??F

1
?????S??S? ??F ????H??S ?a?a???ta ?p???a
Fa?µa??p????
????? S???????
???a??µ???? ??F
2
????????????
Y????G??? ?G???S, ?G???. ????????S
?ST????S
EC, ????
EOF
????? ????
?O???S ???T?S??S
F???????????S ????????S
???GG???????S ?G???S
F????????, F???/??T???S ?at. ????s?? ?t??. F
3
????pa??? p???t??? ??a Fa?µa?e?t??? ??????ta

• S?????? t?? ??µ?? (1957)
• ?s?te???? ?????
• S?????? t?? ??ast??? (1992)
• ???stas?a t?? ?ata?a??t??
• S?????? t?? ?µste??taµ (1999)
• ???stas?a t?? ??µ?s?a? ??e?a? (????? 152)

4
?? ????pa??? S?st?µa

• ?a ???t? ???? e??a? ? ????t???a d??aµ? p??
  e?asfa???e? t? sta?e??t?ta ?a? ße?t???e? t??
  ap?d?s? t?? s?st?µat?? st?? ???-e????t????
  ?et-e????t???? d?ad??as?e?
• ?? ???? e??a? ? S??det???? ?????? t??
  s??e??as?a? s??t???sµ?? t?? e?e??e??? t?? ?-?
• ? e?e???µ???? µ??a??sµ?? ep????????a? e??a? ?
  ?s??? t?? s?st?µat??

5
?? ????pa??? S?st?µa

• ???a? ??a s??e?t??? s?st?µa µe
• t?sse??? d?ad??as?e? ?????s??
• ?e?t????, ?µ??ßa?a ??a?????s?, ?p??e?t??µ???,
  ??????
• ??a e??s??µ??? s?st?µa fa?µa??epa???p??s??
• ??a e??a?? s?st?µa e??????, pa?a????? ?a?
  ?????f???a? t?? p?????t??

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??a???s? Fa?µa?e?t???? ??µ??es?a? St????

• e?d???µ?s? t?? p??stas?a? t?? d?µ?s?a? ??e?a?
• (fa?µa??epa???p??s?, pa??????t???
  ?e?ape?a, ??d??a? de??t?????a?)
• e???????s? t?? ?a???t?µ?a?
• ?p?st????? t?? ß??µ??a??a? ?e??s?µ?? fa?µ????
• ß??t?st? a???p???s? t?? a????p???? d??aµ????
• ße?t??s? d?ad??as???, ep?t????s? ????? ap?f?se??
• ?µfas? st? d?af??e?a d?asf???s? ap? s??????s?
  s?µfe???t??
• ????????s? t?? es?te????? a?????
• ?a??te?? ??e??? t?? a?????
• ????????s? t?? ???d???? t?? fa?µ???? ??a t?
  pe??ß?????

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??F ?a???sa ?at?stas?

• ??a?µ???s? µe t?? ????pa??? ??µ??es?a
• ???? (?enchmarking ?f European Medicines
  Agencies)
• ?µpe??? p??s?p??? ?µ??
• ?????? ??a ???? a???p???s?
• ?????? ??a s??e?? ep?µ??f?s?
• ???e??? ????t???? S?st?µat?? ??????s??
• ???e??? p??t?ß?????? ??a d?aµ??f?s? p???t????
  ??a t? f??µa?? se ?????? EU ep?ped?

8
??F ?a???sa ?at?stas?

• ??µ?a? ????????s?? Fa?µ.??????t??
• ????????a??? ????? ??a t?? p??stas?a t?? d?µ?s?a?
  ??e?a?
• ??e?e??e?ta? µe ???s? ?????? e??te????? e?s???t??
  ?µ??
• ?e? e??a? e????e??µ???? µe t?? µe??d?????a t??
  a???????s?? (e?e?d??e?s?)
• S???? ad??at??? ?a a?tap???????? sta
  ?????d?a???µµata
• ??st??
• ??s???e?a a?tap????s?? se ?????d?a???µµata ??????
  ???? ???e???? ????? a???p???s?? t?? p??s?p????,
  ???e????p??s?p???? ?a? ??????s??

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??F ?a???sa ?at?stas?

