introduction to ifpma

Introduction to IFPMA | Committed to a healthier future

Rapid PV landscape change in Africa & Middle East

Drugs Regulatory Unit Ministry of Health

•  External influence e.g.

European Good Vigilance

Practice Guidelines (GVP)

•  Strategic focus of WHO in

Low/ Middle Income

Countries (LMICs)

•  Access to technology


WHO International Drug Monitoring Program

131 countries are full members of WHO International Drug Monitoring Program


Technology is a driver •  Regulators developing and adopting new technology to optimise

Adverse Event (AE) reporting; •  Use of social media may accelerate change


Middle East - snapshot

•  Regional legislation , pan-Arab GVPs launched in July 20015, by League of Arab States. Heavily influenced by EU GVPs

•  No regional regulatory authority to coordinate assessment etc. Gulf Cooperation Council (GCC) plays role in other activities.

•  Arab countries have implemented to varying degrees; Egypt and Saudi Arabia taking the lead.

•  Jordan/ Saudi Arabia have begun inspection programmes


Africa snapshot – 1


Africa snapshot – 2


African Medicines Agency (AMA) AMA treaty signed in May 2018, includes safety monitoring/ market surveillance as some of the AMA roles

* Select Medicinal Products

Coordination

Regulatory Oversight

Pooling Resources

Objectives

Marketing Authorization*

Inspection

Market Surveillance

Safety Monitoring

Oversight of Clinical Trials

Quality Control

*


African Medicines Regulatory Harmonisation (AMRH) Launched in March 2018, representing Africa Charter of the WHO led CIP. Platform establishes a PV JAG and TWG.


Implementation Challenges Despite similarity in some national PV legislations, we are seeing an increase in divergence in PV requirements in key areas: Mismatch between legislation and capacity to implement •  ICSR reporting : Local versus Global, and timelines •  PV System Master File (PSMFs) •  Qualified Person for PV (QPPV) •  Additional Monitoring requirements •  PSUR & RMP: formats and regional annexes •  Inspections


“Right Size” PV systems

Right-size PV systems fulfil core PV requirements to protect national patient safety and:

–  align to international PV standards where possible to assess local data in global context

–  right-size alternatives may be incorporated where there are other means to protect patient safety.

–  Trust building, data sharing and work-sharing between regulators is encouraged


Conclusions

•  Africa & Middle East countries are rapidly building PV capacity

•  Digital technology is a key accelerator

•  We encourage global PV convergence and “Right-size” PV systems

•  We are driving a unified industry voice

•  Industry, like all stakeholders in safety, need a seat at the table to play our part when the need for robust PV systems is being discussed

Thank You

www.ifpma.org

16!www.efpia.eu+

 Bruce+Donzan3+

  The!author!is!employed!by!Genentech!Inc.,!A!Member!of!the!Roche!Group!and!is!a!stock!

holder!in!Roche!Holding!AG,!Pharmaceu@cal!Company.!

 Gillian+Winstanley+

  The!author!is!employed!by!Amgen!Canada!Inc.!and!is!a!stock!holder!in!Amgen.!

  The!views!expressed!in!this!presenta@on!reflect!the!personal!views!of!the!author.!They!

should!not!be!aFributed!to!the!Interna@onal!Society!of!Pharmacovigilance!and!do!not!

necessarily!reflect!the!views!of!the!authors’!employers!or!any!ins@tu@ons!the!authors!

are!otherwise!affiliated!to.!

Disclaimer+

17!

Agenda+

•  Key!Drivers!and!challenges!•  EFPIA!IPVG!LatAm!team!priori@es!

•  How!can!Private!sector!collabora@on!support!na@onal!regulatory!systems!for!PV?!!

•  Overview!of!Vigilan@a!

18!www.efpia.eu+

 !Rapid!development!of!PV!legisla@on!in!LATAM!in!last!few!years!

 !Divergence!in!countryRspecific!PV!requirements!!

 !Appe@te!for!global!harmonisa@on!(ICH)!but!limited!experience!to!

support!implementa@on!

 !Infrastructure!and!capacity!at!Health!Authori@es!needs!to!

con@nue!to!evolve!to!support!robust!PV!systems!aligned!with!

interna@onal!standards!e.g.!E2B!

!

Key+drivers+and+challenges+

PV!in!LATAM!is!challenging!with!!

impact!to!meet!compliance!and!resource!needs!

19!www.efpia.eu+

PV+environment+is+rapidly+evolving+

!

2017!R!

NOMR220!

&!

guidelines!

2017!R!ICH!

membership!

