Friday, 17 June 2022
그런데 또 옥탄 of rose red outlet onl 늦을 수 있겠 ssr co-worker ooh tote 아무
Thursday, 16 June 2022
all right greetings fellow clinicians dr g back again and if you're anything
excited that you um have have come to see our session today before we get
welcome to this short course on clinical investigations for medical devices
subjects using medical devices i will be showing you the key provisions of the medical device specific gcp standard the iso 14155 and describe its role in the
welcome to this short course on clinical investigations for medical devices and
the iso 14155 standard my name is maria niakar and i'm a clinical research
professional and i've worked in the medical device industry for 15 years now and
i'm very passionate to share my knowledge about clinical research and medical
device technology and i hope you will enjoy this course as a consultant
entrepreneur and founder of a medical device cro i have an excellent perspective
of the current challenges that medical device manufacturers are facing when
setting up clinical investigations in this video i will share my knowledge and
understanding and help you set up clinical investigations of medical devices
let's get started the goal of this short course is that you should get a basic
understanding of what the clinical investigation for medical device is and why
you should care about this and based on that you should be able to figure out if
the full course on clinical investigations of medical devices and the iso 14155
standard that we offer medical device hq could help you in your job or career
the full course is similar to this course but much more comprehensive and with
more in-depth information and quizzes at the end of each topic to test your
knowledge and understanding the full course also gives you an iso 141 gcp
certificate at the end of the course which many auditors and employers will be
looking for so what is the iso 14155 about well the first edition of this iso
standard was published in 2003 and the second revision of the standard was
released in 2011 and the third and current version of the standard was released
in july 2020 this course is based on the 2020 version of the standard the iso
14155 standard is an excellent guidance document and i encourage you to
carefully read it and understand it it will almost guarantee that you will set
up and conduct clinical studies with high regulatory compliance and high
scientific credibility so let's look at what clinical research is and why it's
important clinical research is necessary to develop new treatments for different
diseases and conditions that occur in humans to develop these new treatments we
have to perform clinical studies to get proof that the new treatment works and
that it's safe in humans clinical trials and studies using medical devices are
called clinical investigations in the iso 14155 standard the term clinical trial
or clinical study are synonymous with clinical investigation so clinical
investigations are carried out to assess what works and does not work as
treatment in humans and more elegantly this is described in the iso 14155 as
clinical investigations is defined as any systematic investigation involving one
or more human subjects undertaken to assess the clinical performance
effectiveness or safety of a medical device so the purpose of the clinical
investigation is to establish and verify clinical safety or establish and verify
performance or establish and verify clinical benefits or detect any undesirable
side effects i want to emphasize that clinical investigation should not be
confused with the term clinical evaluation it is easy to misuse or use the terms
interchangeably but it's important to know the difference so we know if we speak
about one thing or the other so in other words a clinical investigation is when
you're using a medical device on real patients to demonstrate the safety and
performance of that medical device whereas the clinical evaluation is a
theoretical and scientific assessment of existing data from many different
clinical investigations and other sources of clinical data furthermore the
clinical evaluation is about answering two important questions such as is there
sufficient clinical evidence to confirm compliance with relevant requirements
for safety and performance when using the device according to the instructions
for use very few and is the clinical investigation needed now let's look a bit
more in detail at clinical investigations so do all medical devices need a
clinical investigation well here it's important to make a distinction between
clinical research of drugs and clinical research of the devices so when studying
new drugs a clinical trial is always required however when studying medical
devices a clinical investigation may be required and this decision is based on
the novelty of the device the risk classification of the device the outcome of
the clinical evaluation and the conclusion from the risk analysis of the device
you may think that why wouldn't all new medical devices need a clinical
investigation how can you know that they're safe well if you are manufacturing a
syringe or scalpel it might be possible to say that the device is safe and
performs well by using results from relevant pre-clinical testing of that device
including bench test in vitro test ex ex-vivo test animal tests and so on
together with an evaluation of published literature on that device nevertheless
in the united states all high-risk medical devices such as class 3 devices and
some class 2 require a clinical investigation in the eu the european union all
high risk devices such as class 3 devices and implantable medical devices
require a clinical investigation some class 2 devices require clinical
