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Articles by Lifecycle Safety
Why more pharma companies are outsourcing their EU QPPV function
Blog Why more pharma companies are outsourcing their EU QPPV function The critical role of the EU Qualified Person for Pharmacovigilance (QPPV) In today’s complex regulatory environment, pharmaceutical and biotech companies are under growing pressure to stay compliant while remaining agile and cost-effective. One area where this balance is especially critical is pharmacovigilance, and more specifically, the role of the EU Qualified Person for Pharmacovigilance (QPPV).
Advancing Drug Safety: IQVIA’s Co-Authored Chapter on Causality Assessment in Pharmacovigilance
As a leader in enhancing pharmacovigilance efficiencies through AI/ML-enhanced safety services, IQVIA is always at the forefront of leveraging cutting-edge methodologies for clinical research. In line with this commitment, we are pleased to share our latest contribution to the field: a chapter titled “Causality Assessment in Pharmacovigilance,” co-authored by IQVIA’s Anand Harugeri M.
Rethinking pharmacovigilance efficiencies amidst APAC's diverse regulatory landscape and rising drug development costs
Globally, the pursuit for treatments with better patient outcomes and more effective care is a never-ending quest. As diseases and viruses evolve, the research and development of new medicines and treatments has also grown rapidly. Around the world, the global funding of Emerging Biopharmaceutical companies (EBPs) has grown rapidly, from $18 billion in 2010 to over $130 billion in 2020, with a compound annual growth rate of over 20%.
Shifting to Innovative Data Collection
In drug development, there is a critical focus on protocol design, because it is a key component to running a successful clinical trial. And, in traditional trial design, developing a data management strategy often comes after the protocol is finalized. This can leave study teams juggling between operationalizing the protocol and mapping out optimal data collection and flow in parallel.
Reimagining The Future of Pharmacovigilance (PV): Regulations, Tech, Public Perceptions
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.
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