2018!R!GPvP!public!

consulta@on,!XML!

transmission!

!

2014!–!

Decree!1782!

20!www.efpia.eu+

 Review+LATAM+PV+environment+to+promote:+

  Iden@fy!key!na@onal!requirements!in!need!of!convergence!&!harmonisa@on!

  Adop@on!of!ICH!requirements!as!base!approach,!where!possible!!

  Reduce!complex!&!countryRspecific!requirements!that!do!not!impact!public!safety!

  Industry!and!Regulators!to!use!resources!more!effec@vely!and!increase!compliance!

  A!scienceRbased!approach!to!pharmacovigilance!

 Ensure+industry+groups+endorse+approach,+align+and+speak+with+one+voice+at:++

  Regional!level:!e.g.!EFPIA!IPVG!LATAM,!FIFARMA,!IFPMA!

  Na@onal!level:!!ensuring!engagement,!endorsement!and!support!from!na@onal!trade!

associa@ons!before!progressing.!!

 Support+IPVG+objec3ve+of+‘rightUsize’+PV+systems+and+interna3onal+coopera3on+

+

EFPIA+IPVG+LatAm+team+priori3es++

We!will!work!in!PARTNERSHIP!and!!

TRANSPARENTLY!with!local!industry!associa@ons!!

21!www.efpia.eu+

Technical!knowledge!

•  Network!of!experienced!pharmacovigilance!professionals!

•  Provide!support!for!implementa@on!of!new!technologies!e.g.!electronic!exchange!

Educa@on!and!awareness!

•  Sponsorship!or!provision!of!speakers!to!allow!informa@on!to!be!shared!with!stakeholders!in!LatAm!

•  Promote!culture!of!adverse!event!repor@ng!

Global!PV!knowledge!

•  Provide!feedback!to!support!development!of!‘rightRsized’!PV!systems!and!regula@ons!

•  BestRprac@ce!sharing!of!PV!developments!in!other!countries!

How+can+Private+sector+collabora3on+support+na3onal+regulatory+systems+for+PV?+

+

22!VIGILANTIA!is!a!mul@stakeholder!project!sponsored!by!FIFARMA!and!funded!by!AbbVie!

PV+Training+in+a+box+is!an!effec@ve!training!combo!

on!Pharmacovigilance.basic.aspects.modularly!assembled!

as!a!OneRFitsRAll!project!to!

sa@sfy!different!audiences!

(HCPs,!Pharmacists,!Payers,!

Journalists,!PAGs)!with!a!1R

DAY!AGENDA!session.!

A!CoRsponsored!Annual+ISoP+Symposium+offers!a!unique!chance!to!discuss!

drug!safety!and!signal!

detec@on!from!different!

points!of!view!and!to!share!

ideas!on!how!pa@ents'!safety!

could!be!further!improved!

among!mul@Rstakeholders.!

Peers+and+voice+is!a!Scien@fic!Network!with!

the!objec@ve!to!address!

and!amplify!the!maFers!that!has!become!

more!of!a!challenge!for!

HCPs,!Drug!Agencies,!

Scien@fic!!!organiza@ons,!

Universi@es,!State!

Authori@es,!and!

Pharmaceu@cal!Industry.!!

Demonstrate!how!

FIFARMA!is!

pioneering!on!the!

pharmacovigilance!

educa@on!arena!and!

help!to!address!the!

subRop@mal!postR

marke@ng!surveillance!

(Agencies)!in!La@n!

America!before!the!

arrival!of!new!

biosimilars.!

MEDICAL!EDUCATION! ISOP!EXTERNAL!COLLABORATION! PEERS!AND!VOICE! FIFARMA!


PV+Training+in+a+box!



A!CoRsponsored!Annual+ISoP+Symposium+with!the!La@n!American!Chapter!


RSVP!Data!from!5th!Symposium!ISoP!La@n!American!Chapter!over!118!preRregistered!aFendees!

25!

2014+ 2015+

2016+ 2017+

550+

27!

Leader:!Clara!Sanchez!Luna!

Academic!Expert:!Carlos!Maldonado!Leader:!Eduardo!Tinao!

Academic!Expert:!María!Rosa!Papale!

Leader:!Fernando!Fon!

!

Leader:!Jean!Jaques!Duhart!

Leader:!Rosa!Luz!Guerrero!Terán!

Leader:!Rosana!Mastellaro!

!

MEDICAL!EDUCATION! PEERS!AND!VOICE!ISOP!EXTERNAL!COLLABORATION! FIFARMA!

28!


THANK!YOU!

