The$EDCTP2$programme$is$supported$under$Horizon$2020,$the$European$Union’s$Framework$Programme$for$Research$and$InnovaDon.$

Prof.$Frank$Cobelens$Prof.$Ambrose$Isah$

$ISOP$18TH(ANNUAL(MEETING(

Geneva,(12(November(2018((

$$

Strengthening(Pharmacovigilance(in(Africa(

(

I$have$no$conflict$of$interest$to$declare$

European(&(Developing(Countries(Clinical(Trials(Partnership((EDCTP)((

(

Clinical$research$to$accelerate$the$development$of$new$or$improved$drugs,$vaccines,$microbicides$and$diagnosDcs$against$povertyLrelated(infecNous(diseases(in(subLSaharan(Africa((HIV/AIDS,$TB,$malaria,$NTDs)$$Focus$on$phase$II$and$III$clinical$trials$

Call:(strategic$acDons$to$strengthen$the$capacity$of$health$systems$to$effecDvely$deliver$new$products$and$to$monitor$their$postSmarket$safety$$$

Background

$•  Significant$ increase$ in$ the$ introducDon$of$new$drugs$ in$Africa$mainly$ targeDng$poverty–related$diseases,$oVen$based$on$limited$trial$data$

•  Pharmacovigilance$ processes$ in$ most$ SSA$ health$ systems$ are$ sDll$ inadequately$ prepared$ to$manage$these$new$products$

! $increase$readiness$of$health$systems$to$introduce$and$absorb$new$intervenDons$for$PRDs$$

! $ increase$ the$ coverage,$ accessibility$ and$ effecDveness$ of$ evidenceSbased$ intervenDons$ in$ subSSaharan$Africa$$

$EsDmates$2017,$Africa:$$

•  2.5(million(people$fell$ill$with$new$(incident)$TB$•  People$living$with$HIV$accounted$for$27%$•  0.65(million(people$died$from$TB,$38%$with$HIV$

•  90,000$people$had$incident$mulDdrugSresistant$TB$$

$

Tuberculosis

MDR5TB6has6poor6treatment6outcomes620#24%months%treatment,%pre#2018%guidelines

Global&TB&Report,&WHO&2018&&

Revised6MDR5TB6treatment6guidelines6(August62018)

TB6drugs6clinical6development6pipeline6(August62018)

TB6acCve6drug6safety6monitoring6(aDSM)

PAVIA

Aim(

To$strengthen$naDonal$PV$systems$in$a$collaboraDve$effort$with$Public$Health$Programmes,$including$NaDonal$TB$Programmes$(NTPs)$$

ObjecNves((

In$this$context:$$1.  strengthen$governance$and$financial$capacity$of$PV$systems$in$enforcing$PV$acDviDes$

2.  improve$the$efficiency$and$effecDveness$of$naDonal$surveillance$systems$in$capturing$and$processing$reports$

3.  build$PV$capacity$and$skills$to$exercise$safetySmonitoring$acDviDes$throughout$the$country$

4.  create$an$enabling$environment$to$implement$and$sustain$PV$acDviDes$

$

PAVIA6–6Key6outcomes

" Country–specific$frameworks$supported$by$guidance$and$documentaDon$for$implementaDon.$$$

" Financial$sustainability$models$for$exploitaDon$of$PV$acDviDes.$$

" Overall$strengthened$PV$surveillance$system.$

" In$country$trained$and$skilled$cohorts$of$local$PV$personnel.$

" $CollaboraDve$models$of$implementaDon$adoptable$to$specific$naDonal$environments.$$

IHVN%NAFDAC%

University%of%Benin%AHRI%FMHACA%

Baylor%%MoH:S%

AIGHD%LAREB%KNCV% University%of%

Verona%

KCRI%TFDA%

Nigeria'

Tanzania'

Ethiopia'

Italy'

The'Netherlands'

Swaziland'

PAVIA6–6ParCcipaCng6InsCtuCons

Involvement$of$NTPs$through$KNCV$Country$Offices$$

Project6acCviCes6&6deliverables

Key(acNviNes(

1.$Assessments$

2.$Triangle$3.$Training$&$capacity$building$

4.$System$strengthening$

$$

Key(deliverables(

1.  Country$roadmaps$

2.  BlendedSlearning$courses$3.  Data$tools$

4.  Policy$frameworks$

5.  Blueprint$(lessons$learned)$

Publicly&available&wherever&possible&

Assessments

SituaDonal$analysis$at$baseline$and$endSofSproject$in$each$project$country$$Using$standard$tools$&$indicators$(including$WHO$indicators)$$

IdenDfy$the$gaps$and$deficiencies$in$the$PV$system$&$improvements$over$the$project$lifeDme$$

Components:$

1.  Policy,$Law$and$RegulaDon$2.  Systems$Structure$and$Stakeholder$CoordinaDon$

3.  Signal$GeneraDon$and$Data$Management$4.  Risk$Assessment$and$EvaluaDon$$

5.  Risk$Management$and$CommunicaDon$

+$Public$Health$Programme$and$Healthcare$FaciliDes$$

Roadmaps

UDlisaDon$of$assessment$results$to$define$country(roadmaps(so$as$to$highlight$and$further$enable$the$countries$to$address$countrySspecific$issues$

$•  Framework$and$strategies$with$a$clear$acDon$plan$to$realise$set$objecDves$

$

•  Builds$on,$or$provides$the$basis$for,$a$naDonal$strategic$PV$plan$

•  DraV$discussed$in$country$stakeholder$workshop$$

•  AcDons$can$be$taken$up$by$PAVIA$or$by$other$projects$or$stakeholders$$$

$$

(Country(ownership(is(key!(

(

PAVIA6triangle

PV$acDviDes$for$tuberculosis$as$the$“building$and$training$ground”$for$strengthening$collaboraDon$with$Public$Health$Programmes$