• ??µ?a? ????????s?? Fa?µ. ??????t??
• ??epa???? s?µµet??? se e?s???t??? ????
• ?e?t???? d?ad??as?a (Rapporteur, Co-rapporteur)
• d?ad??as?a aµ??ßa?a? a?a?????s?? (RMS)
• ep?st?µ????? s?µß???? (scientific advice)
• d?aµ??f?s? ?ate????t????? ?d?????
• ??ad??as?e? ??d?s?? ade??? p??sfat? p?st?p???s?
  µe ISO 9001

10
??F ?a???sa ?at?stas?

• ??µ?a? ?a?a?????, ??a????s??, ????es??
• ???sfat? ??ap?ste?s? ??ad??as??? (ISO 17020)
• S?µµet??? se d?e??? ???a??sµ? fa?µa?e?t????
  ep??e???se?? (PIC/S)
• ?p?t??e?? a???????se?? ?????t???? ?a? d?e??e??
  (MRA µe ?a?ad? ?a? ?ap???a)
• ???p???s? Barcode
• ?µ?? ? ??e???? p??pe? ?a e?d??aµ??e? ?a? ?a
  d?e?????e? ?????? st?? fa?µa?ap????e?, s?µe?a
  d???es??, ??µ?ast???a ?a? ?t???at????
  f??µa?a-fa?µ.???t??f??

11
??F ?a???sa ?at?stas?

• ???ast???a??? ??e????
• A???????s? t?? ?????? ??
• ???sfat? ??ap?ste?s? ???ast?????
• (ISO 17025)
• S?µµet??? st? d??t?? OMCL-Ph.Eur
• ???? a? ?a? ? ??e???? ??e? ße?t???e? ?a?
  e?s???????s?e? ??e???eta? ste????s? µe p??s?p???
  d?af??et???? e?d???t?t??

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??F ?a???sa ?at?stas?

• ?p???e?a fa?µ????
• ???a????af?µ???, on-line s?st?µa pa?a???????s??
  t?? p???se?? ?a? t?? d?a????s?? t?? ta???a?
  ???s??t?ta?.
• ?µ?? de? ???eta? epa???? a???p???s? stat?st????
  s?µpe?asµ?t?? ?ata????s??

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??F ?a???sa ?at?stas?

• ?p???e?a fa?µ????
• S??e??? p??sp??e?a a?t?µet?p?s?? t?? e??e??e??.
• ?µ?? de? ?p???e? ?esµ???? µ??a??sµ?? e??????
  t?? t?µ?? t?? e?sa??µ???? fa?µ????, ?p?? a?t??
  ?p?ß?????ta? ap? t? ?F?? ? fa?µ/?e? eta??e?e?
• ??e???? t?? at?µ???? pa?a??e????.
• ?µ?? ta ???t???a s???? de? e??a? sta?e?? ?a?
  a?aµf?sß?t?ta

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??F ?a???sa ?at?stas?

• ??µ?a? Fa?µa??epa???p??s??
• ?e?????sµ???? a???µ?? a?af???? ??
• ???ß??µa p???t?ta? t?? ded?µ????
• ?? a???????s? t?? ????
• ?? d?e????e?a s?et???? ep??e???se??

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??F ?a???sa ?at?stas?

• ??µ?a? ???????? d???µ??
• ?e???? µ??? a???????s? t?? p??t??????? ????????
  µe?et??
• ??s???e?a st? d?e????e?a ep??e???se?? (GCP) ????
  e??e??e?? p??s?p???? ?at?????a e?e?d??e?µ????
• ?a??ste??se?? st?? d?ad??as?e? ?????s??

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??F ?a???sa ?at?stas?

• ??µ?a? ?????f???s??
• ?st?se??da ??F ?a??st???s? a?aß??µ?s??
• ?????? S??ta??????? ?a??st???s? epa?e?d?se??
• ??d?se??, pe???d???-pa????µ??a
• ?p??s?a µ??a??sµ?? es?te????? ep????????a? ?a?
  e??µ???s?? t?? p??s?p????

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??F ?a???sa ?at?stas?

