Situación del comercio electrónico en America Latina y el papel de la política pública
Marcos Pueyrredon- Director del grupo Latinvia®, Presidente del Instituto Latinoamericano de Comercio Electrónico, Argentina
Situación del comercio electrónico en America Latina y el papel de la política pública
Marcos Pueyrredon- Director del grupo Latinvia®, Presidente del Instituto Latinoamericano de Comercio Electrónico, Argentina
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
The realm of product design is a constantly changing environment where technology and style intersect. Every year introduces fresh challenges and exciting trends that mold the future of this captivating art form. In this piece, we delve into the significant trends set to influence the look and functionality of product design in the year 2024.
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits.
To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups.
Technology
For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did.
While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis.
Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad.
Age and Gender
When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same.
Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers.
Race Affects Attitudes
As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
This article is all about what AI trends will emerge in the field of creative operations in 2024. All the marketers and brand builders should be aware of these trends for their further use and save themselves some time!
A report by thenetworkone and Kurio.
The contributing experts and agencies are (in an alphabetical order): Sylwia Rytel, Social Media Supervisor, 180heartbeats + JUNG v MATT (PL), Sharlene Jenner, Vice President - Director of Engagement Strategy, Abelson Taylor (USA), Alex Casanovas, Digital Director, Atrevia (ES), Dora Beilin, Senior Social Strategist, Barrett Hoffher (USA), Min Seo, Campaign Director, Brand New Agency (KR), Deshé M. Gully, Associate Strategist, Day One Agency (USA), Francesca Trevisan, Strategist, Different (IT), Trevor Crossman, CX and Digital Transformation Director; Olivia Hussey, Strategic Planner; Simi Srinarula, Social Media Manager, The Hallway (AUS), James Hebbert, Managing Director, Hylink (CN / UK), Mundy Álvarez, Planning Director; Pedro Rojas, Social Media Manager; Pancho González, CCO, Inbrax (CH), Oana Oprea, Head of Digital Planning, Jam Session Agency (RO), Amy Bottrill, Social Account Director, Launch (UK), Gaby Arriaga, Founder, Leonardo1452 (MX), Shantesh S Row, Creative Director, Liwa (UAE), Rajesh Mehta, Chief Strategy Officer; Dhruv Gaur, Digital Planning Lead; Leonie Mergulhao, Account Supervisor - Social Media & PR, Medulla (IN), Aurelija Plioplytė, Head of Digital & Social, Not Perfect (LI), Daiana Khaidargaliyeva, Account Manager, Osaka Labs (UK / USA), Stefanie Söhnchen, Vice President Digital, PIABO Communications (DE), Elisabeth Winiartati, Managing Consultant, Head of Global Integrated Communications; Lydia Aprina, Account Manager, Integrated Marketing and Communications; Nita Prabowo, Account Manager, Integrated Marketing and Communications; Okhi, Web Developer, PNTR Group (ID), Kei Obusan, Insights Director; Daffi Ranandi, Insights Manager, Radarr (SG), Gautam Reghunath, Co-founder & CEO, Talented (IN), Donagh Humphreys, Head of Social and Digital Innovation, THINKHOUSE (IRE), Sarah Yim, Strategy Director, Zulu Alpha Kilo (CA).
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands.
It’s important that you’re ready to implement new strategies in 2024.
Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024.
You’ll learn:
- The latest trends in AI and automation, and what this means for an evolving paid search ecosystem.
- New developments in privacy and data regulation.
- Emerging ad formats that are expected to make an impact next year.
Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape.
If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.
5 Public speaking tips from TED - Visualized summarySpeakerHub
From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world.
With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively.
The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage.
Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience.
See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers
See the original article on Forbes here:
http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world.
Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance.
For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age.
Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.
A brief introduction to DataScience with explaining of the concepts, algorithms, machine learning, supervised and unsupervised learning, clustering, statistics, data preprocessing, real-world applications etc.
It's part of a Data Science Corner Campaign where I will be discussing the fundamentals of DataScience, AIML, Statistics etc.
Time Management & Productivity - Best PracticesVit Horky
Here's my presentation on by proven best practices how to manage your work time effectively and how to improve your productivity. It includes practical tips and how to use tools such as Slack, Google Apps, Hubspot, Google Calendar, Gmail and others.
The six step guide to practical project managementMindGenius
The six step guide to practical project management
If you think managing projects is too difficult, think again.
We’ve stripped back project management processes to the
basics – to make it quicker and easier, without sacrificing
the vital ingredients for success.
“If you’re looking for some real-world guidance, then The Six Step Guide to Practical Project Management will help.”
Dr Andrew Makar, Tactical Project Management
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
The realm of product design is a constantly changing environment where technology and style intersect. Every year introduces fresh challenges and exciting trends that mold the future of this captivating art form. In this piece, we delve into the significant trends set to influence the look and functionality of product design in the year 2024.
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits.
To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups.
Technology
For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did.
While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis.
Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad.
Age and Gender
When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same.
Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers.
Race Affects Attitudes
As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
This article is all about what AI trends will emerge in the field of creative operations in 2024. All the marketers and brand builders should be aware of these trends for their further use and save themselves some time!
A report by thenetworkone and Kurio.
The contributing experts and agencies are (in an alphabetical order): Sylwia Rytel, Social Media Supervisor, 180heartbeats + JUNG v MATT (PL), Sharlene Jenner, Vice President - Director of Engagement Strategy, Abelson Taylor (USA), Alex Casanovas, Digital Director, Atrevia (ES), Dora Beilin, Senior Social Strategist, Barrett Hoffher (USA), Min Seo, Campaign Director, Brand New Agency (KR), Deshé M. Gully, Associate Strategist, Day One Agency (USA), Francesca Trevisan, Strategist, Different (IT), Trevor Crossman, CX and Digital Transformation Director; Olivia Hussey, Strategic Planner; Simi Srinarula, Social Media Manager, The Hallway (AUS), James Hebbert, Managing Director, Hylink (CN / UK), Mundy Álvarez, Planning Director; Pedro Rojas, Social Media Manager; Pancho González, CCO, Inbrax (CH), Oana Oprea, Head of Digital Planning, Jam Session Agency (RO), Amy Bottrill, Social Account Director, Launch (UK), Gaby Arriaga, Founder, Leonardo1452 (MX), Shantesh S Row, Creative Director, Liwa (UAE), Rajesh Mehta, Chief Strategy Officer; Dhruv Gaur, Digital Planning Lead; Leonie Mergulhao, Account Supervisor - Social Media & PR, Medulla (IN), Aurelija Plioplytė, Head of Digital & Social, Not Perfect (LI), Daiana Khaidargaliyeva, Account Manager, Osaka Labs (UK / USA), Stefanie Söhnchen, Vice President Digital, PIABO Communications (DE), Elisabeth Winiartati, Managing Consultant, Head of Global Integrated Communications; Lydia Aprina, Account Manager, Integrated Marketing and Communications; Nita Prabowo, Account Manager, Integrated Marketing and Communications; Okhi, Web Developer, PNTR Group (ID), Kei Obusan, Insights Director; Daffi Ranandi, Insights Manager, Radarr (SG), Gautam Reghunath, Co-founder & CEO, Talented (IN), Donagh Humphreys, Head of Social and Digital Innovation, THINKHOUSE (IRE), Sarah Yim, Strategy Director, Zulu Alpha Kilo (CA).
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands.
It’s important that you’re ready to implement new strategies in 2024.
Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024.
You’ll learn:
- The latest trends in AI and automation, and what this means for an evolving paid search ecosystem.
- New developments in privacy and data regulation.
- Emerging ad formats that are expected to make an impact next year.
Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape.
If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.
5 Public speaking tips from TED - Visualized summarySpeakerHub
From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world.
With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively.
The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage.
Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience.
See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers
See the original article on Forbes here:
http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world.
Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance.
For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age.
Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.
A brief introduction to DataScience with explaining of the concepts, algorithms, machine learning, supervised and unsupervised learning, clustering, statistics, data preprocessing, real-world applications etc.
It's part of a Data Science Corner Campaign where I will be discussing the fundamentals of DataScience, AIML, Statistics etc.
Time Management & Productivity - Best PracticesVit Horky
Here's my presentation on by proven best practices how to manage your work time effectively and how to improve your productivity. It includes practical tips and how to use tools such as Slack, Google Apps, Hubspot, Google Calendar, Gmail and others.
The six step guide to practical project managementMindGenius
The six step guide to practical project management
If you think managing projects is too difficult, think again.
We’ve stripped back project management processes to the
basics – to make it quicker and easier, without sacrificing
the vital ingredients for success.
“If you’re looking for some real-world guidance, then The Six Step Guide to Practical Project Management will help.”
Dr Andrew Makar, Tactical Project Management
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
269 2015-d1-rs
1. Page 1 of 3
BMS CA209172
Dodatek 1 ke
Smlouvě o zabezpečení klinického hodnocení
Amendment 1 to
Agreement on Clinical Study
Tento dodatek 1 ke Smlouvě o zabezpečení
klinického hodnocení („dodatek 1“) mezi:
PPD Czech Republic, s.r.o., se sídlem Budějovická
alej, Antala Staška 2027/79, 140 00 Praha 4, Česká
republika, dceřiná společnost PPD International
Holdings GmbH., jednající prostřednictvím MUDr.
Dariny Hrdličkové – jednatelky společnosti a zapsaná
v obchodním rejstříku vedeném Městským soudem v
Praze, část C, č. vložky 37941.