investigation too there may be some exceptions to this and in our course on
scene marking on medical devices you can learn more about how to classify the
risk of a medical device now that you know more about what clinical research is
and what clinical investigations are let me bring you up to speed on what good
clinical practice is so good clinical practice also known as gcp is an
international quality standard that describes how to manage clinical trials
involving human subjects governments can use this standard to transpose it into
regulations for how to set up and manage clinical studies the gcp standard is an
ethical and scientific quality standard for designing conducting recording and
reporting clinical trials that involve human subjects it provides public
assurance that the rights safety and well-being of subjects are protected and
that clinical data is credible the gcp standard also established what is
required in terms of how to prepare gcp required documentation such as a
clinical study protocol how to maintain important records how to train study
staff how to qualify the clinical sites and its facilities how to maintain
quality assurance and perform monitoring and auditing you may have seen the
acronym ich in the context of gcp the ich stands for the international council
for harmonization of technical requirements for pharmaceuticals for human use
wow i almost wasted my time there anyway the mission of ich is to promote public
health by achieving a greater harmonization of global drug development the ich
does this by developing technical guidelines and and requirements that can be
used by the regulatory authorities and the pharmaceutical industry harmonization
leads to more rational use of humans and animals and other resources it aims to
eliminate unnecessary delays in the development of new therapies and that's
really great isn't it so the gcp follows ich and enforces tight guidelines on
the ethical aspects of clinical research the ich gcp document therefore provides
a unified standard for the european union switzerland canada japan and the
united states on how to generate clinical data now let's switch gears to one of
my favorite standards the iso 14155 this standard was specifically developed for
clinical investigations of medical devices it's an excellent tool to help you
implement gcp when conducting clinical investigations for medical advices
similarly to ica's gcp the iso 14155 is an international quality standard which
governments also can use to transpose into regulations for how to manage
clinical investigations with medical devices in human just like ich gcp this
standard includes protection of human rights for the subjects in the clinical
investigation the iso 14155 standard provides a detailed instruction on how to
set up and perform a scientifically credible clinical study the standard also
helps you understand how to properly document the clinical outcomes and
everything else related to the study to meet the requirements of the iso
standard you have to create the well-structured and complete clinical
investigation plan the cip there's even a specific index to help you with this
and xa of the iso 14155 you also have to keep a good organization of important
study documents called records the standard also describes how important it is
to train the study staff and how to qualify the clinical sites and the
facilities and finally how to maintain quality assurance performing monitoring
visits and auditing so it's clear that gcp and iso 14155 the standards are
important and that remaining compliant with these standards is essential but who
is responsible to ensure compliance let's look at this now who are the
stakeholders that will ensure good clinical practice and make sure that it's
implemented and followed we will look at the main part is now involved in
clinical research the stakeholders that share responsibilities to ensure gcp
compliance are the sponsor the principal investigator the research nurses and
clinical research coordinators the ethics committees and the regulatory
competent authorities the contract research organizations cros and monitors the
medical monitor all these stakeholders are bound by three basic concepts and
duties their ethical scientific and administrative responsibilities to summarize
the sponsor is ultimately responsible for the clinical investigation the quality
planning conduct as well as ensuring appropriate communication with the
regulatory authorities such as the competent authority the investigator is
responsible for the day-to-day conduct of the clinical investigation and the
investigator must be qualified by education training and experience the ethics
committee is the independent body that should give opinions on the ethical and
scientific matters of the clinical investigation and the competent authority is
the regulatory body that acts on behalf of the government to ensure that the
legal requirements are applied any of the stakeholders can unfortunately and
often without knowing it breach the requirements i outlined in the gcp and the
iso 14155 standard much of our work as clinical research professional is to know
that the gcp and the iso standards so well that we can anticipate and avoid
making these mistakes in the full course we talk more about the breach of gcp
serious protocol deviations and how to make sure that you can avoid this now
that you understand the importance of the iso 14155 let's look at some of the
specific sections and its requirements the standard released in 2020 has 10
clauses and 10 in excess three normative and access and seven informative it's
almost twice as long as the previous standard version it starts by providing an
overview of terms and definitions and there are quite a few of them actually 55.
