Tip:
Highlight text to annotate it
X
I am going to start the conference now, so welcome to the Oracle Argus Safety and Oracle
Argus Safety Japan webinar presented by Rodney Lemery and Paul Dobrowolskyj. My name is Adrian
Hampshire and I am managing director of the Europe, Middle East, and Africa division of
BioPharms systems. I am going to go over some short housekeeping items before we start.
During the presentation all participants will be in listen only mode but any listener may
type in a question into the chat feature. Other participants will not be seeing your
questions or the comments and if we have time we will address any questions that have been
provided. Just as a reminder today's call is being recorded and will be posted to the
website in 24 hours so if you lose the connection you can download the session afterwards. Let's start with the
session proper.
We are going to introduce the agenda. We are going to have two sections today starting
with a presentation by Rodney Lemery, director of our safety practice at BioPharm system
and Rodney's will be "Working with Argus in a Global Community." Then we will take a specific
look at "Argus Safety Japan—An Overview" by Paul Dobrowolskyj, a senior sales consultant
at Oracle Health Science global business unit and Paul will give some specifics around Argus
safety to reinforce how Argus provides a unified approach to a global environment and then
if there is time after that we will do a question and answer to answer some of your chat questions.
Let me turn it over first to Rodney Lemery to talk about Argus in a Global Community.
RL: Good morning, afternoon, or early evening. I would like to discuss are the general key
features of the Argus system, the base Argus Safety product that facilitate a globalization
of your company in a safety environment. So I will first go over some high level Argus
Safety features that are basic for any configuration and then I will cover some specific key features
that are very helpful from a global company's perspective.
First, Argus Safety by default supports all types of products. Drugs, devices, vaccines,
biologics, or any other combination therapies that you can think of. It is a highly semi-configurable
system in that your business needs that might be specific to a globalization all encompass
right in the Argus Safety environment itself. Many companies would not require customization
in order to globalize their company in the safety management space so all of the configurations
can be performed right within a graphical user interface, administration and configuration
very easy to perform. The work flow engine is also incredibly flexible and allows us
to create very process specific work flow environments to accommodate today's global
environment.
A completely compliant with both the electronic records and the electronics signature of CFR
part 11 within the united states for the FDA. It has a wonderful integrated query module
that allows for simple and complex types of analysis and surveillance right from the Argus
safety system without having to do any additional analysis or reported tools associated to the
system. This makes it a very flexible system with respects to global analysis and tracking
of our safety data. And of course the ability to track all of our reports and submissions
both in the us and internationally when it comes to expedited and periodic reporting
the system has a phenomenal ability to track all of that data. The key piece here for globalization
would be to track all of your periodic reports from a single screen. It makes Oracle Argus
a very approachable software for this type of work.
It has a rudimentary document management system in that you may attach a document to your
case data and it has out of the box the ability to interface with Documentum and other systems.
It has internal the ability t o the abilities to interface with MedDRA and WHODrug for all
of your coding and versioning needs so a key import case could be safety puggle when talking
about safety management in a global environment.
We use these systems because of the changing face of safety in the global world. Now we
are entering a new age of product safety where as companies, tracking the safety data, we
are becoming more and more expected by the regulatory authorities to focus on pharmacovigilance
and business surveillance in ways that are not traditional in past product safety environments.
Some of the challenges that we face in a global environment are getting cases where case data
and global partners into a central model, how do we facilitate the reviewing or processing
of these cases at the center and distribute back to our partners any type of requirements
for local labeling or even specific case reviews? We also need to track and generate the various
case safety reports that are required for global reporting authorities.
How then does Argus help? There are basically two models that we have seen companies utilize.
The first model would be partners or affiliates having direct access to the central depository
via the corporate network. The second model would be the implementation of an additional
piece of software called the Argus Local Affiliate module which would allow for the case entry,
local entry, and labeling and reporting into a central depository so the central repository
would be synchronizing with the local database via modules. Either method could support a
fast and effective distribution of cases and appropriate reports between affiliates and
the central, responsible authority.
Some of the main components of Argus include case processing areas, worklist areas, which
are the to do list the local affiliate area and the Argus Console which is where we contain
all of our global configuration for globalization. And just as the case is the basic unit of
entry and that we would use as defined by the ICH.
Let's look at our globalized case processing in the first model which we can see would
have certain case data that could be entered into our affiliate area in the local language.
For instance a sample case narrative, event terms, etc. These can be placed into work
lists and assigned to global groups to keep all the case processing well organized. For
example, notification of local labeling or reporting needs. We then look at our central
depository of reporting rules and that central repository and information would allow us
to track individual case safety reports that are being submitted to various agencies. Again
Argus has a fantastic capability tracking all of the periodic reports which are maintained
in a central screen and this allows for very clear tracking and compliance auditing with
your periodic reports.
