Presentation held at eCTD Lifecycle Management Conference, Brussels 23-24 February 2010. Find out more about how you can work with your team, processes, tools and active decision making.
LeasePlan's implemententation for the Social Connections event IIPim van Wetten
This is the presentation I gave for the Social Connections event II in Cardiff. It's about the IBM Connections implementation that e-office has done for LeasePlan.
LeasePlan's implemententation for the Social Connections event IIPim van Wetten
This is the presentation I gave for the Social Connections event II in Cardiff. It's about the IBM Connections implementation that e-office has done for LeasePlan.
The data and analytics of the new life sciences marketplace handoutFrank Wartenberg
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Presentation delivered at the 9th International Pharmaceutical Compliance Congress and Best Practices Forum, Brussels, 2015
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
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This SlideShare explores the full results of this study, including detailed market-by-market breakdowns of intention levels for each technology – and how attitudes change with age, location and seniority level. If you’re marketing a tech brand – or planning to use VR and wearables to reach a professional audience – then these are insights you won’t want to miss.
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This presentation was made at a UK APMG-International Showcase event. Join us in London, 20th June 2013 for keynote addresses, masterclasses and round table discussions with leading PPM visionaries. Free to attend if you pre-register. http://uk.apmg-showcase.com/
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10R - Gemalto : Révolution contrôlée des systèmes de formation...FFFOD
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Presentation by Pascal Chardonnet from Université de Savoie. Presentation was held at the EMAP training seminar in Tallinn for future Erasmus Mundus Joint Doctorates consortia (18-21 January 2012). For video see http://vimeo.com/38026297.
Ms. Cristina Martinez, Head of FInES Cluster, presented the FInES Cluster's
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The data and analytics of the new life sciences marketplace handoutFrank Wartenberg
Trends in the global healthcare market. Development of pharmaceuticals, market data and insights.
Presentation delivered at the 9th International Pharmaceutical Compliance Congress and Best Practices Forum, Brussels, 2015
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Study: The Future of VR, AR and Self-Driving CarsLinkedIn
We asked LinkedIn members worldwide about their levels of interest in the latest wave of technology: whether they’re using wearables, and whether they intend to buy self-driving cars and VR headsets as they become available. We asked them too about their attitudes to technology and to the growing role of Artificial Intelligence (AI) in the devices that they use. The answers were fascinating – and in many cases, surprising.
This SlideShare explores the full results of this study, including detailed market-by-market breakdowns of intention levels for each technology – and how attitudes change with age, location and seniority level. If you’re marketing a tech brand – or planning to use VR and wearables to reach a professional audience – then these are insights you won’t want to miss.
The Pistoia Alliance Information Ecosystem WorkshopPistoia Alliance
Michael Braxenthaler, president of the Pistoia Alliance, introduces the concept of the information ecosystem in life science research and discusses the role the Pistoia Alliance can play within this ecosystem. The workshop occurred in October 2011.
This presentation was made at a UK APMG-International Showcase event. Join us in London, 20th June 2013 for keynote addresses, masterclasses and round table discussions with leading PPM visionaries. Free to attend if you pre-register. http://uk.apmg-showcase.com/
Spreadmart To Data Mart BISIG PresentationDan English
Presentation at the North Central BI Special Interest Group (BISIG) going over a case study of converting an Excel Spreadmart solution to a SSAS data mart solution
Emilie Robert Observatory of free healthcare in Mali 2012Emilie Robert
This presentation was given at the 2nd global symposium on health systems research, in a panel on knowledge translation strategies in West Africa to promote access to healthcare. This panel which I organized was chaired by Valéry Ridde. The symposium took place in Beijing (China) in November 2012.
10R - Gemalto : Révolution contrôlée des systèmes de formation...FFFOD
10R - Marseille 2012 - Atelier "Des réseaux pour apprendre" - Gemalto : Révolution contrôlée des systèmes de formation et de partage de connaissances par Frédéric Chauvin, Group manager
EMJD: Programme management, quality assurance and sustainability EMAP Project
Presentation by Pascal Chardonnet from Université de Savoie. Presentation was held at the EMAP training seminar in Tallinn for future Erasmus Mundus Joint Doctorates consortia (18-21 January 2012). For video see http://vimeo.com/38026297.
Ms. Cristina Martinez, Head of FInES Cluster, presented the FInES Cluster's
Strategic directions for 2012. She outlined the FInES areas of activity and proposed the next steps.
(FInES Cluster Meeting, December 2012)
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With the explosion of new frameworks, a mountain of automation, and our applications distributed across hundreds of services in the cloud, the level of complexity in software development is growing at an insane pace. With increased complexity comes increased costs and risks. When diagnosing unexpected behavior can take days, weeks, or sometimes months, all while our release is on the line, our projects plunge into chaos. In the invisible world of software development, how do we identify what's causing our pain? How do we escape the chaos? Janelle Klein presents a novel approach to measuring the chaos, identifying the causes, and systematically driving improvement with a data-driven feedback loop. Rather than measuring the problems in the code, Janelle suggests measuring the "friction in Idea Flow", the time it takes a developer to diagnose and resolve unexpected confusion, which disrupts the flow of progress during development. With visibility of the symptoms, we can identify the cause—whether it's bad architecture, collaboration problems, or technical debt. Janelle discusses how to measure Idea Flow, why it matters, and the implications for our teams, our organizations, and our industry.
