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.

1. Closing the eCTD
GAP in one year
The Ferring Story
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2. about the speaker
HR AZ F
Anna Dibell
Associate Director
eSubmission Team and Ferring Central Archive
CORE Solutions, Global Regulatory Affairs
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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.
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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.
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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
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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
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7. eCTD architecture
W W
ECTD
EDMS 0001
system 0002
PDF PDF
2008 2009 2010
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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
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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
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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
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11. work with that you can influence
?
? ?
tools team
? ?
roles phases
? ?
?
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12. “whether you believe you can do a
thing or not, you are right” (H. Ford)
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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
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14. the phases
plan
follow up author
submit compile
publish
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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
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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
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17. team environment
risk taking
active decisions
compliance
home base concept
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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)
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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?
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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
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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
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22. thank you for listening
Anna Dibell
+45 2878 7661
adl@ferring.com
“Live out of your imagination, not your history.”
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