Regulatory Affairs, Bioethics & Bio-Safety - 17BT61 PDF

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PR( P4£ U R~H IP BIO· BU$11 £~S AtlD EN TR( 17BT61 ?V.:\IOOt.:LE - 5 , BIO ET HI CS & 810-S~fFE TYT RE GU LA TO RY AF FA IRS tor y bod i~ ss-regula and at/cir regulations (ex.FD A , EU ~ DSIR. , Regulatory affairs in Bio busine ii: prvecs s ~f.6iotcchnology inv olv ed in gen era tin g new ic edu cat ion of\J A YU SH , FSS AI ctc.,)P ubl log y res ear ch and orm ed decisio n-m aki 112. C'1hbf' concerns of bio tec hno forms of life for inf risk s. Ra tio nal VS. wit h nat ure fea r of unk nown unequal dis trib utio n of innovation-Interfere nce osu re and ks ~b e~.fi ts, ' ~cl atio ~hi p between ris ~ haz ard , exp ~ubjective perceptions of ris of society, reg ion , cou ntr y and s. Bio saf ety co nc ~r , c ~e l individuals, institutions, safeguard. ~ bi_osafety. Biosafety ma nag em ent the world. The Ca rta ge na ET HI CS & BIO-SAFETY: REGULATORY AF FA IR S, BIO ns (eL FD ~ EU , ain m Bio ba sia as- rqu lat ory bodies and the ir reg ula tio Rq ula tor y aff DS I~ A YV SH , FS SA I et~ ) arm ace uti cal s, me dic al airs is a pro fes sio n wit hin regulated industries nam ely -ph ind ust rie s Regulatory Aff ban kin g It has spe cifi c meaning wit hin hea lth car e devices, energy and (ln thi s blo g I am goi ng ,, namely- pha rm ace utic als , me to deal abo ut Re gul ato ry Affair Regulatory Affairs in the dic pha al dev ice s, biologics and fun ctio nal foo ds. s rel ate d to pba nna ceu tica ls me rm a ind ust ry ma ant for hu ma n use ). y be defined as..Th e int erf ace bet we en the ncies across the world. pharmaceutic al company and the reg ula tor y age ise s- RA as pro fes sio n is bro ader than registration of pro duc ts, they adv Role of RA Professioaal hest level Th eir role begins right fro m and t«b nic all y at the hig companies both scrategical)y po st ma rkd ing. □ Th ey advice at all stages kin g. ma rke tin g and development of a product to ma.rt1 11aim hel p com pan ies sav e a lot of tim e uir em ent s and both in tam s of legal and tedmical req t:o mp iW II., Dr.l.mgdl,arGouri pur Pa ge 18 6 0q t ofBT, TOCE  17BT61 and. BIO-BUSINESS AND (NTREPRENEURSHIP money in dcvcto. Ping the Prod. company s success both U\:t nnd markctin U1c s..~ Efficacy ofth comm1:rcially and sci. t'fig rune. They haven major con1ribu1ion in e Products en I as per n:gulation laid ically · Thci r mam · I · ro e 1s to comply with Safety In an organization th.. down by the government. d ctr pnmc l'\.'S 'h.. ocumc.-nts to l"l" I rons1 ihtics involves. man. gu atory agencies and preparation and presentation of registration ctmg authorization (MA) for th codarry out all following discussion to obtain and maintain e pr ucts concerned. Goals of Rc~'Ulatory Aff:.. all'S as profession- ~ Protc.-ction of human health Ensuring safi ty. c n- , e icacy and quality of drugs ~ r A. Ensunng appropriateness and accuracy of prod. fi. uct in orrnation Roles of Regulatory Affairs professionals- Act as a liaison with reoulatory aoen. o o CICS. Prepar.ition. of orgamz= · -~- and scientifi II subnusswns ca Y valid NOA, ANDA,INDA ,MAA,DMF ;.. Ensure ad~erence and compliance with all.'.:.-uiddmes, regulatwns and laws the applicable cGMP. ICH, GCP, GLP. Providing expertise and regulatory intellioen.. pracucal workable plans c. ce m translatmg regulatory requirements into Ad\'ising the companies on rcgulato as. proposed activities ry pects and climate that would affect their Ap:::1 ~omalthelabovc main roles, there are various other roles which Regulatory Affairs pro1ess1on s p ay. General work profile of a Regulatory Affairs professional in a Drug Product /Fini hed product/Fonnulation manufacturing company _ s. Filing a NDA/ANDA/MAA of drug products with regulatory agencies for getting ID.1Iketmg approval. Assessing and filing suppJements/amendmentslvariations to the information (which may be related to manufacture, controi stability studies etc) in NDA/ANDAIMAA with the Rcgujarory agencies for prior approval or after their implementation. ~.ior supplements/amendments are to be reported prior to their implementation while l'Jinor supplements/amendments may be reported annually. The classification of amendments will be dealt in the Jater posts. '. Filing Annual/Biannual reports (Which contain list of changes to the NDA/ANDAIMAA) 'lib the regulatory agencies. ' D-... adv ,r_...., have occurred/may occur due to the use drug ~-tNrtm g any erse eu""'.... -.L:-1. wDIWI Maintenance of the complete histoly of each Drug products (Filing history with customers, amcndmam, annual iq,oru) "i, r.-pllld by o,.Gangdhar Gourlpur Paae 187 Br, TOcE - 17BT61 IIIO HU';INL',5 AND [ NlR[PRtN(UR!.IIIP Taking part in design nnl,,~1,·.1I R,·s,,111YC ( \ 11lrl'~". ~ P tkn,nn.mn~~"'L"" ln,o,nfety and h;n,mmty ~ R At the U\\'C' ~ hng, ;n 2003, one_dckgot, u,ed. th;, ,;mpl_c fo.,(~ -;si p:lrth.'tp.tnt,; dtfkrcnttatc between btosafety and btosecunty ,4es: V Btt,wko protff~ ,.,,,,1, f,om ge,m, - bfomu,;ty p w t e ~,1/;:'m.people.. \\ lnk thc,e. obJceltvos a,e ,eloted, and both a,e remam d1stmct. As a result, biosecurity c99te~ ~~rfiom b,osafety concepts. The r~ the Conventton, the" pu,posc, approaches used to achieve them are often ~iru1~-fu utually reinforcing, but in some cases may conflkt. A commoo e,amp~ ~ t : rises w;th the transport of dangernu, pathogens: in the interests of bioJf;ty;\u~fouhogens should be clearly labelled during transport, but from a biosecur ilpe~e, labelling the pathogen being shipped may increase the risk of t h e f t ~ ~ - n. Pnvious agr ~land ings and proposals ion 9. B i o ~ 1 ed with the aims and objectives of the Convention. and the concept is ~~i~io ned in Article II. ~is ~cle requires States Parties to "d~troy, or to ' -~-peac eful purposes" any b1olog1cal weapons they have, and specifies that in \.~~cotin g this requirement "all necessary safety precautions shall be observed to tect populations and the environment". J0. Subsequent review conferences agreed that "States parties should take all necessary safety precautions to protect populations and the environment in relation to activities not prohibited by the Convention."9 This understanding bas thus extended the requirement for biosafety measures, fiom the destruction and diversion activities under Article 11 to all Dept ofBT, TOCE Compiled by Dr.Gangdhar Gourlpur Pagel92 ~ I ,_~