Barry Mulchrone

By Ana Pedro Jesuíno, Dominique Coleman, and Barry Mulchrone The pharmacovigilance (PV) field is changing rapidly amidst evolving regulations, growing adverse event reporting, and an increasingly global pharmaceutical landscape. To best adapt to these shifts, Marketing Authorization Holders (MAHs) are determining how AI can be integrated into workflows to improve efficiency and reduce the burden on human experts.

Monitoring the safe and effective use of medicines has now been an essential part of public health policy for several decades. New advances in technology (e.g., ICH E2B for the electronic exchange of case reports) over the past 20 years coupled with progressive legislation have been a catalyst for an explosion in safety data over this period.

By Barry Mulchrone & Annette Williams With COVID-19 again on the rise, the global pandemic continues to impact daily lives and company operations. The pharma sector has seen significant disruption, including how it ensures effective safety monitoring of COVID-19 vaccines and medicines following expedited development and accelerated approvals.