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.

ASCRO at 7th Nordic Conference on Clinical Trials

ASCRO attended the 7th Nordic Conference on Clinical Trials in Oslo on 18-19 Nov 2019 with one delegate. The conference was well organised with approximately 170 participants from authorities, pharma companies, academia and CROs. The first day focused on updates from authorities and changes to regulations, and the second day had more forward focus into what might come in the future. There were good discussions during panels and between the presentations.

All the presentation slides are available for ASCRO members on the internal pages.

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.

Svar på artikel i DN 27/3 2018 ang CRO-branschen i Sverige

Vad är ett CRO-företag replik DN 28 mars 2018 final

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.

ASCRO represented at the National Conference on Clinical Studies in September 2017

ASCRO participated with a booth at the annual, national conference on clinical studies, this year arranged by “Kliniska Studier Sverige” (KSS) and KTA in Stockholm. Approximately 650 people attended the conference, mostly from healthcare/academia, but also from pharmaceutical industry and CROs. The representatives from ASCRO interacted with many representatives both from the member companies, industry and academia/healthcare. We also learned a lot about the status of national projects to improve the climate for clinical research. The theme for the conference was Clinical Trials of the Future.

Speakers came from: The Swedish CA, Nodes/KSS, Swedish Regions’ Research units, Academic Research Units, Patient Advocacy Groups, Pharmaceutical Industry, and more.

The program,  and presentation slides from the conference are available for ASCRO’s members in the internal pages of this website.

 

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.

ASCRO confirms associated membership in LIF

LIF, branschorganisationen för forskande läkemedelsföretag i Sverige och ASCRO, branschorganisationen för CRO-företag har ingått ett associationsavtal vilket innebär att organisationerna och dess medlemsföretag knyts närmare varandra.
– Den forskande läkemedelsbranschen stärks av samarbetet då vi, tillsammans med ASCRO, företräder en stor del av den företagsfinansierade och patientnära forskningen, säger Anders Blanck, VD för LIF.

– Antalet kliniska läkemedelsprövningar i Sverige har nästan halverats sett över en tjugoårsperiod, vilket i slutändan drabbar patienterna då de inte får snabb tillgång till nya innovativa behandlingsmetoder. Vårt samarbete innebär bland annat att vi, med en gemensam röst, kan verka för att fler kliniska prövningar genomförs i Sverige, säger Peter Asplund, vice ordförande ASCRO.

Associationsavtalet innebär i korthet att ASCRO:s medlemmar ansluter sig till Läkemedelsbranschens etiska regelverk, får tillgång till den infrastruktur LIF erbjuder och tar plats i flera av de expertnätverk och grupper som driver frågor inom kliniska studier. ASCRO flyttar också in och kommer att finnas representerade i lokalerna på Sveavägen 63.