Session 4: Looking beyond registrational RCT data sets
Session Chair: Flor Muñoz, Baylor College of Medicine, U.S.A.

Contextualising prematurity
Jezid Miranda
Universidad de Cartagena, Colombia

Prematurity Across the Lifecourse: Consequences, Context, and Inequity
Hannah Davies
London School of Hygiene & Tropical Medicine, UK

Lessons Learned from Maternal Immunization
Janet Englund
Seattle Children’s Hospital, U.S.A.

Is a different methodology needed for RCT’s and non RCT data sets?
Stephen Evans
London School of Hygiene & Tropical Medicine, UK

Assessing the Safety of Maternal Immunization in Observational and Real World
Data: Lessons learned from a global study
Benjamin Atkins
Global Vaccine Data Network, Australia

How to tackle causality assessment of adverse events following immunization (AEFI) and maternal immunization (AEFMI)
Kathryn Edwards
Vanderbilt University, U.S.A.

How to tackle causality assessment of adverse events following immunization (AEFI) and maternal immunization (AEFMI)

Madhava Ram Balakrishnan
WHO, Switzerland

Panel Discussion: methods for post approval assessment of safety of maternal
vaccination – What was learned?
Nick Andrews
UKHSA, UK
Marco Cavaleri
EMA, UK
Stephen Evans
London School of Hygiene & Tropical Medicine, UK
Deshayne Fell
Pfizer, U.S.A.
Kirsty Le Doare
City St George’s,
University of London, UK
Shabir Madhi
University of Witwatersrand, South Africa
Annette Regan
Kaiser Permanente, U.S.A.
Katerina Rok Song
IVI, South Korea

Session 5: Break Out Session - What can be done differently with observational & RWE data sets

Breakout discussion & Feedback: Brainstorming on how future data sets best are generated?
Annette Regan
Kaiser Permanente, U.S.A.

Strengthening quality assurance in clinical research in resource constrained settings: The ethical imperative to develop, implement, and evaluate ancillary care policies
Gwen Lemey
University of Antwerp, Belgium

Session 6: Wrapping up
Session Chair: Kathryn Edwards, Vanderbilt University, U.S.A.

Wrap-up: ways forward from a statistical/methodological perspective
Annette Regan
Kaiser Permanente, U.S.A.
Benjamin Atkins
Global Vaccine Data Network, Australia

Wrap-up: ways forward from a clinical/medical perspective
Kirsty Le Doare
City St George’s, University of London, UK
Flor Muñoz
Baylor College of Medicine, U.S.A.

Ways forward from a regulatory and NITAG perspective
Marco Cavaleri
EMA, UK

Actions to progress
Steve Black
Global Vaccine Data Network, U.S.A.