[EQ] Open discussion on Proposed Harmonized Requirements for the Licensing of Vaccines in The Americas

            Reminder: dateline to send comments - May 30, 2008

 

PAHO/WHO Initiative
Proposed Harmonized Requirements for the Licensing of Vaccines in The Americas

 

The two draft documents are:
Proposed Harmonized Requirements for Licensing of Vaccines in the Americas, and an accompanying attachment entitled Guidelines for Preparation of Applications.

They are available in the original Spanish, as well as in English and French translations

Website: http://www.paho.org/English/AD/THS/PANDRH_Initiative_Eng.htm

 

The information required is structured using the International Conference on Harmonization (ICH) Common Technical Document (CTD), specifically adapted to the market authorization of vaccines, and complemented by Recommendations for vaccines published by the World Health Organization’s Technical Report Series. Because of their special characteristics, vaccines should always be considered as new products for the purpose of market authorization.

The purpose of these documents is to achieve greater harmonization in the information submitted in the application for Market Authorization of vaccines for human use. They apply to all vaccines to be registered, regardless of whether they are manufactured in the country of origin or not. Since the same information should be submitted to all countries in the Americas, the licensing process and ultimately the availability of vaccines should be facilitated. It is expected that having a common document will also benefit the region by making more efficient use of technical and financial resources, as well as facilitating mutual recognition processes where appropriate.

These draft documents are posted on the PAHO as well as the Health Canada websites for the purpose of inviting comments and suggestions on the proposals contained therein. 

Comments proposing modifications to the texts MUST be received by May 30, 2008 and should be addressed to:
Maria de los Angeles Cortes, Regional Advisor on Vaccines and Biologicals,
Technology, Health Care, & Research (THR/EV), Pan American Health Organization PAHO/WHO Washington DC. 
Email: cortesan@paho.org

 

Documents

Proposed Harmonized Requirements for Licensing of Vaccines in the Americas

(110 KB) Español

(63 KB) English

(96 KB) Français

Guidelines for Preparation of Applications

(108 KB) Español

(91 KB) English

(96 KB) Français

 

 

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This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic
health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics;
Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMS Area]

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[EQ] Global Health Diplomacy - Washington DC

Global Health Diplomacy Workshop March 11–13, 2007 - Working Papers and Abstracts available online Website: http://igcc.ucsd.edu/research/globalhealth/globalhealthpapers.php

Project Background

Global Health Diplomacy Summer Program

 

21-25 July 2008 -  One week course on Global Health Diplomacy in Washington, D.C.

 

The Centers for Disease Control and Prevention (CDC) and the University of California’s Institute on Global Conflict and Cooperation

 

 “….Health Diplomacy occupies the interface between international health assistance and international political relations.  It may be described as a political change agent that meets the dual goals of improving global health while helping to repair failures in diplomacy, particularly in conflict areas and resource-poor countries.  The CDC has cited health diplomacy as a way of improving trust and providing resources for health protection and promotion around the world.  Emerging disease, globalized medicine and science, persistent international conflicts, and new threats to human security, call for defining Global Health Diplomacy as an academic discipline for our times.

 

A special focus of the course will be the negotiation process, in particular the interface between technical and political issues that arise in global health agreements. Other topics that will be discussed over the five days are: 

·          Key challenges and goals of global health diplomacy

·          The changing interface of health and foreign policy

·          Dimensions of the new global health policy

·          Ensuring policy coherence in global health

·          Global health diplomacy integration across government

·          Global health and development

·          The role of public health law

·          The impact of large-scale philanthropy on health diplomacy

·          Health and the Politics of Development

 

Course Directors:

Professor Ilona Kickbusch from the Global Health Program of the Graduate Institute of International and Development Studies (HEI) from Geneva
Dr.Thomas Novotny, Professor of Epidemiology and Biostatistics, and Director of International Programs at the UCSF School of Medicine
 

Audience: Professionals with backgrounds ranging from ministries of foreign affairs and health, international organizations, diplomatic missions, development agencies, non-governmental organizations, and the private sector.

Enrollment for this course is by invitation only at this time. 
For questions, please contact Thomas Novotny at novotnyt@globalhealth.ucsf.edu

 

 

 

*      *      *     *  This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics; Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMS Area]  “Materials provided in this electronic list are provided "as is".Unless expressly stated otherwise, the findings and interpretations included in the Materials are those of the authors and not necessarily of The Pan American Health Organization PAHO/WHO or its country members”. --------------------------------------------------------------------------------------------------- PAHO/WHO Website: http://www.paho.org/ EQUITY List - Archives - Join/remove: http://listserv.paho.org/Archives/equidad.html

 

    IMPORTANT: This transmission is for use by the intended recipient and it may contain privileged, proprietary or confidential information. If you are not the intended recipient or a person responsible for delivering this transmission to the intended recipient, you may not disclose, copy or distribute this transmission or take any action in reliance on it. If you received this transmission in error, please notify us immediately by email to infosec@paho.org, and please dispose of and delete this transmission. Thank you.  

[EQ] Payment for Performance (P4P): International experience

Payment for Performance (P4P): International experience and a cautionary proposal for Estonia

 

Health Financing Policy Paper, Division of Country Health Systems - 2008

Alan Maynard, Professor of Health Economics at the University of York, England

 

Available online PDF [36p.] at: http://www.euro.who.int/Document/HSF/P4P_Estonia.pdf

 

Can hospitals be encouraged to perform better?

 

“….Some health systems in Europe use financial incentives for hospitals and specialist physicians linked to process and outcome indicators of performance in an attempt to improve health gain. This is called paying for performance (P4P).

 

Can Estonia’s health system reward value for money and improved quality in hospital and other specialized care and, if so, how? These questions are discussed in a WHO report launched today: Payment for performance (P4P): international experience and a cautionary proposal for Estonia. The report advises caution in undertaking P4P but says that it can offer good value for taxpayers and the users of health services….”

 

Content:

Executive summary

Background

Common Problems confronting purchasers and providers

Introduction: focus on structure, process and outcome

Common problems in the delivery of health care

Incentivizing change in health care provision and purchasing

The importance of incentives

Paying hospitals

Paying doctors

Reinforcing the purchaser role: the development of normative incentives

Normative incentives for hospitals

Normative incentives for doctors

Conclusions

References

 

 

 

 *      *      *     * 

This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic
health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics;
Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMS Area] 

“Materials provided in this electronic list are provided "as is".Unless expressly stated otherwise, the findings
and interpretations included in the Materials are those of the authors and not necessarily of The Pan American
Health Organization PAHO/WHO or its country members”.
---------------------------------------------------------------------------------------------------
PAHO/WHO Website: http://www.paho.org/
EQUITY List - Archives - Join/remove: http://listserv.paho.org/Archives/equidad.html

 

 

 

    IMPORTANT: This transmission is for use by the intended recipient and it may contain privileged, proprietary or confidential information. If you are not the intended recipient or a person responsible for delivering this transmission to the intended recipient, you may not disclose, copy or distribute this transmission or take any action in reliance on it. If you received this transmission in error, please notify us immediately by email to infosec@paho.org, and please dispose of and delete this transmission. Thank you.