As an example of local language, our narrative, we could have an English narrative and then
the Spanish equivalent placed into the Spanish equivalent field so the Spanish field could
appear on Spanish individual case safety reports. Our worklists are all available to us and
they come in different forms. They all specifically show us cases that have something that we
need to work on for that day, or that month, or that period of time. Many times in that
worklist there are some submenus that facilitate the processing of that case data without having
to open up the case into case entry and conduct the activity that we are trying to do. So
for example if we were to go to worklist action items we would see all of the cases that have
an action associated to our user account or to the group we belong to. We can then, right
from that screen, close out an action item once it is completed so this type of common
feature really does facilitate the activities associated with case processing without having
to open up the case in case entry mode.
In a second model which is the LAM module, we could have a subset of cases that are all
entered into the LAM applications even in local language. Then our cases are transferred
on a routine basis in to the central repository for review and the local partners are then
notified once the local labeling is required by any of the local affiliate modules we will
utilize the system to notify those LAMs that further case processing is required. Again,
further reporting or local labeling. All of the local work would occur within the local
affiliate module and the central repository would contain all of our report rules and
that would track all of the individual case safety reporting rules for our environment.
This is a screen shot of the local affiliate module which allows you to enter as an affiliate
all of the pertinent case data that are needed to facilitate the execution of a case safety
report and transmitted back to the central database. Once the central database notifies
the local affiliate that some type of local labeling is required there is a local labeling
screen that appears in the LAM module which facilitates the local labeling right in the
screen activity. So again this kind of assists us in facilitating the globalization of our
computers.
We also have the ability to generate local language reports. I gave the example of a
local language report in Spanish before and we have some French reports and German reports
out of the box and Paul will be covering the Japanese equivalent. In general I am hoping
that these slides have demonstrated some basic features of the Oracle Argus safety system
that will aid in globalizing your company, making it a very user friendly application
and quite robust in meeting all of your case safety and reporting needs. So with that said
I think I can turn this over to Paul to discuss specifically the Japanese benefits of Oracle
Argus safety.
AH: Thank you Rodney and I think just before Paul starts let me remind everyone that if
you want to ask any questions type them into the chat box and we will handle them at the
appropriate time. Paul, over to you.
PD: Thanks Adrian and thanks Rodney as well. So what we wanted to give you as well as an
overview with the global process is a lot of companies talk about global process and
exclude Japan or do not know what to do with Japan so we wanted to give you a look at that
with Oracle Argus safety you can truly have a global process and harmonize your process
and tasks globally. And how do we do this, what is more appropriate if you want, why
Argus Japan? And before I start with the benefits I just wanted to say that Argus J , one thing
you have to understand that this is not a separate product. It is simply integrated
with the Argus suite of products, fully part of the Argus safety suite, just an additional
functionality that really allows us to harmonize the benefits of having a global system and
allows you to be more in compliance with what is happening around your company.
One of the biggest benefits of Argus safety is of course to have this portion that is
Argus Safety Japan. So again this is a single global database so tat the architecture level
it is the same database as where the English case is stored, and the English Case and the
Japanese case are actually a single case with the language separated into the case form.
And what does that mean for us? It means it is a single application so when you have Argus
safety in house if you need the operation in Japan and you want to use the same system
then all you need to do on the licensing aspect you can license to also use Argus Japan and
if you are Japanese company in Japan only or are looking at starting in Japan and expanding
into the rest of the world, you can start with Oracle Argus Safety in Japan and establish
your business process and then slowly expand into countries that you want because it is
a single global database. Obviously one of the biggest benefits is that you deal with
only one case. It is in English or it is in Japanese but it is the same information. This
also reduces overhead and by that we mean anything that has to do with multiple systems
could be the double data entry, to a global system and a Japanese system. It could mean
also reduction in duplication of case assessment because now you need to assess the case in
Japan as well as the rest of the world. You could have a business process that establishes
a link via HB between the two systems. This can be eliminated. The maintenance costs of
multiple servers and validation costs and obviously business process, if you have multiple
business process you want to harmonize this into a globalized way of capturing and storing
your data as well as measuring compliance with having a single system you can now have
a true picture of your compliance around the globe and produce the right metrics. Also
looking at signaling and with having a single database you can also start performing more
intelligent signal detection and a globalized view of your product and portfolio and risk
benefits of your product instead of segregating this by country. In order to put these in
place we needed to make sure that the system is compliant with the different requirements
which are driven not only by Europe and the US but also by the MHLW and the PMDA. So we
took those into consideration and we built within the Argus J compliance to make sure
that we fully respect the reporting requirements. This also allows you to do queries on both
the Japanese and English data and having a single database means you always have access
to the source documents when using Argus to store your source documents.
