Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report

被引：6

作者：

Viviani, Laura ^{[1
]}

Reid, Kirsty ^{[2
]}

Gastineau, Thierry ^{[3
]}

Milne, Catherine ^{[4
]}

Smith, Dean ^{[5
]}

Levis, Robin ^{[6
]}

Lei, Dianliang ^{[7
]}

van Ooij, Mark ^{[8
]}

Gilbert, Philippe Alexandre ^{[9
]}

Vandeputte, Joris ^{[10
]}

Xie, Jianxun ^{[11
]}

Madhuri, Leena ^{[12
]}

Shaid, Shahjahan ^{[13
]}

Kubiak, Vaughn ^{[10
]}

Suri, Rajinder ^{[14
]}

Mizukami, Takuo ^{[15
]}

Shirasaki, Yoshihisa ^{[16
]}

Li, Xiantang ^{[17
]}

Zhou, Ying-Ying ^{[18
]}

Trapkova, Alla ^{[19
]}

Goel, Sunil ^{[20
]}

Prakash, Jai ^{[21
]}

Subagio, Amrullah Aninditio ^{[22
]}

Suwarni, Eniek ^{[23
]}

Jung, Kyung Jin ^{[24
]}

Sanyal, Gautam ^{[25
]}

Das, Pradip ^{[26
]}

Coppens, Emmanuelle ^{[3
]}

Wright, David ^{[27
]}

Peng, Zhechu ^{[28
]}

Northeved, Helle ^{[29
]}

Jungback, Carmen ^{[30
]}

Kirpitchenok, Tatiana ^{[2
]}

Del Pace, Lorenzo ^{[31
]}

Seo, Borami ^{[32
]}

Poojary, Brinda ^{[33
]}

Ottoni, Antoniana ^{[34
]}

机构：

[1] Humane Soc Int, Basel, Switzerland

[2] European Federat Pharmaceut Ind & Assoc, Ixelles, Belgium

[3] Sanofi Pasteur, Lyon, France

[4] European Directorate Qual Med & HealthCare EDQM, Strasbourg, France

[5] Hlth Canada, Ottawa, ON, Canada

[6] US FDA, Rockville, MD 20857 USA

[7] WHO, Geneva, Switzerland

[8] Janssen, Leiden, Netherlands

[9] Bill & Melinda Gates Fdn, Seattle, WA USA

[10] Int Alliance Biol Standardizat, Strasbourg, France

[11] Janssen, Xian, Peoples R China

[12] Indian Immunol, Hyderabad, Telangana, India

[13] GlaxoSmith Kline, Munich, Germany

[14] Developing Countries Vaccine Manufacturers Networ, Hyderabad, Telangana, India

[15] Natl Inst Infect Dis, Tokyo, Japan

[16] GlaxoSmith Kline, Tokyo, Japan

[17] Pfizer, Shanghai, Peoples R China

[18] Meck, Rahway, NJ USA

[19] Minist Hlth, Sci Ctr Expert Evaluat Med Prod, Fed State Budgetary Inst, Moscow, Russia

[20] Serum Inst India, Pune, Maharashtra, India

[21] Indian Pharmacopoeia Comm, New Delhi, India

[22] BioFarma, Bandung, Indonesia

[23] Food & Drug Adm, Cent Jakarta, Indonesia

[24] Korea Inst Toxicol, Daejeon, South Korea

[25] Vaccine Analyt LLC, Kendall Pk, NJ USA

[26] Biol E, Hyderabad, Telangana, India

[27] Pfizer, New York, NY USA

[28] Boehringer Ingelheim GmbH & Co KG, Duluth, GA USA

[29] Lundbeck, Copenhagen, Denmark

[30] Int Alliance Biol Standardizat, Lyon, France

[31] Humane Soc Int, Padua, Italy

[32] Humane Soc Int, Seoul, South Korea

[33] Humane Soc Int, Mumbai, Maharashtra, India

[34] Humane Soc Int, Rio De Janeiro, Brazil

来源：

BIOLOGICALS | 2022年 / 78卷

基金：

比尔及梅琳达.盖茨基金会;

关键词：

Vaccines; Batch release testing; Batch safety test; Abnormal toxicity test; Public health; ELIMINATION; REMOVAL;

D O I：

10.1016/j.biologicals.2022.06.003

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and bi-ologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Phar-maceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries. Partici-pants reported on country-and region-specific regulatory requirements and, where present, on the perspectives on the waiving and elimination of the Abnormal Toxicity Test. With AFSA, HSI, EFPIA and IABS representatives as facilitators, the participants also discussed specific country/global actions to further secure the deletion of ATT from all regulatory requirements worldwide.

引用

页码：17 / 26

页数：10

共 29 条

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