IČ: 63671077
DIČ: CZ63671077
(„PPD”)
a
Všeobecná fakultní nemocnice v Praze, U
Nemocnice 499/2, 128 08 Praha 2, Česká republika,
zastoupená Mgr. Danou Juráskovou, Ph. D., MBA –
ředitelkou
IČ: 00064165
DIČ: CZ 00064165
(„Poskytovatel“)
a
prim. MUDr. Ivana Krajsová, MBA,
trvalým bydlištěm Naskové 1c, 150 00 Praha 5,
Česká republika
Datum nar.: 10. 3. 1952
(„Zkoušející“)
je doplňkem smlouvy o zabezpečení klinického
hodnocení mezi PPD, poskytovatelem a zkoušejícím,
která byla plně podepsaná dne 21. srpna
2015(„Smlouva“).
This Amendment 1 to Agreement on Clinical Study
(“Amendment 1”) between:
PPD Czech Republic, s.r.o., registered address at
Budejovicka alej, Antala Staška 2027/79, 140 00
Prague 4, Czech Republic a subsidiary of PPD
International Holdings GmbH., represented by
MUDr. Darina Hrdlickova, executive of the
company, and registered in the Commercial Register
at the Municipal Court in Prague, Section C, Insert
37941.
Company ID no.: 63671077
Tax ID no.: CZ63671077
(“PPD”)
and
Vseobecná fakultni nemocnice v Praze, U
Nemocnice 499/2, 128 08 Praha 2, Czech Republic,
represented by Mgr. Dana Juraskova, Ph. D., MBA
director
Company ID no.: 00064165
Tax ID no.: CZ00064165
(“Medical Facility”)
and
prim. MUDr. Ivana Krajsova, MBA,
permanent residence at Naskové 1c, 150 00 Praha 5
Czech Republic
DOB: 10. 3. 1952
(“Investigator“)
shall be an Amendment to that certain Agreement on
Clinical Study between PPD, Medical Facility and
Investigator fully executed on August 21, 2015
(“Agreement”).
SMLUVNÍ STRANY PROHLAŠUJÍ, ŽE WITNESSETH
VZHLEDEM K TOMU, že PPD, poskytovatel a
zkoušející uzavřeli smlouvu, podle které
poskytovatel/zkoušející poskytují PPD určité služby
spojené s klinickým hodnocením dle protokolu č.
CA209172: „Jednoramenné, otevřené
multicentrické klinické hodnocení s přípravkem
nivolumab (BMS-936558) pro pacienty s
histologicky potvrzeným melanomem ve stadiu III
(neresektabilním) nebo stádiu IV, progredujícím
po předchozí léčbě obsahující Anti-CTLA-4
monoklonální protilátku“ CheckMate 172:
CHECKpoint pathway a nivoluMAb clinical Trial
WHEREAS, PPD, Medical Facility and Investigator
have entered into the Agreement pursuant to which
the Medical Facility/Investigator provides certain
clinical study services to PPD according to protocol
no. CA209172:“A Single-Arm, Open-Label
Multicenter Clinical Trial with Nivolumab (BMS-
936558) for Subjects with Histologically
Confirmed Stage III (unresectable) or Stage IV
Melanoma Progressing After Prior Treatment
Containing an Anti-CTLA-4 Monoclonal
Antibody” CheckMate 172: CHECKpoint pathway
and nivoluMAb clinical Trial Evaluation 172; and
2. Page 2 of 3
Evaluation 172, a
VZHLEDEM K TOMU, že si smluvní strany přejí
upravit podmínky smlouvy, jak je stanoveno v tomto
dodatku 1,
DOHODLY SE smluvní strany s ohledem na obsah
tohoto dodatku 1 a s úmyslem být jím právně vázány
takto:
WHEREAS, the parties desire to amend the terms of
the Agreement as set forth herein.
NOW, THEREFORE, for the valuable consideration
contained herein, and intending to be legally bound,
the parties agree as follows:
1. Na základě dodatku k protokolu bude příloha č. 1
smlouvy – Rozpis plateb –vyjmuta a plně
nahrazena přílohou č. 1 tohoto dodatku 1
2. Smluvní strany berou na vědomí, že smlouva a
tento dodatek, pokud je to potřeba, budou
uveřejněny v registru smluv („registr“)
v souladu se zákonem 340/2015 Sb. o registru
smluv. Smluvní strany se dále zavazují
nezveřejnit v registru žádné informace, které
mohou být považované za obchodní tajemství
smluvních stran ve smyslu § 504 zákona
89/2012 Sb., občanský zákoník v platném znění.
Zadavatel považuje za obchodní tajemství
zejména: jakékoliv informace o struktuře
klinického hodnocení, protokol, investigátorskou
brožuru, dávkování hodnoceného léčiva,
pojištění klinického hodnocení (smlouvu a
certifikát), detailní rozpočet, plánovaný počet
léčených pacientů a duševní vlastnictví.
Smluvní strany se dohodly, že Poskytovatel
uveřejní verzi této smlouvy včetně dodatku 1,
kterou mu za tímto účelem připraví a poskytne
PPD nejpozději v den podpisu tohoto Dodatku, a
to ve strojově čitelném formátu v elektronické
podobě zasláním na e-mailovou adresu
okh@vfn.cz.