Some of the other effects of having the Japanese enabled within the application is obvious
translation and we see a couple of screenshots where the translation aspect has been taken
care of. Any piece of information in the case form in any time you can have a split screen
that allows you to look at the information in both Japanese and English and make the
appropriate translation. The multi-language that Rodney mentioned that is available in
both text fields in the application has also been enhanced to allow you to capture the
Japanese aspect. As well as auto-encoding so when a case is entered and you uncode in
advance via MedDRA because MedDRA J is also supported and for things that do not match
it lets the Japanese users make a more appropriate match if they choose to do so. We also support
the J terms and the WHOdrug functionality and there for the product coding you can do
that. Because it is a single system the maintenance and administration is maintained by the web
interface that Rod talked a little bit about and you have the specific J items that you
can have control over and some translation tables that your products and your licenses
are translated in country as well so you can see that it matches the English and do not
have to maintain this outside of the application.
To give you an example of the translation screen, When you are an Argus user and you
have the J available this little flag opportunity that shows you the Japanese and the English
and a split screen with the information which can be vertical or horizontal and one nice
feature is that even though you may be a Japanese user and you are entering the case you may
have to do the translation English to Japanese or Japanese to English and you can unlock
the part of the case form that you want to edit in the language that you want to edit.
If it is a Japanese case that is being entered and you are entering the narrative and now
you need to enter the English narrative so that he rest of the company has a good narrative
you can unlock that part of the case form in the English form and enter it in English
as well as the Japanese and then the rest of the company will have the narrative in
English.
In the same manner when you go to the same note fields this is the same little screen
that Rodney was showing, the multi-language screen that allows you to capture French or
Spanish and this can be enhanced with all of this to be captured in Japanese specific
text. Again, you can document as much as possible in a single case and have all the information
required on that case no matter where you are in the world.
On the coding aspect Argus allows you to code in English and in Japanese and shows you the
relation between the terms so you can make sure that if for a particular reason you have
a term that is not current the dictionary will highlight that term and give you the
ability to choose a different one depending on your business process. Again in the same
aspect we talked about the supports for J terms as well as the WHOdrug dictionary so
the application allows you to browse the dictionary and select the more appropriate commented
drugs or different suspect drug that you may have. That is as far as that is concerned.
Obviously one big concern is how do we meet specific requirements in Japan, one of which
is that the reporting timeline starts when Japan becomes aware of the case so it may
be a little different than in other cases. The dates used by the rest of the world. We
have taken that into consideration and added to that to the application. So you will see
a PMBA tab in the analysis tab that will allow you to tackle the requirements specific to
Japan, namely the difference to the receive date and the narrative specific to the license
used and there there is a requirement for a different narrative for each product and
rearranging the products when the reports are produced. So those requirements have also
been tackled. This is all the benefits that you can get with a single application that
allows you to take care of those requirements and when it comes to the HB the Japanese requirements
are a little more complex than in Europe and the US and we needed to make sure that those
requirements were handled properly and the difference files that are required for each
submission are handled properly. The I format and the J format are being created and packaged
and this is something that was mandatory and that the engineering department has done a
good job with. If you do submit a paper copy then we also have those forms available so
additionally to the forms that will be showed with the number of forms that are available
in Argus Safety the Japanese forms will also be part of that selection when it is enabled.
A couple of last slides we wanted to show you were some of these requirements. This
slide shows you how the Japanese is captured in a specific requirement like the receive
date and the licensing and the report times that are required for Japan. This is in the
case form as the regular Argus safety however it allows the Japanese user to have access
to that and provide the available information. The one more within that same time we have
this specific with the narrative and the comments for a license that the J item requires and
this is part of the application there to be documented at any time. Argus J then allows
you to harmonize your global business process and openly tackle some of the challenges that
we have seen in the industry that tell us how do we handle that there are two systems
that many of you may be using. We have tried to regroup all of this in the same application
to tackle these challenges and business processes in Argus Safety. I hope this gives you a nice
overview of Argus J and at this time we have some time for questions and answers.
AH: Yes, we have a number of questions so let's deal with as many as we can. So the
first one is I am not sure I fully understand the two components. Would Argus J be able
to enter a case for the rest of the company?
