Regulatory authorities’ emphasis on the centralisation and standardisation of all product-related data has a profound effect on life sciences and pharmaceutical companies, compelling them to adopt more-collaborative processes and reassess the workflow between regulatory and pharmacovigilance. Those activities span clinical and post-marketing, with each step integral to ensuring the integrity of the information the authorities require in the assessment of a product. Markus Dehnhardt, PhD, Senior Toxicology and Pharmacovigilance Consultant at ProductLife Group, explores the intersections between regulatory and pharmacovigilance and how the two should be dealt with in order to mitigate inconsistencies and missteps in the management of critical data.
https://www.jforcs.com/7/wp-content/uploads/2016/01/Coming-together….pdf