December 16, 2025 • 18 mins
This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy.
In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.
Want to know more?
- Read WHO’s “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025).
- Explore WHO’s work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team.
- Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines.
- Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member.
- Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it.
Join the conversation on social media
Follow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMC
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Graeme Nadasy (00:15):
Welcome to Drug Safety Matters, the podcast from
Uppsala Monitoring Centre wherewe explore the latest issues in
pharmacovigilance and patientsafety.
I'm Graeme Nadasy, and you'relistening to a special episode
recorded at the 43rd AnnualMeeting of the WHO Programme for
International Drug Monitoringheld in Cairo, Egypt at the end
(00:37):
of October.
The meeting brought togetherrepresentatives from more than
80 member states, along withsenior experts and regulatory
leaders from WHO headquartersand regional offices.
Discussions focused onstrengthening pharmacovigilance
for women of childbearing ageand children, in light of WHO's
(01:00):
newly finalized Global SmartPharmacovigilance Strategy.
Amid the bustle of staffclearing tables and delegates
chatting between sessions, I satdown with WHO Pharmacovigilance
team lead Shanthi pal to learnmore about the strategy and what
it means for countries.
The strategy was firstpresented to regulators at the
(01:22):
International Conference of DrugRegulatory Authorities in New
Delhi in October 2024 and isbased on recommendations from
the 2018 meeting in Dublin.
It builds on two main ideas: work sharing and regulatory (01:32):
undefined
reliance among nationalauthorities.
You'll find links to the GlobalSmart Pharmacovigilance
Strategy and the WHO Programmefor International Drug
Monitoring in the episode shownotes.
And now over to Shanthi at theSemiramis Intercontinental Hotel
(01:54):
in the Garden City area ofdowntown Cairo.
So I'm sitting withShanthi Pal.
We're in Cairo, Egypt, for the43rd Annual Partners Meeting.
And we're here to talk aboutthe Global Smart Surveillance
(02:14):
Strategy, which has now beenfinalised.
Shanthi, what's the thinkingbehind the strategy?
Shanthi Pal (02:20):
So thank you, Graeme, for the question, and
thank you also for thisopportunity to speak a little
bit about the strategy.
So we've been working on thisfor a few years now, but I
believe we have brought itto a place where it's
comprehensive enough to supporta few principles that we are
advocating.
(02:41):
And that is we don't haveenough resources to do
everything, and there arecompeting priorities.
So then how do you balancethese two paradoxes?
So it's about risk-basedprioritisation.
So the need to use yourresources efficiently,
effectively, by doing what youhave to do so that you can get
(03:05):
to where you need to go.
And that means that there are afew things that you cannot
delegate, so you keep those asyour utmost priorities.
And then there are some thingswhere you can lean on the work
done by other stakeholders, youcan adopt those or adapt those.
And then there are some whereyou may come together as a
(03:29):
community to take the workforward, and that makes your
systems grow in a cost-efficientway and in a sustainable way.
So that's the thinking behindit.
So when you have competingpriorities but resources are
finite, how do you work smartly?
Graeme Nadasy (03:47):
There are four main pillars.
So could you just in a nutshellexplain what those are?
Shanthi Pal (03:54):
Okay, so yes, the strategy definitely builds on
four pillars.
The first pillar we say is thatbefore you start anything, just
look at the landscape.
What's already available outthere?
And that's the existinginfrastructure and learning
from the past.
How did you use those andwhat have you learned and how
(04:15):
can these be put to use?
So that's the first pillar,leaning on learnings and
existing infrastructure.
And the second one isrisk-based prioritisation.
So you say that where are yourhighest risks?
So you put your preciousresources to address those as a
priority.
So, for instance, if you thinkyou're getting a vaccine for
(04:37):
pregnant women, and you knowthat the volume of use is going
to be quite large, and youknow that this population in
general hasn't received a lot ofattention in pharmacovigilance,
but you know the scale of useis going to be tremendous and
it's a new vaccine, then thatbecomes a big risk for you.
So you would put your effortsinto that.
(04:58):
So that's risk-basedprioritisation.
That's the second pillar.
And the third pillar isreliance and work sharing.
So what you can do use of,either as an individual country
or as a group of countries, andthat's work sharing, or where
one or more countries may relyon the results from another
country that's reliance.
