The challenge of maximising drug safety and maintaining public confidence has become increasingly complex. Pharmaceutical and biotechnology companies must not only monitor, but also proactively assess and manage drug risk throughout a product’s lifecycle, from development to post-market.
Should the Food and Drug Administration (FDA), European Medicines Agency (EMEA) or other government regulatory agencies have reason to question the safety of a drug, any one of these agencies could halt a clinical study, delay drug approval or recall an approved drug from the market. The consequences of ineffective adverse drug event reporting and pharmacovigilance processes, procedures and plans could include brand damage, class action suits and exorbitant fees, among others.
PwC works closely with manufacturers to assess the effectiveness of existing pharmacovigilance and drug safety programmes and to identify practical solutions for enhancing the internal and contracted processes that impact the entire life cycle of a company's adverse event reporting and pharmacovigilance system. We identify and assist with implementation of systems and tools that increase the value and accuracy of data collection and reporting.