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Strategies for success in conducting post-authorization vaccine studies and surveillance activities

1 hour, 2 minutes

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July 24, 2015

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Please join us for a complimentary webinar on current approaches to conducting real-world post-authorization studies and surveillance activity for vaccines, including those conducted under the interim EMA guidance for enhanced safety surveillance for seasonal influenza vaccines in the EU of April 2014. Assessment of the safety and effectiveness of seasonal and pandemic influenza vaccines as well as other newly introduced vaccines presents different considerations and challenges than for other medical products. Widespread use in healthy populations, including children, pregnant women, and the elderly establishes high societal requirements for demonstrated benefit (effectiveness) and product safety. Challenges for surveillance include need to monitor numerous seasonal vaccine products that may differ in reactogenicity or other adverse effects between products or batches, and the desire to obtain rapid assessment of product safety and assessment that may be available for evaluation within the current influenza season, i.e. near real-time. Accordingly the EMA has instituted new requirements for annual enhanced surveillance of seasonal influenza vaccine safety and effectiveness.

This webinar will address, among other topics:

  • Enhanced surveillance of seasonal influenza vaccines under interim EMA guidance of April 2014
  • Challenges of implementing near real-time safety reporting
  • Direct-to-patient follow-up approaches in vaccine PAS studies

Speakers

Priscilla Velentgas, MS, PhD
Senior Director of Epidemiology
Quintiles

Ombretta Palucci
Senior Director Real World Evidence Strategy, EMEA
Quintiles