This workshop is an opportunity for vaccine researchers and health professionals in Brazil and the region to gain a deeper understanding on vaccine pharmacoepidemiology methods. The goal is to improve researcher and health professionals’ awareness on the importance of safety monitoring not only in the post-marketing but also during the clinical evaluation (Phase I to III) of new vaccines, awareness of the importance of performing pharmacoepidemiology studies; vaccine effectiveness evaluation and adverse events reporting.

During this event, the participants will improve their knowledge on the important and extensive period of investigation which preceeds vaccines availability to the general population but also goes beyond beyong clinical studies. Although clinical trials (and their phases I, II and III) are fundamental for obtaining product registration, they have limitations regarding their ability to assess safety, effectiveness and implementation issues. Considering these limitations, international organizations (WHO, FDA and EMA) have promoted the need for pharmacoepidemiology studies based on “real world evidence”. Despite the importance of the topic, there are few research groups in Brazil that have the expertise in new and robust methods used in pharmacoepidemiology.

The programme is organised in 2 sessions: the morning session will cover topics on pharmacoviglance and the afternoon session will be focused on pharmacoepidemiology topics, followed by two discussion panels. There will be opportunity for interaction during both sessions, so participants can contribute to the discussions. The sessions will cover topics such as passive and active safety post-marketing studies, signal detection methods, studies using medico-administrative data, effectiveness studies, interdisciplinary methods to evaluate vaccine hesitancy and pharmacoeconomic studies.

Pharmacovigilance

by Katharina Hartmann

Passive x Active Pharmacovigilance

by Katharina Hartmann

Vaccine Effectiveness

by José Cássio de Moraes

Active Pharmacovigilance Studies

by Fabio Lievano

Real World Studies

by Morgan Marks

Pharmacoeconomic Studies

by Ana Marli Christovam Sartori

Discussion Panel: Challenges in implementing coronavirus vaccines

Discussion Panel: Hesitancy and vaccination coverage