Přibližná celková hodnota smlouvy je
4.312.290,- Kč
1. On the basis of Protocol amendment, Appendix
no. 1 of the Agreement – Payment Schedule -
shall be deleted and fully replaced by Appendix
no. 1 of this Amendment 1
2. The Parties acknowledge that the Agreement,
and its amendments if applicable, shall be
published at the Registry of Agreements
("Registry") pursuant to Act No. 340/2015 Coll.,
on Registry of Agreements. The Parties further
undertake not to publish at the Registry any
information which can be considered as a trade
secret of Parties within the meaning of Sec. 504
of Act No. 89/2012 Coll., Civil Code, as
amended. The Sponsor considers mainly the
following to be their trade secret: any
information concerning the Clinical Study
design, the Protocol, the Investigator Brochure,
the Investigational Medicinal Product Dossier,
the Clinical Study insurance (contract and
certificate), budget details, the planned number
of treated patients, and intellectual property.
Parties agree, that the Medical Facility will
publish version of the Agreement and this
Amendment 1 as provided by PPD, at the latest
at the date of the signature of this Amendment in
machine readable form via email to okh@vfn.cz.
The approximate total value of the Agreement is
CZK 4.312.290,-
3. Dodatek 1 se podpisem smluvních stran stane
součástí smlouvy a veškeré odkazy na smlouvu
budou znamenat odkaz na smlouvu včetně
dodatku 1.
3. Upon execution, this Amendment 1 shall be made
a part of the Agreement and shall be incorporated
by reference therein.
4. Všechna ostatní ustanovení a podmínky smlouvy
zůstávají v plné platnosti a účinnosti. V případě
jakéhokoli rozporu mezi ustanoveními smlouvy
a tohoto dodatku 1 budou rozhodující a řídící
ustanovení tohoto dodatku 1.
4. All other terms and conditions of the Agreement
shall remain in full force and effect. In the event
of any conflict between the terms of the
Agreement and this Amendment 1, the terms of
this Amendment 1 shall govern and control.
5. Veškerá použitá terminologie, která není blíže
definována v tomto dodatku 1, bude mít stejný
význam jako je uvedeno ve smlouvě.
5. All capitalized terms used, but not otherwise
defined herein, shall have the meanings ascribed
to them in the Agreement.
6. Smluvní strany se dohodly, že práva a povinnosti
vyplývající z tohoto dodatku a jeho příloh budou
použité také na jejich vzájemné vztahy vzniklé
6. Parties agree that rights and obligations settled in
this Amendment and it´s Appendices shall be
applicable from August 21, 2015.
3. Page 3 of 3
ke dni 21. srpna 2015.
NA DŮKAZ SOUHLASU se zněním dodatku 1
připojují smluvní strany své podpisy níže.
IN WITNESS OF THEIR CONSENT to this
Amendment 1, the Parties have signed below.
PPD: ________________________
Datum/Date: _________________
Poskytovatel/ Medical Facility: ________________________
Mgr. Dana Jurásková, Ph. D., MBA
Datum/Date: _________________
Zkoušející / Investigator: ________________________
prim. MUDr. Ivana Krajsová, MBA
Datum/Date: __________________
Seznam příloh k tomuto dodatku:
Příloha č. 1: Rozpis plateb
Příloha č. 2: Protokol klinického hodnocení (vázán
separátně)
List of appendices to this Amendment:
Appendix no. 1: Payment Schedule
Appendix no. 2: Protocol of the Clinical Study (bound
separately)
4. CA209172_PI Krajsova 1/8
Příloha č. 1 – Rozpis Plateb Appendix no. 1 – Payment Schedule
ke smlouvě mezi:
PPD Czech Republic, s.r.o.
Poskytovatel: Všeobecná fakultní nemocnice
v Praze
Zkoušející: prim. MUDr. Ivana Krajsová,
MBA
to an Agreement between:
PPD Czech Republic, s.r.o.