So that's the third pillar: work sharing and reliance. (05:18):
undefined
Graeme Nadasy (05:21):
Could I be a pain and cut in there and just say
it's not lost to me anyway,sitting here in this meeting,
that so goes hand in hand withwhat the programme's about.
Shanthi Pal (05:31):
Yes.
You know, it's intuitive.
I mean, and it is inherentwithin the entire PIDM, you
know, the Programme forInternational Drug Monitoring.
So you're absolutely right.
But sometimes you've got tocall out, you've got to say,
call it.
You've got to say, this is whatyou're doing.
So, you know, you give it aname and then it goes further.
So that's the thinking behindit.
And reliance as a concept hasbeen applied in the regulatory
(05:54):
world for some years, where youknow you can have a group of
countries coming together,assessing a product and
registering it.
And then a third set ofcountries would say, we don't
need to go through the wholeapproval process.
We'll simply take theirdecision and introduce a product
into our market.
The advantage is that you knowyou save on work, but you also
(06:17):
speed up access to products.
So reliance as a concept in theregulatory approval was already
there.
And we have been relying inpharmacovigilance on the global
database, you know.
All countries are sharing andeverybody relies on that shared
good, right?
But slightly to nuance it a bitfurther is to say, you know,
when you want to do characterisean event, you know, you say
(06:38):
this is a say a thrombocytopeniaor Guillain-Barré syndrome,
and then you want to do astudy.
It might not be sufficient,you know, to just look at a
database even more.
Sometimes because of thespecial demographics of your
population or the comorbiditiesof your population, you may want
(07:00):
to study a certain product moredeeply for safety in your
population.
That's when reliance can alsobe of immense help because then
you can come together and do astudy together.
So you're increasing your thepower of your study by pulling
the data from between countries.
Or the even better option islet's say Ghana or Nigeria is
(07:23):
doing it, and maybe Togo canrely on the results of, say,
Nigeria rather than starting todo that study.
So that's the reliance part ofit.
So these are those aspects thatcountries haven't fully
grasped.
And when we introduced activemethodologies, everybody wanted
to do active surveillance ofmalaria, active surveillance of
HIV drugs.
And we simply don't have thatluxury of using resources for
(07:47):
asking the same researchquestion, you know.
So that's where we wanted toalso draw your attention,
attention of countries that youhave been relying on, the global
database, but it's alsopossible to draw from those
principles to your other aspectsthat you're trying to do
independently.
Graeme Nadasy (08:04):
Okay, great.
Thank you for explaining that.
Sorry, I cut you off.
And the fourth pillar.
Shanthi Pal (08:10):
Okay.
So the fourth pillar is aboutbeing part of a regulatory
system strengthening.
Because in many countries,pharmacovigilance developed
like a research question.
It wasn't really part of aregulatory framework, you know,
what the regulator needs to doto keep their population safe.
So we are saying that by beingpart of the regulatory
(08:32):
framework, you know, there arenine regulatory functions that
we assess when we are assessinga regulator's performance,
competence, capacity, etc., wedo that.
And vigilance is one of them.
So we are saying that by addingvigilance to the overall
regulatory deliverable, youknow, you are strengthening the
regulator in their deliverable,in their overall function.
(08:54):
But at the same time, theregulator becomes responsible
for you.
Regulator is accountable foryou, which means the regulator
will fund you, you know, becauseyou make them do well and look
good.
You know, as a mature system,they can say that we are mature
in all nine functions,regulatory functions.
So they take you on, you helpthem, but at the same time, they
(09:18):
are responsible for you andthey sustain you.
So that's a regulatoryframework.
So let's be part of a biggerpicture of the winning team,
help them and get helped.
So it's a win-win, that's thefourth pillar.
Graeme Nadasy (09:30):
Okay.
Obviously, this has been in theworks for some time.
These things just don't appearovernight.
But now that it's here, how doyou envisage it being put into
practice?
Shanthi Pal (09:40):
So it's it's already being used in
different ways betweencountries, but we'll push it
primarily through the globalbenchmarking tool, and where we
go to countries, uponinvitation, of course, where
we're invited to go assess theirregulatory system.
And that's where we'll start.
