V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH): Information and propositions of 9 working groups presented for consideration. Buenos Aires, Argentina. 17–19 November 2008

Pan American Network for Drug Regulatory Harmonization (PANDRH): Technical Working Groups: Bioequivalence Working Group.  Framework for Implementation of Equivalence Requirements for Pharmaceutical Products: Document for Public Opinion.

The first part refers to scientific criteria for implementing therapeutic equivalence. In developing this part of the document, the WG/BE analyzed in detail the WHO document “Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability,” which was being prepared by the WHO Expert Committee for Pharmaceutical Preparations.

The second part of the document refers to the strategic framework for the implementation of studies of drug equivalence. This part describes the reality of the Region of the Americas, serving the special features of Latin America and considering that most of the multisource products (products of different origin and/or manufacturers) marketed in the region were approved in accordance with the drug registration requirements of each country at the time of their registration.

Pan-American Network On Drug Regulatory Harmonization

(PANDRH). Working Group BE

Pan American Network On Drug Regulatory Aarmonization. Proposal For The Statutes Renewal. November 2008.

Annex 6. Good manufacturing practices for sterile pharmaceutical products

World Health Organization. Who Technical Report Series, No. 937, 2006. Annex 5. Good  distribution practices for Pharmaceutical Products

Annex 4. Good Manufacturing Practices for pharmaceutical products: main principles

WHO Technical Report Series 929

WHO Technical Report Series 937

 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.