Consultant – Regulatory Systems Strengthening (Pharmacovigilance), Dar-es-Salaam, Tanzania At Management Sciences for Health (MSH)

Consultant – Regulatory Systems Strengthening (Pharmacovigilance)

In trod u c tion and Back grou nd: F und ed by t he U. S. Age ncy for I nte r nati o nal D ev elo pm e nt (U S AID), t he Me d ic i ne s,

Tec h nolo gies, a nd P ha rmace u ti c al Se rvi ces ( M Ta P S) pro gram im ple me nted by Ma nage me nt Sc ie nces for H eal th pr ovides p ha rmac e ut ical system st re n gt h e n i ng assist a nce for s usta i ned im prov em e nts in h eal th system pe r fo rman ce a nd to advan ce U S AID ‘s g oals of preve nt i ng c hi ld a nd mat e r nal deat hs, c o nt roll i ng t he HI V / AIDS e pide mi c, a nd co mb a ti ng i nf ect i o us di sease t h reats, as w ell as e x p a ndi ng es se n tial heal th co ve rage.

T he g oal of t he gl oba l, five -year (201 8-202 3) pro gram is to e nab le l o w- a nd mid dl e -i nco me co u nt ries to st re ng t h en t heir p ha rmac e u ti cal syste ms to e n s u re s ust ai na ble a ccess to a nd a ppro priate use of sa f e, ef fec tive, q ua lit y – ass u re d, a nd a ffo rda ble ess e nti al m edic i nes a nd m edic i ne – r elated p ha r mace u ti cal se r vi ces. To a c hieve t his g oal, t he M T APS pro gram has t he foll ow i ng ob jecti ves:

•  p ha rmac e ut ical s ector g ove r n a nce str e ng t he ned
•  i ns tit u tio nal a nd h um an res o u rce cap ac ity for pha rmace u ti c al ma nage m e nt a nd se rv ices i ncrea se d, i nc l ud i ng re g ula tion of m ed ical p ro d ucts
•  avai l ab i lity a nd use of p ha rmac e ut ical i n fo rma tion for d ec isi on ma ki ng i ncre ased a nd global lea r n i ng a g e nda advan ced
•  p ha rmac e ut ical s ector f i na nc i ng, i nc l ud i ng res o u rce all ocat i on a nd use, op timized
•  p ha rmac e ut ical se rvi ce s, i nc l ud i ng pro duct a vai l ab il ity a nd pati e n t -ce nte red care to ac h ieve desired he alth o utco mes, im prov ed

T he g oal of M T a PS in T a nz a nia is to st r e ngth en t he c o u nt ry’s p ha rmac e u ti cal s ystem to e n s u re s ust ai n ab le ac cess to and a ppro priate use of s a fe, ef fe ctive, q ual it y -a ss u re d, a nd a ffo rda ble esse n tial m e di c i nes, i nc l ud i ng AR Vs, he alth te c h nolo gie s, a nd r elated p ha rmace u ti c al servi ces. A st ron ger p ha rmac e u ti cal system in T a nz a nia w ill e nab le a c hievem e nt of global go als, i n cl u di ng co nt ro ll i ng t he HI V / AIDS a nd TB epi de mi cs, prev ent i ng c h ild a nd mate r nal dea t hs,

co mbat i ng o t her i nfe cti o us di sease t h reats, a nd e x pa n di ng ac ce ss to ess e ntial m ed ical pro d ucts in t he jou r ney t o wa rd a c hie vi ng u nivers al heal th cove rage in t he c o unt ry.

T he Ta n za nia Me di c i nes a nd M e di cal D evi ces A ge ncy ( TM DA) is t he na tional re g ulato ry a u t ho rity ( N R A) in T a n za nia. It is an e xe c ut ive a ge ncy u nd er t he M OH re s pons i ble for regula ti ng t he q ual it y, s a fety, a nd e f fec tiv e ness of m edic i nes, me di cal d evi ces, a nd diag n osti cs. Its co re f u nct i o ns a re pr escribed in Sec t ion 5 of t he Ta nz a nia Me di ci n es a nd M edic al Dev ices Act, Cap 219, i .e., t he re g ula tion of a ll matte rs re lati ng to q ual ity, s a fety, a nd e ff ica cy of h um an a nd vet er i na ry me di c i n es, he rb al me di ci nes, me di cal de vi ces, a nd dia g no sti cs; t he re g ulat i on of im po rtatio n, ma n u fac t u ri ng, labe li ng, ma rki ng or ide n ti f icat i o n, sto rage, p ro motion, s ale, a nd dist ri b uti on of sam e; a nd t he m o nito r i ng a nd a na lysis of e xi st i ng and n ew adve rse ev e nts, i nte ra ctio ns, a nd i nfo rm ation abo ut PV of p ro d uc ts; a nd act i ng u pon s aid a naly sis.

