Ndeapi Mabasa ari muGreat Demand?
Maererano neRégulatory Affairs Professional Society (RAPS) inotarisira hurumende inyanzvi dziri kudiwa, uye chido ichi chiri kuwedzera. Kuwedzerwa, mubhadharo wemabasa akawanda muhutano hwezvematongerwo enyika huri kuwedzera zvakare.
"Vadzidzisi vezvemagariro ... vanoita mabasa akawanda anokosha mukuunza hutano hwezvokurapa kuti vatengese, uye basa racho rakaratidza kusagadzikana kumakambani ekuderedza," mhinduro yavo yemazuva ano inotaura pawebsite yeRAPS.
Dzemitemo yehurumende inosungirirwa kuongorora mishonga yezvokurapa uye zvinodhaka kuti uone kubudirira kwavo nekuchengeteka kwavo kune varwere nevatengi. Mishonga yemakiriniki nekutsvakurudza zvinotungamirirwa nemhando dzakasiyana-siyana dzezvesayenzi, vanachiremba , vanachiremba, vashandi vezvokurapa vashandi , uye vashandi vakawanda vehutano vanoshanda pamwe chete nehutungamiri hwezvematongerwo enyika, avo vane basa rekuona kuti zvese zvinogadzirwa nemishonga zvinowirirana nehurumende mitemo ye mishonga yemakirini nemishonga.
Kuti udzidze zvakawanda pamusoro peizvi kazhinji zvisingakanganwi chikamu chemashandiro ehutano hwehutano, Mutungamiri Mukuru weRégulatory Affairs Professional Society (RAPS) akagovera ruzivo rwake rwakakura rwebasa nesu.
Sherry Keramidas, Ph.D., FASAE, CAE yakapindura mibvunzo inotevera pamusoro pebasa muDare Rezvemutemo:
Q. Ndezvipi zvekuchengetedza zveMatongerwo emabasa zviri kunyanya kuda zvino? Unyanzvi hupi uye hunyanzvi hunodiwa zvikuru munharaunda yeR RA?
A.
Pane chido chevadzidzisi vekutonga pazvinenge zvose zvehutano hwemabasa, uye kunyanya kubva kune unyanzvi kusvika kune VPs. Izvo zvinodiwa zvinoratidzwa munzvimbo dzakawanda dzakasiyana-siyana dzekushanda - mhizha (maduku maduku uye mapakati-size kusvika kune dzimwe nyika), masangano ehurumende (saU.S. FDA, European Medicines Agency, nezvimwewo), kliniki uye hospital https: // www. / chii-is-hospital-observing-status-1738754 ital settings, vunivhesiti inobatanidzwa mukutsvakurudza uye kuongororwa kwemakiriniki, mazano uye masangano ekutsvakurudza kwekliniki anoshandisa makiriniki ekuedzwa.
Vashandi ndivo vanonyanya kudiwa vadzidzisi vane mamiriro akaenzana nehutano, hutungamiri hwehupenyu uye / kana mutemo wezvigadzirwa zvehutano.
Pazvinzvimbo zvekupinda, vashandi vanowanzotsvaka vashandi vanonzwisisa chikwata chemishonga uye vane ruzivo rwemitemo. Vanofanira kuita zvinopfuura kungoyeuchidza mitemo. Vadzidzisi vezvekutonga vanofanira kuda kuziva mitemo yakakodzera, hongu, asi ivo vanofanirawo kunyatsoongorora mitemo yekugadzirisa uye kushandura zvinorehwa nemitemo kune basa remasangano avo. Vanofanira kukwanisa kushandisa ruzivo rwavo nekufunga zvakadzama. Vanofanirwawo kuva vatauriri vanobudirira, kubatsira vashandi vavo kune dzimwe nzvimbo dzemasangano avo kunzwisisa zvinorehwa.
