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
Fermer ce répertoireTransparency in monitoring the safety of medicines
Afficher le documentSignal generation
Afficher le documentSafety issues - lessons learnt
Afficher le documentResponse to a drug alert situation
Afficher le documentPrinciples of risk communication
Afficher le documentExisting mechanisms of information exchange
Afficher le documentRecommendations
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
Ouvrir ce répertoire et afficher son contenuSafety issues of plasma-derived medicinal products
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. Countries setting up systems for drug safety monitoring should make use of existing experience, including that from WHO and other countries. In this way, scientific resources can be harnessed.

2. Networks for electronic exchange of drug information, in particular relating to safety and which allow for rapid communication, should be established. WHO should take the lead in this endeavour.

3. Regulators should be prepared for crises and guidelines should be available on how to manage a crisis situation involving drug safety.

4. Plans for post-marketing surveillance should be made during drug development.

5. All relevant stakeholders need to be involved in drug safety issues identified by drug monitoring.

6. New drug safety monitoring programmes can be instrumental in the detection of counterfeit drugs, unexpected “lack of efficacy” should be considered and managed as an adverse drug reaction.

7. Authorities should cooperate with other regional authorities when important signals are detected in order to ensure the earliest possible awareness.

8. Principles of good communication should be developed by WHO with input from WHO Member States and regional authorities.

 

vers la section précédente vers la section suivante
 

Dernière mise à jour: le 3 mai 2013