Regulato ry s ys te ms play a key role in e ns u r i ng t he q ual it y, sa f e ty, a nd e f f ica cy of me di c al pro d ucts. T he TM DA h as atta i ned W HO ma t u ri ty level 3 (ML 3) st at us f or setti ng up a stab le, we l l – f u nct i o n i ng, a nd i n teg rated me di c i n e/va cc i ne regulato ry s yste m, as be n c hma rked ag ai nst t he Wo rld He alth Organ ization ( W H O) Glob al B e n c hma rk i ng To ol (GB T) in 2018. It has a lso establ is hed m ob ile a nd patie nt re po rt i ng s y ste ms for sa fety m o nito ri ng of m edic i nes.

T he Me d ical Sto res De p a rtm e nt (M SD) is an a utonom o us d epa rtm ent u n der t he M OH res pons i ble for d ev elo p i ng, ma i nt ai ni ng, a nd m a nag i ng an e f fi cie nt a nd cos t-e f fec tive system of proc u re me n t, sto rage, a nd distri b uti on of a pprov ed me di c i nes a nd me di cal s u p pl ies r e q uired for use by pub l ic h eal th se rvi ces.

M Ta PS is t he r e fo re see k i ng a c o n s ult a nt to provi de tec h n ical a ssist a nce to s u ppo rt m edi ci nes regist ratio n, m edi cal p r oducts im po rtati on proc edu res a nd p ha rm acovi gi la nce to a c hieve t he g oal of st r e ng t he ni ng re g ulato ry s y ste ms in t he R e p ub lic of T a nz a n i a.

Supervi s ion and repo r t ing re sp on s ib i l i t y: T he consult a nt wi ll be s u pe r vised by, a nd re po rt to t he P ri nc i pal T ec h ni cal Adviso r – Pha rm acovig il a n ce (P V) L ea d. T he co ns ul ta nt wi ll l i aise wi th t he C o unt ry P r o ject Direc t or for Ta nza ni a; t he P ri nc i pal Te c h ni cal A dviso r – Pha rm ace uti c al Regulato ry Syste ms ( P T A – P RS ), M T a PS hea dqua rte rs a nd regi o nal te c h ni c al st a ff, a nd wo rk in col labo ra tion w i th t he n atio n al re gulato ry a ut ho r i ty and rel eva nt g ove r n me nt de pa rtm e nt s.

A: Des cr i p tion of Ser vices to be pro v ided

Bas ed on t he b ackg ro u nd i nfo rm ation pro vided by M Ta P S, t he c o n s ult a nt is e x p ected to provide

tec h ni cal assis ta n ce by und ert aki ng i nte rv e nti o ns in m edi ci nes regi st r atio n, m edi cal pro d ucts i mpo rtation proce d u res a nd p ha rm acovig il a n ce t hat wi ll st re n gt h en regul ato ry syste m s, co nt ri b u ti ng to ac ce ss to q ual ity as s u red m edic al pro d uct s.

Speci f ica ll y, t he co ns ult a nt wi ll u nd ertake t he f ol lowi ng act ivit i es: 1) Act ivity 1 .1.1: C o nd uct a process im prov em e nt ma ppi ng for re gistrati on a nd im po rtati on of a ntiret rovi r al me d ic i nes ( A RVs ), i nc l ud i ng d o l ut eg ravir (D TG ), for t he pub lic sector ( L OE