i can really recommend to carefully read them since it's very useful that you
use the correct term that is widely accepted and well defined what is new in the
2020 version is a summary of the gcp principles which have been aligned with
with the ica's gcp principles and this is presented in clause 4. this is an
excellent summary the 13 gcp principles are summarized and start with that a
clinical investigation must be conducted in accordance with the ethical
principles that have their origin in the declaration of helsinki you also have
to ensure that the foreseeable risks are weighed against anticipated benefits
for the individual subject as well as the society the rights safety and
well-being of human subjects are the most important consideration and should
prevail over interest of science and of society the available preclinical and
clinical information on the investigational device should be adequate to support
the proposed clinical investigation and the clinical investigations must be
scientifically sound and we described in a clearly detailed clinical
investigation plan the cip the clinical investigation must receive prior ethics
committee approval and approval from the regulatory authorities where needed the
medical care given to the subjects and the medical decisions made is the
responsibility of a qualified healthcare professional each person involved in
designing conducting recording and reporting a clinical investigation must also
be qualified by education training and experience to perform their task each
subject should freely give an informed consent prior to the participation in the
clinical investigation all clinical investigation related information should be
recorded handled and securely stored the confidentiality of records that could
identify subjects must be protected and respect the privacy and confidentiality
rules investigational devices must be designed manufactured handled and stored
correctly and they must be used in accordance with the approved clinical
investigation plan and the ib and manufacturer's instructions for use and
finally there should be a quality system in place with procedures that ensures
the quality of every aspect of the clinical investigation i also want to show
you that while clinical investigations of medical devices have many similarities
to clinical trials for pharmaceuticals the regulatory evaluation of devices is
distinct to that of drugs and there are critical differences in the way that
device studies are designed and executed let's look at this so clinical research
is broken up into series of phases each with a distinct purpose phase one to
phase four pharmaceuticals must undergo the full clinical trial phase sequence
before market release for medical devices the sequence is similar however most
medical devices will go through clinical investigation stages instead of faces
this table provides a side-to-side comparison of pharmaceutical trial phases
versus medical device stages it also shows the main differences between the
different phases and stages for drugs versus devices i know it contains a lot of
information and in the full course we review this stage by stage and finally i
would like to end this short course by speaking a bit about the clinical
development process and the importance of carefully preparing a clinical
research budget and to monitor costs and timelines i have prepared this flow
chart outlining critical steps that you need to adequately plan and execute
towards this is of course simplified and there could be many more pitfalls
during this journey we will review all of these steps in the full course and you
will learn how to anticipate some of these challenges and avoid some of the
pitfalls clinical investigations are notorious for the complexity they typically
take many years to reach completion and are often very costly but in this course
you will see that there are several actions that you can take to optimize the
process and make sure that you set up a successful study and even save money we
have now come to the last part and with all that you have learned you have
probably realized that you need to build a solid clinical budget to convince
your manager the sponsor and possibly investors about the project's feasibility
you will need to identify the key cost parameters for your clinical research
project it is also important to make sure that you keep an eye on the
differences in costs related to assessment specified in the clinical
investigation plan and these costs are sometimes country specific in the full
course we will review all the cost drivers and how to carefully craft a clinical
research budget the better you plan your study from the beginning the more you
can optimize your budget and control the costs remember if you're failing to
plan you're planning to fail thank you for watching this short course i hope you
found it interesting and valuable if you need templates to give you inspiration
on how to write these clinical documents or if you require more knowledge on
clinical investigations of medical devices on medical device hq you can find
some free templates of essential documents that are required in clinical
investigations or you can purchase the full course introduction to clinical
investigations for medical devices and iso 14155 you can find that on medical
device hq we offer online courses public classroom courses as well as in-house
trainings on clinical investigations clinical evaluations cm marking risk
management design control and project management for medical devices drop us a
line on support at medicaldevicehq if you want to learn more about your options
or receive a proposal you can also email us on the same email address if you
have a question related to clinical investigations and clinical evaluation or
share what you think are the most challenging topic in the clinical evaluation
process i hope to see you soon again
device and if that is not possible it shall be placed on the packaging
so i am pontus yada i have worked as the technical planning manager for an mdr
notified body for several years and this video is part of my course introduction
to mdr the medicaid device regulation and are you interested in the full course
on the mdr check out the course by visiting the course page that is linked below
and if you need a record of your training in this area the full course will
result in you receiving a course certificate before we start ensure that you are
