Pecyn Cymorth Gweithgynhyrchu a Pharatoi
Mae'r Pecyn Cymorth hwn yn gasgliad o ddogfennau sy'n manylu ar arferion gorau a chanllawiau arbenigol mewn perthynas â gweithgynhyrchu Cynhyrchion Meddyginiaethol Therapi Uwch (ATMPs). Ei bwrpas yw lledaenu gwersi o'r ATTCs a chynyddu ymwybyddiaeth o arferion gweithgynhyrchu da ar gyfer ATMPs.
Mae canllawiau wedi'u categoreiddio i dair maes; Dadansoddi Celloedd, Gweithgynhyrchu Celloedd, a Fferylliaeth a Rheoleiddio.
Pecyn Cymorth Parodrwydd Therapïau Uwch y GIG
Mae pecyn cymorth parodrwydd y GIG yn darparu adnoddau ar gyfer sefydliadau gofal iechyd sy'n gweithio tuag at ddarparu therapïau uwch i gleifion. Fe'i bwriedir ar gyfer gweithwyr proffesiynol ar draws arbenigeddau allweddol sy'n ymwneud â darparu therapïau uwch.
Clinical Trial start up tool for ATMPs in the UK
The Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) has developed a tool which collates the various regulatory guidance documents and processes encountered along your pathway to an active ATMP clinical trial. The tool aims to highlight efficiencies that may support progress towards making the UK government’s goal of 150 days from clinical trial submission to first patient applicable to ATMPs.
A glossary of the review bodies involved in trial site start‑up across the United Kingdom is provided, and the scope and underlying assumptions are defined. An interactive pathway then cross‑links to relevant cheat sheets aligned to each process step. Information has been reviewed by the relevant regulatory bodies.