So although I talked aboutthe four pillars in a certain
(10:04):
order, in reality, it's thebottom-up.
You start with the assessmentand then you prioritize, then
you say, What do I need to doalone?
And what can I rely on?
But before I do anything, whatare the resources available to
me already in terms of database,in terms of tools, technology,
innovations, etc.
So it's a bottom-up.
(10:24):
But that's how we plan to doit.
We start with an assessmentthrough the global benchmarking
tool, and the countries will dothat.
I mean, countries can do aself-benchmarking, that's the
first step, and then when theyare ready, they would call WHO
to do a formal benchmarking.
So, and that's where we areguiding countries, start with
this, and while by doing that,you are automatically following
(10:47):
the smart strategy because youassess, you identify the gaps,
you prioritise which gaps are tobe filled ASAP, as soon as
possible.
And when filling those gaps,how do you do it?
Who do you do it with?
What are the resources you willuse?
And we have out of the 50-oddcountries, 55, I guess, if you
take it as a continent, inAfrica, nine already have
(11:09):
achieved that optimal maturitylevel three, you know, of the
regulatory function, whichincludes pharmacovigilance.
So it you can really seemeasurable goals.
Graeme Nadasy (11:22):
Okay.
Shanthi Pal (11:22):
And when you see that, when countries see that
it's very satisfying.
And it also gives them a clearvision on where they want to go
and how they're going there.
And when they reach there, theyknow it and they get
acknowledged for it.
Graeme Nadasy (11:37):
Okay.
Shanthi Pal (11:38):
So the strategy is one thing, and then the the
success at the national level isanother, you know.
Graeme Nadasy (11:43):
As the de facto head of the program, how will
you measure the success of thestrategy?
Shanthi Pal (11:48):
Right.
So for us, the strategy,success of the strategy would be
in its uptake.
How many countries are usingthis approach?
So what we plan to do ismaybe a year from now, we will
do a survey and ask how manycountries have applied this,
the benchmarking system, hasit an IDP, which is, sorry
(12:12):
for the acronym, theInstitutional Development Plan,
and what maturity level havethey reached, and where were
they a year ago, etc.
For us, having a plan is evenmore important than getting
there, because I keep tellingthe countries that maturity
level three is the, you know,the gold standard, you want to
go there, but the journey isjust as important because it's
(12:34):
filled with you know manychallenges and many breaks and
stations that they have to geton and off.
So every bit of that journey isimportant.
So if they have a plan, for me,that would be a huge success
metric.
Graeme Nadasy (12:49):
And to be super clear about this, are we talking
about low and middle-incomecountries only here?
Shanthi Pal (12:56):
Our focus has been in the vigilance has been on
low and middle-income countries,but the benchmarking tool is
for all member states.
I mean, EMA has gone throughit.
So, you know, it's it'sintended for all of them.
And especially because ifyou're going to promote
reliance, they still have toplay by the same rules and
standards, right?
Graeme Nadasy (13:17):
Okay. So last but not least, what will you look
to UMC for, in terms of support?
Shanthi Pal (13:24):
So they (UMC) could already support in
the assessments, you know, onthe technical: are they up to
scratch?
Do they have the relevantstandards, know-how, expertise,
etc.?
They can help that.
So they can work with WHO asassessors and they are
considering that.
But I think their major supportis going to be in the
(13:45):
development plan.
Once a development plan hasbeen crafted by the country,
then you need technical groupsto help implement that
development plan.
Because a development plan canbe something as simple as having
a report management system.
It can be as simple as that, orit can be as complex as
(14:06):
pharmacogenomics.
You know, I keep telling thecountries, low and middle-income
countries that pace yourselves,have your development plan.
It should be a, you know, afour or five-year plan, and you
will have short-term,medium-term, and long-term
goals.
And short-term, you will do theminimum, and medium term you
will build more competence andexpand the scope of work, and
(14:28):
long term you will aim tobecome maturity level three or
best of class, you know.
So UMC can help with the actualtechnical tools and skills
and competency building in thecountry.
Graeme Nadasy (14:42):
Okay.
Does that also includescientific expertise and
know-how?
Shanthi Pal (14:46):
Absolutely.
Absolutely.
Because, so you have, let'stake signal detection, for
instance, right?
So you have, UMC has clearlythe lead.