Annual ISoP Meeting | Geneva 2018.11.12 Private sector collaboration with National Regulatory Systems | J. Christophe Delumeau 30

Annual!ISoP!Mee@ng!2018!|!Geneva!2018.11.12!

!

Private!Sector!Collabora@on!

with!Na@onal!Regulatory!Systems!

!AsiaRPacific!&!China!

Eurasian!Economic!Union!

Simplifying!and!Improving!Global!ICSR!Submission!!

!

J.!Christophe!Delumeau!


J.!Christophe!Delumeau,!MD,!PhD!

•  FullR@me!employee!of!Bayer!South!East!Asia!(Singapore)!as!head!of!pharmacovigilance!policy!strategy.!

•  Not!holding!any!stock!op@on.!

•  Not!holding!any!share!of!any!pharma!nor!health!care!company.!

•  Not!receiving!any!consul@ng!fees!or!grants.!

•  Receiving!no!compensa@on!for!serving!as!Board!and!Execu@ve!CommiFee!member!of!the!Interna@onal!Society!of!

Pharmacovigilance!(ISoP).!

•  Receiving!no!compensa@on!for!serving!the!chair!or!coRchair!of!working!groups!or!ini@a@ves!of!the!Interna@onal!of!

the!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!(EFPIA).!

•  Receiving!no!compensa@on!for!serving!as!Visi@ng!Expert!at!DukeRNUS!university,!Singapore.!

•  The!views!expressed!in!this!presenta@on!reflect!the!personal!views!of!the!author!and!do!not!necessarily!reflect!the!

views!of!the!authors’!employers!(Bayer)!nor!ISoP,!nor!EFPIA,!nor!any!other!ins@tu@ons!the!author!may!otherwise!

be!collabora@ng!with.!

Disclaimer!and!declara@on!of!conflicts!of!interest!


•  EAEU:!Eurasian!Economic!Union!

•  EFPIA:!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!

•  EFPIARIPVG:!EFPIA!Interna@onal!PV!Global!Team!

•  EFPIARIPVRWS:!EFPIA!Interna@onal!PV!(regional)!WorkRStream!

•  HCP:!Health!Care!Professionals!

•  HCS:!Health!Care!System!

•  ICH:!Interna@onal!Council!for!Harmonisa@on!of!Technical!Requirements!for!Pharmaceu@cals!for!Human!

Use!

•  ICHRE2B!(ICH!standard!for!ICSR!data!transmission!!

•  ICSR:!Individual!Case!Safety!Reports!

•  NRA:!Na@onal!Regulatory!Authority!

•  NRS:!Na@onal!Regulatory!System!

•  MAH:!Market!Authorisa@on!Holder!

•  PV:!Pharmacovigilance!

•  SiGiR:!Simplify!and!improve!Global!ICSR!Repor@ng!(one!of!EFPIARIPVG!strategic!ini@a@ve)!

•  WHORIPDM:!WHO!Interna@onal!Program!for!Drug!Monitoring!

•  WHORUMC:!Uppsala!Monitoring!Centre!(WHO!collabora@ng!centre!

Abbrevia@ons!used!in!this!presenta@on!


Ini3a3ves+aimed+to+improve+pharmacovigilance+systems+e.g.+

•  Contribute!to!the!development/improvement!of!country!PV!legisla@ons!and!guidance!

•  Improve!ICSR!repor@ng!from!HCPs!and/or!Pa@ents!

•  Improve!ICSR!submission!methods!and!infrastructure!(E2B)!

•  Educate!and!Train!PV!professionals!and!other!HCPs!

•  Improve!the!methods!applied!in!PV!and!Pharmacoepidemiology!

•  Create/develop/improve!risk!minimisa@on!solu@ons!suitable!for!diverse!HCSs!

•  Contribute!to!the!PV!component!of!Public!Health!programs!

Examples!of!Private!Sector!–!NRA!Partnership!in!Pharmacovigilance!


Possible+se^ngs+

•  LargeRscale!collabora@ve!ini@a@ves!e.g.!partnering!between!the!European!Union!and!the!

EFPIA!for!the!components!of!the!IMI!project.!

•  Country!pharma!associa@on!or!specific!companies!approaching!a!NRA!proposing!a!

collabora@ve!ini@a@ve,!program!or!event.!

•  NRA!appoin@ng!a!country!pharma!associa@on!or!selected!companies!Specific!companies!to!

contribute!to!an!event,!pilot!a!procedure!or!tool,!or!for!providing!training!or!knowRhow.!

•  The!collabora@ve!serng!may!involve!other!stakeholders!such!as!a!university!or!ISoP.!

•  Other!types!of!collabora@ve!serngs!

