Pharma IQ Members

Mollie Shields-Uehling

Global Regulatory Leadership from European Medicines Agency

When it comes to greater efficiencies and cost savings in filing electronic submissions, the European Medicines Agency is well ahead of any other regulatory agency on the planet. They're on record stating... The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and eliminate the need to archive paper documents. It may also bring about cost savings for companies, by removing the need to print documentation and reducing courier charges.

by: Mollie Shields-Uehling
Published: September 29, 2014
Tags: Mollie Shields-Uehling, global regulatory leadership, European Medicines Agency, electronic documents, digitally signed electronic documents, Digital Signatures


Mollie Shields-Uehling

The Power of One

There is elegance in the apparently simple solution to the complex problem. I say "apparently" because so many solutions are complicated in their detail and the people responsible for them struggle to tell their stories in simple terms -- in ways that decision-makers and end-users can understand and appreciate. That's why we at SAFE-BioPharma have been on a quest to make the standard easier... Read more

by: Mollie Shields-Uehling
Published: August 19, 2014
Tags: digital workflows, Systems, Mollie Shields-Uehling, SAFE-BioPharma, SAFE-BioPharma systems


Mollie Shields-Uehling

What Every CRO Should Know When Becoming Fully Electronic

As the global CRO community studies how to most efficiently move to fully electronic business processes, there are numerous issues that must be addressed to assure secure global collaboration. These include identity trust, data integrity, regulatory compliance, and time and cost savings.

by: Mollie Shields-Uehling
Published: December 6, 2011
Tags: Mollie Shields-Uehling, SAFE-BioPharma standard, SAFE-BioPharma, electronic laboratory notebooks, ELNs, ELN, electronic business processes, informatics, SAFE-BioPharma digital identity, CRO


Mollie Shields-Uehling

Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution

When evaluating any digital identity or digital signature solution, ask these questions. The answers will help determine if you’re about to get full value for this important decision

by: Mollie Shields-Uehling
Published: October 5, 2011
Tags: Mollie Shields-Uehling, digital identity, digital signature, digital signing solutions, SAFE-BioPharma, digital identity standard, digital signature standard, DEA compliant, SAFE-BioPharma standard


Mollie Shields-Uehling

Nobody Knows You’re a Dog

A few years ago, The New Yorker magazine published a cartoon of two dogs sitting in front of a computer monitor. One was explaining to the other: “On the Internet, nobody knows you’re a dog.” Given the regulated nature of the global biopharmaceutical industry, the explosion in global collaboration, and our reliance on the Internet, it is absolutely essential that we know and trust the identity of people on the other side of the screen.

by: Mollie Shields-Uehling
Published: July 13, 2011
Tags: Mollie Shields-Uehling, SAFE-BioPharma, SAFE-BioPharma standard, SAFE-BioPharma Association, cloud computing, digital identities, digital security, digital identity, digital signature standard, digital pharma