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WHO Guidelines on Post Approval Changes- Appendix 1 Reporting categories and suggested review timelines
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: Workshop on management of post approval changes, 03-05/12/2024, Hanoi-Viet Nam, WHO, Hanoi, Viet Nam (2024) Keywords: post approval changes vaccine Health Topics: ...
WHO Guidelines on Post approval Changes- Appendix 2+3 Reporting procedures and data requirements for quality changes to antigens + finished products
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: Workshop on management of post approval changes, 03-05/12/2024, Hanoi-Viet Nam, WHO, Hanoi, Viet Nam (2024) Keywords: post approval changes vaccine Health Topics: ...
Guideline for Respiratory Syncytial Virus (mRNA) Vaccine
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: Tesolin, L.; Bruysters, M.; Campitelli, L.; Pullirsch, D.; Oppling, V.; Garcia, D. Source: EDQM, Strasbourg (F), p.18 (2024) Accession Number: PA/PH/OMCL (24) 66 DEF ...
Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; H. Meyer; D. Lei; T. Jivapaisarnpong; M. Welin; A. Cheung Source: WHO, Geneva, switzerland, p.9 (2023) Health Topics: Vaccine batch conformity Vaccin lo ...
OCABR: Respiratory Syncytial Virus (rDNA) Vaccine
p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywords: EDQM guideline OCABR RSV Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des ...
WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
by the OMCL, this can be proposed by the manufacturer but is finally decided by EDQM and depends whether or not an OCABR guideline for the type of vaccine in question is already in force. For the ...