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Folder VIII CPANDRH documents

Documents

pdf Panel A. The implementation of technovigilance in the Region (Elkin Otálvaro – INVIMA and Javier Guzmán)[Only in Spanish]  Published Popular

1894 downloads

pdf Panel B. OTC: control of places and conditions of sale (Sebastián Duarte, ANMAT, Argentina) [Only in Spanish]  Published Popular

937 downloads

pdf Panel C. Gene therapy and cell therapy: regulation challenges faced by NRAs. (Maria Teresa Ibarz, INHRR) [Only in Spanish]  Published Popular

1048 downloads

pdf Panel C. Gene therapy and cell therapy: regulation challenges faced by RNAs (Joao Batista da Silva Junior, ANVISA, Brazil)  Published Popular

634 downloads

pdf Panel D. Post-market surveillance - market withdrawal of medications (Juan Roldón, ISP, Chile) [Only in Spanish]  Published Popular

1789 downloads

pdf Panel D. Traceability systems (María José Sánchez, ANMAT, Argentina) [Only in Spanish]  Published Popular

1373 downloads

pdf Panel E. Quality Management Systems (QMS): NRA perspectives Pablo Ortíz (ISP, Chile) [Only in Spanish]  Published Popular

1001 downloads

pdf Panel E. Quality Management Systems (QMS): NRA perspectives. Dalia Castillo(MoH, Dominican Republic) [Only in Spanish]  Published Popular

1752 downloads

pdf Panel E. Quality management. Industry perspectives (Elmer Torres (ALIFAR)). [Only in Spanish]  Published Popular

651 downloads

pdf Thematic Session 01: International experiences: IGDRP (Mariana Gebara-Coghlan, TGA, Australia)  Published Popular

560 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: The benefits of convergence with international standards (Jaime Oliveira, FIFARMA)  Published Popular

748 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: International experiences: IMDRF, MDSAP and REPS (Fabio Pereira Quintino, ANVISA, Brazil)  Published Popular

1168 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: International experiences: Update after one yerar of operation of the ICH Association (legal entity) (Lenita Lindström-Gommers, ICH)  Published Popular

1322 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: Opportunities for the adoption of common standards (Maria Luz Pombo, PAHO/WHO)  Published Popular

638 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: Partner and donors: Bill and Melinda Gates Foundation (Murray Lumpkin, BMG Foundation)  Published Popular

723 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 01: Short Case Study: Implementation of the International Standards Organization (ISO) for the Identification of Medical Products (IDMP) (Joan Blair, FDA, USA)  Published Popular

1408 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 02: The role of the evaluation tool in implementing core regulatory functions (José Peña, PAHO/WHO) [Only in Spanish]  Published Popular

482 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City. Regulatory Convergence for Universal Health Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.

Date: October 19th-21st 2016

VIII Conferencia Panamericana para la Armonización de la Reglamentación Farmacéutica (CPARF), Ciudad de México
Convergencia Regulatoria para la Salud Universal
Fortaleciendo capacidades, ampliando acceso y facilitando la cooperación regulatoria en la Región de las Américas
Fecha: 19 al 21 de octubre de 2016


Sesión Temática 2: Funciones Regulatorias esenciales y modelos operativos innovadores

El rol de los instrumentos de evaluación en la implementación de las funciones regulatorias esenciales (José Peña, OPS/OMS)

pdf Thematic Session 02: Caribbean Regulatory System. CARPHA perspective (Lucette Cargil, Caribbean Public Health Agency)  Published Popular

1432 downloads


VIII Conferencia Panamericana para la Armonización de la Reglamentación Farmacéutica (CPARF), Ciudad de México
Convergencia Regulatoria para la Salud Universal
Fortaleciendo capacidades, ampliando acceso y facilitando la cooperación regulatoria en la Región de las Américas
Fecha: 19 al 21 de octubre de 2016

Sesión Temática 2: Funciones Regulatorias esenciales y modelos operativos innovadores

