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Biosimilar and interchangeable biosimilar products – USFDA Curriculum Materials for Health Care Degree Programs

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. For more information go to https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars

 
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Unmasking safety signals in an ‘Infodemic’ – a Pharmacovigilance Workshop

World Health Organization

Regulation and Prequalification (RPQ)

When: 6 DECEMBER 2021 14:00 (CET/local time Geneva)
Topic: Unmasking safety signals in an infodemic
Link below to join the webinar:
https://who.zoom.us/j/94283439124
Meeting ID: 942 8343 9124
Password: 1NfoD3+c

 
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Launching a collaborative Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas

Join Launching of the Regional Platform to Advance the Manufacturing of COVID-19  Vaccines and other Health Technologies in the Americas

➕ INFO: https://bit.ly/paho-platform

 

Launching event

WHAT: Launching a collaborative Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas

WHEN:  27 August 2021 – 10:30 a.m. – 12:15 p.m.  (EDT) Washington,  D.C. Time

HOW:    The event will be broadcast on PAHO’s YouTube channel  https://www.youtube.com/PAHOTV

COVID-19 has shed light on the high dependence of Latin America and the Caribbean on imports of health technologies from outside the Region and the vulnerability of global supply. PAHO its Member States and regional partners have renewed the efforts to improve local production capacities in the region and, at the request of Member States, PAHO is launching a collaborative Platform that can convene public and private stakeholders to facilitate the expansion of vaccine and other health technology research, development, and manufacturing in the Region.

This first meeting of the Regional Platform will formalize the launch of this forum and will facilitate a high-level dialogue amongst Member States, development agencies and partners. Acting as a convener, PAHO will ensure that the public health perspective is central to the agenda and will be used to guide the construction of alliances that can accelerate vaccine and other critical health technology manufacturing in the Americas.

The platform will foster research and incentivize development and manufacturing of essential and strategic health technologies in the Americas, expanding manufacturing capacities to ensure access to safe, effective, and quality products, facilitate information exchange and foster cooperation between partners and countries.

In addition, a rational and coherent regional approach will include considerations for regulatory oversight, articulation with the PAHO Revolving Fund and contemplating all elements of the value chain to ensure that the region becomes less dependent on imports and, especially, self-sufficient during public health emergencies.

AGENDA

  • Welcome and opening remarksCarissa F. Etienne, Director, PAHO
  • An opportunity for high-level engagement to foster manufacturing of health products in the Americas: A regional Platform Jarbas Barbosa da Silva Jr., Assistant Director, PAHO
  • The global context and initiatives United Nations Agencies, Non-government Organizations and Development banks
    • Soumya Swaminathan, World Health Organization
    • Anabel González, World Trade Organization
    • Richard Hatchett, Coalition for Epidemic Preparedness Innovation (CEPI)

Moderator: Analía Porrás, Unit Chief, Medicines and Health Technologies, PAHO

  • The regional context and initiatives Ministers of Health, Production, Science and Technology, Research institutions, Non-Government Organization, and Development bank
    •  Daniel Salas Peraza, Minister of Health, Costa Rica
    • María Apólito, Subsecretaria de Economía del Conocimiento, Argentina
    • Andrés Couve, Minister of Science, Technology, Knowledge and Innovation, Chile
    • Nísia Trindade Lima, President Oswaldo Cruz Foundation
    • William Savedoff, Inter-American Development Bank (IDB)
    • Alberto Arenas, Economic Commission for Latin America and the Caribbean (ECLAC)

Moderator: James Fitzgerald, Director, Health System and Services Department, PAHO

  • Closing remarks Carissa F. Etienne, Director PAHO
 
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WHO: Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2

Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas

26 March 2021

Medical product alert
Geneva
Reading time: 2 min (443 words)

Alert Summary

This WHO Medical Product Alert refers to falsified COVID-19 Vaccine identified as “BNT162b2” detected in Mexico in February 2021 and recently confirmed as falsified to the WHO. The falsified product was supplied and administered to patients outside authorized vaccination programs.

This falsified COVID-19 Vaccine may still be in circulation in the region and may continue to be offered to patients outside authorized vaccination programs.

Laboratory analysis of the contents of the falsified products is pending and this Alert will be updated as soon as results are available.

Genuine COVID-19 Vaccine BNT162b2 is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 16 years of age and older. The use of genuine COVID-19 vaccines should be in accordance with official guidance from national regulatory authorities.

Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to identify and remove these from circulation.

The product identified in this alert is confirmed falsified on the basis that it deliberately/fraudulently misrepresents identity, composition, or source:

  • The genuine manufacturer of COVID-19 Vaccine BNT162b2 confirmed they did not manufacture the product.
  • The batch number and expiry dates are falsified.
  • The glass vials and label are different from genuine COVID-19 Vaccine BNT162b2 vials.

 

Table 1: Products subject of WHO Medical Product Alert N°2/2021

Table 1. Falsified COVID-19 Vaccine details

Advice to regulatory authorities and the public

WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and any other suppliers of medical products.

All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.

If you are in possession of the above products, please do not use them.

If you have used these products, or you suffered an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

National regulatory/health authorities are advised to immediately notify WHO if these products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact the WHO Global Surveillance and Monitoring System via rapidalert@who.int

 

Table 2: Photographs of products subject of WHO Medical Product Alert N°2/2021

Table 2. Falsified COVID-19 Vaccine images

 

WHO Global Surveillance and Monitoring System

for Substandard and Falsified Medical Products

For more information, please visit the web pages of the WHO Global Surveillance and Monitoring System or Email: rapidalert@who.int

Source: https://www.who.int/news/item/26-03-2021-medical-product-alert-n-2-2021-falsified-covid-19-vaccine-bnt162b2

 
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31st edition of the RedETSA Webinars – Healthcare cost base

Dear all,

We are pleased to invite you to the 31st  edition of the RedETSA Webinars program, next Friday, March 19, at 2pm, Washington DC time.  

Alfredo Palacios, from the Institute for Clinical Effectiveness and Health Policy (IECS), Argentina,  will give a presentation on “Healthcare cost base.The session will take place in Spanish, without translation. 

The WebEx link that we will use is the following:

Please feel free to extend this invitation to all those who might be interested.

Best regards,

RedETSA Secretariat