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NIH’s Principles for Clinical Pharmacology
designed by the NIH Clinical Center, the USA.

                                                2009    11       16    20
                                           (           307         )

     Juan J. L.
     Lertora,
     M.D., Ph.D.,
     Director, Clinical
                                               (GlobalMD)
     Pharmacology
     Program, Clinical
     Center, NIH
                                                                       (307             )
     Arthur J.
     Atkinson,
     Jr., M.D.,
     Professor,
     Feinberg School
     of Medicine,
     Northwestern
     University


     Shiew-Mei
     Huang,                                (NIH)                                         ,
     Ph.D., Deputy
     Director, Office
     of Clinical                                             FDA,
     Pharmacology,
     CDER, FDA                                               ,                  FDA


     Diane Mould,
     PhD, Senior                NIH    ,        NIH
     Advisor for NIH               NIH
     PCP Training
     Program,
     President,                                (11     20        )               ”
     Projections
     Research, Inc                                           ”                        SFDA

     Dr Frank J,          CRO                                               ,
     Gonzalez, PhD.
     Head of Nucleic
     Acids Section,
     Laboratoy Chief,
     NIC, NCI
NIH’s Principles for Clinical Pharmacology designed by
                                                                                           the NIH Clinical Center, the USA.




                       (GlobalMD)                                                                                                     (307
 )                                   (NIH)                                        ,       2009 11                 16     20
 ”                         (NIH)                                                             ”

                 ,                                          ,         ”                       ”                                      NIH
       ,                                                                                                                          FDA,
                                ,         FDA                                                                                       FDA
                              GlobalMD - NIH

       ,                                                                                                      ,
               (Panel Discussion).                                                                    ;
(GCP       )                         (SOP)                                            :           ,                       ,
                                                                                                                                  ,
                                                                              ,


                                                     ”NIH                                 ”                              200
                 800                                              ,                                                        GlobalMD
NIH                                                                       ,                                            ,        NIH
  ,    NIH                                   ,                  NIH

       ,                                                                                                                      ,
                                                 ,                                                                            ,
                                                                                                          ,                             ,




                                                       -1-
NIH’s Principles for Clinical Pharmacology designed by
                                                                                           the NIH Clinical Center, the USA.




Juan J. L. Lertora, M.D., Ph.D., Director, Clinical Pharmacology Program,
Clinical Center, NIH
      Lertora                                          (NIH)                                                        .
                         Lertora                                 I   II                                              ,              ,              ,
             ,                , HIV             ,    M.TB
      Lertora                                                                  (CRO),                               Northwestern
                                        .           , Lertora                   NIH-NIAID                            AIDS
        NIH      AIDS                                     ,                                                               Lertora
  FDA                                                  ,

Arthur J. Atkinson, Jr., M.D., Professor, Feinberg School of Medicine,
Northwestern University
      Atkinson                                         AB                                                                   Northwestern
      , Atkinson                                                                                                     ,
                                                                                       ;
        ,
      Atkinson             NIH                                            .
                             .                  ,           NIH                                                                     Atkinson
                                    ,                                                      ,                                    ,


Shiew-Mei Huang, Ph.D., Deputy Director, Office of Clinical Pharmacology,
CDER, FDA.
                   FDA
  ,   Illinois                                                                                         1996     FDA         ,               15
                         FDA                                                                       ,      FDA
                         100                                                  /                                                                    ,
                                    60                                                                                                         ,
                                                    2009-2010

Diane Mould, PhD, Senior Advisor for NIH PCP Training Program,
President, Projections Research, Inc.
      Mould         1984                                                                                    .        1989
                                            ,                                                              18   ,
                     ,                                                        , Mould                                                   ,
                                                                                               26
8      ,           52                                                                                      ,        41
Providence       Rhode Island                           ,   NIH

Dr Frank J. Gonzalez, PhD. Head of Nucleic Acids Section, Laboratoy Chief,
NIC, NCI
      Gonzalez           Madison                                                       ,
                                                                                                   ,
“    Rawls Palmer              ”    “John J. Abel ”                                                                         “               Bernard
B. Brodie ”                        “George Scott ”                                                                                      “         ”
      Mahidol                                                   “                              ”
                                                                 5                14
          P450




                                                       -2-
NIH’s Principles for Clinical Pharmacology designed by
                                                     the NIH Clinical Center, the USA.




                    11    16
08:30-09:00
09:00-10:30                                                 J. Lertora
10:45-12:15                                                 A. Atkinson
13:00-14:30                                                 F. Gonzalez
14:45-16:15                                                 J. Lertora
16:30-17:15                                                 Panel

                    11    17
09:00-10:30                                                 J. Lertora
10:45-12:15                                                 F. Gonzalez
13:00-14:30                                                 J. Lertora
14:45-16:15                                                 A. Atkinson
16:30-17:15                                                 Panel

                    11    18
09:00-10:30                                                 S. -M. Huang
10:45-12:15                                                 J. Lertora
13:00-14:30                                                 D. Mould
14:45-16:15                                                 A. Atkinson
16:30-17:15                                                 Panel

                    11    19
09:00-10:30                                                 A. Atkinson
10:45-12:15                                                 D. Mould
13:00-14:30   FDA                                           S. -M. Huang
14:30-15:00         FDA            GCP                      Panel
15:15-16:45
16:45-17:15

                    11    20
09:00-15:00   “                                  ”            (           )



                          -3-
NIH’s Principles for Clinical Pharmacology designed by
                                                                            the NIH Clinical Center, the USA.




