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Dailypharm

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[Ư] Ǿǰ ȭ, ߿Ѱ
ϸ 2017-09-11 06:14:54
[Ư] Ǿǰ ȭ, ߿Ѱ
ϸ 2017-09-11 06:14:54
˸ġ PV ̻



[1] ȿ ๰ ۾ Ǿǰ ֱ (Whole Life-Cycle Safety Managements)

  ˸ġ PV ̻
ֱ Ǿǰ žళ ܰ迡 ΰ Ǹ ı ֿ ļ ؼ Ž, , ϴ ֱ Ǿǰ (Whole Life-Cycle Safety Managements) ߿伺 ǰ ִ.

๰(Pharmacovigilance, PV) ߿伺 Ǿǰ 氢 Բ 2004 ü ̵[ICH E2E; ๰ ȹ (Pharmacovigilance Planning)] õʿ ๰ ܼ ۿ ͸ ܰ迡 Ǿǰ ؼ ҳ ȭŰ ġ, ȹ, , ϴ ؼ ϱ⿡ ̸.

ICH E2E ̵ο ǰ ʱ ๰ (PV Expert) ϵ ϰ ִ. , ӻ ڷ 򰡷κ Ͽ ӻ ๰ Ͽ ö غ ߻ ó ȱ ؾ Ѵ. ̷ ȹ Ǵ ǰ㰡 û 籹 Ǹ Ͽ ϴ ʼ̴.

ü Ǿǰ ö ๰ ۾ ϰ ȴ. ̵ ๰ ǰ㰡 ؾ ϸ PV /ǻ翡 ߿ ҷ ġѴ. ๰ ۼ/ϰ ֱ ̸ ȿ ؾ Ѵ.

๰ÿ ǥ ۾δ SMP, RMP, DSUR, PBRER ִ.

ӻ迡 ϰ Ǹ ȹ(Safety Management Plan, SMP) ۼϿ ϴ õȴ. SMP ش ӻ迡 ߻ϴ Ȱ Ͽ ӻ õ , , CRO ü , å Ͽ ڷῡ ó ϵ Ѵ. ̷ SMP ӻ ϸ ȿ ִ.

, ӻ ų Ǿǰ ֽź (Developmental Safety Update Report, DSUR) Ͽ ϵ Ѵ. ϰ ICH E2F ̵ DSUR ǹȭ ̱ ̸ غϴ ٶϴ.

, ๰ , ؼ ȹ(Risk Management Plan, RMP) ׸(Safety Specification) ๰ ȹ(Pharmacovigilance Plan) Ǹ ž ƴ϶ ο ̳ ο ߻ 쿡 ̹ ǰ ȹ ִ. RMP ״ ֱ Ǿǰ ϵ Ǿǰ ú , ӻ ڷκ ڷḦ ӻκ 迭 Ǿǰ ڷ , ش Ǿǰ 並 Ͽ ۼؾ Ѵ.

ؼ Ǿǰ õ ؼ Ȯ, Ư¡ȭ, Ǵ ּȭϱ Ϸ ๰ Ȱ Ȱ ǵǸ ؼ (Risk Assessment and Evaluation), ؼ (Risk Confrontation), ؼ (Risk Intervention), ؼ (Risk Communication) ؼ (Risk Management Evaluation) ܰ ȴ. RMP ǰ㰡 , Բ ؾ ϸ ǰ㰡 Ŀ 򰡸 Ͽ ÷ ϰ ȴ.

ǰ㰡 Ŀ RMP ǰϿ ȹ ͼ-ؼ (ICH E2C(R2); Periodic Benefit-Risk Evaluation Report, PBRER) ۼϿ ؾ Ѵ. PBRER Ǿǰ ο ؼ̳ ߻ ؼ мϿ ش Ǿǰ 㰡 ͼ ִ ֵ ۼؾ Ѵ. ⺸ Ⱓ ۼ PBRER RMP Ͽ ӵǾ Ѵ.

̷ ๰ ۾ Ǿǰ м򰡸 Ͽ ߿ ߻ 쿡 ﰢ, ü 򰡴 ̷ ֵ ۼؾ Ѵ.

, ؾ δ ๰ÿ ο ַ õdz ش Ǿǰ ͼ-ؼ (Benefit-Risk Assessment) ȿ(Effectiveness), (Limitation of Use), üġ(Alternative Treatment) ο ش Ǿǰ ؾ ϴ ߿ ġ Ѵٴ ʵ ؾ Ѵ.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
B(120) 70,000 60,000 10,000 62,308
׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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ͳݽŹϹȣ: 00048 | 2005.09.09 | 2005.09.09 | : | : ȣ
ּ: ı 128 SK V1 GL ƮνƼ A 401ȣ
ȭ : 02-3473-0833 |ѽ : 02-3474-0169 | ûҳ⺸ȣå(å ű)
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