Closing the eCTD gap in one year


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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.

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Closing the eCTD gap in one year

  1. 1. Closing the eCTD GAP in one year The Ferring Story 2
  2. 2. about the speaker HR AZ F Anna Dibell Associate Director eSubmission Team and Ferring Central Archive CORE Solutions, Global Regulatory Affairs 3
  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. 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. 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. 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
  7. 7. eCTD architecture W W ECTD EDMS 0001 system 0002 PDF PDF 2008 2009 2010 8
  8. 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. 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. 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. 11. work with that you can influence ? ? ? tools team ? ? roles phases ? ? ? 12
  12. 12. “whether you believe you can do a thing or not, you are right” (H. Ford) 13
  13. 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. 14. the phases plan follow up author submit compile publish 15
  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. 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. 17. team environment risk taking active decisions compliance home base concept 18
  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. 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. 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. 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. 22. thank you for listening Anna Dibell +45 2878 7661 “Live out of your imagination, not your history.” 23