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After two rounds of DSP Team Training, DSP has accumulated 10 team projects and has graduated more than 60 alumni who are passionate about data science. During this journey of developing and deploying teams trained in data science, the most valuable aspects we walked away with was the witnessing of members growing in confidence from the learning and experience, the building of team work, and the overall growth of each individual. At the end of the day, our hope of as members of DSP, including myself is to instill and motivate more people to devote themselves to the exploration of data science. Now think about how you can do the same.
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Kyiv PMDay 2024 Summer
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Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
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Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
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In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
At Techbox Square, in Singapore, we're not just creative web designers and developers, we're the driving force behind your brand identity. Contact us today.
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Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
2. about the speaker
HR AZ F
Anna Dibell
Associate Director
eSubmission Team and Ferring Central Archive
CORE Solutions, Global Regulatory Affairs
3
3. about ferring I
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to
identifying, developing and marketing innovative products in the fields of infertility,
obstetrics, urology, gastroenterology, endocrinology and osteoarthritis.
R&D facilities are located in Denmark, Israel and California, USA.
Ferring has its own production facilities in several European countries, in South
America, Israel and China.
Ferring’s marketing, medical services and sales teams, led by corporate headquarters
in Saint-Prex, Switzerland, operate from more than 45 countries and employ more
than 3500 people throughout the world, while treatments are available in more than 70
countries.
More than 100 Swedes cross the bridge between Denmark and Sweden each day to go
to work at the International PharmaScience Center (IPC) in Copenhagen, where 24
nationalities work side by side in the 80m high building - one of the highest in Scandinavia.
International PharmaScience Center employs close to 400 people. The majority work in
the development centre where all Ferring’s product development activities were
consolidated in 2002.
4
4. about ferring II
Ferring’s infertility treatments give infertile couples the chance to have babies
In obstetrics, Ferring helps premature children to be born healthy and
without handicaps
With treatments in endocrinology, Ferring gives children the chance to
overcome growth deficiencies
Ferring’s inflammatory bowel disease (IBD) treatments enable young adults
with IBD to live a normal life
In urology, Ferring’s treatment for nocturia and bedwetting helps adults and
children to an undisturbed night’s sleep
Ferring’s testosterone replacement treatment improves the key symptoms of
low testosterone, reduces fat and improves muscle strength and mood
Ferring’s hormonal therapy for prostate cancer offers a new treatment
option to men with an advanced hormone-dependent cancer
Ferring’s strength is our extensive knowledge of peptides and the role they play in
the human body.
Ferring has over 2000 product registrations.
5
5. contents
what Ferring did to implement eCTD as a part of
everyday life after filing of the first eCTD submission
focus on establishing an organisation, processes, and
tools to support a continued eCTD sequence growth
kicking off back in 2007...
2008 2009 2010
6
6. some statistics
2110
national national national
total cpr dcp mrp
eea us ca
sequences 224 26 4 41 106 35 12
submissions 1187 702 27 305 106 35 12
2008 2009 2010
7
8. a momentum for change
Flagship Project + First eCTD +
simultaneous submissions in US and EU
Crazy? Maybe... but we made it. On time.
So, we knew we could make eCTDs... how could we integrate
it with the rest of the portfolio and make it a part of daily life?
2008 2009 2010
9
9. a new organisation develops
1 part time
1 team lead 3 eSubmission Managers 1 student
consultant
mission: roll out eCTD in Ferring
2008 2009 2010
10
10. challenges at start-up
how do you plan
unknown number of eCTD
resource needs when
sequences - what is the business
you don’t know what’s
need?
coming?
limited experience how can you provide
of eCTDs and life cycle support to the rest of the
management - how do you organisation when you are
build up in-house skills struggling to understand eCTD
and competencies? yourself?
2008 2009 2010
11
11. work with that you can influence
?
? ?
tools team
? ?
roles phases
? ?
?
12
13. our basic rules
all submissions follow the same phases - large or
small
generic eCTD roles can be applied to persons
independent of their title
built in scalability in the tools and processes
roll-out priorities
1 mandatory eCTD
2 synergies if part of MRP or DCP
3 national with no paper requirement
14
14. the phases
plan
follow up author
submit compile
publish
15
15. the roles
responsible for documents that are
author to be included in the submission
plan, author
responsible for the submission on
content manager the content side
all phases
submission responsible for the submission on
all phases
manager the eCTD and format side
person(s) compiling the eCTD in
publisher the system
compile, publish
logistics DVD/CD production, packing,
submit, follow up
coordinator shipping
16
16. the tools
submission pipeline planning and transparency
tracking tool the compilation blue print
logistics log who gets what and how many?
sequence log keeping an eye on workload trends
time tracker resources and time per submission type
17
17. team environment
risk taking
active decisions
compliance
home base concept
18
18. “When in doubt - base your decision on what you believe
would be the right thing to do, rather than basing it on
fear of making a mistake” (yours truly)
19
19. staying sharp
A story about the cutting
of the tree and the sharpening of the blade
do you remember to sharpen the blade once in a while or are you just cutting down trees?
20
20. challenges now
Centralised vs
decentralised model Constant
and the consequences optimisation of
Be on the lookout for
new trends processes to be able to
absorb more work
within the current
Keeping up to date setup
with authority eCTD
developments
Strict and
structured vs.
ultraflexible Living with uncertainty
Resourcing
2008 2009 2010
21
21. wish list
1. gateways 4. increased use of metadata
2. uniform approach 5. generic CD/DVD labels and
throughout Europe other practicalities
3. less country specific 6. fully electronic/paperless
requirements - one cover
letter, one application form 7. (iPad)
2008 2009 2010
22
22. thank you for listening
Anna Dibell
+45 2878 7661
adl@ferring.com
“Live out of your imagination, not your history.”
23