Medical Facility: Vseobecna fakultni
nemocnice v Praze
Investigator: prim. MUDr. Ivana Krajsová,
MBA
Bristol-Myers Squibb Bristol-Myers Squibb
CA209172 CA209172
Platby: Platby se budou poukazovat na účet
příjemce plateb (dále jen „příjemce plateb“):
Payments: Payments should be made to the
following account of the payee (further, the
“Payee”):
Příjemce plateb/Payee Name: Všeobecná fakultní nemocnice v Praze
DIČ/Tax ID no.: CZ 00064165
Název a adresa banky/Bank name and address: Česká národní banka
Číslo účtu/Acct. no.: 24035021/0710
IBAN: CZ33 0710 0000 0000 2403 5021
SWIFT: CNBACZPP
VS/Reference no.: 5202315237
Faktury: : Podklady pro fakturaci a veškerá
oznámení poskytovateli budou zaslána
společností PPD do Oddělení klinického
hodnocení a výzkumu, U nemocnice 499/2,
Praha 2, 128 08 - kontaktní osoba pí. Bc. Jana
Ulbrikova (study-invoices@vfn.cz,
+420 224 963 096 ). Platba bude prováděna na
základě fakturace poskytovatelem. Fakturu
vystaví poskytovatel na základě kalkulace
uskutečněných návštěv vytvořené
zadavatelem/PPD a odsouhlasených
zkoušejícím. Případné nedodání kalkulace
uskutečněných návštěv nezbavuje poskytovatele
práva vystavit příslušnou fakturu dle platebních
podmínek dohodnutých ve smlouvě. Fakturace
bude probíhat čtvrtletně, ale nejpozději vždy k
30. 11. běžného roku. Všechny originály faktur
týkající se klinického hodnocení musí být
předloženy k proplacení společnosti PPD
(a jako plátce na nich musí být uvedena
společnost PPD) na níže uvedenou adresu
a musí obsahovat přesný rozpis všech poplatků,
doprovodných dokumentů a referenční
fakturační číslo daného řešitelského centra.
Splatnost faktur je čtyřicet pět (45) dní ode dne
Invoices: Invoicing details and all other
announcements to the Medical Facility will be
mailed by PPD to Oddeleni klinickeho
hodnoceni a vyzkumu, U nemocnice 499/2, 128
08 Praha 2 – contact person Ms. Bc. Jana
Ulbrikova (study-invoices@vfn.cz, +420 224
963 096). Payment will be made on the basis of
an invoice provided by Medical Facility.
Invoice will be issued by the Medical Facility
on the basis of calculation of performed visit
provided by Sposnor/PPD and approved by
Investigator Any failure to deliver the
calculation of conducted visits to Medical
Facility does not relieve the right of the Medical
Facility to issue the relevant invoice according
to payment terms agreed in the Agreement.
Billing will be done quarterly but no later than
30. 11. regular year.All original invoices
pertaining to the Clinical Study must be
submitted for reimbursement to PPD (and must
reference PPD as the invoicee) at the following
address and shall include a correct itemization
for all fees, supporting documentation, and a
site invoice reference number. The invoice due
date is forty five (45) days from the day the
5. CA209172_PI Krajsova 2/8
obdržení faktury společností PPD.
V případě nedodržení splatnosti faktury je
poskytovatel oprávněn účtovat smluvní úrok z
prodlení ve výši 0,05 % z fakturované částky za
každý den prodlení.
invoice is received by PPD.
In case of non-payment of the invoice the
Medical Facility is authorized to charge a
penalty of 0.05% of the invoiced amount for
each day of delay.
Fakturační adresa/Invoicing address:
PPD Czech Republic, s.r.o.
Do rukou / Attn.: Finanční oddělení / Finance Department
Budĕjovická alej
Antala Staška 2027/79
140 00 Praha 4
Česká republika / Czech Republic
DIČ/Tax ID no.: CZ63671077
Zasilatelská adresa/Shipping address:
PPD Czech Republic, s.r.o.
Do rukou / Attn.: Finanční oddělení / Finance Department
Budĕjovická alej
Antala Staška 2027/79
140 00 Praha 4
Česká republika / Czech Republic
DIČ/Tax ID no.: CZ63671077
And to email address:
InvestigatorPayments@ppdi.com
Nábor: Poskytovatel a zkoušející berou na
vědomí, že se jedná o klinické hodnocení
vypracované pro vyhodnocení daného počtu
subjektů hodnocení. Očekává se, že zkoušející
vynaloží veškeré úsilí k náboru, jak je uvedeno
ve smlouvě. Jakmile bude dokončen nábor
cílového počtu subjektů hodnocení pro celé
klinické hodnocení, budou o tom poskytovatel a
zkoušející informováni a budou instruováni, aby
již neprováděli nábor dalších subjektů
hodnocení.
Enrollment: The Medical Facility and
Investigator acknowledge that this is a Clinical
Study designed to evaluate a set number of
Clinical Study subjects. The Investigator will be
expected to apply best efforts for enrollment as
provided for under the Agreement. When
enrollment of the target number of Clinical
Study subjects for the entire Clinical Study is
complete, the Medical Facility and Investigator
will be notified and instructed not to continue
enrolling Clinical Study subjects.
Platby v rámci klinického hodnocení budou
realizovány následovně:
The Clinical Study shall be payable as
follows:
Náklady na subjekt hodnocení: Příjemci
plateb bude poskytnuta platba za dokončený a
hodnotitelný subjekt hodnocení, jak je
definováno níže, a sice na základě plateb
uvedených v tabulkách plateb níže, navýšených
o DPH. Platby se budou provádět čtvrtletně
v českých korunách a budou se zakládat na
počtu dokončených návštěv, potvrzených
v elektronických záznamech subjektu hodnocení
(eCRF) a doručení správně vyplněné faktury
s rozepsanými položkami snížené o 10%
zádržné částky. Dokončený a hodnotitelný
Cost Per Subject: The Payee will be paid per
completed and evaluable Clinical Study subject
as defined below based on the rates set forth in
the Tables of Payments below, plus VAT.