A!diversity!of!collabora@ve!serngs!


Who+are+the+people+from+the+Private+Sector+engaging+into+partnering+with+NRA+

•  Employees!of!pharma!companies!engaging!into!ini@a@ves!involving!their!respec@ve!

companies!

•  Private!sector!employees!engaging!into!collabora@ons!with!NRA!as!members!of!an!

organisa@on!different!from!their!company!!

o  The!Interna@onal!Society!of!Pharmacovigilance!(ISoP).!

o  The!European!Federa@on!of!Pharmaceu@cal!Industries!and!Associa@ons!(EFPIA).!

o  IFPMARaffiliated!country!pharma!associa@on.!

o  In!the!context!of!an!academic!serng!e.g.!a!UniversityRdriven!ini@a@ve.!

A!diversity!of!collabora@ve!serngs!


IPV+Regional+WorkUStream

IPVG+Ini3a3ve+

IFPMARaffiliated!Country!pharma!

associa@ons!!

People!from!

specific!!pharma!

companies!!

NRA


Training+and+provision+of+know+how+

Involvement!of!staff!from!Indonesian!affiliates!of!mul@na@onal!pharma!companies!into!the!

ISoP!Indonesia!Chapter!to!provide!interna@onal!knowRhow!to!Indonesian!stakeholders!from!

the!Public!sector!or!domes@c!pharma!companies.!

Appointment!of!experts!from!pharma!companies!to!provide!lectures!e.g.!!

•  Annual!APECRCoE!PV!training!organised!by!the!Korean!Health!Authority!(Seoul)!

•  DukeRNUS!CoRE!Graduate!Cer@ficate!on!Fundamentals!in!Pharmaceu@cal!Regula@on!

(Singapore)!

•  ISoP!Training!organised!in!coopera@on!with!NRAs!(e.g.!Thailand,!China,!Australia,!

Indonesia)!!

•  PV!training!organised!by!NRA!of!mul@ple!Asian!countries!possibly!in!coopera@on!with!

Country!pharma!associa@on.!

Collabora@ve!ini@a@ves!in!the!AsiaUPacific+Region+


Other+types+of+collabora3ve+ac3vi3es+

•  Involvement!of!EFPIARIPV!India!WorkRStream!and!Indian!pharma!associa@ons!into!the!

making!or!!revision!of!the!Indian!PV!legisla@on!framework!(e.g.!PvGI)!

•  Collabora@on!between!NMPA’s!CDE!or!CDR!and!RDPAC!for!reviewing!the!new!Chinese!

safety!regulatory!framework!aimed!at!mee@ng!ICH!requirements.!!

•  Involvement!of!RDPAC!in!the!defini@on!of!E2B(R3)!specifica@ons!applicable!to!China!

•  Involvement!of!selected!companies!in!tes@ng!concepts!to!be!implemented!in!the!future!PV!

regula@on!of!Malaysia.!

•  Review!by!the!EFPIARIPV!WorkRStream!of!drats!of!new!regula@on!from!AsiaRPacific!

countries.!Provision!of!a!consensus!feedRback!

•  ISoP!Special!Interest!Group!on!Risk!Minimisa@on!methods!for!Asian!Countries!involving!

NRA!representa@ves,!Academic!experts!and!PV!professionals!from!pharma!companies!

Collabora@ve!ini@a@ves!in!the!AsiaUPacific+Region+


•  Involvement!of!PV!representa@ves!of!the!AIPM!(Russian!pharma!associa@on)!into!the!

Working!Group!on!Na@onal!PV!Legisla@on!Update!in!!charge!of!revising!the!PV!regula@on!

and!Good!Vigilance!Prac@ce!framework!applicable!to!Russia.!This!includes:!

o  Par@cipate!into!regular!official!mee@ngs!at!the!Roszdravnadzor!

o  Provide!consultancy!input!

o  Drat!norma@ve!documenta@on.!

•  Pharma!industry!representa@ves!are!appointed!to!contribute!to!training!and!conference!

organised!by!the!Roszdravnadzor!intended!to!PV!professionals!of!public!and!private!sectors!

•  Interna@onal!Pharmacovigilance!conference,!organised!jointly!by!the!Roszdravnadzor!and!

the!AIPM!in!Moscow!on!October!10th!2018.!Involvement!of!local!and!global!speakers!from!

pharmaceu@cal!industries.!

Collabora@ve!ini@a@ves!in!the!Russian+Federa3on+


•  Involvement!of!pharma!representa@ves!into!the!working!groups!in!charge!of!elabora@ng!

the!supraRna@onal!GxP!regula@ons!applicable!to!the!Eurasia!Economic!union!i.e.!Russia,!