subscribed to our channel to make sure you're always on top of content then
click the notification button too let's dig right into it now let's look at the
requirements related to the unique device identifier or just short udi udi is
applicable to all manufacturer of medica devices in europe and before we dig
into the udi requirements in europe i would just like to clarify once and for
all that the udi requirements in europe are not identical to the udi
requirements of other markets like the u.s market a colleague of mine once said
during a training session we had on medicare devices that should be a slogan for
udi i think okay i said and what would that be he answered udi more than just
the barcode and i actually have to admit that he was quite right at the time it
is a lot more than just the barcode even though i never heard this slogan again
after that meeting sorry i know it's a bit nerdy but what more can we do to
bring more attention to this important subject but jokes aside this udi thingy
is actually a whole world of its own so let's start to introduce you to this
world let's start with an overview of the udi concept we can picture it as three
pillars starting from the left and i will then further elaborate the pillars
first we have the basic udidi or sometimes called beauty the purpose of the
basic udidi is to act as the main key in udemy and relevant documentation like
certificates declaration of conformity technical documentation periodic safety
update reports and sscps but also certificates of free sales worth noting for
those of you taking this course outside europe is that the basic udidi is unique
to the european union and therefore there is no corresponding codes available in
for example us which has already and will probably continue to cause some
confusion the basic udidi is kind of a collective code used to cover devices
with the same intended purpose risk class and essential design and manufacturing
characteristics the basic udidi shall not be on any device or packaging it is
only to be used as a collective term for grouping devices and for reporting into
udemed moving down in this blue pillar now one basic udidi can then cover
several udis as i just explained but a udi cannot be included in several basic
udidis the actual udi is then split into two parts the udidi and the udi pi di
stands for device identifier and pi stands for production identifier the udi
part is mandatory for all medicaid devices whereas the udi pi part is only
applicable where production related information is required to be included in
the labeling like lot number serial number software release or when expiry date
is essential to communicate so please understand that if expiry date or
manufacturing date is essential for your device independent on class a udi pi is
required so basically we can say that any essential information on the label
that is defined during the production will require a udi pi the udi shall be
placed on the product by the manufacturer and no one else and thereby it is also
a requirement that the manufacturer has integrated the assignment and
application of the udi in their qms below this video you'll find an mdcg endos
document explaining the udi requirements in relation to the manufacturer's qms
it is really quite a good guidance so i recommend you to read it and i expect or
actually i know that notified bodies will follow this guideline both the
beauties and the duties shall be unique to the manufacturer and must be obtained
from a designated issuing entity in accordance to that issuing entities
nomenclature there is a list of currently available issuing entities below this
video the basic udidi is an alphanumeric code that shall be readable for humans
a human readable interface or short hri so no need for barcodes on the basic
udidi but the udi including then the udidi and pi shall both be readable to
humans and to machines and machine readable interface is abbreviated aidc which
stands for automatic identification and data capture examples of aidcs are 2d
barcodes dot matric codes biometric codes or rfid as i just mentioned the basic
udidi is for example used for certificate but also needed when registering the
actual device in udemad together with the udidi and those two are the so-called
static parts of the udi system meaning as long as you don't change your device
or add or remove devices they remain the same there is an mdcg endorsed document
mdcg 2018-1 published that explains when you need to change gud idi and also the
relationship to the basic udidi for those you find the link under the video
focusing on the udi di a bit then the udidi must be unique to a manufacturer and
a device and it shall be both human and machine readable so to put it in normal
words the ud idi is kind of corresponding to the order number that you will use
for selling your devices this is also known as the ref number but please note
that this doesn't mean that you need to replace your order number ref number
with the actual udidi code but they must be linked internally and also in udemed
this also means if you offer your product in different quantities for example a
five pack of a product or a twenty pack and they have different order numbers
you need to have different udi idis for those levels of packaging meaning one ud
idi for the actual device and another udidi for the sales package if so if in
anything else than a single pack but please note that shipping containers are
excluded from the udi requirements that was a summary of the udi setup now let's
continue with the udi carrier which is basically the label then first of all
let's just make it clear again the udi carrier shall not include the basic udidi
only the udidi and if applicable to udi pi and once again the udai carrier shall
be readable both to humans and machines the udi shall be placed on the actual
let'sdevice and if that is not possible it shall be placed on the packaging 
then focus a bit on the udi pi part the pi production identifier part of the udi
code is the code that is dynamic and used to identify the specific data related
to the production of that specific device such as serial number lot number
software identification manufacturing or expiry date or both of those dates and
for devices exclusively intended for retail sales for example band aids the udi
pi is not required to appear on the sales packaging as aidc meaning machine
