의약품의 pl 리스크 및 사례
DESCRIPTION
New Vision. KSAC PL Center. consulting. 의약품의 PL 리스크 및 사례. Product Liability Center . 02-369-8567. P L 센 터. 목 차. 1. 의약품의 PL 리스크 2. 설계단계 리스크 및 사례 3. 제조단계 리스크 및 사례 4. 표시 리스크 및 사례 5. 제품안전경영시스템. 1. 의약품의 PL 리스크. 1. 의약품의 PL 리스크. - PowerPoint PPT PresentationTRANSCRIPT
PowerPoint Product Liability
5.
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.
thalidomide . PL
HIV
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, 1962
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.) . 1967 ,
, , 1976 Chloroquine
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1975 , (
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.
HIV
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2.
New Vision
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6 52 , ,
.
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.
(1993 11 15)
3.
- , 1998,7,22 , 4,962
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1997 ( )
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1998 222 1 () 4,962
PL
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1.
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PSMS
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()
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L
I
.
.
GMP ,
.
, ·
.
. ·
.
,
..
.
5.
New Vision
, ,
,
· ,
,
·
, , ,
1. PL
*
,
,
. ·
,
, ,
() ,
, 100%
PL ,
1. PL
*
•
· · · · Biotechnology .
· · .
Screening
. . 1 .
•
.
.
.
· () .
() . ,
.
2
3
, .
•
, . . .
.
GMP
•
, , , .
•
JGSP
GPMSP
•
, , , , , .
• (PMS)
, (GPMSP) .
•
6(4 ) orphan drug 10 , .
•
()
· , Thalidomide
1958 . 1961 11 thalidomide
, 11 . 1961
. , ,
thalidomide .
12,000 . 1962 5,
.
1963 , ,
. 1974 ,
2,800 4,000 .
.
thalidomide . PL
HIV
*
Chinoform()
1900 · . 1933 ,
· . 1955
( ) ,
, 1970 8 () Chinoform
, .
1 1,127( 650) .
1971
. 1975
23 4,400 .
1978 Chinoform ( ·
) . 1979 , ,
.
Chloroquine ( )
1934 1945 .
, 1962
. , 1955
1961 Chloroquine( Chloroquine ,
.) . 1967 ,
, , 1976 Chloroquine
, . 1974
, 2
. 300 2,000 .
1975 1982 , . , 1988 , , .
2.
Streptomycin ( )
Streptomycin 1944 (1953 · ) ,
. .
.
. 1978
, .
2.
( )
1951 1963 6 .
, . 1965
,
.
1970 2 ,
, , . ,
, . , ~1
. , ,
, .
(), , 1971 . . , 22 36 4 3,700 . 1972 7 2 .
2.
1993 7 , · .
( 1986 ,
3 .)
9 , ,
1 16 . , ( ) .
2.
( )
1975 , (
) . 1985 1,200
HIV( ) . 1978
() , ,
. 1983 HIV ,
, .
, , . 1985,
, ( 2 4 ).
, 5,000 1,868 438(1996 8 )
.
HIV
5 . 1996 3 , 4,500 , 3 5,000~5, 15, , ,
2.
New Vision
HMG-HCG
, HMG
, HCG . ,
. 1995 3
6 52 , ,
.
1992 , 1995
. .
3 ,
. .
.
(1993 11 15)
3.
- , 1998,7,22 , 4,962
1995 8 2
1997 ( )
“ “
1998 222 1 () 4,962
PL
- , 1998,10,28 , 8,160
19981028 “ ”
(2) (
•
.)
“
”
()
1 2 . . 3 .
()
, , . , .
(1984 3 11)
, , . ,
5.
*
*
b. ·
c.
d. ,
, ·
, 1,000
,
1.
*
New Vision
( )
, ,
.
GMP(Good Manufacturing Practice)
.
1.
.
:
.
· ,
.
:
*
. .
(1994 10 19)
1.
1.3
New Vision
30
, ,
,
a.
b. 1 ,
c.
(Press-Throught-Pack : PTP)
d. PTP ,
( )
PTP. , ,
2.
PTP
, .
*
New Vision
,
.
. .
.
, , , ,
, , 2
.
2.1
, (10 ) . , .
(1994 8 13)
*
New Vision
, ,
,
()
a. ,
b.
c.
1. •
()
, , , , ,
·, , , , · , , , , , ,
, , , , ,
·
- ,
-
-
,
.
. , 30
3000 4 1
1500 .
(1995 5 4)
1 400mg, 39
, , 26
5 ,
.
.
(1995 10 30)
1. •
New Vision
50 .
26, 50 .
1 30, 1 7900 .
, 520 , .
7 24 () . 50
, . ,
. 50 , , ,
. , , 50
.
, .
1. •
7 27
*
New Vision
, , ,
,
, () ,
()
,
,
,
1. •
2.
PL
PSMS
, ,
,,
3
, PS
(, , ) ,
(Product Safety Management System)
1. (PSMS)
PSMS PS, / PS, PLD, PLI
→ → → PLP
P
S
/
()
CLAIM ()
) PLI PLD
P
L
I
.
.
GMP ,
.
, ·
.
. ·
.
,
..
.