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Folder Vaccines and Biologicals

Categories

Documents

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

1625 downloads

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.

pdf 1 V Conference WorkingGroup BE  Published Popular

1097 downloads

Pan-American Network On Drug Regulatory Harmonization

(PANDRH). Working Group BE

pdf Bioequivalence and Bioavailability Working Group. Proposals to the V Conference  Published Popular

1212 downloads

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

pdf Biotechnological Products Working Group Report. PANDRH. 17 Jun 2010  Published Popular

650 downloads

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.

pdf Biotechnological Products Working Group Report. PANDRH. 17 Jun 2010  Published Popular

666 downloads

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.

pdf Harmonized requirements for the licensing of vaccines in the Americas and Guidelines for preparation of application  Published Popular

925 downloads

pdf Medicines and Biologicals in the Americas:  Published Popular

842 downloads

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

pdf Recent Developments in the Field of Regulation of Biological Products  Published Popular

784 downloads

pdf Update of WHO biosafety risk assessment and guidelines. May 2009  Published Popular

666 downloads