PharmaLex and NDA Group join ASCRO

We are happy to welcome two more new member companies into the ASCRO family:

PharmaLex and NDA Group

Looking forward to collaborating with you both and to support you as your life science service provider business organisation!

CTC – new member in ASCRO

We are very pleased that CTC – Clinical Trial Consultants re-joined ASCRO late last year,
We look forward to involving them in our community and welcome them back to take part in all of our activities!

Arex Advisor new member in ASCRO

We are delighted to welcome Arex Advisor as the latest new member in ASCRO! We very much look forward to their contributions to our activities and our network!

Viedoc new member in ASCRO

We are thrilled to welcome our latest member company into ASCRO: Viedoc!
Looking forward to receiving new perspectives and thoughts in our group.

ASCRO a member of EUCROF

On the same day as our 10 year anniversary, ASCRO rejoined our European business organisation EUCROF.

We are very happy to again be part of this association that bring CROs in Europe together!

We also look forward to being able to both contribute and benefit from all the activities and meetings within and by EUCROF.

ASCRO 10 Years 29Sep2021!

What a night and what a fantastic event!

We want to thank everyone who came and contributed to the interesting discussions and the festive atmosphere!

A special thanks to the experts on the discussion panel:
Anders Blanck, Peter Asplund, Hans Winberg, Björn Arvidsson and Jennie Nordborg.

Material and information about the upcoming CTIS from EMA

Time to start preparing for real – soon CTIS goes live!
You can find useful information and training materials on the EMA website:

Clinical trials information system: training and support | European Medicines Agency (europa.eu)

New Associate Board Member

We are happy to announce that we have a new associate board member in ASCRO: Annsofie Holmborn.

Annesofie is a dedicated Life Science professional with a background as a registered nurse and registered pharmacist presently working as a Clinical Manager, Start-up Operational Delivery for Finland, Norway and Sweden at PPD. She also holds a position within Global Regulatory Affairs at PPD since 2012, currently as Regulatory Affairs Manager.
Drug development, clinical trials and Regulatory Affairs has been her area of expertise since 2008 and she is also a member of the GCP workstream in LIF (Läkemedelsindustriföreningen), the trade association for the research-based pharmaceutical industry in Sweden.

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.