They have global data, andthey have a certain advantage in
having that global data, andthey can through their own
development and research areimproving their signal detection
(15:07):
every day.
And you know, the data sourcesthey consider is also growing,
not just the database, butthey're also looking at other
data sources.
So they clearly are, in myview, and can become even
stronger as a lead group forsignal detection.
So they will be the leadscience group for signal
detection and innovations aroundthat.
(15:28):
And then breaking it down tocountries so that you can help
them do case analysis,understanding how these signals
look in their country, thecharacterisation of those
signals for their population,those kinds of capacity building
in science can also be fromUMC.
So, you know, at the globallevel, the scientific leader,
(15:51):
and at the at the nationallevel, you know, the mentor.
You know, we have also, as apart of all of this, we have
something called Coalition ofInterested Parties.
And Coalition of InterestedParties was created primarily to
support countries towards amature regulatory system.
And UMC has been recentlyrecognized as that coalition
(16:11):
partner.
And so that's another waybecause not only as their role
as a collaborating centre, butthey also wear this hat now.
So we bring them to the table,we say ten countries have a
development plan.
Who can do what amongst the CIPpartners?
And UMC has a certainhistorical engagement in this,
(16:31):
but then also under this hat, wecan give them more visibility
but also engage more for thesmart strategy.
Graeme Nadasy (16:38):
Okay.
Well, that's all we have timefor, Shanthi.
Thank you.
It was a pleasure talking toyou.
That's all for now.
But if you'd like to learn moreabout the Global Smart
Pharmacovigilance strategy andthe WHO Programme for
(16:59):
International Drug Monitoring,we put together some links for
you in the episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit UppsalaReports.org tostay up to date with news,
research and trends in thefield.
And don't forget to subscribeto the newsletter for the latest
(17:22):
articles.
If you have any comments orsuggestions for the podcast or
the magazine, please feel freeto reach out on Facebook,
LinkedIn, Blue sky or X.
You can also visit our websiteto learn more about what we do
to promote safe use of medicinesand vaccines for everyone
everywhere.
(17:42):
If you like the podcast, pleasesubscribe to make sure you
won't miss an episode.
And spread the word so otherlisteners can find us too.
For Drug Safety Matters, I'mGraeme Nadasy.
Thanks for listening.
Welcome to Drug Safety Matters, the podcast from
Uppsala Monitoring Centre wherewe explore the latest issues in
pharmacovigilance and patientsafety.
I'm Graeme Nadasy, and you'relistening to a special episode
recorded at the 43rd AnnualMeeting of the WHO Programme for
International Drug Monitoringheld in Cairo, Egypt at the end
(00:37):
of October.
The meeting brought togetherrepresentatives from more than
80 member states, along withsenior experts and regulatory
leaders from WHO headquartersand regional offices.
Discussions focused onstrengthening pharmacovigilance
for women of childbearing ageand children, in light of WHO's
(01:00):
newly finalized Global SmartPharmacovigilance Strategy.
Amid the bustle of staffclearing tables and delegates
chatting between sessions, I satdown with WHO Pharmacovigilance
team lead Shanthi pal to learnmore about the strategy and what
it means for countries.
The strategy was firstpresented to regulators at the
(01:22):
International Conference of DrugRegulatory Authorities in New
Delhi in October 2024 and isbased on recommendations from
the 2018 meeting in Dublin.
It builds on two main ideas: work sharing and regulatory (01:32):
undefined
reliance among nationalauthorities.
You'll find links to the GlobalSmart Pharmacovigilance
Strategy and the WHO Programmefor International Drug
Monitoring in the episode shownotes.
And now over to Shanthi at theSemiramis Intercontinental Hotel
(01:54):
in the Garden City area ofdowntown Cairo.
So I'm sitting withShanthi Pal.
We're in Cairo, Egypt, for the43rd Annual Partners Meeting.
And we're here to talk aboutthe Global Smart Surveillance
(02:14):
Strategy, which has now beenfinalised.
Shanthi, what's the thinkingbehind the strategy?
Shanthi Pal (02:20):
So thank you, Graeme, for the question, and
thank you also for thisopportunity to speak a little
bit about the strategy.
So we've been working on thisfor a few years now, but I
believe we have brought itto a place where it's
comprehensive enough to supporta few principles that we are
advocating.
