For Chronic Myeloid Leukemia Patient Group Advocates

The Glivec International Patient Assistance Program #GIPAP is a unique direct-to-patient program that provides imatinib (Glivec) at no cost to eligible patients in low- and middle-income countries with CML or GIST.

Read this interesting article analysing the impact of the program between 2001 and 2014 using data collected by our member organisation, The Max Foundation.

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Please, read this guidance, agreed by the Clinical Trials Expert Group (CTEG) of the European Commission supported by the EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of the Heads of Medicines Agencies (HMA) and the GCP Inspectors’ Working Group coordinated by the EMA. 
 
Very interesting topics for patient advocates as additional clarification on obtaining informed consent, the link to methodological guidance on statistical considerations in relation to COVID-19 pandemic, advice on IMP stocks, safety reporting, the conduct of audits and temporary halts as well are included in this document.
 
This is Version 2 (27th March 2020) but due to the rapidly evolving situation, further updates to this guidance are possible and likely.