nav-left cat-right

Pharmacovigilance, Drug Safety & Risk Management 11-12 May 2015, London UK

The expansive field of drug surveillance has increased the complexity of problems across the board in relation to PV auditing and meeting the standard requirements. Companies continue to face challenges of understanding the key considerations when presenting to auditors and knowing how to adequately adapt to different regulatory environments and changes. Moreover, clarifying individual roles within the PV system is paramount to setting out clear goals and meeting regulatory expectations.

For any company looking to globalize their business, the governance of reporting adverse drug events by different centralized authorities, along with heterogeneous terminologies and competing priorities has created greater uncertainties and barriers to enter new markets. The daunting task of complying with multiple regulations also heightens the danger of unrealistic expectations as well as mounting costs and time that will have long-term implications on investment.
Therefore, the importance of a centralised database has never been more vital to employ knowledge sharing and product awareness.

Join SMi in tackling these issues: 2015 will bring a focus on drug surveillance and signal detection; analysis and prevention of adverse drug reactions with MedDRA, industry experiences and global regulatory coverage of developments. Furthermore, we will cover Eudravigilance, and the growing trend of outsourcing Pharmacovigilance, as well as navigate through the challenges of compiling PSUR’s and frequent safety reports and how to adapt better to regulatory updates by preparing key areas that will be most impacted.