Closing the eCTD GAP in one year

The Ferring Story

2

about the speaker

Anna DibellAssociate Director eSubmission Team and Ferring Central ArchiveCORE Solutions, Global Regulatory Affairs

HR AZ F

3

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.

4

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.

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

some statistics

total cpr dcp mrpnational

eeanational

usnational

ca

sequences 224 26 4 41 106 35 12

submissions 1187 702 27 305 106 35 12

2110

2008 2009 2010

7

eCTD architecture

ECTDsystem

EDMSW

PDF

W

PDF

00010002

2008 2009 2010

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

a new organisation develops

2008 2009 2010

mission: roll out eCTD in Ferring

1 team lead 3 eSubmission Managers1 part time consultant

1 student

10

challenges at start-up

unknown number of eCTD sequences - what is the business need?

how do you plan resource needs when you don’t know what’s coming?

2008 2009 2010

how can you provide support to the rest of the organisation when you are

struggling to understand eCTD yourself?

limited experience of eCTDs and life cycle management - how do you build up in-house skills

and competencies?

11

work with that you can influence

tools

roles phases

team

?

?

?

? ?

?

??

12

“whether you believe you can do a thing or not, you are right” (H. Ford)

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

the phases

plan

author

compile

publish

submit

follow up

15

the roles

author responsible for documents that are to be included in the submission

plan, author

content manager responsible for the submission on the content side

all phases

submission manager

responsible for the submission on the eCTD and format side

all phases

publisher person(s) compiling the eCTD in the system

compile, publish

logistics coordinator

DVD/CD production, packing, shipping

submit, follow up

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

team environment

compliance

home base concept

active decisions

risk taking

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

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

challenges now

2008 2009 2010

Constant optimisation of processes to be able to absorb more work within the current

setup

Living with uncertainty

Strict and structured vs. ultraflexible

Centralised vs decentralised model and the consequences

Be on the lookout for new trends

Keeping up to date with authority eCTD developments

Resourcing

21

wish list

1. gateways

2. uniform approach throughout Europe

3. less country specific requirements - one cover letter, one application form

4. increased use of metadata

5. generic CD/DVD labels and other practicalities

6. fully electronic/paperless

7. (iPad)

2008 2009 2010

22

thank you for listening

“Live out of your imagination, not your history.”

Anna Dibell+45 2878 7661

adl@ferring.com

23