockholm/Online
Ever longed for support on how to ensure regulatory documentation compliance internally and towards authority? Or on how to effectively project lead cross functional teams to meet the required timelines? This course gives you the insight of the do’s and don’ts and is a practical guide to current requirements and tools as well as a sneak-peak into the near future solutions, such as eCTD 4.0.For whom?
For Regulatory Affairs Managers or Regulatory Affairs Managers to be, who seek practical documentation guidance. We recommend having knowledge or experience equivalent to Läkemedelsakademin’s Basics of Regulatory Affairs at the least, to fully understand and benefit from the course.
Learning objectives
- Knowledge of applicable content and format for different regulatory applications, submissions and approvals
- Skills to plan, project manage and how to compile applications for various submissions.
- Competence to support in planning and execution of different regulatory submissions during the product’s life cycle and provide regulatory guidance on documentation requirements and format.
From the program
- Regulatory compliance - why? (Documentation requirements then and now, archiving requirements, traceability, Good Documentation Practice systems)
- Documentation structure - to authority (eCTD, Publishing in electronic submission platforms, communication with regulatory authorities)
- Documentation structure – internally (Document management - manual vs electronic systems, version control, product and submission overviews)
- Audit and inspection (Internal and by health authority)
- Regulatory project management (Practical tools and guides to lead the crossfunctional team and keep the time lines)
- Future documentation requirements - possibilities and potential risk aspects? (eCTD 4.0 and more)
Time and Venue
The course is held at Apotekarsocieteten, Wallingatan 26A in Stockholm and online. The course starts at 09.00 and ends approximately at 16.00 hrs. To register to the online course, please follow the link.
Participation fee
Early-bird participation fee is 8700 SEK until Apr 5th and thereafter 9800 SEK. Documentation and certificate in digital format, lunch and coffee are included in the fee. All prices are excl. 25% VAT.
Registration and 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.
Want even more regulatory competence?
Build your life science and regulatory affairs expertise with our longer program: Regulatory Affairs Academy
Coming events: Events in English
Date | Date | Event | Days | Location |
12 nov 2024 | nov 12 | 17th Symposium on Pharmacokinetics and Drug Metabolism Mölndal | 2 | Mölndal |
18 mar 2025 | mar 18 | 2nd Nordic Conference on Computational Chemistry Göteborg | 2 | Göteborg |
Details
Course
Regulatory documentation, content and format guide
Date: 2025-05-07
Venue: Biblioteket, Walling. 26A, Apotekarsocieteten
Town/City: Stockholm
Participation fee
Price: 8700 SEK
Early registration
Price: 9800 SEK
Late registration
All prices are excl VAT.
Registration
Contact
Project administrator
Lena Berlin
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
Utbildningar
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