当前位置: X-MOL 学术Biologicals › 论文详情
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Biologicals ( IF 1.801 ) Pub Date : 2020-01-17 , DOI: 10.1016/j.biologicals.2019.12.008
Meenu Wadhwa,Hye-Na Kang,Teeranart Jivapaisarnpong,,Lucia Rizka Andalucia,Carolina Damas Rocha Zarate Blades,Mary Casas Levano,Weihong Chang,Jing Yin Chew,Mumbi Bernice Chilufya,Parichard Chirachanakul,Heeyoun Gloria Cho,Yi O Cho,Kyung Min Choi,Sannie Chong,Hui Ming Chua,Ali Vasheghani Farahani,Mumun Gencoglu,Mariam Raouf Wefky Ghobrial,Prasunkumar Guha,Maria-Teresa Gutierrez Lugo,Sung Bae Ha,Suna Habahbeh,Hugo Hamel,Yeosun Hong,Aleksei Iarutkin,Hyunsook Jang,Ramalingam Jayachandran,Teeranart Jivapaisarnpong,Hye-Na Kang,Dong-Young Kim,Gi Hyun Kim,Yunjeong Kim,Hyuk-Sang Kwon,Jacob Larsen,Aileen HyoJu Lee,Jiyoung Lee,Ksenia Medvedeva,Zuma Munkombwe,IlUng Oh,Jooyoung Park,Jooyoung Park,Desi Eka Putri,Jacqueline Rodgers,Sungmun Ryu,Maria Savkina,Thomas Schreitmueller,Oleh Semeniuk,Mira Seo,Yung In Shin,Jinho Shin,Shraddha Srivastava,HyeonHo Song,Suwon Song,João Tavares Neto,Meenu Wadhwa,Teruhide Yamaguchi,Hyun-Jun David Youn,Minae Yun

The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.
更新日期:2020-01-17

 

全部期刊列表>>
AI核心技术
10years
材料学研究精选
Springer Nature Live 产业与创新线上学术论坛
胸腔和胸部成像专题
自然科研论文编辑服务
ACS ES&T Engineering
ACS ES&T Water
屿渡论文,编辑服务
杨超勇
周一歌
华东师范大学
段炼
清华大学
廖矿标
李远
跟Nature、Science文章学绘图
隐藏1h前已浏览文章
中洪博元
课题组网站
新版X-MOL期刊搜索和高级搜索功能介绍
ACS材料视界
x-mol收录
福州大学
南京大学
王杰
左智伟
电子显微学
何凤
洛杉矶分校
吴杰
赵延川
试剂库存
天合科研
down
wechat
bug