20 Da ys)

a. D evelop an im plem e nta tion pl an for t h is ac tiv ity w i th c l ear tasks a nd ti mel in es for reac h i ng process im pro ve me nt m ilest o nes

b. Liaise w i th t he M T a PS Ta nz a nia C o u nt ry o f fi ce to i ni tiate me eti n gs with t he Natio nal Regu lato ry A u t ho ri ty, TM D A, a nd M S D, a nd pl an for col l ect i on of i nfo rm ation a nd im ple me ntati on of t he act ivity

c. D evelop a c hec kl is t/qu estio n naire for data c ol le ction on t he s e qu e nce of act ivi ties to register a nd im po rt A R Vs, i nc l ud i ng DTG, for p ub lic sector dist r ib ution a nd use

d . Ad m i nister t he q uesti o n naire to re lev a nt e ntit i es i n cl u di ng M SD, TM DA

e. P re pa re dra ft re po rt on t he fi n di ngs of t he proce ss ma ppi ng i nc l ud i ng c o nside rati o ns for process im prov em e n ts

f . Faci l itate a o ne – day vir t ual wo rk s hop to va lidate t he fi n di ngs

g. Fi na lize t he re po rt on p rocess ma pp i ng im prov em e nt for reg ist rati on a nd im po rtation of A RVs, i n cl ud i ng DTG, for t he p u blic secto r.

2) Act ivity 1 .1.2: S usta in t he capacity of T M DA to assess q u al ity, sa fety, a nd ef f ica cy of A RVs

(LOE 15 da y s)

a. D evelop an im plem e nta tion pl an for t h is ac tiv ity w i th c l ear tasks a nd ti mel in es for reac h i ng t he cap ac ity mi lest o nes a nd s ha re it w ith t he P T A-P RS

b. Liaise w i th M T a PS Ta n za nia C o u nt ry o f fi ce to i n itiate mee ti ngs w i th t he Natio nal Regulato ry A ut ho ri ty, TMDA, a nd pl an for d el i ve ry of vir t ual/ i n- pe rs on co u rse to co n d uct ca pac ity b ui ld i ng on co mpr e he n sive a ss essm e nt of q u al ity, sa fety, a nd ef f ica cy of A RV a pp li ca tions for regi st rati o n. T he capacity b ui ld i ng s h o uld im pa rt know le dge a nd t ra n s fer skills to TMDA assess ors in basic d ossier as sess me nt of A RV pro d uct d oss ie rs for t he new me di c i ne eva l uato rs (n ew st a ff, i n te r ns, a nd e xte r n als ); a nd t ra i n i ng to c u rre nt m edic i ne ev aluat ors on s pecial ized a reas, s u ch as assess i ng b io eq u ival e nce s t u dies a nd ac tive p ha rmac e ut ical i ng re di e nts, fo c us i ng on A RVs

c. Liaise w i th t he a ppro priate acad e mic i nst it u tion for col labo ra tion while im pleme nt i ng the capa city b ui ld i ng wo rk s hop

d. P re pa re mate ri als for d e livery of a 5 -day ca pac ity b u ild i ng c o u rse on eva l uation a nd regist ration of m ed ic i ne s, cove ri ng t ra i n i ng of n ew assesso rs a nd r e f res h er t rai n i ng for e x iste nt assess ors

e. Organize a nd fac il itate cond uct of an i n – pe rson ca pac ity b u ild i ng wo rk s hop on assess m e nt of p ro d uct dossie rs for m ed ic i nes

f. P re pa re Re po rt on ca p ac ity b ui ld i ng wo rk s hop on pro d uct re gistra ti on for m edic i nes for regulato rs in Ta nz a n ia

g. Organize a nd fac il itate cond uct of a pro d uct d os sier eva l uati on ret reat for 5 da ys for t he ass esso rs to a pply t he kno wledge a nd ga in h a nd s- on e x pe ri e nce in e val ua ti ng pro d uct s, s p ec i fi ca lly m edic i nes used to m a nage HI V / AIDS

h. P re pa re Re po rt on pro duct d ossier ev a l uati on ret reat a nd n umber of pro duct f iles for manag i ng A RVs eva l ua te d.

