Download presentation: EMA regulatory activities in the area of vaccines: an update

In November 2012 over 200 delegates participated in the 13th Annual World Vaccine Congress Lyon in France. This event brings together vaccine leaders and policy makers from around the globe. Attendees at this highly successful event were fortunate enough to hear this exciting presentation delivered by Marco Cavaleri, Head of Anti infectives and Vaccines, ‘EMA regulatory activities in the area …

Developing a Scientifically Guided, Risk-Based Virus Safety Concept for a Cell-Derived Vaccine

How should we regulate the development and production of vaccines? Tell us below! Dr Jens-Peter Gregersen, Technology Development, Virus Safety and New Projects, Novartis Vaccines & Diagnostics joined us at the World Vaccine Congress earlier this year in Washington. To open, he began by asking: what is a scientifically guided, risk based concept? Scientifically guided Scientific data where possible and …

Viral contamination and continuous quality and safety of cell line produced vaccines

Regulation protects us: be it from food poisoning from a restaurant or from dangerous vaccines. It is a part of everyday business. Dr Isabelle Sainte-Marie, Head of the Viral Safety Unit, AFSSAPS joined us at the World Vaccine Congress in Washington in 2012 to discuss viral contamination and continuous quality and safety of cell line produced vaccines. There are, of …

Presentation download: Addressing the approval and safety surveillance of licensed vaccines in Taiwan

Dr. Der-Yuan Wang the Chief of Section of Biologics & Advanced Therapeutic Product Analysis, Division of Research and Analysis for Food and Drug Administration (Taiwan FDA) of Taiwan joined us at World Vaccine Congress Asia in Singapore this June to address the issue of approval and safety surveillance of licensed vaccines in Taiwan. Dr Wang covered the following points in …

FDA & EMA viewpoints: regulating adjuvanted #influenza #vaccines

Dr Pieter Neels, Member Committee for Medicinal Products for Human Use at the European Medicines Agency spoke at last year's World Influenza Congress in Vienna on the reasoning behind regulatory standpoints in Europe.   And he did address the elephant in the room before getting started, saying that:   "Regulators cannot do any good: If we are critical: we are …