Combination Products: Post-marketing safety reporting

Understanding the expectations and challenges The pharmaceutical and medical device industries are seeing a substantial increase in combination products, and the related regulatory environment has been very dynamic. Recently, I was privileged to moderate a PharmaVOICE webinar on the latest U.S. FDA post-marketing safety reporting (PMSR) ruling and guidance. Expert …

patient safety

The future of pharmacovigilance

Leveraging technology to transform patient safety The challenges of maintaining complex pharmacovigilance (PV) systems in a global, ever-evolving regulatory environment are increasing daily. With growing public awareness, social media connectivity and media scrutiny, pharmaceutical companies need to manage PV activities diligently. Cost-reduction pressures on one hand and the challenges of …


Overcoming the unique drug safety and regulatory challenges faced by small and medium biopharma

Leveraging an Integrated, Holistic Solution Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often …

drug safety

Pharmacovigilance: a focus on EU drug safety excellence

A compelling model for small and medium-sized organizations in the current EU regulatory landscape Regulatory dynamics in the EU continue to evolve, with higher expectations for pharmacovigilance (PV) as each nation has rigorous and complex patient safety regulations. The shifting landscape represents a unique challenge for small- and medium-sized enterprises …

drug safety covid

Monitoring drug safety during COVID-19 – five key questions and answers

Identifying, recording, and reporting adverse events is vital for ensuring drug safety, both in the pre-marketing and post-marketing settings. Today, the COVID-19 pandemic makes these activities both more critical and more challenging. Let’s consider five key safety questions and answers:

Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly. In our previous blog post, we focused on the value of early drug abuse potential testing. …