The Evolving Landscape of Drug Safety: Research, Reporting, and Real-World Outcomes

Moderator(s)

• 

  Amir Sarayani, PhamrD, MPH, PhD (he/him/his)

  Associate Director
  Janssen Research & Development, Johnson & Johnson, United States
• 

  Peter Mol, PhD PharmD (he/him/his)

  Professor of drug regulatory science
  Dutch Medicines Evaluation Board, Netherlands

Presentations:

• 8:00 AM – 8:15 AM CEST

  Development of the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies-Standards for Reporting of Implementation Studies Extension (RIMES-SE)
  

  Presenting Author: Meredith Y. Smith, PhD, MPA, FISPE – Evidera. Inc., PPD, a part of Thermo Fisher Scientific

  Co-Author: Elaine H. Morrato, DrPH FISPE – Loyola University of Chicago

  Co-Author: Nallely Mora – Parkinson School of Health Sciences and Public Health, Loyola U Chicago

  Co-Author: Viviana Nguyen – Evidera, Inc/PPD a part of Thermo Fisher Scientific

  Co-Author: Hilary Pinnock – Usher Institute, Edinburgh, Scotland

  Co-Author: Almut G. Winterstein, PharmD, PhD, FISPE (she/her/hers) – University of Florida, Pharmaceutical Outcomes & Policy and Center for Drug Evaluation and Safety
• 8:15 AM – 8:30 AM CEST

  Public's perspective on COVID-19 adenovirus vector vaccines after thrombosis with thrombocytopenia syndrome (TTS) reports and associated regulatory actions: A cross-sectional study in six EU member states
  

  Presenting Author: Shahab Abtahi, MD, PhD – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

  Co-Author: Caroline Buhl – University of Copenhagen

  Co-Author: Ramune Jacobsen, MSc MPH PhD – University of Copenhagen

  Co-Author: Anna Birna Almarsdóttir – University of Copenhagen

  Co-Author: Ella Van Vliet – National Institute for Public Health and the Environment (RIVM)

  Co-Author: Armin Andersen – University of Copenhagen

  Co-Author: Elena Deligianni – Democritus University of Thrace

  Co-Author: Foteini Dermiki-Gkana, MSc student (she/her/hers) – Democritus University of Thrace

  Co-Author: Christos Kontogiorgis, PhD (he/him/his) – Laboratory of Hygiene and Environmental Protection, School of Medicine, Democritus University of Thrace, Aexandroupolis, Greece

  Co-Author: Chara Oikonomou – Democritus University of Thrace

  Co-Author: Mirdza Kursite – Riga Stradins University

  Co-Author: Elita Poplavska – Riga Stradins University

  Co-Author: Ingrid Hegger – National Institute for Public Health and the Environment (RIVM)

  Co-Author: Marloes Van Der Goot – National Institute for Public Health and the Environment (RIVM)

  Co-Author: Paula Barão Sousa Ferreira, PharmD MSc PhD – University of Lisbon

  Co-Author: Inês Ribeiro-Vaz – University of Porto

  Co-Author: Ana Marta Silva – University of Porto

  Co-Author: Mitja Kos – University of Ljubljana

  Co-Author: Nanča Čebron Lipovec – University of Ljubljana

  Co-Author: Teresa Leonardo Alves – National Institute for Public Health and the Environment (RIVM)
• 8:30 AM – 8:45 AM CEST

  Changes in Neutropenia Outcomes after the 2019 Clozapine Risk Evaluation and Mitigation Strategy Update
  

  Presenting Author: Ting-Ying Huang, PhD – Komodo Health

  Co-Author: Jana Chang, MPH – Komodo Health

  Co-Author: Kenneth Taylor, PhD, DPT – Komodo Health

  Co-Author: Yuqin Wei, MS – Komodo Health
• 8:45 AM – 9:00 AM CEST

  Impact of the US Food and Drug Administration Warning for Increased Risk of Aortic Aneurysms or Dissections on Fluoroquinolone Prescribing Trends
  

  Presenting Author: John G. Rizk, BSPharm, MSc – University of Maryland, Baltimore

  Co-Author: Julia F. Slejko, PhD – University of Maryland School of Pharmacy

  Co-Author: Emily Heil, PharmD, MS – University of Maryland, Baltimore

  Co-Author: Dominique Seo – University of Maryland, Baltimore

  Co-Author: Danya M. Qato, PhD, PharmD, MPH – University of Maryland, Baltimore
• 9:00 AM – 9:15 AM CEST

  Media Coverage of COVID-19 Vaccine Risks in Australia During 2021: Risk Communication During a Rapidly Evolving Situation
  

  Presenting Author: Ashleigh Hooimeyer – The University of Sydney

  Co-Author: Eliza McEwin – The University of Sydney

  Co-Author: Annim Mohammad – The University of Sydney

  Co-Author: Zhicheng Wang, PhD – The University of Sydney

  Co-Author: Kellia Chiu, PhD – University of Toronto

  Co-Author: Sally McDonald – The University of Sydney

  Co-Author: Barbara Mintzes, PhD (she/her/hers) – The University of Sydney
• 9:15 AM – 9:30 AM CEST

  Comparative effectiveness and safety of different hydroxychloroquine doses for patients with systemic lupus erythematosus: nationwide analysis using target trial emulation framework
  

  Presenting Author: Brian Meng-Hsun Li, MClinPharm – Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Taiwan

  Co-Author: Meng-Yu Weng, MD, PhD – Division of Allergy, Immunology and Rheumatology, National Cheng-Kung University Medical Center

  Co-Author: Edward Chia-Cheng Lai, PhD (he/him/his) – Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Taiwan