• ??µ?a? ?t???at????? Fa?µ????
• ?a??µ??a ?at?stas? µe e?e??? t?? a???. ???s??
• ??d??? p??ß??µata
• S?st?µa pa?a???????s?? ?ata????s?? ?t??. Fa?µ.
  (p??t? efa?µ??? 2001) ?µ?? s?µe?a ?p??e?t????e?
• ??a??p? ??d?s?? ?t???at????? S??ta????????
  (te?e?ta?a ??d?s? 2001)

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?????S??S

• ???s???? e?d??e?µ???? p??s?p????, ????te??
  a???p???s? t?? ?p?????t?? ?a? s??e??? ep?µ??f?s?
  
• µe s??p? t??
• ?e?t??s? p???t???? ?a? p?s?t???? pa?aµ?t??? st??
  ?????s? fa?µ. p?????t??, p??t??????? ????????
  d???µ??, fa?µa??epa???p??s?? ?a? ????? a?t?µ?t??
• ??e????s? ?a? ße?t??s? t?? e??????, e??ast???a???
  ?a? ??µ?µ?? ?????f???a?
• ???pt??? - d?e????s? ep??e???se?? (GMP, GLP, GCP,
  Ph/nce)

19
?????S??S

• S?µµet??? µe e?s???t??? ????
• st?? ?????t???? d?ad??as?e? ?????s??
  (Rapp/Co-rapp,RMS)
• st? d?aµ??f?s? ?????t???? ?ate????t?????
  ?d?????
• st?? d?e??e?? e?a?µ???se??
• ???pt??? µ??a??sµ?? ??a t?? pa???? ep?st?µ??????
  s?µß????? (scientific advice), a?t?st????? ????
• ??tap????s? st?? ep?st?µ????? ?a???t?µ?a µ?s?
  ??sp?s?? ?ata?????? µ??a??sµ?? p?. F??µa?a
  p????µ???? ?e?ape??? (????d?a?? ?a? ??tta????
  ?e?ape?a, µ??a???? ?st??)

20
?????S??S

• ?a??d???s? t?? e???????? pa?a??????? µ???d?? ??a
  p???t??? a??pt??? t??? ?a? st????? t?? ??????
  ep??e???µat???t?ta? e?t?? ?a? e?t?? s??????
• ??s?ast???p???s? t?? e?????? ?a? ?e?????s?
  s?µf??a µe d???t??? ???d???
• ????????s? ?ata????s?? p????f???a??? ?e?µ????
  (??? F??) st? GREDIS-GREVIS µe d??at?t?ta
  p??sßas?? ??e????µ???? ?a? ?????? st? Website

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?????S??S

• ?aµp???e? p????f???s?? st?? ???? ???s? t??
  fa?µ????
• ?a?eµß?se?? ??a p????f???s? t?? ?????? µe ?e?t?a
  ??p?? se ep??a??a ??µata
• ?e?t??s? saf??e?a? F?? (Readability test)

22
?????S??S

• Stat?st??? epe?e??as?a ???? t?? st???e??? p??
  s???????ta? st?? ??F, ta ?p??a ?a ?????ta? ???st?
  s?µf??a µe ?a???e? d?af??e?a?
• ????p???s? s?µpe?asµ?t??
• ?a????st??? pa??µßas? t?? ??F st? d?aµ??f?s? t??
  t?µ?? t?? fa?µ????
• ?e?t??s? µ??a??sµ?? a?t?µet?p?s?? t?? e??e??e??
• ??e???? t?µ?? - ste????s? t?? ?p??es???
• ?e?t??s? d?ad??as?a? e?????? at?µ???? pa?a??e????
  µe ?a?????s? sta?e??? ?a? d?afa??? ???t?????

23
?????S??S

• ??d??? ??a F??µa?a ?t???at????? ???s??
• ???p?p???s? t?? e?????? ??µ??es?a?
• ??a????sµ?? a?µ?d??t?t?? µeta?? ??F ?a?
  ?p.????t???? ???pt???? ???f?µ??
• ta ?t???at???? F??µa?a ?a p?????ta? µ???? ap?
  ?t????t???? ?a? Fa?µa??p????? (?p?? se ??? t??
  ??)

