Spring Intro 2023

22/03/2023

The Future ahead in Regulatory Affairs: what to expect next

TOPRA Spring introductory course, 31 st March 2023 Laura Liebers - Director Vertex International Regulatory Policy and Intelligence

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Abbreviations

AI – Artificial Intelligence ANVISA - Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency) ATMP – Advanced Therapy Medicinal Product ECDC – European Centre for Disease Prevention and Control

MHRA - Medicines and Healthcare products Regulatory Agency MS – Member States OMP – Orphan Medicinal Products R&D – Research and Development RWE – Real World Evidence ROW – Rest of World TGA – Therapeutic Goods Administration (Australia) RWD – Real World Data

EMA – European Medicines Agency EHDS – European Health Data Space FDA – Food and Drug Administration GMO – Genetically Modified Organism HMA – Heads of Medicines Agencies HTA – Health Technology Assessment

WTO – World Trade Organisation WHO – World Health Organisation

IVD – In-Vitro Diagnostics IP - Intellectual Property

The Organisation for Professionals in Regulatory Affairs

2

2

1