Sezvo vachikwira basa remabasa, rinova rinonyanya kukosha kune vashandi vekutonga kuti vawedzerewo hutano hwavo hwebhizimisi (mari, kutengesa, mutemo, nezvimwewo) uye vanogona kuunganidza ruzivo rwavo rwekutonga mune zvebhizimisi hurongwa nekuita zvisarudzo, kazhinji kune dzimwe nyika scale.
Q. Ndeupi mazano aungapa kune vanhu vanofarira basa rekugadzirisa zvinhu? Ndekupi kwavanofanira kutanga, uye vanofanira kuitei kuti vatengese zvikuru kune vashandi?
A.
Vanhu vazhinji vanoita shanduko muhutano hwekutonga vane ruzivo rwakakosha pane ruzivo rwekushanda munzvimbo dzakabatana (semuenzaniso, kutsvakurudza nekuvandudza, unhu kana basa rechipatori). Vamwe vanogona kushanda mune sangano rine dhipatimendi rinodzora. Mumamiriro ezvinhu akadaro, zvinobatsira kubatanidza nekutaura nevamwe vashandi vekutonga uye kunyange kutsvaga mikana ye "mumvuri" iwoyo kana kutungamirirwa. Vashandi vanowanzotarisa vanotora avo vanogona "kurova pasi vachimhanya," uye vanotora basa rechokwadi, rakaoma nekugadzirisa pakarepo pavanenge vashandira. Kuwana kushandiswa kwebasa rinotungamirira kubva musangano kunogona kupa mukana wekuwana ruzivo rwekutonga usati waita shanduko yepamutemo kupinda mumunda.
Chimwe chinhu chinonyanya kukosha pakutengesa kune vashandisi ndivo Regulatory Affairs Certification - kuzivikanwa kweRAC. IRAC ndiyo chete yakagamuchirwa, yepamushure-dzidzo, chiziviso chemhizha kune unyanzvi hwekutonga ari kushanda muhutano hwezvigadzirwa zvehutano.
I-RAC inotarisana neongororo, pamwe nekuongorora kwakagadzirwa maererano nemabasa chaiwo evadzidzisi vekutonga. RAPS 'tsvakurudzo inoratidza kuti vashandi vane ruzivo rweRAC vanowana zvakawanda kupfuura vezera ravo (vanenge 10% muNorth America), uye vari kufambira mberi mumabasa avo. Vamwe vashandi vanopa mavari kune vashandi veRAC mubasa ravo rekubhadhara, sezvo rinoratidza hutano hwekunzwisisa mitemo, unyanzvi hwokushandisa ruzivo rwekutonga uye kuzvipira kwekudzidza nguva dzose nekusimudzira ruzivo (RAC inoda kugadziriswa kwemakore ose matatu).
Zvakakosha kucherechedza, zvisinei, kuti kuongorora kweRAC kunoshandiswa kune vadzidzisi vane makore matatu kusvika mashanu ekutonga kwekutonga, saka kune mumwe munhu achangopinda mukutonga, zvingava chimwe chinhu chingaisa muzvirongwa zvekuita basa ravo kwemakore mashomanana pasi pemugwagwa .
Q. Ndeapi mapurogiramu ezvidzidzo waungakurudzira kune vanhu vanofarira mabasa ekugadzirisa nyaya?
A. Kune zvakawanda zvingasarudzwa kune avo vanofarira kupinda mukutonga kuti vabatsire kuvakira ruzivo rwavo rwekugadzirisa kwemishonga yehutano. RAPS inopa mafundo akawanda eIndaneti anowedzera pfungwa dzinokosha dzehutano hwezvigadzirwa zvemitemo nekugadzirisa nyaya pachikamu chimwe nechimwe cheupenyu hwemichero uye kumativi akasiyana enyika. RAPS inopawo chigwaro mune zvinyorwa zvekurapa zvigadzirwa zvemishonga uye / kana mishonga yemishonga, iyo inowanikwa nekuzadzisa zvakatevedzana zvezvikoro izvi, uye RAPS inopawo mavara ezvinyorwa zvinyorwa nezvimwe zvidzidzo zvekudzidza semitambo, webcasts, nezvimwewo. kupa zvikwereti zvidzidzo kana madhigirii echikoro mukuraira.