Belarus,!Kazakhstan,!Armenia,!Kyrgyzstan.!This!includes:!

o  Good!Pharmacovigilance!Prac@ce!

o  Good!Clinical!Prac@ce!o  Eurasian!Registra@on!Rules!o  Requirements!to!CCDS!

o  List!of!Terms!used!in!Eurasian!GxP!Documents.!

•  Contribute!to!PV!training!sessions!and!conference!organised!by!the!Health!Authori@es!of!

EAEU!countries.!

Collabora@ve!ini@a@ves!in!other!Eurasian+Economic+Union+countries+(EAEU)!


•  Some!NRAs!are!s@ll!reques@ng!MAHs!to!

submit!ICSRs!on!CIOMS!forms!on!PDFs!

•  Those!CIOMS!forms!are!entered!manually!by!

NRA!staff!into!the!VigiFlow!container!of!the!

country!whereas!those!ICSRs!are!available!in!

E2B!format!in!the!safety!database!of!the!MAH!

! SubUop3mal+se^ng+that+can+be+fixed+if+NRAs+accept+receiving+ICSRs+as+XMLUE2B+files.+

!

Non-E2B National PV database

MAH Database E2B

VigiBase

ICSR submitted on paper

ICSRs in E2B format available but missed by VigiBase®

PublicRPrivate!Partnering!for!implemen3ng+eUsubmission+


E2B VigiFlow National PV database

MAH Database E2B

VigiBase

ICSRs submitted via XML

ICSRs in E2B format available

•  In!2015,!Bayer!PV!AsiaRPacific!collaborated!with!the!UMC!to!deploy!ICSRs!submission!in!the!

format!of!E2BRXML!files!in!all!AsiaRPacific!

countries!equipped!using!VigiFlow!as!na@onal!

pharmacovigilance!database!

! To+address+a+broader+array+of+ICSR+submission+issues+with+a+global+scope,+EFPIA+Interna3onal+PV+has+set+the+SiGiR+ini3a3ve+to+Simplify+and+Improve+Global+ICSR+Repor3ng.+

!

PublicRPrivate!Partnering!for!implemen3ng+eUsubmission+


✱  Monitor!the!ICSR!repor@ng!environment!interna@onally!

✱  Enter!into!a!dialogues!with!NRAs!looking!for!solu@ons!to!upgrade!their!na@onal!PV!database!to!the!ICHRE2B!standard!for!transmission!of!ICSR!data!

✱  Analyse!the!issues!faced!by!those!NRAs!for!upgrading!their!systems!to!E2B!in!the!context!of!

upcoming!obsolescence!of!E2B(R2)!and!proposed!solu@ons.!

✱  Advocate!for!most!harmonised!E2B(R3)!solu@ons,!especially!those!to!address!Na@ve!language.!

✱  Collaborate!with!the!UMC!and!IT!system!vendors!for!op@mizing!solu@ons!

✱  Review!Apps!&!online!portals!for!direct!ICSR!collec@on!and!transmission!from!reporters!to!

NRAs,!providing!an!industry!view!on!their!use!when!needed.!!

!  The!SiGiR!ini@a@ve!is!aiming!at!collabora@ng!with!IFPMARaffiliated!pharma!associa@ons!of!the!

specific!countries!as!well!as!interna@onal!organisa@ons!engaged!in!global!harmonisa@on.!

Simplify+and+Improve+Global+ICSR+Repor3ng+|+Goals!of!the!SiGiR!ini@a@ve!


✱  As!a!first!step,!the!SiGiR!ini@a@ve!is!focusing!on!taking!advantage!from!the!new!language!

facili@es!added!to!E2B(R3)!for!hos@ng!contents!in!Na@ve!languages.!

✱  The!purpose!of!this!approach!is!to!maintain!the!harmonisa@on!of!the!E2B!framework!in!a!

context!where!an!increasing!number!of!countries!reques@ng!to!receive!contents!in!Na@onal!

languages!are!aiming!at!moving!to!E2B.!

!

!  The+overarching+goal+of+the+SiGiR+ini3a3ve+is+to+facilitate+the+implementa3on+of+harmonised+solu3ons+which+will+op3mise+the+use+of+resources+on+both+NRA+and+MAH+sides.+

Purposes+and+goals+of+the+EFPIA’s+SiGiR+ini3a3ve+


✱ Thank!you!for!your!aFen@on+


European Federation of Pharmaceutical Industries and Associations

www.efpia.eu


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Most African countries now WHO members