3) Act ivity 2 .1.1: St re n gt h en e xis ti ng passive m edi ci ne safety s u rv ei ll a nce sys tem for pe diatr ic m edic i nes used in nati o nal HIV pr og ram (LOE 20 da ys)

a. In co lla bo ra tion w i th rel eva nt TM DA a nd M T a PS sta f f, pl an a nd set up a pe diatric s u b -co mmi ttee as pa rt of t he nati o nal sa fety advi so ry co mmittee to e va l ua te adve rse d r ug reacti on ( AD R) re po rts on pe diatr ic D TG a nd ot her pe diatr ic A RVs in t he co u nt ry

i. U nd erta ke revi ew of t he te rms of refe r e nce of c u r re nt nati o nal s a fety adviso ry co mm ittee a nd revise it for sett i ng up t he pe diatric s ub -co m mitt ee as ne cessa ry

ii. Establ i sh a g ove r n a nce s t r uc t u re for t he pe diatr ic s u b -co mmi ttee with c le ar d el ive ra bles for e n ha nc i ng t he sa fety of pe di at ric D TG and A RVs in gene ral

iii. S u ppo rt i n a u g u rati on of t he co m mittee m e mbe rs a nd at least o ne mee ti ng of t he co m mitte e.

b. In co lla bo ra tion w i th W H O, relev a nt i n d ust ry e xpe rts, a nd M T a PS st a ff, pla n, e xe c ute a nd m o nitor ca pac ity b u ild i ng of TM DA sta ff on e va l uat i ng m a nu fac t u re rs’ risk manag em e nt pla ns ( RM Ps) a nd pe rio dic s a fe ty u pdate re po rts ( P S U R s) for pe diatric d r ug fo r m ula tions as pa rt of a syst e m -w ide s ust ai n ab le capaci t y-b ui ld i ng ef fo rt

i. Review or d ev elop t ra i n i ng mate ri als

ii. Und erta ke t ra i n i ng of s ta ff i n cl u di ng h a nd s- on p ract ice iii. Generate a re po rt of t he t rai n i ng.

c. Wo rk w i th TM DA a nd relev a nt stak e hold ers i nc l ud i ng b ut not li mited to p ub lic heal th pro gram s, hos pit als, a nd re po rte rs to st re ngthen t he e xist i ng s yst em for providi ng co nst r uc tive fee dback to s takeh olde rs t hat re po rt AD Rs. T h is wi ll e nta il revie w i ng t he c u rre nt fe edback me c h a nism a nd i de nt i fy i ng im ple me nt ati on ga ps, i n cl u di ng dis i nc e nti ves for re po rti ng

i. Review c u rre nt fee dback m ec h a n i sm ava ila ble at TMDA a nd id e nt i fy im pleme ntati on ga ps

ii. D evelop a revi sed stak e hold er fee db ack f ram ewo rk and me c h a nism

d. D evelop a pro posal for a foll o w- on ac tiv ity t hat i de nt i fies a nd te sts d i ffe r e nt st rategies for im prov i ng re po rti ng with a vi ew to fi n di ng t he m ost a ppro priate a nd co nt e xt rele va nt st rategy to im prove ADR re po rt i ng in Ta nza ni a.

T otal L OE: 55 days

B: De l ive rable s /M i le s t ones

1) Im plemen tati on pl an for Act ivity 1 .1.1 with c lear tasks and time li n es for r eac h i ng t he

process im prov em e nt m ilesto nes

2) D ra ft re po rt on t he fi n d i ngs of t he proce ss ma pp i ng i nc l ud i ng c o nsi de rat ions for process im prov em e nts

3) Re po rt on p rocess im pr ove me nt ma ppi ng for reg ist ration a nd im po rtation of A RVs, i n cl u di ng DTG, for t he p ub lic s ector

4) Im plemen tati on pl an for Act ivity 1 .1.2 with c lear tasks and time li n es for r eac h i ng t he capacity mi lest o nes

5) Mate ria ls for del ive ry of a virt ual 5 -day cap ac ity b u ild i ng c o u rse on eva l uation a nd regist ration of me d ic i nes

6) Re po rt on virt ual ca pac i ty b u ild i ng on m edi ci nes regist ration for reg ulato rs in T a nz a nia

7) Re po rt on p ro d uct d os sier eval uati on ret reat a nd nu mber of p ro d uct fi les for manag i ng

A RVs eva l uated

8) Te rms of refe re nce for a pe diatric ad viso ry s ub -co mmittee, i n cl u di ng g o ve r na nce st r uc t u re

9) Res ults of D TG a nd ot h er pe diatric A RVs ADR r eview

10) Re po rt of trai ni ng for TMDA s ta ff on re view of RM Ps a nd P S U Rs for p ediat ric A RVs

11) P ro posal for foll o w – on act ivity on st ra tegies to im prove re po rti ng of A D R s.