Mubvunzo. Sei mumwe munhu angafarira basa mune zvekutonga? Ndezvipi zvinhu zvakanakisisa zvekushanda mumunda RA?
Kudzora inzvimbo yakaoma uye ine simba. Basa uye mabasa zvinobatanidza ruzivo uye unyanzvi kubva munzvimbo dzakasiyana siyana-sayenzi uye teknolojia, zvipatara masango, mutemo, mutemo, bhizinesi. Kune vanhu vazhinji, izvi zvinopa mikana yekuwedzera nekushandisa ruzivo rwavo uye unyanzvi munzvimbo itsva.
Izvo zvinosimba zvebasa rekutonga zvinoratidzwawo kuti basa iri rakashanduka sei nekuchinja mune sayenzi yezvokurapa uye teknolojia iyo inowedzera kukura kwechigadzirwa, kuwedzerwa kwekudyidzana kwepasi rose kwehutano hwezvigadzirwa zvehutano uye kuchinja kudiwa kwevanhu. Uye zvechokwadi, pakupedzisira, basa rekutonga rinobatanidzwa mukuunza zvinhu zvakachengeteka uye zvine utano kune vanhu pasi pose. Basa raunogona kunyanya kuzvikudza.
Q. Ndeapi mamwe ematambudziko makuru pamusoro pemabasa ekutonga? Chii chakanyanya kuoma kune vanotsvaka basa uye iye zvino maR profession?
Pakati pematambudziko makuru ndeahutano hwakasiyana uye hupamhi hwebasa. Kuchengetedza ikozvino uye kukura, vadzidzisi vekutarisira vanofanira kuisa pfungwa pane dzimwe nzvimbo dzakasiyana pane pane imwe nzvimbo yakamanikana. Icho chiwo chinhu chakanaka kune vazhinji vadzidzisi. Iko kunowanzova yakawanda yematambudziko mumitemo, inoda kunyatsoongorora, mamiriro ekufunga, uye kududzirwa. Apo vashandi pamwe nevatongi vangave vachitsvaga mhinduro yakajeka-yakatemwa, izvi hazvisi nguva dzose zvichibvira; zvinorehwa nemitemo iripo kana inogona kuve inogona kuva yakawanda.
Kurairirwa kunewo nzvimbo inodhura mumhizha uye mune dzimwe masangano, inenge isina simba kune dzimwe nzvimbo kusanganisira kutengesa uye kutengesa. Zvisinei, kuwedzera, CEOs iri kuona kukosha kwehutano hunokosha hwehutano hwekutonga sechinhu chinokosha chebhizinesi rezvebhizimisi. Pakupedzisira, mukugadzirisa nzira yekugadzirisa, vatungamiri vekutungamirira vanofanira kutora maonero akaoma pasi rose, kusanganisira marudzi akawanda emaketani emaketani ekugadzira michina, kutengeswa kwepasi rose, uye kutengesa, uye zvakasiyana-siyana, kusiyana kwekutengesa uye postapproval kuongororwa zvinoda nzvimbo dzakawanda.
Kune vatsvaki vemabasa avo vari kutoshanda maitiro mune dzimwe mamiriro, vanogona kutarisana nechinetso chokuwana mukana wekutamira munzvimbo yekutonga pasina ruzivo rwekutonga. Mune zvimwe zviitiko, vangave vachifanira kugamuchira danho riri pasi muhurukuro uye mubhadharo kusvikira vachigona kuratidza mano avo. Ph.D. mutevedzeri we laboratori haafaniri kutungamira zvakananga mumutungamiri mukuru wepamusoro.
Q. Unoona kupi munda weR RA mumakore mashanu, uye makore gumi kubva zvino? Ko pachava nekuchinja kukuru kwekutsvaga here kana iwe unofunga kuti ikozvino maitiro emabasa achaenderera mberi maererano nekukura uye kuda?
