Regulatory Changes, Implications, Drug Safety

Global Regulatory Changes and Resulting Implications On Drug Safety

At the 2014 World Drug Safety Congress Americas, Bruce Donzanti, Genentech inc, gave a presentation on “Global Regulatory Changes and Resulting Implications On Drug Safety”. Download and learn: Recent major global Drug Safety Regulatory Changes Differences and Bridging the Gaps Health Agency Perspective on Solicited Programs CIOMS V: Concept of Incidental Data Solicited Programs: Volume and Interactions A Risk-Based Approach …

Strategic, Standards, Implications, Demands, Clinical, Trial, Sourcing, Solution, Disruptive Innovation

Strategic Standards Implementations: How to Meet the Demands of a Plethora of Clinical Trial Sourcing Solutions

  At the 2014 Clinical Innovation Congress, Jason Housley, Shire, gave a presentation on “Strategic Standards Implementations: How to Meet the Demands of a Plethora of Clinical Trial Sourcing Solutions”. Download and learn: Purely competitive outsourced models Preferred providers Partnerships / alliances In-house models Standards solutions Other considerations The bigger picture – Industry standardisation and the opportunity to innovate and disrupt …

Download: The growth of HTA- Implications for the industry

  According to a recent article on PMlive, "while harmonised regulatory approval processes have created synergies that decrease the workload of European payers and institutional stakeholders, the same may not be said for the case of health technology assessment (HTA)." With a diverse range of country specific HTA processes for new drug entrants, the growth of HTA across European healthcare …