readable so that is excluded for those retail devices and at the other end of
the risk scale there are active implantable medical devices and for them the
serial number on unit level is mandatory to be included in the udi pi so what
could one of those machine readable codes look like well here is an example of a
2d barcode udi including the udidi and the udi pi and as you hopefully
understand if the pi part needs more data then we need a longer code and if your
product doesn't have a really big label it could become a challenge to fit this
barcode onto the existing one but there are dot matrix codes available to use
also if a 2d barcode will be too long but still the data must be able to be read
by humans also so when do you need to comply with this marking of the udi on
your device here you see the dates when the udi carrier must be on your device
the upper row is for normal devices and the bottom row is for devices that are
intended to be reduced like surgical instruments and the dates for those
reusable devices shown here is the date when the actual device needs to be the
udi carrier themselves so basically meaning marking the device itself with the
full udi not just on the label as you can see now udi is more than just a
barcode so the majority of the mdr requirements are collected in article 27 and
annex 6 but i have to admit that this annex is quite messy and not the best part
of the mdr actually and since there are quite many things in the mdr that needs
to be clarified in relation to udi the mdcg has been busy in issuing guidance
documents on this subject so i strongly recommend you to frequently check the
mdcg web to see if when new or updated guidelines are published related to udi
and be aware that there are some specific requirements for software and
procedure packs plus some other devices that have specific guidelines published
by the mdcg for the udi feel free to drop a comment or question below i'd love
to talk to you are you on linkedin make sure you follow medicaldevicehq there
and do tell our friends from the medical device industry to connect with us too
that's all for now thanks for watching once again and see you next time
just screen and buttons when talking about a medical device all kinds
introduction to usability engineering and iec 62366-1 you'll find it on
medicaldevicehq.com usability engineering if you want more premium medical
device content don't forget to click the subscriber notifications button so you
don't miss out usability engineering is about understanding who uses the device
the tasks of the users the environment in which they will use it and designing a
great user interface there are directly two terms i would like to introduce to
you the first and probably the most important one in the whole usability
engineering work is user a user is simply the person who is interacting with the
medical device and the second term when talking about a great user interface is
of course user interface and in the medical world the user interface actually
includes more than you might think the user interface means so much more than
accompanying documentation and basically everything that the user can interact
with needs to be considered a user interface it even includes auditory signals
and the instructions for use so where does the usability engineering process
start it starts with the preparation of a used specification the use
specification is a document that includes all the information about your users
you can imagine it as an extended form of the intended use and getting
information right is really crucial for the success of your product that becomes
really clear if you have a look at this example imagine you are talking about a
glucose measuring device if it is used in a home use environment by a young
child you will need to prepare a different device compared to a device that will
be used by a professional caregiver in a hospital environment even more the same
could be true if you're looking only at home use environment imagine you're
comparing a device that will be used only by kids with one that is used only by
elderly people they will most probably be designed completely differently to
make sure that your device will be good and safe you have to take great care of
identifying the right user profiles and writing down all the information that
makes this user so special and please remember this not only includes
characteristics of the person but also characteristics of the tasks and the use
environment and this is the starting point for the usability engineering process
based on what the use and the users are like you should analyze what could go
wrong with regards to the safety of the user interface this is similar to
identifying hazards or answering questions relating to the safety of the device
that many would be doing as part of risk management process according to the iso
14971 standard let's have a look at the graphic from the standard again as you
can see safety plays a major role in usability engineering for medical devices
in the original process looking at things that could go wrong makes a total of
three steps i just group them together for the sake of simplicity and when
speaking about things that could go wrong one term that comes up is the term use
error the term use error has a very broad definition because you could say that
a use error happens every time a human and the machine misunderstands each other
not every use error will lead to hazardous situation far from but some use
errors may and those are the ones usability engineering is focusing on the
formal definition of use error is a use error is defined as a user action or
lack of such an action while using a medical device that leads to different
results as intended by the manufacturer or expected by the user of the device
typical examples of a use error could be a nurse who accidentally pulls out the
cable of the sensor of a monitoring device without noticing it or it could be a
healthcare professional who touches a sterile tissue with his or her bare
fingers before applying it to wound but it could also mean that someone
accidentally connects a cable to the wrong part of a medical device and the
signal is not transduced correctly as you can see there are a lot of different
potential use errors and please note it's not called the user error if you think
so you won't pass the final exam of this course because user error implies it's
