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Brexit and HOVON sponsored studies

04 Mar 2019

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Brexit and HOVON sponsored studies


Dear pharmacists,
 
With just one month to go until Britain is set to leave the European Union, the final outcome of Brexit remains uncertain.
 
When no agreement is reached between the UK and the EU before March 30th, 2019,  supply of medicinal products from the UK to EU may be disrupted.
This may concern drugs that are manufactured in the UK and/or drugs that are QP released in the UK and/or drugs that are supplied from the UK.
 
To prepare for the consequences of a “no deal Brexit” we have made an inventory of the clinical supplies of all studies that are sponsored by HOVON.
(for studies that HOVON is participating in but not the main sponsor, you will be informed by the sponsor of the study, if applicable)
 
There are four scenarios applicable to HOVON sponsored studies:
1.       Study drugs are manufactured, released and supplied from facilities on EU territory
2.       Study drugs are manufactured and batch released in the UK but QP released and supplied by a vendor on EU territory
3.       Study drugs are manufactured, batch and QP released and supplied by facilities in the UK
4.       Study drugs are manufactured and batch released by facilities on EU territory but QP released and supplied by a vendor in the UK
 
Which measures are taken with regard to the respective scenarios?
1.       No actions required
2.       Vendors in the EU have received sufficient stock of the study drug to cover for at least 6 months of supply.
Manufacturers are relocating their facilities to EU territory or are acquiring the necessary import authorizations to assure continuous supply to the EU vendors
3.        
a.       Vendors located in the UK have relocated their activities (including QP release) for the EU to their facilities on EU territory.
They have sufficient stock of the study drug
Clinical Trial Applications (EudraCT form) will be amended accordingly.
b.      Manufacturers are relocating their facilities to EU territory or are acquiring the necessary import authorizations to assure continuous supply to the EU vendors
Clinical Trial Applications (EudraCT form) will be amended accordingly.
4.       Vendors located in the UK have relocated their activities (including QP release) for the EU to their facilities on EU territory.
They have sufficient stock of the study drug
Clinical Trial Applications (EudraCT form) will be amended accordingly.
 
Which measures do sites need to take?
1.       Check the inventory of your study drugs for the following studies:
HO87, HO89, HO95, HO114, HO129, HO134 and HO147
2.       Discuss with the site investigator the status of the study, the active patients and the expected accrual of patients
3.       Order study drug if necessary to cover for the next 3 to 4 months for active and expected patients
Try to avoid any hoarding at your site.
4.       Order before March 8th, 2019 to assure drug delivery before the Brexit
 
In summary…..
As currently known, none of the HOVON sponsored studies will experience any problems regarding drug supply or QP release, since vendors and/or manufacturers have relocated their activities to EU territory or sufficient stock is present on EU territory.
Sites are advised to order drug for the next quarter before March 8th, 2019.
 
We hoped to have informed you sufficiently. Please do not hesitate to contact us in case of any questions (hdc@erasmusmc.nl).