Payments will be made on a quarterly basis in
CZK and will be based on completed visits
verified in the subject electronic case report
forms (eCRFs) and receipt of correct and
itemized invoice less 10% withholding. A
complete and evaluable Clinical Study subject is
defined as follows: (i) all procedures must be
performed according to the Protocol and ICH
6. CA209172_PI Krajsova 3/8
subjekt hodnocení je definován následovně: (i)
všechny postupy musí být provedeny v souladu
s protokolem a směrnicemi ICH GCP, (ii)
pacient bude zařazen pouze na základě kritérií
pro zařazení/vyřazení a (iii) veškeré údaje
budou přesně a úplně zdokumentovány.
V případě, že subjekt hodnocení nedokončí
všechny návštěvy tak, jak je uvedeno
v protokolu, společnost PPD bude povinna
uhradit za takový subjekt hodnocení pouze
poměrnou část dokončených návštěv dle eCRF.
GCP guidelines, (ii) a patient will only be
included according to the inclusion/exclusion
criteria, and (iii) all data are documented
accurately and completely. In the event that a
Clinical Study subject does not complete all
visits as specified in the Protocol, PPD shall
only be obligated to make payment for such
Clinical Study subject on a pro-rated, completed
visit, and eCRF basis.
Neúspěšné skríningy: Příjemci plateb bude
uhrazena částka za každý neúspěšný skríning
dle uvedení v tabulkách plateb níže, maximálně
za 5 neúspěšných skriningů. Pro účely této
smlouvy se za neúspěšný skríning bude
považovat každý pacient, který zjevně splní
kritéria pro skíning, podepíše formulář
informovaného souhlasu, absolvuje
skríningovou návštěvu, avšak nebude do
klinického hodnocení zařazen. Platba za
neúspěšný skríning se bude výše uvedenému
příjemci plateb hradit na základě doručení
správně vyplněné faktury s rozepsanými
položkami.
Screen Failures: The Payee will be reimbursed
for each Screen Failure per the Tables of
Payments below up to a maximum of 5 Screen
Failures. For purposes of this Agreement, a
Screen Failure shall mean any patient, who
initially appears to meet the criteria for
screening, signs the informed consent form,
completes the screening visit but is not enrolled
into the Clinical Study. Payment for Screen
Failures will be payable to the above listed
Payee based upon the receipt of correct and
itemized invoices.
Lékárenský poplatek za přípravu léčiva:
Příjemci plateb bude proplacen lékárenský
poplatek za každou individuální přípravu léčiva
ve výši uvedené v tabulkách plateb níže.
Pharmacy Preparation Fee: The Payee will
receive reimbursement of a Pharmacy
Preparation Fee payable for each individual
preparation of the Study Drug in the amount
listed in the Table of Payments below.
Lékárenský poplatek za audit: Příjemci plateb
bude proplacen paušální poplatek ve výši
1.000,- Kč za každý zahraniční audit vyžádaný
zadavatelem nebo paušální poplatek ve výši
600,- Kč za každý tuzemský audit vyžádaný
zadavatelem.
Pharmacy fee for audit: The Payee will
receive reimbursement of a Flat Fee in the
amount of CZK 1.000,- for each foreign audit
and Flat Fee in the amount of CZK 600,- for
each local audit required by Sponsor
Náhrada subjektům hodnocení: Náklady
subjektů hodnocení na stravu a/nebo cestovné
do a z místa návštěvy v klinickém hodnocení
budou dle požadavků protokolu každému
subjektu hodnocení za jednu návštěvu
nahrazeny poukázkou v hodnotě 500,- Kč. Za
vedení záznamů veškerých vydaných a
nevydaných poukázek bude zodpovědný
zkoušející. Poskytování poukázek musí být
kontrolováno ze strany PPD při pravidelných
monitorovacích návštěvách.
Subject Reimbursement Vouchers: Clinical
Study subject costs incurred for meals and/or
transportation to and from Clinical Study visits
as required by Protocol shall be reimbursed to
each Clinical Study subject per visit in the form
of vouchers in the amount of CZK 500,-. The
Investigator shall be responsible for keeping an
accounting log of all used and unused vouchers.
The provision of vouchers shall be monitored by
PPD during regular monitoring visits.
7. CA209172_PI Krajsova 4/8
Neplánované návštěvy: Neplánovaná návštěva
se definuje jako taková návštěva subjektu
hodnocení, která není výslovně uvedena
v protokolu, jejíž absolvování je však v rámci
klinického hodnocení nutné. Neplánované
návštěvy budou uhrazeny částkou 825,- Kč, na
základě doručení správně vyplněné faktury
s rozepsanými položkami.
Unscheduled Visits: An Unscheduled Visit is
defined as a Clinical Study subject visit which is
not expressly set forth in the Protocol, but is
otherwise required for the Clinical Study.
