Ny ASCRO-styrelse 2020

ASCRO har ny styrelse och ordförande sedan årsmötet den 31:a mars 2020.

Ny ordförande är
Helena Lüning, ICON

Övriga styrelsemedlemmar är:
Hedda Magnusson, Syneos Health
Martina Stenerdal, PPD
Jan Hellqvist, KLIFO
Fredrik Hansson, CTC
Erik Olaisson, Scandinavian CRO

E-learning Biobankslagen: uppdaterad och kostnadsfri

Denna e-learning är en grundläggande utbildning som grundar sig på material framtaget av Biobank Sverige.
Projektet startades 2016 av Läkemedelsakademin/Apotekarsocieteten, ASCRO, Biobank Sverige och LIF.

Uppdaterad och kostnadsfri

Utbildningen har nu uppdaterats i enlighet med ändringar i biobankslagen från 2019.
En annan nyhet för 2020 är att aktörerna i projektet erbjuder utbildningen kostnadsfritt för alla i branschen.

Innehåll och format

Utbildningen är som förut 100 procent webbaserad och tar cirka 60 minuter att genomföra. Efter en kort kursutvärdering kan du ladda ned ditt kursdiplom.

  1. Kort om biobankslagen – när gäller den?
  2. Biobank – regelverk, inrätta, biobanksansvariges uppdrag, kvalitetshandbok
  3. Provhantering – utlämna/skicka för analys, hantering, förvaring
  4. Vad ska provgivaren samtycka till (utomlands, förvarandetid, destruera prov)
  5. Olika avtal för tillgång till prov (singelcenter- och multicenterstudie)
  6. Under studiens gång (väsentliga förändringar, kompletteringar, avslut)
  7. Fall 1 – 5 (genomgång av olika typfall)

Målgrupp

  • Personer som skriver ansökningar om tillgång till prov för forskning.
  • Organisationer som ska bedriva kliniska prövningar med prover i Sverige, även utländska aktörer som inte har lokal anknytning.

Access

Klicka här och registrera dig kostnadsfritt:
https://lma.learnster.com/invitation/be1e8e521df37bdf0e6fef464d590ac6?vendor=lakemedelsakademin

Happy Learning!

Läkemedelsakademin, ASCRO, Biobank Sverige, LIF.

Ulrika Heldestad – new member of the board

Ulrika Heldestad from Scandinavian CRO is a new member of the board of ASCRO as of June 2019.

We welcome her to the team and very much look forward to her contributions to the work we plan to do together in the future!

ASCRO at Nordic Life Science Days Sep 2018

ASCRO attended the Nordic Life Science Days in Stockholm 11-12Sep2018 with a number of representatives being present both from the board of ASCRO and from member companies. Discussions were held with potential new members, but also with other parties such as different companies within drug development and organisations such as Sweden Bio. There are many interesting initiatives going on in Sweden, as well as in our neighboring countries, within the Life Science sector and they all have the goal to strengthen and develop this area. Two that are worth to mention are Testa center in Uppsala and the Finnish project with the national biobank and genomic mapping.

ASCRO attending 6th Nordic Conference on Clinical Trials, Helsinki, October 2017

ASCRO attended the 6th Nordic Conference on Clinical Trials in Helsinki, October 25-26 2017.

The conference was focused on the new regulations for both clinical trials on medical products and medical devices. Different speakers from both authorities, pharma industry, healthcare and academia presented different topics around the regulations and the current preparations that are ongoing, and there were also examples given on how collaboration between the Nordic countries can be productive.

Unfortunately the CRO companies were not represented among the speakers or panelists during discussions at all. Good interaction was despite this achieved with both representatives from authorities, industry and healtchare/academia. Next conference with themes relevant for clinical researches will be in Thailand, Koh Samui, with possibility to rent accommodation on YourKohSamuivillas.com.

In summary – we all have a lot to gain from working together across the Nordic borders, and there will be need for CRO support of the medical advice industry with the new regulations. Slides from the presentations can be found in the members’ pages.

Members’ meeting with MPA update

A members’ meeting was held in Stockholm on 12Jun17 during which Catharina Forzelius, from the Swedish MPA, informed about the preparations that are ongoing for the new EU legislation around clinical trials. She also informed ASCRO about the new test-portal and procedure for applications for clinical trials. After this, Christina Forselius, chair of te board, discussed the new ICH GCP R2.