The Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH) met at the Headquarters of the Pan American Health Organization (PAHO) in Washington, DC, on 27 and 28 May 2015. Other Authorities from the Region participated both in person and virtually.

The Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH) met virtually on 16 May 2015 and had personal participation of some Members, Authorities and Observers of the Region at the Headquarters of the Pan American Health Organization (PAHO) in Washington, DC.

Foro Permanente de regulación de biológicos de las Américas.

 

World Health Organization. WHO Technical Report Series, No. 902, 2002Annex 3. Good practices for national pharmaceutical

 

VII PANDRH Conference

VII PANDRH Conference.

Bioequivalence and Bioavailability  Working Group. Proposals to the V Conference. Buenos Aires, Argentina. 17 - 19 November, 2008.

VII PANDRH Conference.

BIOTECHNOLOGICAL PRODUCTS WORKING GROUP REPORT.PAN AMERICAN NETWORK ON DRUG REGULATORY HARMONIZATION (PANDRH)

Meeting date: 17 June 2010

Place: Punta Cana, Dominican Republic

Objectives

1. To select the main and alternate country coordinators for the working group (WG).

2. To establish short- and middle-term objectives for the WG, as well as to define the chronogram of activities.

3. To establish communication mechanisms.

VII PANDRH Conference.

VII PANDRH Conference.

VII PANDRH Conference.  

Minuta de la Reunión virtual del Comité Directivo Red PARF.  18 de julio del 2017.

La Red Panamericana para la Armonización de Regulación Farmacéutica (PARF), Grupo Técnico Ensayos Clínicos,  le invita a participar de la consulta pública de los contenidos de la Guía para el Manual del Investigador
 
Fecha de Inicio: 28 de enero de 2011
Fecha de Término: 28 de marzo de 2011

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Title: Assessing CPP requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches.
Cross-cutting areas: Authorization, Registration and Licensing of products and facilities and Good Regulatory Practices and Regulatory Sciences

Initiator: Latin America Federation of the Pharmaceutical Industry - FIFARMA

PANDRH WG/GMP. V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Buenos Aires, Argentina. November 17th – 19th, 2008.  Decision tree for the implementation of the Guideline for Good Manufacturing Practices Inspection

The implementation of this Guideline supports compliance with the WHO GMP standards according to Report #32 and updates until 2003, date of preparation of the Guideline.

The Guide for GMP Inspection was adopted by PANDRH at the IV Conference. 

 The working group on GMP (WG/GMP), considering the differences among the levels of development of the pharmaceutical industry in the Region and the political and economic realities of the countries in the Americas, considered it necessary to define a Decision Tree to guide the countries in applying these standards and to set priority of the actions to follow. The document is aimed to guide the NRA and the pharmaceutical industry in prioritizing the requirements of the standards. However, it is estimated that the application of the priorities as they are presented in this document have the flexibility that the national situation requires.

This document is based on a proposal carried out in Venezuela and on resolution 01267 of 2/8/2001 from Colombia.

The document, prepared by the PANDRH WG/GMP members has been approved during their VI meeting (March 2006) as draft for public opinion. It is currently available in the webpage of PANDRH. In compliance of PANDRH process, all comments from the public will be reviewed by the WG/GMP in preparation of the final version.

VII PANDRH Conference.

Exigences harmonisées pour l'homologation des vaccins Dans la Région des Amériques et Guide d'application

RPHRP Document technique

No. 1 Réseau panaméricain d'harmonisation de la réglementation pharmaceutique

Groupe de travail sur les vaccins

Final Minutes PANDRH - January 15

Pan American Network on Drug Regulatory Harmonization Working Group on BE. Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. Proposal to be submitted to the V Conference for Drug Regulatory Harmonization. October 2008

 

Pan American Network on Drug Regulatory Harmonization.Working Group on BE. Framework for implementation of equivalence requirements for pharmaceutical products.  Document approved in the V Conference for Drug Regulatory Harmonization. Buenos Aires, Argentina. 17 - 19 November, 2008.

PAHO.GOOD PRACTICES SELF-EVALUATION GUIDE FOR NATIONAL PHARMACEUTICAL CONTROL LABORATORIES

VII PANDRH Conference.