Expert Insights

Planning for Health Canada’s New Transparency Initiatives for Clinical Data

By Regina Parott, September 12, 2019
In March 2019, Health Canada created a new transparency requirement. Health Canada’s Public Release of Clinical Information (PRCI) states that their “objective is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes following the completion of Health Canada’s regulatory review process, while adhering to Canada’s Privacy Act”.

Pharmaceutical Industry Experts Speak Out: Five Productivity Tips for Working from Home

By Don McLean, MBA, September 5, 2019
In the pharmaceutical industry, the right talent can often live in a variety of locations. When talking to our colleagues who have the privilege to work from home (WFH), we found that they are happy, productive, and active contributors to the workplace on a daily basis. According to an article on Inc.com, employee attrition decreases by 50 percent for those who work remotely and employees work a true full-shift, compared to those working in the office.

Using Real World Data in Drug Development: Five Questions with Vijay Ivaturi, PhD

by Staff Writer, August 22, 2019
The idea and practice of using real world data in the pharmaceutical industry has driven much conversation as of late. As groups like the Health Analytics Collective begin to bring game-changing methodologies to the marketplace, we sat down with Vijay Ivaturi, PhD, assistant professor at the University of Maryland School of Pharmacy and co-founder of the Collective, to get a sense of what the future holds.

Recommended Reading from Eight Pharmaceutical Experts This Summer

by Staff Writer, August 15, 2019
Summer reading isn’t reserved for school-aged children, as adults and professionals alike can gain knowledge and insights from consistently reading material during the hottest months of the year. With Book Lover’s Day last week, we asked eight colleagues from varying departments and levels within the organization to share what they’re reading this summer.

Using Real World Data in Pharmaceuticals: A Conversation with Chris Hurley

by Staff writer, July 18, 2019
The idea and practice of using real world data in the pharmaceutical industry has driven much conversation as of late. As groups like the Health Analytics Collective begin to bring game-changing methodologies to the marketplace, we sat down with Chris Hurley, Associate Director, Data Sciences with MMS – co-founder of the Collective – to get a sense of what the future holds.

Partner Spotlight: A Conversation with Julia Computing

by Staff writer, July 11, 2019
As an integral member of the Health Analytics Collective, Julia Computing is seen as the programming language of the future. We sat down with Andrew Claster, Director of Marketing & Communication at Julia Computing to get a sense of what Julia is and where they are headed.

Developing Treatments for Rare Diseases – Reviewing Recent FDA Draft Guidances

By Amanda Beaster, PhD, et al, June 13, 2019
Every day, new and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are reviewed on a monthly basis internally to identify which deliverables are impacted and to determine which processes or trainings need to be created or updated as a result.

 

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