(02:41):
And that is we don't haveenough resources to do
everything, and there arecompeting priorities.
So then how do you balancethese two paradoxes?
So it's about risk-basedprioritisation.
So the need to use yourresources efficiently,
effectively, by doing what youhave to do so that you can get
(03:05):
to where you need to go.
And that means that there are afew things that you cannot
delegate, so you keep those asyour utmost priorities.
And then there are some thingswhere you can lean on the work
done by other stakeholders, youcan adopt those or adapt those.
And then there are some whereyou may come together as a
(03:29):
community to take the workforward, and that makes your
systems grow in a cost-efficientway and in a sustainable way.
So that's the thinking behindit.
So when you have competingpriorities but resources are
finite, how do you work smartly?
Graeme Nadasy (03:47):
There are four main pillars.
So could you just in a nutshellexplain what those are?
Shanthi Pal (03:54):
Okay, so yes, the strategy definitely builds on
four pillars.
The first pillar we say is thatbefore you start anything, just
look at the landscape.
What's already available outthere?
And that's the existinginfrastructure and learning
from the past.
How did you use those andwhat have you learned and how
(04:15):
can these be put to use?
So that's the first pillar,leaning on learnings and
existing infrastructure.
And the second one isrisk-based prioritisation.
So you say that where are yourhighest risks?
So you put your preciousresources to address those as a
priority.
So, for instance, if you thinkyou're getting a vaccine for
(04:37):
pregnant women, and you knowthat the volume of use is going
to be quite large, and youknow that this population in
general hasn't received a lot ofattention in pharmacovigilance,
but you know the scale of useis going to be tremendous and
it's a new vaccine, then thatbecomes a big risk for you.
So you would put your effortsinto that.
(04:58):
So that's risk-basedprioritisation.
That's the second pillar.
And the third pillar isreliance and work sharing.
So what you can do use of,either as an individual country
or as a group of countries, andthat's work sharing, or where
one or more countries may relyon the results from another
country that's reliance.
So that's the third pillar: work sharing and reliance. (05:18):
undefined
Graeme Nadasy (05:21):
Could I be a pain and cut in there and just say
it's not lost to me anyway,sitting here in this meeting,
that so goes hand in hand withwhat the programme's about.
Shanthi Pal (05:31):
Yes.
You know, it's intuitive.
I mean, and it is inherentwithin the entire PIDM, you
know, the Programme forInternational Drug Monitoring.
So you're absolutely right.
But sometimes you've got tocall out, you've got to say,
call it.
You've got to say, this is whatyou're doing.
So, you know, you give it aname and then it goes further.
So that's the thinking behindit.
And reliance as a concept hasbeen applied in the regulatory
(05:54):
world for some years, where youknow you can have a group of
countries coming together,assessing a product and
registering it.
And then a third set ofcountries would say, we don't
need to go through the wholeapproval process.
We'll simply take theirdecision and introduce a product
into our market.
The advantage is that you knowyou save on work, but you also
(06:17):
speed up access to products.
So reliance as a concept in theregulatory approval was already
there.
And we have been relying inpharmacovigilance on the global
database, you know.
All countries are sharing andeverybody relies on that shared
good, right?
But slightly to nuance it a bitfurther is to say, you know,
when you want to do characterisean event, you know, you say
(06:38):
this is a say a thrombocytopeniaor Guillain-Barré syndrome,
and then you want to do astudy.
It might not be sufficient,you know, to just look at a
database even more.
Sometimes because of thespecial demographics of your
population or the comorbiditiesof your population, you may want
(07:00):
to study a certain product moredeeply for safety in your
population.
That's when reliance can alsobe of immense help because then
you can come together and do astudy together.
So you're increasing your thepower of your study by pulling
the data from between countries.
Or the even better option islet's say Ghana or Nigeria is
(07:23):
doing it, and maybe Togo canrely on the results of, say,
Nigeria rather than starting todo that study.
So that's the reliance part ofit.
So these are those aspects thatcountries haven't fully
grasped.
And when we introduced activemethodologies, everybody wanted
to do active surveillance ofmalaria, active surveillance of
HIV drugs.
And we simply don't have thatluxury of using resources for
(07:47):
asking the same researchquestion, you know.
