Zoekresultaten - 83 results
Advanced GMP/CMC
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans Source: Capacity Building for vaccine manufacturers in Iran, Issue European Centre for ...
Communication on out of specification results for vaccine Drug Substances
Publication Type: Scientific poster, presentation or proceeding Authors: Karine Meunier; Stéphane Maisonneuve; François Cano; Wim Van Molle; Camille Domicent; Florence Masquelier Source: Annual OMCL ...
EU Annual report: batch release of human vaccines
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: Waeterloos, G.; Van Molle, W.; Tesolin, L.; Ribaucour, F.; Florens, M.; Masquelier, F.; Clouet, S.; ...
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Tim; Siggers, Richard; Smith, Dean; Stickings, Paul; Uhlrich, Sylvie; Wim Van Molle; Walker, Angela; Wu, Tong; Zhou, Tiequn; Baca-Estrada, Maria Source: Biologicals, Volume 86 (2024) Keywords: Reference ...
Ethical approval for controlled human infectious model clinical trial protocols- A workshop report.
Publication Type: Peer reviewed scientific article Authors: Jamrozik, Euzebiusz; Littler, Katherine; Meln, Irina; Wim Van Molle; Morel, Sandra; Olesen, Ole F; Rubbrecht, Michelle; Balasingam, ...
Regulatory workshop on challenge strain development and GMP manufacture- A stakeholder meeting report.
Hassan, Khaole; Hoefnagel, Marcel; Kamerling, Ingrid; Krut, Oleg; Lane, Chelsea; Liebers, Reinhard; Luke, Catherine; Wim Van Molle; Morel, Sandra; Neels, Pieter; Roestenberg, Meta; Rubbrecht, Michelle; ...
The Role of EDQM and OMCLs
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Training « Responsable des affaires réglementaires », Issue Culture in vivo ASBL (2024) Service: ...
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans; Wim Van Molle; L. Tesolin Source: Training on The assessment of quality part (M3) of the eCTD for the ...
WP20 Regulatory update,
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Inno4Vac 2nd annual meeting 2023, Lyon, France (2023) Service: Qualité des vaccins et produits ...
Regulatory progress and future plans
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Inno4Vac 2nd annual meeting 2023, Lyon, France (2023) Service: Qualité des vaccins et produits ...