The pharmaceutical industry is one of the most highly regulated and scrutinised industries in the world, and pharmacovigilance (PV) is subject to some of the strictest legislation put in place to ensure the safety of the general public.
Even though regulatory authorities such as the FDA and the EMA enforce these regulations primarily for public safety, non-compliance can have a serious impact on the manufacturers of pharma products. A failure in drug safety can not only cost a company millions, it can destroy their reputation and lead to criminal legal action being taken against them.
Because of this, it is imperative that PV departments understand precisely what their obligations are with regards to regulatory compliance. In the whitepaper we discuss:
- The current landscape of EU and US regulations concerning PV
- Areas of critical concern
- Guidance to those seeking to achieve excellence in their PV operations.