WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017
| Autor: | Rauza Volkova, Jayoung Jeong, Byoungguk Kim, Teruhide Yamaguchi, Beverley Alway, Tzer Jing Seng, Kyung Won Seo, Carolina Damas Rocha Zarate Blades, Jinho Shin, Jacqueline Rodgers, Mai Allam, Zuma Munkombwe, Wei Wei, Heidi Meyer, Jaeho Jung, Patricia Aprea, Elwyn Griffiths, Teeranart Jivapaisarnpong, Daecheol Kim, Yujin Jung, Sundar Ramanan, Eduardo Spitzer, Hugo Hamel, Parichard Chirachanakul, Thomas Schreitmueller, Soo Kyung Suh, Hye-Na Kang, Meenu Wadhwa, Sannie Chong, Suwon Song, Yeowon Sohn, Hea Jeong Doh, Songmei Xie, Martin Schiestl, Juliati Dahlan, Kwang-Seok Seo, Ilung Oh |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Standardization media_common.quotation_subject Bioengineering Harmonization World Health Organization Applied Microbiology and Biotechnology Expert committee 03 medical and health sciences Republic of Korea Humans Quality (business) Informal consultation media_common Pharmacology Licensure Medical education General Immunology and Microbiology Public consultation General Medicine Congresses as Topic Biological Therapy 030104 developmental biology Who guidelines Practice Guidelines as Topic Business Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 52 |
| ISSN: | 1095-8320 |
| Popis: | In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Regulation of changes to approved biotherapeutic products is a key in ensuring that products of consistent quality, safety and efficacy are distributed after they receive authorization or licensure. Participants agreed that the guidelines would contribute to assuring the continued quality, safety and efficacy throughout the life-cycle of biotherapeutics as well as continuity in supply and access. In the meeting, participants further requested WHO should assist national regulatory authorities in improving technical expertise in the evaluation of biotherapeutics and their post-approval changes by organizing implementation workshops and developing case studies and e-training modules on various technical topics. At its meeting in October 2017, the WHO Expert Committee on Biological Standardization formally adopted the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. |
| Databáze: | OpenAIRE |
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