Is-Segretarju Parlamentari Deo Debattista jinawgura l-espansjoni tal-bini u żieda fl-impjegati tal-Awtorità dwar il-Mediċini

Is-Segretarju Parlamentari Deo Debattista jinawgura l-espansjoni tal-bini u żieda fl-impjegati tal-Awtorità dwar il-Mediċini

 L-Awtorità dwar il-Mediċini taħdem fuq tliet pilastri: l-effikaċja, is-sigurtà u l-kwalità tal-mediċini. Is-suċċess tal-Awtorità dwar il-Mediċini huwa attribwit lill-impjegati professjonali motivati ​​li jaħdmu f’ambjent proattiv sabiex isostnu l-iżvilupp dinamiku fix-xjenza u l-ħtiġijiet regolatorji kemm lokali u dawk Ewropej. L-Awtorità dwar il-Mediċini esperjenzat tkabbir sostenibbli f’impjegati bi kwalifiki għolja.

 L-investiment estensiv fil-kapaċità jirrifletti l-espansjoni tar-rwol regolatorju tal-Awtorità dwar il-Mediċini skont il-leġiżlazzjoni nazzjonali u Ewropea fi tħejjija għall-isfidi u l-opportunitajiet ippreżentati minn Brexit. Il-funzjonijiet regolatorji ewlenin tal-Awtorità qed jiġu ottimizzati. Id-Direttorat tal-Liċenzjar żid b’mod sinifikanti n-numru ta’ prodotti mediċinali rreġistrati f’Malta. Id-Direttorat tal-Post-Liċenzjar eċċella fil-farmakoviġilanza. Id-Direttorat tal-Ispettorat u l-Infurzar żied l-ispezzjonijiet ta’ pajjiżi terzi. Id-Direttorat tal-Istrateġija, l-Operazzjonijiet u l-Affarijiet Regolatorji kien strumentali biex inkiseb rikonoxximent Ewropew u internazzjonali u ġiet żgurata s-sostenibbiltà tal-Awtorità.

 Id-Direttorat għall-Inizjattivi Xjentifiċi Avvanzati ġie stabbilit biex isaħħaħ is-settur xjentifiku tal-Awtorità dwar il-Mediċini u biex imexxi inizjattivi avvanzati li jseħħu f’Malta u fl-Ewropa, inkluż ir-regolamentazzjoni tal-kannabis għall-użu mediku. Għaddejjin diskussjonijiet ma’ stakeholders lokali u internazzjonali sabiex tiġi assigurata l-kwalità u s-sigurtà tal-prodotti tal-kannabis mediċinali miż-żerriegħa sal-pazjent. Qed isiru wkoll proġetti oħra dwar ir-regolamentazzjoni xjentifika tat-tagħmir mediku u tal-mediċini veterinarji.

 Ir-riċerka, it-taħriġ u l-edukazzjoni huma fundamentali għat-titjib tal-portafoll tal-Awtorità dwar il-Mediċini. B’numru ta’ modi diversi, l-impjegati tal-Awtorità dwar il-Mediċini jingaġġaw f’edukazzjoni kontinwa bħala parti integrali mix-xogħol tagħhom. L-għarfien iggwadanjat saħħaħ il-pożizzjoni adottata biex jintlaqaw sfidi u żviluppi fl-ambjent dinamiku tar-regolazzjoni tal-mediċini.L-isforz kollettiv, il-kooperazzjoni u l-koordinazzjoni bejn l-impjegati professjonali u l-stakeholders poġġa l-Awtorità dwar il-Mediċini bħala regolatur eċċelenti.

 Is-Segretarju Parlamentari għall-Protezzjoni tal-Konsumatur u Valletta 2018 Deo Debattista qal li l-Awtorità dwar il-Mediċini ġiet rikonoxxuta mill-European Regulatory Network u l-US Food and Drug Administration għall-istandards professjonali u xjentifiċi tagħha. Dan is-suċċess tal-Awtorità dwar il-Mediċini qed jissarraf f’kontribut attiv fl-ambjent internazzjonali, xjentifiku u teknoloġiku.

 L-estensjoni tal-bini inawgurat illum ifakkar sitt xhur mill-mewt ta’ Micheal Chetcuti, assessur eżemplari u intelliġenti tal-mediċina. Dan il-post tax-xogħol jikkonsolida l-istrateġija tal-Awtorità dwar il-Mediċini bħala regolatur independenti, xjentifiku u li jpoġġi l-pazjent fiċ-ċentru tax-xogħol tiegħu.

PRESS RELEASE BY THE PARLIAMENTARY SECRETARIAT FOR CONSUMER PROTECTION AND VALLETTA 2018

Parliamentary Secretary Deo Debattista inaugurates the extension of the premises and an increase in personnel of the Malta Medicines Authority

The Malta Medicines Authority works on three pillars: efficacy, safety, and quality of medicines. The success of the Malta Medicines Authority is attributed to the motivated professional employees who operate in a proactive environment to meet the dynamics of scientific development, stakeholder needs, and local and European regulatory requirements. The Malta Medicines Authority has experienced sustainable growth with the help of highly qualified employees.

 The extensive investment in capacity building reflects the expanding regulatory role of the Malta Medicines Authority in line with national and European legislation in preparation for meeting the challenges and grasping the opportunities presented by Brexit. The core regulatory functions of the Authority are being optimised. The Licensing Directorate significantly increased the number of registered medicinal products in Malta. The Post-Licensing Directorate excels in pharmacovigilance activities.  The Inspectorate and Enforcement Directorate increased its third country inspections.  The Strategy, Operations and Regulatory Affairs Directorate was instrumental in gaining European and international recognition and ensuring the sustainability of the Authority.

 The Directorate for Advanced Scientific Initiatives was established to enhance the scientific acumen of the Malta Medicines Authority and to lead advanced initiatives in line with developments occurring in Malta and in Europe, including the regulation of medicinal cannabis. Discussions are ongoing with local and international stakeholders to ensure the quality and safety of medicinal cannabis products from seed to patient. Forthcoming projects in line include the scientific regulation of medical devices and veterinary medicines.

 Research, training and education are fundamental for enhancing the Malta Medicines Authority portfolio. In a number of diverse ways, the personnel at the Malta Medicines Authority engage in continued education as part and parcel of their commitments. The expertise obtained is key to strengthening the knowledge-based approach adopted to respond to challenges and developments in the dynamic environment of the Malta Medicines Authority. The collective effort, cooperation and coordination of best practices between all professional employees and stakeholders has positioned the Malta Medicines Authority as a forward-looking best in class regulator.

 Parliamentary Secretary for Consumer Protection and Valletta 2018 Deo Debattista stated that the Malta Medicines Authority is recognised by the European regulatory network and the US Food and Drug Administration for its high professional and scientific standards. Following this success, the Malta Medicines Authority is taking on new challenges as an active contributor in the rapidly changing international, scientific, and technological environment.

 The extension of the premises inaugurated today is dedicated to Micheal Chetcuti, an exemplary and intelligent medicine assessor who passed away six months ago. This workplace consolidates the strategy of the Malta Medicines Authority as an independent, scientific, and patient-centred regulator.

 

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