Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoOpening Ceremony
Abrir esta carpeta y ver su contenidoGood regulatory practice
Abrir esta carpeta y ver su contenidoGood certification practice
Abrir esta carpeta y ver su contenidoCounterfeit drugs: challenges and solutions
Abrir esta carpeta y ver su contenidoCurrent issues in regulation and quality
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization: implementation and implications
Abrir esta carpeta y ver su contenidoDrug utilization studies
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization and the common technical document
Abrir esta carpeta y ver su contenidoKeynote address
Abrir esta carpeta y ver su contenidoGlobal and national efforts to reduce tobacco use
Abrir esta carpeta y ver su contenidoElectronic communication in the regulatory process
Cerrar esta carpetaTransparency in monitoring the safety of medicines
Ver el documentoSignal generation
Ver el documentoSafety issues - lessons learnt
Ver el documentoResponse to a drug alert situation
Ver el documentoPrinciples of risk communication
Ver el documentoExisting mechanisms of information exchange
Ver el documentoRecommendations
Abrir esta carpeta y ver su contenidoPharmaceutical products for use in special groups
Abrir esta carpeta y ver su contenidoNeed for Bioequivalence
Abrir esta carpeta y ver su contenidoAntimicrobial resistance: battling the bugs
Abrir esta carpeta y ver su contenidoSafety issues of plasma-derived medicinal products
Abrir esta carpeta y ver su contenidoHerbal medicines
Abrir esta carpeta y ver su contenidoRegulation and access to essential drugs
Ver el documentoParticipants
Ver el documentoBack 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.

 

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Última actualización: le 3 mayo 2013