4 key questions to ask yourself about the growing eCTD platform
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Ferring and the growing eCTD platform how do we improve and work effectively? “THE ROAD TRIP VERSION” 2
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Presentation meant to inspire you to ask some key question on how you work with your team and organisation. Topic on eCTD but can be applied generally as well. Expect no detailed answers, but some key questions that will help you get to where you are going.
Transcript of 4 key questions to ask yourself about the growing eCTD platform
Ferring and the growing eCTD platform
how do we improve and work effectively?
“THE ROAD TRIP VERSION”
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about the speaker
Anna DibellAssociate Director eSubmission Team and Ferring Central ArchiveCORE Solutions, Global Regulatory Affairs
HR AZ F
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about ferring IFerring 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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about ferring IIFerring’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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the team
1 team lead 3 eSubmission Managers 1 student
mission: roll out and production of eSubmissions* within Ferring
*part of CORE Solutions - Compliance, Optimisation, Records Management, eSubmission
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some statistics since 2008...
total cpr dcp mrp nationaleea
nationalus
nationalca
sequences 325 29 13 79 141 50 12
submissions 2023 851 139 825 146 49 12
3623
ESG=27
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Presentation outline
How resourcing and development make you meet your eCTD targets and deadlines within
your current team environment
Dealing with increasing eCTD activities over the next few years
How to grow your eCTD business without growing your department too much
Handling peaks and troughs, finding a baseline for your eCTD work
Planning in an ever changing environment - staying alert
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Imagine you are going on a road trip.
You have packed your bags and are ready to go.
You have a full tank of gas, a shining car, good
travel company and you know where you
want to go
Let’s go then...
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Are you stuck in traffic or crusin’ on a scenic route?
ROAD WORK
Road Map
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Our challenge in the Ferring environment
Ad hoc submissions with last minute tight deadlines need to be prioritised and handled together with planned on-schedule submissions.
Busy weeks vs. slow weeks, how will we know what is coming? How about next month?
ROAD WORK
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Try to plan your work together with the people having an impact on it.
Road MapMeetings cross-functionallySubmission PipelineSequence PipelineSubmission Forecasting Submission statisticsInvolve affiliates
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Do you have excess luggage weighing you down?
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Our challenge in the Ferring environment
Being a fairly new discipline in the company, we are still finding our way and trying out processes. Still, we’ve been around as a team since end 2008 and have managed to form some habits. Time to take a look inside and see what is slowing us down...
ROAD WORK
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VIRUS CHECK ON EVERY DISC
SHIPPING
Try to identify heavy processes or unnecessary tasks that are there out of old habit and not adding any value to your business.
This should free up some space and you can absorb more within the team without increasing the workload...
ARCHIVING
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Do you take the time to stop for gas or do you just drive?
E F
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Our challenge in the Ferring environment
Where are we going in the future? What do we need to plan for? How can we future-proof our eCTD business area?
Everyone has a busy schedule. There are always important tasks that need attention now. When will we ever find the time to think the big thoughts about the future?
ROAD WORK
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Try to actively budget for time to develop. If you don’t take the time to stop for gas, you won’t get to your destination.
However - if you do; not only will you get to where you are going, you will also enjoy the ride!
There will never come a perfect time - set aside time in the calendar anyway. It is worth it, both for you and the company.
E F
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Do you focus on your destination or on which route to take? goal 10 km
goal 10 km
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Our challenge in the Ferring environment
Working in such a regulated environment means having procedures and SOPs to help you navigate in the requirement landscape. It can become quite heavy at times. At the same time, we want to be innovative and culture new ideas. How can we balance this?
ROAD WORK
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Try to focus on the destination instead of which specific route to take. There can be many roads leading to the same goal.
Why do we want to go to GOAL?
What got us started in the first place?
How can we avoid ending up in bureaucracy-town?
goal 10 kmgoal 10 km
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Presentation outline
How resourcing and development make you meet your eCTD targets and deadlines within
your current team environment
Dealing with increasing eCTD activities over the next few years
How to grow your eCTD business without growing your department too much
Handling peaks and troughs, finding a baseline for your eCTD work
Planning in an ever changing environment - staying alert
E F
goal 10 kmgoal 10 km
ROAD WORK
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And it’s all smooth cruisin’ from there...
just don’t activate cruise control - stay awake!
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“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)
thank you for listening
Anna Dibell+45 2878 7661
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