Regulatory Science Forum

Helga Gardarsdottir, PhD

• Associate Professor
• Utrecht University, Netherlands

Signals from a national spontaneous reporting system; What regulatory action do they lead to?

Florence van Hunsel, PharmD, PhD

• Head Signal Detection
• Netherlands Pharmacovigilance Centre Lareb, Netherlands

Do labels of drugs with the same mechanism of action describe the same adverse drug reactions? A case study on TNF-a inhibitors

Lotte Minnema, MPharm

• PhD candidate/pharmacovigilance assessor
• Utrecht University/Medicines Evaluation Board, Netherlands

The Quality and Robustness of Evidence used to support Regulatory Pharmacovigilance Decisions

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

• Director
• Drug Safety Research Unit, United Kingdom