So that's where we wanted toalso draw your attention,
attention of countries that youhave been relying on, the global
database, but it's alsopossible to draw from those
principles to your other aspectsthat you're trying to do
independently.
Graeme Nadasy (08:04):
Okay, great.
Thank you for explaining that.
Sorry, I cut you off.
And the fourth pillar.
Shanthi Pal (08:10):
Okay.
So the fourth pillar is aboutbeing part of a regulatory
system strengthening.
Because in many countries,pharmacovigilance developed
like a research question.
It wasn't really part of aregulatory framework, you know,
what the regulator needs to doto keep their population safe.
So we are saying that by beingpart of the regulatory
(08:32):
framework, you know, there arenine regulatory functions that
we assess when we are assessinga regulator's performance,
competence, capacity, etc., wedo that.
And vigilance is one of them.
So we are saying that by addingvigilance to the overall
regulatory deliverable, youknow, you are strengthening the
regulator in their deliverable,in their overall function.
(08:54):
But at the same time, theregulator becomes responsible
for you.
Regulator is accountable foryou, which means the regulator
will fund you, you know, becauseyou make them do well and look
good.
You know, as a mature system,they can say that we are mature
in all nine functions,regulatory functions.
So they take you on, you helpthem, but at the same time, they
(09:18):
are responsible for you andthey sustain you.
So that's a regulatoryframework.
So let's be part of a biggerpicture of the winning team,
help them and get helped.
So it's a win-win, that's thefourth pillar.
Graeme Nadasy (09:30):
Okay.
Obviously, this has been in theworks for some time.
These things just don't appearovernight.
But now that it's here, how doyou envisage it being put into
practice?
Shanthi Pal (09:40):
So it's it's already being used in
different ways betweencountries, but we'll push it
primarily through the globalbenchmarking tool, and where we
go to countries, uponinvitation, of course, where
we're invited to go assess theirregulatory system.
And that's where we'll start.
So although I talked aboutthe four pillars in a certain
(10:04):
order, in reality, it's thebottom-up.
You start with the assessmentand then you prioritize, then
you say, What do I need to doalone?
And what can I rely on?
But before I do anything, whatare the resources available to
me already in terms of database,in terms of tools, technology,
innovations, etc.
So it's a bottom-up.
(10:24):
But that's how we plan to doit.
We start with an assessmentthrough the global benchmarking
tool, and the countries will dothat.
I mean, countries can do aself-benchmarking, that's the
first step, and then when theyare ready, they would call WHO
to do a formal benchmarking.
So, and that's where we areguiding countries, start with
this, and while by doing that,you are automatically following
(10:47):
the smart strategy because youassess, you identify the gaps,
you prioritise which gaps are tobe filled ASAP, as soon as
possible.
And when filling those gaps,how do you do it?
Who do you do it with?
What are the resources you willuse?
And we have out of the 50-oddcountries, 55, I guess, if you
take it as a continent, inAfrica, nine already have
(11:09):
achieved that optimal maturitylevel three, you know, of the
regulatory function, whichincludes pharmacovigilance.
So it you can really seemeasurable goals.
Graeme Nadasy (11:22):
Okay.
Shanthi Pal (11:22):
And when you see that, when countries see that
it's very satisfying.
And it also gives them a clearvision on where they want to go
and how they're going there.
And when they reach there, theyknow it and they get
acknowledged for it.
Graeme Nadasy (11:37):
Okay.
Shanthi Pal (11:38):
So the strategy is one thing, and then the the
success at the national level isanother, you know.
Graeme Nadasy (11:43):
As the de facto head of the program, how will
you measure the success of thestrategy?
Shanthi Pal (11:48):
Right.
So for us, the strategy,success of the strategy would be
in its uptake.
How many countries are usingthis approach?
So what we plan to do ismaybe a year from now, we will
do a survey and ask how manycountries have applied this,
the benchmarking system, hasit an IDP, which is, sorry
(12:12):
for the acronym, theInstitutional Development Plan,
and what maturity level havethey reached, and where were
they a year ago, etc.
For us, having a plan is evenmore important than getting
there, because I keep tellingthe countries that maturity
level three is the, you know,the gold standard, you want to
go there, but the journey isjust as important because it's
(12:34):
filled with you know manychallenges and many breaks and
stations that they have to geton and off.
