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Medical Writers van harte welkom

Medical Writers van harte welkom. Bijeenkomst Medical Writers Nederland 8 december 2005. Welkom en kennismaking 14:00 Presentatie van enquete uitslag en discussie 14:30 Discussie over / uitwisselen van ervaring met Quality Control 15:30

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Medical Writers van harte welkom

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  1. Medical Writers van harte welkom

  2. Bijeenkomst Medical Writers Nederland8 december 2005 • Welkom en kennismaking 14:00 • Presentatie van enquete uitslag en discussie 14:30 • Discussie over / uitwisselen van ervaring met Quality Control 15:30 • Common Technical Document (plus Biotechnologie) 16:00 • BioTechnologie en Regulatory Requirements • CTD proces • Safety section of CTD • CTD publishing en eCTD • Borrel 17:00

  3. Enquete

  4. Enquete Volgende meeting: eind juni 2006 of eind augustus 2006 ? Waar?

  5. Enquete CTD 10 keer QC 6 keer PK 5 keer

  6. Enquete

  7. Enquete

  8. Enquete

  9. Enquete

  10. Enquete

  11. Enquete Medicalwriters.nl

  12. Enquete • Nederlandse Medical Writers Vereniging • Dutch Medical Writers Group • Dutch Medical Writer Association • Nederlandstalige Medical Writers Vereniging • Nederlandse Medical Writers Groep • Medical Writers Groep Nederland • Medical Writers Nederland

  13. Enquete As for the setting up of chapters. We have discussed this a couple of times on the EC. EMWA is no where near the scale of AMWA and is likely never to be so large as to require breaking down into chapters. However, I do recognise the importance of having local representation in any given country. I am keen on establishing a country representative for EMWA through whom ideas can be generated and opinions expressed. How many people would we be looking at on Holland, i.e. how many would you think you could have recruited for the Dutch chapter? These sort of questions are important as sometimes I feel we are missing out on reaching some people that may benefit from the EMWA workshops and while we are discussing the locations for our conference the potential to be able to reach local people is always considered (we had remarkable successes with this in London and Munich). The concept of a local representative needs further work, but lets thinks about it and work on a proposition that I can take to the EC. Regards Ian C. Metcalfe Vice President, EMWA

  14. Enquete We kunnen hierna met een groep die dat wil uit eten gaan in Naarden Vesting?

  15. Enquete Dit is ook gebeurd. Sommigen hebben enquete beantwoord. 3 MWs van Tibotec, Mechelen hebben net afgezegd voor deze meeting.

  16. Quality Control (QC) • Wat zijn ieders ervaringen • In welke fase: draft, final? • Ingebouwd in timelines? • Wie doet het? • Hoe doen de grote bedrijven het (SOP, WI) • En hoe de free-lancers • Zijn er formulieren Aanvraag formulier QC Genzyme (draft) Formulier QC Genzyme (draft)

  17. Common Technical Document • BioTechnologie en Regulatory Requirements – Henk Schuring • The Common Technical Document (CTD) Basic & General Information– Miriam Titulaer • Safety section of CTD – Tanja Braakman • CTD publishing en eCTD – Liesbeth Versteeg

  18. Borreltijd !

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