24
?????S??S

• ??d??? ??a F??µa?a ?t???at????? ???s??
• G?a t? ??e??? t?? a????? - p??stas?a t??
  ?ata?a??t?
• ??d???p???s? t?? ?t???at????? fa?µ???? (??e?
  ???e?)
• ?ata??af? ??d???p???s? t?? ?t???t??f????
  ????d??, t?? S?µe??? ???d????? p???s??
  (fa?µa?ap????e?) ?a? t?? ?atast?µ?t?? ??a?????
  p???s?? Fa?µ. ?t???at????? ???s??
• ???µ???s? t?? e?e??t???? µ??a??sµ??
  (?p.????t.???pt????, ??µa???e?, ?F??) ??a p??a??
  ?pa??? ?ata???p?? ap? ??????s? Fa?µ???? se ???e
  s?st?µat??? e?t??f?, p??? ta ??a ?d??????? st?
  sfa?e??
• S?????? p????f????? ??a ep?st?µ????? ??e??a (p?.
  ep?d?µ????????? ??e??e?, a??pt??? a??e?t????
  ste?e??? µ????ß???-pa?as?t?? ??p)

25
???µ??a??a
??F
?p.???.??.???f/??µa???e?/ ?F??
?a?ep?st?µ??
26
?????S??S

• ?µes? epa???d?s? t?? ?t???at????? S??ta????????
• ?pa?a?e?t?????a t?? ?p?t??p?? S??ta???????? ??a
  ?t???at???? f??µa?a
• ?????? S??ta??????? s????? epa?e?d?se??

27
?????S??S

• T?µata ??????s?? ?a? ??????s?? ??F
• St? ?S t?? ??F ?a ?p???e? ??a??p???t???
  e?p??s?p?s? t?? eµp?e??µe??? µe???, ?a??? ?a?
  e?p??s?p?? t?? S??????? ???a??µ???? ?? µ????
• ta µ??? t?? ?S ??F ?a p??pe?
• ?a a?tap???????ta? se ?esp?sµ??a ???t???a p??
  e?asfa?????? t?? e??p???t?s? t?? st???? t?? ??F,
• ?a ?a???????? t?? p???t??? t?? ???a??sµ??,
• ?a a?a?aµß????? ?pe?????? ??µ???
• ?a e?p????? ep??e???s?a?? s??d?? (Business Plan)
• ?a p?????? t?? p???p???se?? ap?f???? s??????s??
  s?µfe???t?? (conflict of interest)

28
?????S??S

• T?µata ??????s?? ?a? ??????s?? ??F
• ?a ?a????s?e? ap? t? ??????s? µ??a??sµ?? ?a?
  µe??d?????a a??a??? t?? ???a??sµ?? µe
  ?????d????aµµa µe ?esµ??? s?µµet??? t??
  e??a??µ???? st?? ??F
• e??s??s? t?? eµp?st?s???? t?? p???t?? st??
  ap?te?esµat??? p??stas?a t?? d?µ?s?a? ??e?a? ap?
  t?? ??F µ?s?
• d?µ?s??p???s?? t?? et?s??? st???? ?a? t??
  ap?????sµ??
• d?µ?s??p???s? t?? d??aµ???? a??pt???? t?? e??????
  se ????? t??? eµp?e??µe???? f??e??

29
?????S??S

• ???pt??? ??F ??tap?d?t???t?ta
• 1998
• S??????? ?ata????s? Fa?µ???? 1.8 d??
• ?a??ß??a st?? ??F 5 e? (3)
• 2005
• S??????? ?ata????s? Fa?µ???? 6 d??
• ?a??ß??a st?? ??F 7 e? (1)
• ??????µ??? st????? ?a? ??t???µ?a ???pt???
  ?e?t??s? ??tap?d?t???t?ta?, ?a??t?ta? ?a?
  ?p?te?esµat???? ???????

30
S??????? ???a??µ???? ??F

• ???a??t??? ?p?t??p? ?µe??da?
• G?a t?? pa???s?as? a?t? e???st??a? ??
• ??a?as??? G.
• G?p??? ?
• ?a??µ?? G.
• ?p???a ?.
• ?eß??? ?.
• ??µp?t? ?.

• ???a??st??µe ??a t?? p??s??? sa?