Tuesday, 3 May 2022

Regulatory Affairs and Pharmacovigilance

 2022 is set to be thrilling for regulatory and pharmacovigilance processes, with a focus on enhancing processes with technological innovations like AI, ML, and RPA. There will be an increased need to step up technologies with a risk of becoming obsolete otherwise. Service providers who are agile and swift in moving towards such advancements will forge better partnerships and drive growth for the next few years. The regulatory affairs outsourcing market from 2021-2026 is expected to grow by 4.63 Billion USD, reflecting exciting times for the BPO market. The conduct of clinical trials in Europe will also see a significant change with the Clinical Trials Regulation (Regulation (EU) No 536/2014) expected to come into effect from 31st January 2022. According to this regulation, a Clinical Trials Information System (CTIS) will now ensure supervision and assessment of clinical trials in Europe.

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