V Conference. PANDRH. Buenos Aire, Argentina. 2008Working Group for Prevention and Combat of Counterfeiting of Medicines

Panel de Iniciativas de Armonización de la Reglamentación Farmacéutica.

Coordinación: ARN de Colombia. Presentación de ICH: Justin Molzon (FDA)

 

ICH: Justin Molzon (FDA);

Pan-American Network On Drug Regulatory Harmonization

(PANDRH).

Good Pharmacovigilance  Practices for the Americas. Public Opinion Document. November 2008.

Good Clinical Practices Workgroup.

Draft under discusion presented at the Fifth Conference of The PanamericanNetwork On Drug Regulatory Harmonization Guide for conducting clinical studies in pediatric populations

 

V Conferencia Red PARF . Panel de Iniciativas de Armonización de la Reglamentación Farmacéutica. Coordinación: ARN de Colombia.

ASEAN: Selvaraja Seerangam (Ministerio de Salud de Malasia)

 

Working Group for Prevention and Combat of Counterfeiting of Medicines .

Work Plan Proposal of the Workgroup for Prevention and Combat of Counterfeiting of Medicines (WG/PCCM). November,  2008 Focal Points Network Model to Combat Medicines Counterfeiting Focal Points Network Model to Combat Medicines Counterfeiting Workshops for Discussion of tools and generation of Proposals for Prevention and Combat of Counterfeiting of Medicines Workgroup for Prevention and Combat of Counterfeiting of Medicines

 

Pan-American Network On Drug Regulatory Harmonization

(PANDRH). Working Group Promtion.

Buenos Aires,  Argentina. November 2008

 

Annex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms

Pan-American Network On Drug Regulatory Harmonization(PANDRH)/ working Group Promotion

Presentación de los Avances de los Grupos de Trabajo (GT). En la V Conferencia de la Red PARF

Coordinación: ARN de Costa Rica. Bioequivalencia (BE): Justin Molzon (FDA, EEUU.),

Pan-American Network On Drug Regulatory Harmonization (PANDRH). Working Group Vaccines

·                                 Proposed Harmonized Requirements for the Licensing of Vaccines in the Americas. Proposal version 11.04.2008. 

Guidelines vesion 11/04/2008. Proposed Harmonized Requirements for the Licensing of Vaccines in the Americas. Guidelines for preparation of applications

WHO Technical Report Series 885

Pan-American Network On Drug Regulatory Harmonization (PANDRH).

Good Practices Self-Evaluation Guide for National Pharmaceutical Control Laboratories.

WORKING GROUP ON GOOD LABORATORY PRACTICES

Regional meeting on regulation of biotechnological products – First meeting of the PANDRH working group of biological / biotechnological products

Agenda in English

IX Pan American Network for Drug Regulatory Harmonization Conference.

Agenda.

Oct. 2018

Agenda. V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Buenos Aires, Argentina. November 17th – 19th, 2008.

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

Envíenos suscomentarios u observaciones a This email address is being protected from spambots. You need JavaScript enabled to view it. o This email address is being protected from spambots. You need JavaScript enabled to view it. ,  a través del formulario correspondiente.

 

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.