C: De l ivery Sched u le/Mi l es to n es

A cti vity 1 . 1. 1: Con duct a p ro c ess i mp ro v e m ent ma pping for re gi s t ra ti on and i mport ation of A RVs, inclu ding

D TG, for the pu blic sec tor

1 ) Del iv er able: Activi ty I mpl e ment at i on pl an w i th cle ar t as ks a nd

ti mel i nes f or r each i ng p r o cess i mp r ov e m e nt mi les t on es ( 1 5 Ju ne 2 0 21)

2 ) Dr aft re p ort on t he fi nd i ngs of t he p r oc ess m appi ng i n cludi ng

co n sid er ati o ns f or p r oc e ss i mp r ov e ment ( 30 Ju ne 2 0 21)

3 ) F in al Re p ort on p r oc ess imp r ov e m e nt m app i ng f or r eg is tr at i on

a nd i mport a ti on of A RVs, i nclud i ng D T G, f or t he p ub lic s ector ( 25 July 20 21)

A cti vity 1 . 1. 2: S us tain the c apa city of T M DA to as sess qu alit y, safet y, and effica cy of A RVs

4) Activity i mpl e ment at i on pl an w ith cle ar t as ks a nd ti meli nes f or r each ing c ap acity mi les t ones ( 1 5 Ju ne 2 0 21)

5) Mate ri als f or delivery of a virtu al 5 -d ay c ap acity buildi ng course on e valu ati on a nd r eg is tr at i on of me dici n es ( 30 Ju ne 2 0 21)

6) Re p ort on c ap acity b ui ld i ng on me dici n es r eg is tr at i on f or r egu l at ors in T a n za nia ( 31 July 20 21)

7) Re p ort on p r o duct d o ss ier e valu ati on r etr eat a nd n umb er of

p r oduct fi les f or m a n ag i ng A RVs ev alu ated ( 31 Augu st 2021

A cti vity 2 . 1. 1: Str en gth en e x i s ting pas si ve m e dici ne sa f e ty su r v eill ance s y s t em for p e dia t r ic m e dicin es u sed in

na tional HIV p ro g ram

8) T erms of r efe rence f or a p edi atric advis ory s u b -co m m itte e, i nclud i ng g ov ern a nce s tru cture ( 3 0 Ju ne 2 0 21)

9) Resu lts of D TG a nd o t her pe di atric A RVs A DR r eview ( 20 Se ptember

2021)

10 ) Re p ort of tr ai ni ng f or T M DA s t aff on r eview of R M Ps a nd

P SU Rs f or p edi atric A R Vs ( 31 Augu st 2021)

11 ) Prop os al f or f ol l o w-on act ivity on s tr ategi es to i mp r o ve

r eporti ng of A D Rs ( 3 1 July 20 21)

D: A u th o r ized T ravel ( if a ppl ica ble)

☒ M SH he reby a u t ho ri zes Con s ult a nt to t r avel in co n necti on w i th provid i ng t he Se rvi ces in ac co rda nce with t he S OW as d escr ibed b elow: Wit hin T a nz a n ia

Consultant qu al ifi cat ion r equir ements:

•  First deg r ee in Ph arm a cy or M edicine
•  Adv an ced d egree in M e dicin e, Ph arm a c eut i cal s c i en ces, or Public H eal th
•  At le ast 7 y ear s’ ex p er i en ce wo rking with US A ID / don or -fun d ed pr ogr ams, Min istry of

H eal th, and global i mpl ementing pa rtne rs

•  Exp eri en ce in providing te chnic al ass istan ce to mu lt iple low- and m iddle -income countri es in r egulato ry sys t ems str e ngthening including medi cines ev al u at ion and r egis tr at ion, appl i cat ion of g ood r eview gui d el in es and good rel i an ce pra c tic e s, r egulato ry ca p aci ty bui lding
•  Exp eri en ce in bu ild ing ph arm acovig ilan ce sys t e ms
•  Exp eri en ce in or kno wl edge of p ubl ic h eal th sys tem s tru cture and h e al th pol i cies in T an zania
•  Strong org aniz at ion al ski lls: d emonstr ated abi li ty to bui ld r elationships and wo rk ef f e ct iv ely with s enior gov ernm ent of fici als and oth er st ak e holde rs.
•  Ex cel l ent w ri tten and v e rb al com munic at ion, abi li ty to g en er ate lucid r ep or ts, and pr es entation ski lls in English and Sw ahi li.

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