Accueil  >>  Master  >>  Biologie moléculaire et cellulaire  >>  Leading international vaccinology education (ERASMUS+)  >>  Vaccine manufacturing, quality, regulatory approval
  • Domaine : Masters du domaine SCIENCES, TECHNOLOGIES, SANTE
  • Diplôme : Master
  • Mention : Biologie moléculaire et cellulaire
  • Parcours : Leading international vaccinology education (ERASMUS+)
  • Unité d'enseignement : Vaccine manufacturing, quality, regulatory approval
Nombre de crédits de l'UE : 3
Code APOGEE : BIO1311M
UE Obligatoire pour ce parcours
UE valable pour le semestre 2 de ce parcours
    Responsabilité de l'UE :
DELPRAT CHRISTINE
 christine.delpratuniv-lyon1.fr
04.72.68.19.54
    Type d'enseignement
Nb heures *
Cours Magistraux (CM)
30 h
Travaux Dirigés (TD)
10 h
Travaux Pratiques (TP)
0 h
Total du volume horaire
40 h
* Ces horaires sont donnés à titre indicatif.
    Programme - Contenu de l'UE :
University of Antwerp
Contact : Peter DELPUTTE, Professor
e-mail : peter.delputte@uantwerpen.be
Keywords : Vaccine development, Vaccine manufacturing, Vaccine quality, Vaccine evaluation, Vaccine standards, GMP, Vaccine regulation, Vaccine licensing,  Vaccine prequalification programme, International supply chains

Aims of “Vaccine manufacturing & quality control process”:

This course will be designed in close collaboration with our industrial partners

Vaccine manufacturing and quality control

-       Vaccine manufacturing: from working seed to filling and packaging

-       Examples of vaccine production: viral and bacterial vaccines, recombinant protein vaccines

-       GMP considerations

-       Industry and new technologies: antigen sparing, cell-culture, thermostability

-       Quality control and quality assurance: supply chain protection, monitoring and testing

Vaccine regulatory approval processes

-       Laws, regulations, guidances

-       CTD format: content and review

-       From development to licensure: examples of EU, US and international procedures

-       Approval, variations and renewals

-       Specific requirements: pediatric population, risk management

-       Role of supranational organisations in vaccine approval and distribution: WHO prequalification and article 58

The tutorials will involve the study of articles or patents covering various topics of this course. Technological monitoring of different subjects in these areas will be conducted in groups and presented during specific sessions

Speakers:
Karin Hardt, Christophe Saillez, Alberta Di Pasquale.

Learning outcomes:
Explain vaccine manufacturing principles, rules and regulations related to vaccine development, manufacturing, assessment and release, explain regulatory process for vaccine review and approval, explain role of supranational organisation in vaccine registration and surveillance and how the expedited procedure fits into  the existing legal framework for licensing of vaccines


Updated on April 9, 2019

    Modalités de contrôle des connaissances et Compétences 2018-2019 :
TypeLibelléNatureCoef. 
CTContrôle TerminalCT : Vaccine manuf.quality regulatoryEcrit session 1 / Ecrit session 23
    Liste des autres Parcours / Spécialité / Filière / Option utilisant cette UE :
Date de la dernière mise-à-jour : 09/04/2019
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