                       ,                         (11    20    )              ”
                   ”               SFDA
         CRO                                   ,
                                           ,



·                          ,
·    I             ,
·                      –           (EDC)
· GCLP         -
· CRO
·




                   CRO         (CROU)




                                           -4-
NIH’s Principles for Clinical Pharmacology designed by
                                                                             the NIH Clinical Center, the USA.




                            (NIH)”                                ”
NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, USA.
        NIH“                           ”                                 101              A   1117   100029
    2009 11    16 - 20                              +86-10-84351699-8014/8003/8004
                         (       307   )            +86-10-64915913
    3900         / ,         ,
                                           E-mail   zhoupin@aceshow.cn; wanghairong@aceshow.cn; chensisi@aceshow.cn




                                           -5-

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GlobalMD NIH FDA Training Program In Beijing China 2009-11

  • 1. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. 2009 11 16 20 ( 307 ) Juan J. L. Lertora, M.D., Ph.D., Director, Clinical (GlobalMD) Pharmacology Program, Clinical Center, NIH (307 ) Arthur J. Atkinson, Jr., M.D., Professor, Feinberg School of Medicine, Northwestern University Shiew-Mei Huang, (NIH) , Ph.D., Deputy Director, Office of Clinical FDA, Pharmacology, CDER, FDA , FDA Diane Mould, PhD, Senior NIH , NIH Advisor for NIH NIH PCP Training Program, President, (11 20 ) ” Projections Research, Inc ” SFDA Dr Frank J, CRO , Gonzalez, PhD. Head of Nucleic Acids Section, Laboratoy Chief, NIC, NCI
  • 2. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. (GlobalMD) (307 ) (NIH) , 2009 11 16 20 ” (NIH) ” , , ” ” NIH , FDA, , FDA FDA GlobalMD - NIH , , (Panel Discussion). ; (GCP ) (SOP) : , , , , ”NIH ” 200 800 , GlobalMD NIH , , NIH , NIH , NIH , , , , , , -1-
  • 3. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. Juan J. L. Lertora, M.D., Ph.D., Director, Clinical Pharmacology Program, Clinical Center, NIH Lertora (NIH) . Lertora I II , , , , , HIV , M.TB Lertora (CRO), Northwestern . , Lertora NIH-NIAID AIDS NIH AIDS , Lertora FDA , Arthur J. Atkinson, Jr., M.D., Professor, Feinberg School of Medicine, Northwestern University Atkinson AB Northwestern , Atkinson , ; , Atkinson NIH . . , NIH Atkinson , , , Shiew-Mei Huang, Ph.D., Deputy Director, Office of Clinical Pharmacology, CDER, FDA. FDA , Illinois 1996 FDA , 15 FDA , FDA 100 / , 60 , 2009-2010 Diane Mould, PhD, Senior Advisor for NIH PCP Training Program, President, Projections Research, Inc. Mould 1984 . 1989 , 18 , , , Mould , 26 8 , 52 , 41 Providence Rhode Island , NIH Dr Frank J. Gonzalez, PhD. Head of Nucleic Acids Section, Laboratoy Chief, NIC, NCI Gonzalez Madison , , “ Rawls Palmer ” “John J. Abel ” “ Bernard B. Brodie ” “George Scott ” “ ” Mahidol “ ” 5 14 P450 -2-
  • 4. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. 11 16 08:30-09:00 09:00-10:30 J. Lertora 10:45-12:15 A. Atkinson 13:00-14:30 F. Gonzalez 14:45-16:15 J. Lertora 16:30-17:15 Panel 11 17 09:00-10:30 J. Lertora 10:45-12:15 F. Gonzalez 13:00-14:30 J. Lertora 14:45-16:15 A. Atkinson 16:30-17:15 Panel 11 18 09:00-10:30 S. -M. Huang 10:45-12:15 J. Lertora 13:00-14:30 D. Mould 14:45-16:15 A. Atkinson 16:30-17:15 Panel 11 19 09:00-10:30 A. Atkinson 10:45-12:15 D. Mould 13:00-14:30 FDA S. -M. Huang 14:30-15:00 FDA GCP Panel 15:15-16:45 16:45-17:15 11 20 09:00-15:00 “ ” ( ) -3-
  • 5. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. , (11 20 ) ” ” SFDA CRO , , · , · I , · – (EDC) · GCLP - · CRO · CRO (CROU) -4-
  • 6. NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, the USA. (NIH)” ” NIH’s Principles for Clinical Pharmacology designed by the NIH Clinical Center, USA. NIH“ ” 101 A 1117 100029 2009 11 16 - 20 +86-10-84351699-8014/8003/8004 ( 307 ) +86-10-64915913 3900 / , , E-mail zhoupin@aceshow.cn; wanghairong@aceshow.cn; chensisi@aceshow.cn -5-