Lista de obras -

1st WHO International Standard antiserum to RSV: Availability and benefits for RSV vaccine development (Commentary on the collaborative study report published in the vaccine journal (Vaccine 2018 36: 7641-7649))

scientific article published on 24 June 2019

A cautionary perspective regarding the isolation and serial propagation of SARS-CoV-2 in Vero cells

scholarly article by Simon G. P. Funnell published in June 2021

Adventitious agents in viral vaccines: lessons learned from 4 case studies.

artículo científico publicado en 2014

An overview of the immunogenicity and effectiveness of current human rabies vaccines administered by intradermal route

scientific article published on 11 December 2018

Animal cell substrates for the production of biologicals: An introduction to WHO documents

artículo científico publicado en 2014

Animal models for COVID-19

scientific article published on 23 September 2020

Biosimilars--global issues, national solutions.

artículo científico publicado en 2011

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

artículo científico publicado en 2014

Demonstrating vaccine effectiveness during a waning epidemic: A WHO/NIH meeting report on approaches to development and licensure of Zika vaccine candidates

article

Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation

artículo científico publicado en 2011

Harmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody

artículo científico publicado en 2019

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility

artículo científico

Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes

artículo científico publicado en 2015

Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI).

artículo científico publicado en 2015

Regulatory evaluation of biosimilars throughout their product life-cycle.

artículo científico publicado en 2018

Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine.

artículo científico publicado en 2008

Report of the international conference on manufacturing and testing of pluripotent stem cells

scientific article published on 24 August 2018

Report of the international conference on next generation sequencing for adventitious virus detection in biologicals

artículo científico publicado en 2018

Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products

artículo científico publicado en 2015

Report on a WHO consultation on the characterisation of BCG strains, Imperial College, London 15-16 December 2003.

artículo científico publicado en 2004

Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective

artículo científico publicado en 2016

Review of the current use and evaluation of cell substrates for producing biologicals in selected countries.

artículo científico publicado en 2015

Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective

artículo científico publicado en 2016

Scientific considerations for the regulatory evaluation of cell therapy products

artículo científico publicado en 2017

The WHO network of collaborating centres on standardization and regulatory evaluation of vaccines.

artículo científico publicado en 2012

The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates

scholarly article by Natalie I Mazur et al published October 2018 in Lancet Infectious Diseases

Thiomersal in vaccines: a regulatory perspective WHO Consultation, Geneva, 15-16 April 2002.

artículo científico publicado en 2004

Vaccine quality--can a single standard be defined?

artículo científico publicado en 2002

WHO Informal Consultation on standardization and evaluation of BCG vaccines Geneva, Switzerland 22-23 September 2009

scientific article published on 06 August 2010

WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13–14 May 2009 ⬇️

artículo científico publicado el 4 de noviembre de 2010

WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11-12 May 2009.

artículo científico publicado en 2010

WHO Working Group on the standardisation and control of pertussis vaccines-report of a meeting held on 6-7 May 2003, Ferney Voltaire, France

artículo científico publicado en 2004

WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.

artículo científico publicado en 2015

WHO discussion on the improvement of the quality control of BCG vaccines. Pasteur Institute, Paris, France, 7 June 2005

scientific article published on 01 May 2006

WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

artículo científico publicado en 2020

WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products

artículo científico publicado en 2017

WHO working group on standardisation and control of acellular pertussis vaccines--report of a meeting held on 16-17 March 2006, St. Albans, United Kingdom.

artículo científico publicado en 2006

WHO/Health Canada meeting on regulatory considerations for evaluation and licensing of new meningococcal Group B vaccines, Ottawa, Canada, 3–4 October 2011 ⬇️

artículo científico publicado el 16 de octubre de 2012

WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.

artículo científico

WHO/KFDA workshop on stability evaluation of vaccines, Seoul, Korea, 23-25 April 2008

article

Lista de obras de

1st WHO International Standard antiserum to RSV: Availability and benefits for RSV vaccine development (Commentary on the collaborative study report published in the vaccine journal (Vaccine 2018 36: 7641-7649))

A cautionary perspective regarding the isolation and serial propagation of SARS-CoV-2 in Vero cells

Adventitious agents in viral vaccines: lessons learned from 4 case studies.

An overview of the immunogenicity and effectiveness of current human rabies vaccines administered by intradermal route

Animal cell substrates for the production of biologicals: An introduction to WHO documents

Animal models for COVID-19

Biosimilars--global issues, national solutions.

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

Demonstrating vaccine effectiveness during a waning epidemic: A WHO/NIH meeting report on approaches to development and licensure of Zika vaccine candidates

Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation

Harmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility

Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes

Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI).

Regulatory evaluation of biosimilars throughout their product life-cycle.

Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine.

Report of the international conference on manufacturing and testing of pluripotent stem cells

Report of the international conference on next generation sequencing for adventitious virus detection in biologicals

Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products

Report on a WHO consultation on the characterisation of BCG strains, Imperial College, London 15-16 December 2003.

Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective

Review of the current use and evaluation of cell substrates for producing biologicals in selected countries.

Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective

Scientific considerations for the regulatory evaluation of cell therapy products

The WHO network of collaborating centres on standardization and regulatory evaluation of vaccines.

The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates

Thiomersal in vaccines: a regulatory perspective WHO Consultation, Geneva, 15-16 April 2002.

Vaccine quality--can a single standard be defined?

WHO Informal Consultation on standardization and evaluation of BCG vaccines Geneva, Switzerland 22-23 September 2009

WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13–14 May 2009 ⬇️

WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11-12 May 2009.

WHO Working Group on the standardisation and control of pertussis vaccines-report of a meeting held on 6-7 May 2003, Ferney Voltaire, France

WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.

WHO discussion on the improvement of the quality control of BCG vaccines. Pasteur Institute, Paris, France, 7 June 2005

WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products

WHO working group on standardisation and control of acellular pertussis vaccines--report of a meeting held on 16-17 March 2006, St. Albans, United Kingdom.

WHO/Health Canada meeting on regulatory considerations for evaluation and licensing of new meningococcal Group B vaccines, Ottawa, Canada, 3–4 October 2011 ⬇️

WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.

WHO/KFDA workshop on stability evaluation of vaccines, Seoul, Korea, 23-25 April 2008