Unscheduled Visits will be reimbursed at a rate
of CZK 825,- upon receipt of a correct and
itemized invoice.
Administrativní poplatek: Jednorázová platba
v klinickém hodnocení fakturovaná příjemcem
plateb po podpisu smlouvy.
Administrative Fee: A one-time non-
refundable fee invoiced by the Payee after
Agreement signature.
DPH a jiné daně: Je-li vyžadována platba
včetně daně z přidané hodnoty, PPD provede
úhradu pouze na základě doručení platné
faktury s vyčíslenou DPH. Doručení faktury
nebo příslušných podkladů pro platby se
vyžaduje i v situacích, v nichž se DPH
neuplatňuje, před provedením úhrady dle této
smlouvy.
VAT and Other Taxes: Where a VAT invoice
is required, payments will only be made once
PPD has received a valid VAT invoice. In
situations where VAT is not applicable, an
invoice or relevant payment request form will still
be required before any payment is made under
this Agreement.
Třetí strany: Příjemce plateb je plně
zodpovědný za úhrady třetím stranám a za krytí
vlastních nákladů souvisejících s tímto
klinickým hodnocením, a to včetně nákladů na
léčbu v případě výskytu újmy na zdraví subjektů
hodnocení vzniklé v důsledku jejich účasti v
klinickém hodnocení, s výjimkou nákladů, které
jsou hrazeny na základě této smlouvy nebo
jejího písemného dodatku.
Third Parties: The Payee is fully responsible for
payments to third parties and paying its own
expenses connected with the Clinical Study,
including costs for therapy in the event of injury
to health of the Clinical Study Subjects resulting
from their participation in the Clinical Study, with
the exception of expenses reimbursed on the basis
of this Agreement or a written amendment to it.
Poplatek etické komisi: Poplatek etické komisi
uhradí PPD mimo tuto smlouvu.
Ethics Committee Fee: The Ethics Committee
Fee will be paid by PPD apart from this
Agreement.
Poplatky centrální laboratoři: Poplatky
centrální laboratoři budou hrazeny zadavatelem
mimo tuto smlouvu.
Central Laboratory Fees: Central Laboratory
costs will be paid by the Sponsor apart from this
Agreement.
Závěrečná platba: Závěrečná platba, včetně
zádržné částky bude realizována po dokončení
závěrečné návštěvy a obdržení následujících
dokumentů společností PPD: (i) veškeré
dokumentace ke klinickému hodnocení, (ii)
přehledu veškerého neužitého hodnoceného
léčiva, (iii) všech vyplněných a správných
eCRF/dotazů a (iv) veškerých doplněných
požadavků k vysvětlení ze strany PPD či
zadavatele, týkajících se údajů nebo záznamů
Final Payment: The final payment will include
withholding and be payable upon completion of
the close-out visit and upon PPD’s receipt of the
following: (i) all Clinical Study documentation,
(ii) the accountability of all unused Study Drug,
(iii) all completed and correct eCRFs/queries,
and (iv) any clarification requests made by PPD
or Sponsor regarding Clinical Study data or
records. The Payee will have thirty (30) days
from the receipt of final payment to dispute any
8. CA209172_PI Krajsova 5/8
klinického hodnocení. Na vznesení námitek
vůči jakýmkoliv nesrovnalostem v platbách
realizovaných v průběhu klinického hodnocení
bude mít příjemce plateb lhůtu třiceti (30) dní
od doručení závěrečné platby.
payment discrepancies during the course of the
Clinical Study.
Bez obdržení předchozího písemného souhlasu
ze strany zadavatele či PPD nebudou brány
v potaz žádné další požadavky na poskytnutí
finančních prostředků.
No other additional funding requests will be
considered without the prior written consent of
Sponsor or PPD.
