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Zoekresultaten - 10 results
A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy
Regulatory roadmap Vaccine Efficacy Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et ...
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge ...
Adjuvants for vaccines, A need for quality time?
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: COST regulatory workshop on adjuvants (2019) Health Topics: Effectiveness and safety of vaccines, ...
How, where and when to get and/ask for information and help,
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: COST regulatory workshop on adjuvants (2019) Health Topics: Effectiveness and safety of vaccines, ...
Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills
alert for genotoxicity in at least one of the two (Q) SAR models. For these substances, genotoxicity data was collected from previous European safety evaluations in different regulatory domains (e.g. by ...
Regulatory Position on Specification Settings
PDA Europe, Issue PDA Europe, Berlin, Germany (2015) Keywords: challenge CHALLENGES conference Countries developing Developing Countries Europe ON Regulatory vaccine vaccines WHO Health Topics: Vaccin ...
General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.
one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically ...
Panel discussion on the adoption of 3Rs and non-animal approaches for quality control and batch release testing of these products
-who-guidelines-understanding-impact-quality-control-and, https://www.nc3rs.org.uk/, Virtual conference, London, United Kingdom (2022) Keywords: 3Rs regulatory hurdles Vaccine quality control Health Topics: Effectiveness and safety of vaccines, medicines and health products- ...
Use of Next Generation Sequencing in Adventitious Virus Screening of Biological Medicinal Products: Regulatory Requirements
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals, IABS, Rockville, MD, USA (2022) Keywords: ...
Application of silver-based biocides in face masks intended for general use requires regulatory control
Publication Type: Scientific poster, presentation or proceeding Authors: Jan Mast; Erik Van Miert; Lisa Siciliani; Karlien Cheyns; Charlotte Wouters; Nadia Waegeneers; Ruud Bernsen; Christiane Vleminckx; Joris Van Loco; Eveline Verleysen Source: (2023) He ...