Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today.
Because of the changing industrial and regulatory environment, sponsors are re-evaluating the advantages and disadvantages of outsourcing their pharmacovigilance obligations. With stricter regulatory requirements, the hiring of experienced safety personnel has become highly competitive. In addition, sponsors have access to unique expertise, intellectual property, multidisciplinary knowledge and an unbiased view. The best relationships between sponsors and contractors are those that are well defined from the outset.
This whitepaper written by Sabine Ritchter, MD, Vice President, Safety and Risk Management, PRA Health Sciences, outlines the best practices to ensures success when outsourcing pharmacovigilance services.
Download to learn:
- Outsourcing Advantages
- Clear path to successful cooperation
- About PRA’s safety and risk management
PRA Health Sciences will be exhibiting at the World Drug Safety USA Congress happening 22-23 April 2015 in Chicago. Find out more >