Ilyssa Levins | Center for Communication Compliance (CCC) & Gil Bashe | Makovsky Health
When you work in healthcare, you are trained to expect a crisis whether it is a failed clinical trial, a life-threatening side effect for a marketed drug, or a decision by a government agency to require additional data before granting approval. Professionals must understand how to prepare for these inevitable regulatory crises and the best ways to manage them.
Continue reading "Preparing for Crisis Communications in a Hyper-Connected World"
In The Headlines
Neel Patel | Campbell Alliance
Through 2013 and the first half of 2014, the biopharma industry experienced a breakout year. The NASDAQ Biotechnology Index ended 2013 at a record high, with US investors embracing biopharma IPOs and follow-on financings at record levels. The total amount of capital allocated within M&A/licensing increased, and the bull market in biopharma continued its surge in the first half of 2014.
Continue reading "Change is in the Wind for Biopharma Deal Making"
Topic of Discussion
Creating Sustainable Compliance Frameworks: Embedding Regulatory Compliance within Optimized Business Processes
Geoff Garabedian | Quintiles Consulting
This is the first of a series of articles that will examine several aspects of how biopharma companies can create more sustainable compliance frameworks. In order to create a culture where compliance is not an afterthought or added cost at the end of a process, companies need to think holistically about the people, process and technology implications of an environment where quality and compliance are truly embedded in the day-to-day operations. This article series will not only highlight key concepts but also provide project examples and lessons learned that can be applied to various situations.
Continue reading "Creating Sustainable Compliance Frameworks: Embedding Regulatory Compliance within Optimized Business Processes"