Date and place

web-course

Hinta

190.00€
(+ VAT)

Do you work in clinical trials in Sweden? Are you familiar with the regulations and laws governing clinical trials, the terminology of clinical trials, and the responsibilities of the different kinds of professionals in Sweden? Do you need to demonstrate your competency in GCP-related matters?
 

The new Swedish GCP web test is now available alongside the popular Finnish version of the GCP web test. With the test and its source materials, you will gain a broad understanding of GCP issues. In the source materials you will find e.g., regulations and laws governing clinical trials in Sweden, the terminology of clinical trials, and the responsibilities of different kinds of professionals.

 

The GCP web test meets the criteria for ICH GCP E6 training and meets the competency requirements for clinical trials in TransCelerate BioPharma member companies. When you pass the test, you will get a certificate in Swedish with which you can demonstrate your competence.

 

If you want to take a test aimed at the Finnish market, register here for the test in Finnish and here for the test in English.
 

Target group

 

The online test is suitable for anyone working in clinical trials, especially in the Swedish operating environment:

 

  • Pharmaceutical industry clinical trial management, research managers, and CRAs
  • Representatives of CROs
  • Healthcare professionals such as researchers, research nurses and coordinators
  • Industry authorities
  • Healthcare ICT actors and those working in health technology and device research
  • Patient organizations

 

In this training

 

  • You will learn the key terminology of clinical trials
  • You will learn what the roles, responsibilities, and obligations of different kinds of professionals are
  • You will familiarize yourself with examples of good and effective ways to work in clinical trials
  • You will acquire information about the regulations and laws governing clinical trials

 

Web Test is based on the following documents

 

  • ICH Guideline for Good Clinical Practice E6 (R2, Step 5) 
  • Helsingforsdeklarationen (Declaration of Helsinki)
  • Lag (2003:460) om etikprövning av forskning som avser människor
  • Läkemedelslag (2015:315)
  • Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor (inklusive ändringsföreskrifter 2016:10 och 2019:40)

Registration

 

You can register using the registration form on this web page. For group orders, please contact us: koulutus@laaketietokeskus.fi.

 

After registration, you will receive a confirmation email with instructions. You log in to pharmacademia.com with personal IDs, which are valid for 40 days from the date of registration (we will charge 50 e + VAT/week for any additional time). Before taking the test, it is important to familiarize yourself with the source materials in the e-learning environment.

 

The test is in Swedish and consists of 34 multiple-choice questions, which take a total of about 1–2 hours to answer. You need 80 % of the maximum score to pass the test. Those who pass the test can print or save a certificate in Swedish. (If you need a certificate in English, you must order an online test here.) Pharmaceutical Information Centre keeps a record of those who passed the test.

 

The price includes

 

  • 40 days to take the test from the date of registration
  • Instructions and materials in electronic form
  • One renewal option
  • Printable certificate of completion of the test

 

In co-operation

 

The web test has received funding from the Nordic Life Science Learning project of the Nordplus Horizontal program.

 

Yhteistyössä