Tabulky plateb / Tables of Payments
Skríning/Screening
Návštěva/Visit
Částka za
návštěvu v
Kč/Amount per
visit in CZK
Platby za jeden
subjekt hodnocení
v Kč v průběhu
klinického
hodnocení (90%) /
Amount per
subject per visit in
CZK during the
Study (90%)
Platby za jeden
subjekt hodnocení
v Kč po ukončení
klinického
hodnocení (10%)/
Amount per
subject per visit in
CZK after the
Study termination
(10%)
Skríning/Screening 7.030,- 6.327,- 703,-
Návštěva 1/Visit 1 875,- 788,- 87,-
Léčebné období/Treatment
Návštěva/Visit
Částka za
návštěvu v
Kč/Amount per
visit in CZK
Platby za jeden
subjekt hodnocení
v Kč v průběhu
klinického
hodnocení (90%) /
Amount per
subject per visit in
CZK during the
Study (90%)
Platby za jeden
subjekt hodnocení
v Kč po ukončení
klinického
hodnocení (10%)/
Amount per
subject per visit in
CZK after the
Study termination
(10%)
Každý cyklus (každé 2
týdny)/Every cycle (every 2
weeks) 4.131,- 3.718,- 413,-
Každý 2. cyklus (každé 4
týdny)/Every 2nd cycle (every
4 weeks) 4.131,- 3.718,- 413,-
Každý 3. Cyklus + vyšetření
TSH (každých 6 týdnů)/Every
3rd cycle + TSH (every 6
weeks) 4.656,- 4.190,-,- 466,-,-
9. CA209172_PI Krajsova 6/8
Kontroly /Follow up
Návštěva/Visit
Částka za
návštěvu v
Kč/Amount per
visit in CZK
Platby za jeden
subjekt hodnocení
v Kč v průběhu
klinického
hodnocení (90%) /
Amount per
subject per visit in
CZK during the
Study (90%)
Platby za jeden
subjekt hodnocení
v Kč po ukončení
klinického
hodnocení (10%)/
Amount per
subject per visit in
CZK after the
Study termination
(10%)
Kontrola-X01 (po 30 dnech +/-
7 dní)/FU-X01 (30 days +/-7
days) 3.866,- 3.479,- 387,-
Kontrola-X02 (70-84 dní po
Kontrole-X01 +/- 7 dní)/FU-
X02 (70-84 days after FUX01
+/-7 days) 3.866,- 3.479,- 387,-
PRO Kontrola po Kontrolách
X01 a X02 (každé 3 měsíce -
telefonická)/PRO Follow-Up
After X01, X02 (Every 3
months - phone) 350,- 315,- 35,-
PRO Kontrola po Kontrolách
X01 a X02 (každé 3 měsíce -
osobní)/PRO Follow-Up After
X01, X02 (Every 3 months -
personal) 825,- 743,- 82,-
Volitelná kontrolní návštěva
(každé 4 týdny)/Conditional
Follow-up Visit (every 4
weeks) 588,- 529,- 59,-
Další vyšetření/ Other examinations
Částka za jednotku v
Kč/Amount per occurence in
CZK
MR mozku/Brain MRI 14.000,-
MR hrudníku/Chest MRI 14.000,-
MR pánve/Pelvic MRI 14.000,-
MR břicha/Abdominal MRI 14.000,-
CT mozku/Brain CT Scan 8.800,-
CT hrudníku/Chest CT Scan 7.000,-
CT pánve/Pelvic CT Scan 7.000,-
CT břicha/Abdominal CT Scan 7.000,-
Specializované fyzikální vyšetření/Focused
Physical Exam 1.650,-
10. CA209172_PI Krajsova 7/8
Laboratorní vyšetření
Částka za jednotku v
Kč/Amount per occurence in
CZK
Hemogram (CBC) 195,-
Lactate Dehydrogenase (LD, LDH) 66,-
Thyroid Stimulating Hormone 525,-
Hepatitis B Surface Antigen (HBsAg) 705,-
Hepatitis C Antibody (HCVAb) 1.149,-
Urine Pregnancy Test, Qualitative 180,-
Free T3 549,-
Free T4 546,-
Lipase 252,-
Další platby/Other Payments
Částka za
jednotku v
Kč/Amount per
occurence in CZK
Platby za jeden
subjekt hodnocení
v Kč v průběhu
klinického
hodnocení (90%) /
Amount per
subject per visit in
CZK during the
Study (90%)
Platby za jeden
subjekt hodnocení
v Kč po ukončení
klinického
hodnocení (10%)/
Amount per
subject per visit in
CZK after the
Study termination
(10%)
Neúspěšný skríning/Screen
Failure 7.030,- 6.327,- 703,-
Neplánovaná
návštěva/Unscheduled Visit 825,- 743,- 82,-
Náhrada subjektům
hodnocení/Subject
Reimbursement Vouchers 500,- NA NA
Lékárenský poplatek za
přípravu léčiva/Pharmacy
Preparation Fee 1.350,- NA NA
Tuzemský audit/Local audit 600,- NA NA
Zahraniční audit/Foreign audit 1.000,- NA NA
Kontrola vykonaná
delegovaným farmaceutem na
centru/Control by the delegated
pharmacist at Study Site 500,- NA NA
Administrativní
poplatek/Administrative Fee 30.000,- NA NA
Strany se dále dohodly, že příjemce plateb obdrží částku ve výši 5.000,- Kč, která slouží k pokrytí
administrativních úkonů spojených s uzavřením každého dodatku ke smlouvě. Tato částka je splatná
11. CA209172_PI Krajsova 8/8
na základě faktury vystavené příjemcem plateb po uzavření tohoto dodatku, a to ve lhůtě 45 dnů ode
dne vystavení faktury příjemcem plateb./Parties further agree that Payee shall receive a fee in the
amount of CZK 5.000,- to cover adminstrative tasks related to conclusion of every amendment to the
Agreement. This amount is payable on the basis of an invoice issued by the Payee after execution of
this Amendment within 45 days from day invoice is issued by the Payee