HSI Symposium on Global Alignment of Vaccine Testing Requirements

Rome, Italy
18th March 2019

Global Harmonization of vaccine testing requirements – Making the elimination of ATT and TABST a concrete global achievement
Troy Seidle, Vice President, Research & Toxicology, Humane Society International
Laura Viviani, Regulatory Science Advisor, Research & Toxicology Department, HSI

Abnormal Toxicity Testing – Origin, propagation and abolition in Europe
Klaus Cussler, Head of Pharmacovigilance of Veterinary Immunological Products and Animal Welfare Unit, Paul Ehrlich Institute, Berlin

The target animal batch safety test: a non-suitable tool to demonstrate the safety of veterinary vaccines
Lukas Bruckner, Swiss delegate to the European Pharmacopoeia Commission

Making the elimination of ATT and TABST a concrete global achievement – Indian Perspective
Sunil K. Goel, Deputy Director QC, Serum Institute of India Pvt Ltd, Pune

Abnormal Toxicity Test- Current Test Requirements in China
Hongtoa Jin, New Dug Safety and Evaluation Center, Chinese Academy of Medical Sciences & Peking Union Medical College

Elimination of the General Safety Test (21 CFR 610.11) US FDA Update
Marion F. Gruber, Director, Office of Vaccines Research & Review, Center for Biologics Evaluation & Research, US Food and Drug Administration

Abnormal Toxicity: Standardisation and Quality Control of Medicinal Products in the Russian Federation
Elena Sakanyan, Chair of the Pharmacopoeial Committee of the EEU, Deputy Chair of the Russian Pharmacopoeia Council of the Ministry of Health of Russia

The Brazilian Pharmacopoeia and the deletion of ATT
Arthur Leonardo Lopes da Silva, Pharmacopoeia Coordination (COFAR), Angência Nacional de Vigilância Sanitária.

The Regulation of Biological Medicines in South Africa: Status of in vivo testing
Derek Litthauer, Director National Control Lab for Biological Products, University of the Free State, Blomfontein, South Africa

Target Animal Batch Safety Test
Geetha B. Srinivas, Section Head, Virology, Center for Veterinary Biologics, US Department of Agriculture

Waiving the Target Animal Batch Safety Test at MSD Animal Health
Marianne Kaashoek, RA Product Manager, MSD Animal Health, The Netherlands

VICH GLs: data to be provided to apply for waiving of TABST (and LABST in future)
Marlies Halder, Scientific Officer, European Commission Joint Research Centre, Italy

Making the elimination of ATT and TABST a concrete global achievement
Patricia Aprea, Director, Evaluation and Control of Biologicals and Radiopharmaceuticals, National Administration of Medicines, Food and Medical Technology, Republica, Argentina

International Alliance for Biological Standardisation (IABS) – Non-animal Testing of Vaccines – A Global Congress

From Media

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