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Vaccines and Biologicals

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Update of WHO biosafety risk assessment and guidelines. May 2009 Update of WHO biosafety risk assessment and guidelines. May 2009

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Date added: 12/09/2010
Date modified: 12/09/2010
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Recent Developments in the Field of Regulation of Biological Products Recent Developments in the Field of Regulation of Biological Products

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Date added: 11/04/2010
Date modified: 11/04/2010
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Downloads: 362

Medicines and Biologicals in the Americas: Medicines and Biologicals in the Americas:

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Date added: 12/17/2009
Date modified: 12/17/2009
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Medicines and Biologicals in the Americas: Adapting Global Strategis to the Reginal Context. James Fitzgerald. Coordinator, Essential Medicines and Biologicals. PAHO/WHO Washington, D.C.

Reunión de discusión sobre políticas farmacéuticas e indicadores de evaluación. Washington, DC. 10 y 11 de diciembre de 2009

Biotechnological Products Working Group Report. PANDRH.  17 Jun 2010 Biotechnological Products Working Group Report. PANDRH. 17 Jun 2010

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Date added: 07/30/2010
Date modified: 07/30/2010
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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.

Biotechnological Products Working Group Report. PANDRH.  17 Jun 2010 Biotechnological Products Working Group Report. PANDRH. 17 Jun 2010

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Date added: 07/30/2010
Date modified: 07/30/2010
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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.

Bioequivalence and Bioavailability  Working Group. Proposals to the V Conference Bioequivalence and Bioavailability Working Group. Proposals to the V Conference

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Date added: 12/09/2008
Date modified: 12/09/2008
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Bioequivalence and Bioavailability  Working Group. Proposals to the V Conference. Buenos Aires, Argentina. 17 - 19 November, 2008.

1_V_Conference_WorkingGroup BE 1_V_Conference_WorkingGroup BE

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Date added: 11/17/2008
Date modified: 11/17/2008
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 Pan-American Network On Drug Regulatory Harmonization

(PANDRH). Working Group BE

(PANDRH): Technical Working Groups: Bioequivalence Working Group.  Framework for Implementation (PANDRH): Technical Working Groups: Bioequivalence Working Group. Framework for Implementation

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Date added: 09/10/2008
Date modified: 09/10/2008
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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.

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