WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019
| Autor: | 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, 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, 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, Teruhide Yamaguchi, Hyun-Jun (David) Youn, Minae Yun, Aziza Ahmed |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Process management Seoul Bioengineering Guidelines as Topic World Health Organization Applied Microbiology and Biotechnology World health Expert committee law.invention 03 medical and health sciences 0302 clinical medicine law Humans National level 030212 general & internal medicine skin and connective tissue diseases Drug Approval Pharmacology Biological Products General Immunology and Microbiology General Medicine Product (business) 030104 developmental biology Guideline implementation Who guidelines CLARITY Drug Evaluation Drug and Narcotic Control sense organs Business High standard Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 65 |
| ISSN: | 1095-8320 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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