The Pharmaceutical Marketing Group

Author: natalie-yeadon

Pharmacovigilance and Pharmacogenomics in the Digital Age: the EU General Data Protection Regulation (GDPR)

Pharmacogenomics: A Brief Introduction Pharmacogenomics is the study of the role of the genome in drug responses. That is, it identifies genetic loci associated with known drug responses on a population-level. Some of the current pharmacogenomic approaches used include multigene analysis and whole-genome single nucleotide polymorphism profiles. Subsequently, the genetic variants affecting an indiv...

Real-world Data, Drug Access, and Digital

What are “Real-world Data”? “Real-world data” (RWD) refer to data collected in a real-life setting within a heterogeneous population. That is, not in a randomized controlled trial (RCT). In turn, analysis of these multi-source data provides real-world evidence (RWE) supporting the value of a product. This is especially important to confirm its long-term safety and efficacy outside of RCTs. Why We ...

Special Access Programs: How to Successfully Implement in Pharma

Before a new product launches, many manufacturers need to decide if they are going to initiate a Special Access Program (SAP; also referred to as an Early Access Program [EAP] in the US or a Compassionate Use Program [CUP] or Named Patient Program [NPP] in the EU) for their brand while they are going through regulatory approval. The demand for SAPs has risen over the years due to the increased usa...