La perspectiva de CARPHA (Lucette Cargil, Caribbean Public Health Agency)

pdf Thematic Session 02: Caribbean Regulatory System. Pacific Alliance (Biby Ferrada, ISP, Chile) [Only in Spanish]  Published Popular

2015 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

VIII Conferencia Panamericana para la Armonización de la Reglamentación Farmacéutica (CPARF), Ciudad de México
Convergencia Regulatoria para la Salud Universal
Fortaleciendo capacidades, ampliando acceso y facilitando la cooperación regulatoria en la Región de las Américas
Fecha: 19 al 21 de octubre de 2016

Alianza del Pacifico (Biby Ferrada, ISP de Chile)

pdf Thematic Session 02: The Caribbean Regulatory System Initiative. Country Perspective - Suriname. (Miriam Naarendorp, Ministry of Health Suriname)  Published Popular

700 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016


VIII Conferencia Panamericana para la Armonización de la Reglamentación Farmacéutica (CPARF), Ciudad de México
Convergencia Regulatoria para la Salud Universal
Fortaleciendo capacidades, ampliando acceso y facilitando la cooperación regulatoria en la Región de las Américas
Fecha: 19 al 21 de octubre de 2016

Sesión Temática 2: Funciones Regulatorias esenciales y modelos operativos innovadores
Sistema regulador del Caribe. La perspectiva de Suriname (Miriam Naarendorp, Ministry of Health Suriname)

pdf Thematic Session 03: Cuba short case (Dulce María Martínez, CECMED, Cuba) [Only in Spanish]  Published Popular

611 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

Thematic Session 03: Competence in good regulatory practices and regulatory science

pdf Thematic Session 03: Global regulatory curriculum -a joint effort  Published Popular

750 downloads

pdf Thematic Session 03: Cooperation between academy. Maria Teresa Ibarz, INHRR, Venezuela. [Only in Spaniish]  Published Popular

615 downloads

pdf Thematic Session 03: Cooperative models between regulator and regulated stakeholders. Pharmaceutical perspectives Alfredo Antia, ALIFAR [Only in Spanish]  Published Popular

469 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

Sesión Temática 3: Competencias en buenas prácticas regulatorias y ciencias regulatorias
Moderadores
Catherine Parker, Biológicos y Terapias Genéticas – Health Canada
Maria Auxiliadora Vargas de Dentice, Dirección Nacional de Vigilancia Sanitaria - Paraguay
Modelos de Interfaz cooperativa entre Regulador y Regulados

La visión de la industria Alfredo Antia, ALIFAR

pdf Thematic Session 03: Global regulatory curriculum (Silvia Bendiner, RAPS)  Published Popular

785 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 03: PANDRH Secretariat: Adoption and implementation of prioritization model for PANDRH operation (Murilo Freitas Dias, PAHO/WHO)  Published Popular

1903 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

Thematic Session 3: Competence in good regulatory practices and regulatory science

pdf Thematic Session 03: Periodic meetings & regulatory education for industry (Patricia Pineda, FDA, USA)  Published Popular

981 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 03: Pharmaceutical perspectives. Alexis José Serlin, CANIFARMA [Only in Spanish]  Published Popular

532 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 03: The European Medicines Agency (Riccardo Luigetti, EMA)  Published Popular

814 downloads

VIII Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH), Mexico City.
Regulatory Convergence for Universal Health

Building Capacity, Expanding Access and Facilitating Regulatory Cooperation in the Region of the Americas.
Date: October 19th-21st 2016

pdf Thematic Session 04: Falsified drugs. The cost to health systems (María José Sánchez, ANMAT, Argentina) [Only in Spanish]  Published Popular

1020 downloads

pdf Thematic Session 04: PDUFA-GDUFA (Khyati Roberts, AbbVie. FIFARMA)  Published Popular

1341 downloads

pdf VIII CPANDRH Agenda. Oct. 2016  Published Popular

1022 downloads

pdf VIII CPANDRH Recommendations and next steps (Secretariat, 21 October 2016)  Published Popular

861 downloads