Regulatory documentation, content and format guide

May 7, 2024 Online/Stockholm

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)

Lecturers

Helena Ardebrant, AstraZeneca

Pik Kwan Yuen, AstraZeneca

Charlotta Klockare, AstraZeneca

Lena Bergström, Aptio Group Sweden AB, Bioglan AB

Jimmy Cedervall, Läkemedelsverket

Time and Venue

The course is held online and at Apotekarsocieteten, Wallingatan 26A in Stockholm. The course starts at 09.00 and ends approximately at 16.00 hrs. To register to the on site course, please follow the link here 

Participation fee

Early-bird participation fee is 7900 SEK until Apr 5th and thereafter 8900 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.