the user's fault but it's most definitely not always the user's fault when
there's a use error another important term that is highly relevant when talking
about things that could go wrong is the term hazard-related use scenarios the
term can be a bit challenging for those that were not always working with risk
management therefore i'd like to introduce you to it a hazard-related use
scenario is a hazardous situation that you occurred as a result of a use error
and we already discussed what use errors and the hazard related use scenarios
are the things you need to identify and document because you will need them in
the next step because then based on the identified use error and on what could
go wrong you decide which things you should evaluate in the very end of your
product development that is to identify hazard-related use scenarios that will
be included in your summative evaluation in the end to ensure that your medical
device is safe providing or verifying that the device is safe is a must because
it is a general principle in both risk management and design control so you have
to check whether your risk control attempts were successful and the success is
checked by the summative evaluation but don't worry i will explain what a
summative evaluation is in a few moments now that we've gone through the first
analysis it's time to specify requirements on the user interface when
implemented those requirements should reduce the risk that we previously
identified to make sure that when we do the final evaluation of the device the
user will not end up in a situation where the risk is unacceptable from a risk
management point of view you could say that these requirements are risk control
measures and that is the great thing about starting with the risk in mind you
now know which user interface requirements you need to include to be able to
reduce those risks nevertheless i would like to encourage you to not only
include requirements that make a safe device but also think about the
requirements that come to mind when thinking about the user environment and the
task of your users so those requirements that would really make a great device
that everybody is delighted to use next you need to implement the requirements
you decided on in the previous step by designing the device and its user
interface while you do you should check that you are on the right track that is
really important because from my experience you won't get the design right on
the first try especially when you're designing a new product there's a term for
making tests along the way and that is called formative evaluation let's look at
the term formative evaluation it's a quite challenging term to remember this
term is actually not only used in usability engineering but also in teaching and
it means almost the same thing in both contexts remember i say that we are
checking that we're on the right track which is also what you would do in
teaching when you're doing formative evaluation in fact when you take this
course and you go through the checkpoint quizzes this is also kind of formative
evaluation having said that i hope i've created a few memory hooks for you to
remember the term formative evaluation so what could a formative evaluation be
like it could be that you show early wireframes to users to see where they would
click you could be making tests with prototypes to see how people interact with
your device or you could do focus groups or surveys a formative evaluation is
basically any method you can come up with that would solicit feedback on your
user interface in its simplest form it's just to ask if someone understands it
or what the symbol should be like on the device more advanced formative
evaluations include testing in an environment that is as real as possible with
multiple users and a product that is similar to the final one the amount of work
you do in this field depends on whether the product is brand new or not and the
severity of the harm that could occur as a result of failure in the user
interface if you are for example making a new iteration of an already existing
product you are likely to do very little formative evaluation or even little
usability engineering at all whereas if you are developing a brand new high risk
product that trusts humans to operate it correctly you are going to invest a lot
more time and resources into this field what if you find that you're not on
track well then you need to iterate on the design and approve this is how you
proceed with the development until you find in your last formative test that
just nothing to improve anymore after having implemented a user interface
according to the requirements you have defined and evaluating it along the way
it's time to do the final summative evaluation the summative evaluation should
demonstrate that the user does not end up in a situation with an unacceptable
risk as a result of poor usability before explaining the summative evaluation
please note it is not the same thing as design validation the design validation
will focus on showing that the user needs have been met while the summative
evaluation is about showing that the user interface is safe there might be a
small overlap in terms of how you do the testing but they do have different
purposes so summative evaluation is testing the usability under conditions of
simulated use it should also be done using production units or equivalent
devices from the point of view once again it's similar to design validation but
remember that the purpose is different lastly all the documentation and records
you have created throughout the usability engineering process will be referred
to as the usability engineering file that was the usability engineering process
in a nutshell if you want to learn more about usability engineering you can sign
up for my online course introduction to usability engineering and iec 62366-1 on
medicaldevicehq.com thanks for watching and stay tuned for the next
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그런데 또 옥탄 of rose red outlet onl 늦을 수 있겠 ssr co-worker ooh tote 아무
민간 들었소만 note is damp ok lee hooker 2 drive test 입니다 이 번 맞을 생각을 해 볼게요 고구마 entered 개나 악수 준 스티커 m 뭘 powers on non 테스트 무 볼 체인 주머니에 넣을 수 4 그 les...
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started just a couple of housekeeping items we encourage our attendees to ask questions so please be attentive and ask questions the more y...