PD: So with Argus being a single application, yes, if the case was then received originally
by a Japanese user then the Japanese user could do the data entry for the company and
for the information respectively, attach the source document, do the translation as required
and then pass this over to the global process for the English portion of the case. Once
the appropriate users open the case in the English format then the application automatically
translates everything that can be translated like the code lists, the products, the licenses,
the narrative.
AH: Do we have international Pharma companies which are currently using both Argus safety
and Argus J together?
PD: The short answer is yes, the long answer is that some of these companies are currently
in the deployment stage so I do not recall and maybe I can verify the answer but I do
not know if any of them are currently live with both systems or both portions of the
application active. Some are planned for the end of the year, that will be the first, but
a lot of people are looking into this process and putting things into places. Most of the
global companies have started with the English portion and are tackling the Japanese as a
phase 2 of the project. I know of five companies that are currently working on the J portion.
AH: Okay and now let's move on to another topic. What is the best way to hand over a
case to another country affiliate after it has been processed by a US based central function?
RL: It would depend on whether or not you have implemented the LAM or a global depository.
I am sure Paul can step in but if in a globalized environment where you have a centralized depository
but we have in the past had safe triggers will cause specific action items to appear
in the case data that are specific to the work lists in the Argus system. So for example
if we needed a German to open the case and perform the scientific process that is customary
in Germany the action items would show an activity that mimics that requirement and
the next time the German logged into Argus in the centralized module they would see the
action item that required that case to be scientifically assessed. For the LAM, if you
invoke the LAM affiliation then that becomes part of the LAM as the case is passed back
for local labeling or requirement processing.
AH: IF I can add to that another question that seems to be related, is there a clear
mechanism to define which site owns a given case?
PD: Yeah, at the database level we do capture what is triggered by which process and to
continue on what Rodney has explained, when you do want to engage the LAM or the affiliate
portion of Argus safety there are business processes that you need to think about and
this will sometimes rearchitect your global process to say we have this functionality,
how do we leverage this? So you can engage somewhat from a consultant or some of our
partners to go back and look at what you are doing and how best to deploy these pieces
of the application in a global environment. There is some architecture and re-engineering
of the business process that needs to occur when you think of deploying the affiliate
or the Argus J module because you are engaging more people and therefore more process.
AH: Is it possible for a central function to pass some labeling against a company spreadsheet
or labeling brochure to the local affiliate?
RL: I will attempt to fill that in. The core data sheets would be stored in the global
repository so you would be asked to assess those but in the LAM module that would be
for local labeling, more geared towards the local requirements labeling and not the central
datasheet. Paul, the core datasheets appear in the LAM module as well?
PD: NO, the local labeling screen will provide you the core assessment call but it will not
show you the datasheet itself, that is a function only in Argus safety but they will have an
idea of the assessment made globally so they will have a reference as well as their own
local datasheet.
AH: there are various questions regarding the local affiliate module, so before we start
on one of those, I have a more general question relating to LAM and Argus J, how do they interact or interface,
by which the questioner means if Argus J is needed, does not not need a LAM for Japan?
PD: Yes, that is the bottom line, we try to, with Argus J, to make sure that the requirements
are met and fulfilled within the Argus J portion and therefore when you have the Argus J portion
enabled you would not deploy an affiliate module to Japan users because it is the full
Argus that is deployed. And because coding is required and other specific tasks those will not be in the affiliate but
Argus J.
AH: Does the local affiliate module allow you to upload cases through xml and if so,
where could he find a description of the feature?
PD: I believe this is, currently, the affiliate module does not allow you to upload anything
like HP or xml files but if I recall correctly this is being evaluated for enhancement and
it could be coming very shortly so it is a function that we have evaluated very strongly
and without being able to tell you more it will be available in a future version.
AH: Very good. So the follow up question is do we know which version that will be in or
not yet?
PD: We do and we can probably get back to you and provide the particular customer the
roadmap.
AH: This is one more question, can literature searches be conducted using Argus safety or
do you have to use the Pubmed for literature review?
RL: Okay, and again Paul, chime in if you have any other experiences but in my experience
I would not log out, I would leave it open, but yes, I would have to use some other type
of search mechanism, whichever your company prefers and once they are discovered you could
pop back into your Argus Safety and continue to use your Argus Safety features. I did not
cover this but there is a feature in Argus Safety that does help with literature case
entry where we can enter one case in entirely and use the copy case entry to copy that for
a case where, for example, we had four hundred people experiencing the same SAE or AE event
and we did not want to rekey that in four hundred times. So depending on your internal
rules on what constitutes case in a literature search you could utilize the copy function
to use that once one case is completely entered?
AH: Anything you want to add Paul?
PD: No, I
think
that covers it.
AH: I will just round this out with a thank you for your participation.