Zvakaoma kunyatsofungidzira kuti basa iri richaonekwa sei mumakore mashanu kana gumi, asi rakaratidza kuti rinogona kugadziriswa pamusoro pemakore makumi maviri akapfuura, saka zvine musoro kutenda kuti zvicharamba zvichigadzirisa uye kuchinja. Kutsvakurudza kwakaitwa neRAPS kwemakore anopfuura makumi maviri zvinoratidza pachena kuti rutivi rwebasa revanodzidza zvekutonga rakagadziriswa nekushanduka kwesayenzi, bhizinesi uye mutemo. Dzimwe ruzivo rwezivo iyo ndiyo nheyo yebasa uye chido chevadzidzisi vekutonga kuti varambe vachiwedzera ruzivo rwavo munzvimbo dzakawanda dzakasiyana kunogona kuva chiratidzo chinoratidza kuti basa racho rucharamba richigadzirisa nekukura.
Kudiwa uye kuda kwezvinhu zvakachengeteka uye zvinobudirira zvehutano zvinotarisirwa kukura mumakumi makumi emakumi anotevera, zvinotungamirirwa nekukwegura vanhu uye kuwedzerwa kwenguva refu, kuwedzera kwezvirwere zvisingaperi, uye kuwedzera kwekuziva nekusvika kune zvigadzirwa zvehutano pakati pevanhu pasi rose. Chido uye chido chevadzidzisi vekutonga munzvimbo dzisina basa iri (Asia, Latin America, Middle East neAfrica) inotarisirwa kukura zvakanyanya mumakore mashanu anotevera uye kupfuura. Izvo zvinoda kuNorth America neEurope zvinofanira kuramba zvakasimba.
Tinotarisira vadzidzisi vekutonga kuti vatonyanya kukosha-zvose mukati mehurumende dzavo uye zvakanyanya mukuedza kuvandudza hutano hwehutano uye hutano hwehutano. Izvo basa riri kutora zvipo zvinokosha kumabhizimisi nemagadziro emitemo, asi maitiro ehutano (mutumbi waro ruzivo, ruzivo rwebasa uye dzidzo nekuenderera mberi kwehutano hunoitwa nhengo dzayo) inofanira kuita kuti basa racho rive rakakosha zvikuru mu ramangwana.
Q. Ndeipi chimwe chinhu chaunofunga kuti chinokosha kune iye zvino uye / kana mune ramangwana RA vadzidzisi kuziva panguva ino? Iwe unayo mamwe mazano, maitiro, nezvimwewo, unoda kugovana nevanhu vanogona kutsvakurudza mabasa munzvimbo yeRA.
A. Ichi ndicho chiitiko chinonakidza uye chakaoma ichocho zvakare "basa" rokuita. Kuti zvibudirire nyanzvi yekugadzirisa inofanira kuva inyanzvi yekufunga iyo inoda uye inokwanisa kubatsira vashandi-kubva kuvatsvakurudzi nevanjiniya, kune vhudzi uye vashandi vekugadzira, vashandi vekuchipatara, kutengesa, uye kutengesa, mari uye vatariri vakuru-vanzwisise zvinorehwa nehutano pane chigadziko cheupenyu hwechibereko. Munguva yakapfuura, mune dzimwe masangano, vashandi vekutonga vakaonekwa se "mabhutiro" ekugadzirwa kwekutengesa nekushambadzira. Izvozvo zvachinja. Vanonyanya kukoshesa mukugadzirisa chisarudzo ikozvino kupfuura kare, uye vatariri vauya kuzoziva kukosha kwehutano hwekutonga mukubatsira kudzivisa ngozi dzinogona kuitika. Mutungamiri wekutungamirira ari munzvimbo yakasiyana-siyana semuchengetedzi wevanhu vanovimba (kuchengetedza mitemo yehurumende inoteererwa) uyewo somuchengetedzi wemufananidzo uye kuvimbika kwesangano raanoshanda.