Podcasts

Jul 19, 2016
Pharmaceutical Executive
Pharm Exec talks to Mollie Shields-Uehling, a leading advocate for high-assurance identity trust for cyber-transactions in the biopharmaceutical industry. Listen to the podcast for a timely, 15-minute discussion covering topics like cyber/technical security; eHealth regulatory compliance; work flow automation, the benefits of eSignature programs, and collaboration around key aspects of drug development like the administration of clinical trials and research partnering.
May 05, 2016
Pharmaceutical Executive
By Pharmaceutical Executive Editors
This is the third of three episodes in our podcast series on a topic that is critical to the pharmaceutical business: how to reduce the safety and financial risks associated with product diversion and counterfeiting. In Episode One, we defined the problems of product security, and explained the risks. In Episodes Two and Three we discuss defenses that pharma companies can consider, as well as both the challenges and opportunities presented by implementing these defenses.
Apr 18, 2016
Pharmaceutical Executive
This is the second of three episodes in our podcast series on a topic that is critical to the pharmaceutical business: how to reduce the safety and financial risks associated with product diversion and counterfeiting. In Episode One, we defined the problems of product security, and explained the risks. In Episode Two and Episode Three (to be released on May 5) we will discuss defenses that pharma companies can consider, as well as both the challenges and opportunities presented by implementing these defenses.
Apr 07, 2016
Pharmaceutical Executive
This is the first of three episodes in our podcast series on a topic that is critical to the pharmaceutical business: how to reduce the safety and financial risks associated with product diversion and counterfeiting. In the first part of this series, we define the problems of product security, and explain the risks. In Episodes Two (to be released on April 21) and Episode Three (to be released on May 5) we will discuss defenses that pharma companies can consider, as well as both the challenges and opportunities presented by implementing these defenses.
Dec 18, 2015
Pharmaceutical Executive
By Pharmaceutical Executive Editors
A 505(b)(2) application is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This approach can lead to approval in a fraction of the time and cost required by traditional paths. For 505(b)(2) in particular, early assessment and preparation are key to identifying needs and avoiding redundancies to set the path to a profitable product. Pre-investigational new drug (PIND) meetings serve as a prudent step in this process and can guide development strategies that reduce time to market and can all but eliminate the possibility of clinical holds.
Jun 04, 2015
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Jun 04, 2015
By Pharmaceutical Executive Editors
Jun 04, 2015
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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