Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuOpening Ceremony
Ouvrir ce répertoire et afficher son contenuGood regulatory practice
Ouvrir ce répertoire et afficher son contenuGood certification practice
Ouvrir ce répertoire et afficher son contenuCounterfeit drugs: challenges and solutions
Ouvrir ce répertoire et afficher son contenuCurrent issues in regulation and quality
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization: implementation and implications
Ouvrir ce répertoire et afficher son contenuDrug utilization studies
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization and the common technical document
Ouvrir ce répertoire et afficher son contenuKeynote address
Ouvrir ce répertoire et afficher son contenuGlobal and national efforts to reduce tobacco use
Ouvrir ce répertoire et afficher son contenuElectronic communication in the regulatory process
Ouvrir ce répertoire et afficher son contenuTransparency in monitoring the safety of medicines
Ouvrir ce répertoire et afficher son contenuPharmaceutical products for use in special groups
Ouvrir ce répertoire et afficher son contenuNeed for Bioequivalence
Ouvrir ce répertoire et afficher son contenuAntimicrobial resistance: battling the bugs
Fermer ce répertoireSafety issues of plasma-derived medicinal products
Afficher le documentRegulatory experience in industrialized countries: USA
Afficher le documentRegulatory experience in industrialized countries: Germany
Afficher le documentRegulatory experience in countries with evolving plasma-fractionation facilities
Afficher le documentRegulatory experience in countries with no production of plasma-derived products: Malaysia
Afficher le documentRegulatory experience in countries with no production of plasma-derived products: Zimbabwe
Afficher le documentRecommendations
Ouvrir ce répertoire et afficher son contenuHerbal medicines
Ouvrir ce répertoire et afficher son contenuRegulation and access to essential drugs
Afficher le documentParticipants
Afficher le documentBack cover
 

Recommendations

1. WHO should collaborate with Member States to strengthen the technical expertise of national control authorities in the regulation of plasma products, especially those countries with plasma fractionation activities or facilities to assure adequate quality, safety and efficacy of plasma products. This includes special emphasis on viral testing, viral inactivation procedures, and surveillance for viral and other transfusion transmitted diseases.

2. WHO should promote the regulation of blood bank facilities by National Control Authorities in order to ensure compliance with GMP principles.

3. WHO should facilitate the development of educational programs and training opportunities for National Control Authorities involved in regulation and control of blood products. WHO should promote regional cooperation and training.

4. WHO should assist Member States in the development of appropriate guidelines for plasma fractionation contract activities.

5. WHO should provide guidelines on information to be included in batch release certificates in order to facilitate acceptance of imported plasma products by national control authorities.

 

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Dernière mise à jour: le 3 mai 2013