Expand$to$other$disease$area/Public$Health$Programme$in$second$half$of$the$project$

Training6&6capacity6building

Strengthen$PVSrelevant$skills$and$competencies$of$PV$staff$and$healthcare$professionals:$$$

1.  HandsSon$training$of$PV$staff$at$naDonal$regulatory$authority$$

2.  Generic$PV$blendedSlearning$course$for$general$health$care$workers$

3.  TBSspecific$PV$blendedSlearning$course$for$health$care$workers$treaDng$(MDR)$TB$

$$

Blended6learning6package

OneSday$faceStoSface$introducDon$Baseline$test$ Individual$$

eSlearning$

ELlearning(module(on(memory(sNck,(interacNve(

OneSday$faceStoSface$finalizaDon$FollowSup$test$CerDficate$

TrainLtheLtrainer(approach(

Course

(module(

Course

(module(

System6strengthening

Strengthen$funcDonal$regulatory$and$organizaDonal$structures$

1.  Define$clear$roles$and$responsibiliDes$for$stakeholders$towards$ensuring$the$safety$of$medicines,$in$parDcular$for$new$PRD$products$

2.  Develop$models$for$financial$sustainability$$

3.  Implement$tools$and$technologies$for$event$detecDon,$reporDng,$analysis$and$disseminaDon$4.  Advocate$for$poliDcal$good$will$from$the$government$with$a$view$to$ensuring$support$for$and$$

good$governance$of$the$PV$system$5.  Obtain$commikment$from$all$levels$of$Government$and$other$stakeholders$to$ensure$a$

mulDstakeholder$engagement$towards$realising$set$goals$and$objecDves$to$promote$PV$

6.  SensiDze$and$promote$awareness$of$medicine$safety$issues$in$the$psyche$of$Government$and$all$other$stakeholders$$

$

$$

Stakeholders6and6target6groups6(1)

Target(audience( Key(messages(

Collaborators(and(implemenNng(insNtuNons(((

• $Regulators$such$as$NaDonal$Drug$Safety$Advisory$Commikees$• $PHP,$Healthcare$ExecuDves$and$Managers$(also$private$sector)$• $InternaDonal$and$local$pharmaceuDcal$industry;$MarkeDng$AuthorisaDon$Holders$• $UniversiDes,$professional$and$regulatory$bodies$for$educaDon$

• (provide(safety(informaNon(on(newly(introduced(drugs(

• (engage(stakeholders(in(PV(acNviNes(

Clinical(((

• $Professional$(clinical)$associaDons$• $Individual$clinicians$• $Community$pharmacists$and$patent$medicine$dealers$• $TradiDonal$medicine$pracDDoners$• $PaDent$and$consumer$organisaDons/paDent$advocacy$groups$

• (create(awareness(about(importance(PV(

acNviNes(• (improve(knowledge(on(detecNon(and(

reporNng(• (inform(about(safety(signals(generated(and(

policy(decisions(

Stakeholders6and6target6groups6(2)

Target(audience( Key(messages(

Policy(and(decision(makers(((

• $Ministry$of$Health$(departments$and$agencies)$• $Development$partners,$NGOs,$FBOs$etc.$• $Government$–finance,$educaDon,$commerce$and$industry$• $Members$of$the$NaDonal$Legislature$• $AMRH/AMA$• $African$regional$economic$communiDes$(RECs)$

• (inform(about(current(situaNon((baseline(assessment)(• (engage(in(PV(acNviNes((country(specific(roadmaps)(

• (safety(informaNon(to(inform(policy(decisions(• (align(iniNaNves(

InternaConal6alignment

Alignment$with$relevant$global$and$regional$iniDaDves$$

UDlize$ the$ linkage$ with$ the$ regional$ and$ global$ partners$ to$ leverage$ resources$ and$ technical$capaciDes$with$all$PV$iniDaDves$in$SSA$$

$$

Through$representaDon$of$regional$and$global$partners$within$the$PAVIA(Advisory(Board(•  World$Health$OrganizaDon$•  Uppsala$Monitoring$Center$(WHO$CC)$•  InternaDonal$Society$of$Pharmacovigilance$•  African$Medicines$Regulatory$HarmonizaDon,$NEPAD$$$•  African$Medicines$Agency$$•  East$African$Community$•  Southern$Africa$Development$Community$

$

Project6Cmeline

assessments$triangle$training$system$

Country$kickSoff$

Roadmap$workshop$$

Midterm$workshop$$

DisseminaDon$workshop$$

COUNTRY$LEVEL$

PROJECT$LEVEL$

Joint$kickSoff$

Annual$meeDng$

Annual$meeDng$

Annual$meeDng$

InternaDonal$disseminaDon$workshop$

PAVIA6organizaCon

Country$(‘triangle’)$teams$$in$each$of$the$4$project$countries$$supported$by$a$country$project$coordinator$$

hkps://paviaSproject.net/$

Complementary6projects

•  Joint$assessments$and$country$plans$in$Ethiopia$and$Tanzania$•  Joint$annual$meeDngs$and$trainings$(2x)$

•  Joint$publicaDons$•  Joint$training$acDviDes,$making$use$of$each$other’straining$modules$

•  Joint$Advisory$Board$recommendaDons$

The$EDCTP2$programme$is$supported$under$Horizon$2020,$the$European$Union’s$Framework$Programme$for$Research$and$InnovaDon.$

This$project$is$part$of$the$EDCTP2$programme.$The$EDCTP$programme$is$supported$under$Horizon$2020,$the$European$Union’s$Framework$

Programme$for$Research$and$InnovaDon.$$

THANK(YOU(