So every bit of that journey isimportant.
So if they have a plan, for me,that would be a huge success
metric.
Graeme Nadasy (12:49):
And to be super clear about this, are we talking
about low and middle-incomecountries only here?
Shanthi Pal (12:56):
Our focus has been in the vigilance has been on
low and middle-income countries,but the benchmarking tool is
for all member states.
I mean, EMA has gone throughit.
So, you know, it's it'sintended for all of them.
And especially because ifyou're going to promote
reliance, they still have toplay by the same rules and
standards, right?
Graeme Nadasy (13:17):
Okay. So last but not least, what will you look
to UMC for, in terms of support?
Shanthi Pal (13:24):
So they (UMC) could already support in
the assessments, you know, onthe technical: are they up to
scratch?
Do they have the relevantstandards, know-how, expertise,
etc.?
They can help that.
So they can work with WHO asassessors and they are
considering that.
But I think their major supportis going to be in the
(13:45):
development plan.
Once a development plan hasbeen crafted by the country,
then you need technical groupsto help implement that
development plan.
Because a development plan canbe something as simple as having
a report management system.
It can be as simple as that, orit can be as complex as
(14:06):
pharmacogenomics.
You know, I keep telling thecountries, low and middle-income
countries that pace yourselves,have your development plan.
It should be a, you know, afour or five-year plan, and you
will have short-term,medium-term, and long-term
goals.
And short-term, you will do theminimum, and medium term you
will build more competence andexpand the scope of work, and
(14:28):
long term you will aim tobecome maturity level three or
best of class, you know.
So UMC can help with the actualtechnical tools and skills
and competency building in thecountry.
Graeme Nadasy (14:42):
Okay.
Does that also includescientific expertise and
know-how?
Shanthi Pal (14:46):
Absolutely.
Absolutely.
Because, so you have, let'stake signal detection, for
instance, right?
So you have, UMC has clearlythe lead.
They have global data, andthey have a certain advantage in
having that global data, andthey can through their own
development and research areimproving their signal detection
(15:07):
every day.
And you know, the data sourcesthey consider is also growing,
not just the database, butthey're also looking at other
data sources.
So they clearly are, in myview, and can become even
stronger as a lead group forsignal detection.
So they will be the leadscience group for signal
detection and innovations aroundthat.
(15:28):
And then breaking it down tocountries so that you can help
them do case analysis,understanding how these signals
look in their country, thecharacterisation of those
signals for their population,those kinds of capacity building
in science can also be fromUMC.
So, you know, at the globallevel, the scientific leader,
(15:51):
and at the at the nationallevel, you know, the mentor.
You know, we have also, as apart of all of this, we have
something called Coalition ofInterested Parties.
And Coalition of InterestedParties was created primarily to
support countries towards amature regulatory system.
And UMC has been recentlyrecognized as that coalition
(16:11):
partner.
And so that's another waybecause not only as their role
as a collaborating centre, butthey also wear this hat now.
So we bring them to the table,we say ten countries have a
development plan.
Who can do what amongst the CIPpartners?
And UMC has a certainhistorical engagement in this,
(16:31):
but then also under this hat, wecan give them more visibility
but also engage more for thesmart strategy.
Graeme Nadasy (16:38):
Okay.
Well, that's all we have timefor, Shanthi.
Thank you.
It was a pleasure talking toyou.
That's all for now.
But if you'd like to learn moreabout the Global Smart
Pharmacovigilance strategy andthe WHO Programme for
(16:59):
International Drug Monitoring,we put together some links for
you in the episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit UppsalaReports.org tostay up to date with news,
research and trends in thefield.
And don't forget to subscribeto the newsletter for the latest
(17:22):
articles.
If you have any comments orsuggestions for the podcast or
the magazine, please feel freeto reach out on Facebook,
LinkedIn, Blue sky or X.
You can also visit our websiteto learn more about what we do
to promote safe use of medicinesand vaccines for everyone
everywhere.
(17:42):
If you like the podcast, pleasesubscribe to make sure you
won't miss an episode.
And spread the word so otherlisteners can find us too.
For Drug Safety Matters, I'mGraeme Nadasy.
Thanks for listening.
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