Global clinical trial regulatory strategy

The increasing globalization of drug development has expanded the use of multiregional clinical trials (MRCTs) to support global development and generate clinical evidence across diverse patient populations. However, differences in regulatory frameworks, health authority expectations, and country- and region-specific requirements introduce complexity into MRCT planning and conduct. An early global regulatory strategy is therefore critical to identify requirements and anticipate key challenges.

Moderator:
-Dr Mathew Cherian, Consultant, USA.

Co-moderator:
-Dr Richard Ohene-Darkoh, Pharmaceutical country manager, Liberia.

Panellist:
-Dr Ana Cruz, Regulatory affairs manager, Clinical research, Thermo Fisher (PPD Portugal), Lisboa, Portugal.

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