Ivana Knezevic, MD, PhD

Member of International Advisory Board, GaBI Journal

Scientist, Technologies, Standards and Norms Team, Group Lead, Norms and Standards for Biologicals, Department of Essential Medicines and Health Products (EMP), Health Systems and Innovation (HIS) Cluster, World Health Organization (WHO), Switzerland

Dr Knezevic is Specialist in Medical Microbiology and Parasitology. She received her MD from the University of Novi Sad, MSc in Medicine (Microbiology) and PhD in Medicine (Virology) from the University of Belgrade, Serbia.

Dr Ivana Knezevic has 22 years of professional experience in standardization, scientific and regulatory overview of biologicals. During the first seven years, the expertise in the production, quality control and overall evaluation of vaccines and biological therapeutics was developed at the national level. Following the WHO Global Training Network on potency testing of live attenuated oral polio vaccines at the National Institute of Biological Standardization and Control (NIBSC) in the UK in 1996, she established virology laboratory for quality control of viral vaccines and interferons at the National Control Laboratory and the National Regulatory Authority in Serbia.

Dr Knezevic is a Scientist at the WHO Biological Standardization Programme, where she joined in September 2000, and since then her activities have been devoted to the standardization and evaluation of biologicals at global level. Since 2006, she has been leading the team for standardization of vaccines and some biological therapeutics which consists of five scientists and three support staff in the WHO Headquarters. Main aspects of the work include development and establishment of WHO International Standards as well as providing assistance to the regulators, manufacturers and other users of these standards. Being responsible for the development and implementation of more than 30 guidelines and recommendations to assure quality, safety and efficacy of vaccines and biotherapeutic products, Dr Knezevic has established a valuable set of scientific principles for regulatory oversight of biologicals. Among them, development of the WHO regulatory guidelines on various aspects of vaccine evaluation, i.e. cell substrates, stability, non-clinical and clinical, as well as the recommendations for production, control and evaluation of selected vaccines, e.g. polio, rabies, pertussis, pneumococcal, dengue, yellow fever, combined vaccines, published in the WHO Technical Report Series, are some of the most important projects.

In the area of biotherapeutics, she coordinated the development of WHO’s Guidelines on evaluation of Similar Biotherapeutic Products (SBPs), and organized a series of workshops to facilitate the implementation of guiding principles for evaluation of biotherapeutic products into regulatory and manufacturers’ practice.

Being responsible for eight WHO Collaborating Centers for standardization and evaluation of vaccines and other biologicals, Dr Knezevic created numerous scientific projects that involve collaborative efforts on the issues of importance for global public health. Working with more than 50 institutions in WHO member states including the national regulatory authorities, standard setting bodies, universities, manufacturers associations, and other expert groups, she developed skills for translating the science into practice, systematic review of evidence and consensus based decisions.

Dr Knezevic is also the author of more than 50 publications that made broad audience aware of WHO’s initiative in the development, establishment and implementation of standards for vaccines and biotherapeutic products.

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