Animated Video Explains Cyber-Security

October 26, 2016

By Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association


Mollie Shields-Uehling

Mollie Shields-Uehling, President & CEO, SAFE-BioPharma Association

How do you explain complicated cyber-security issues in a way that is quick and not confusing?

That was our mission in creating a brief animated video about authentication and digital signatures. Even though it’s specifically about cyber-security in the life sciences, this little gem will be useful explaining issues and solutions to people in any sector.

Click on the image below to view. And, if you agree with my assessment, click “Like” and share with others.

 

 

 

 


Global Regulatory Leadership from European Medicines Agency

September 30, 2014

By Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association
as posted on Pharma iQ 09/29/2014

Mollie Shields-Uehling

Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association

I’m an American who has lived in Paris, London, and numerous other countries around the globe. It’s atypical for my generation. The experience has helped me appreciate the best ideas and policies, wherever they originate.

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.

EMA uses digital signatures “systematically” in its outgoing documents that require a legally binding signature. Currently these are documents related to scientific advice for human medicines, to orphan medicines and to paediatric medicine procedures. The Agency also provides certified PDF electronic application forms to allow companies to sign these forms digitally using a PDF reader application.

It’s all part of EMA’s “strategy to increase electronic-document-only exchanges between the Agency and the pharmaceutical industry.”

I put digital signatures in bold because it’s an important detail in EMA’s policy that people in industry need to understand. By European Union definition, an electronic signature is “digital” when it is uniquely linked to the signatory; capable of identifying the signatory; created using data that the signatory can use under his/her sole control with a high level of confidence, and linked to the signed document in such a way that subsequent change in the document is detectable.

EMA also requires that the digital signature comes from a Certification Authority (CA) listed on an EU member state trust list.

These requirements provide high assurance of the individual’s identity, allowing the credential to be used for a multitude of purposes including applying legally binding, non-repudiable digital signatures to electronic documents.

Importantly, all EU/EMA requirements for a digital signature are consistent with those used in the SAFE-BioPharma® standard, and credentials obtained through Verizon Business UIS, a credential service provider under the SAFE-BioPharma Trust Framework, can be used to sign EMA submissions.

Why is this important? Drug development is now a global collaborative activity relying heavily on working with people and entities via Internet. This requires technologies that deliver greater trust in cyber-transactions. The SAFE-BioPharma standard was created toward that end.

Several widely available signing engines (e.g. DocuSign and Taigle’s MySignatureBook) have become compliant with the SAFE-BioPharma standard.

And not long ago, Adobe added SAFE-BioPharma to its Adobe Approved Trust List. This means that anyone with a SAFE-BioPharma® identity credential is able to sign a PDF document in Adobe® Acrobat®, or Reader® that will be automatically trusted globally by any other user of Adobe Acrobat, or Reader. The Adobe Approved Trust List (AATL) comprises almost 50 member organizations from around the world, including the US government, Japanese government, and members of the European Union Trust List.

Digital signatures based on the SAFE-BioPharma standard are used to sign electronic laboratory notebooks, regulatory submissions, clinical trial documents, and routine day-to-day business documents. This is what the signature looks like:


 

Digital identity credentials based on the SAFE-BioPharma standard are used to manage access across firewalls and to portals and to access protected information, such as electronic health records.

By embracing, using, and requiring digital signatures, EMA “…expects to increase the efficiency of procedures and eliminate the need to archive paper documents.” The new policy will advance cost savings for companies by removing the need to print documentation and reducing courier charges.

In the big picture of drug development and submissions, these may seem like minor savings. If you think that, consider the hidden costs of printing, scanning, copying, archiving/locating, shipping paper documents and/or the CDs and other media on which they’re stored.

EMA is improving it’s own operations and coaxing industry to do the same. I hope other regulatory bodies take note.


The Power of One

September 30, 2014

By Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association
as posted on Pharma iQ 08/19/2014

Mollie Shields-Uehling

Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association

 

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 to understand for those concerned with improving digital workflows, systems, and business processes, in general.

The standard addresses many technical and regulatory details. We’re always available to lift the hood and take those who are interested or need to know on a thorough and detailed tour of how the SAFE-BioPharma standard for managing digital identities and applying digital signatures operates.

But how to get the message to a point where it can be understood by the many?

We recently decided to focus our message around benefits and the Number 1.

• First, readers should know that SAFE-BioPharma is the one industry collaboration helping to improve productivity, reduce costs, and lower time to market by protecting information assets, moving business processes online, and becoming paperless.

• SAFE-BioPharma also is the only identity standard created by the biopharmaceutical industry and its regulators to provide high-assurance identity trust for cyber-transactions across the biopharmaceutical and healthcare sectors. Identity credentials compliant with the standard are regulatory complaint and will be trusted by all US Government agencies, other companies in the SAFE-BioPharma systems and with companies in other industries with similar systems.

• Identity credentials based on the SAFE-BioPharma standard are like a single, trusted, interoperable Internet passport used to authenticate and manage identity and to apply secure digital signatures in electronic transactions. Signatures are linked to the individual’s identity. They are legally enforceable and non-repudiable. They ensure an eDocument’s integrity for as long as the document exists.

• They also are part of one global ecosystem, a rapidly expanding network of users, credential issuers, applications, services and solutions governed by the SAFE-BioPharma Standard. This means that all compliant products can be confidently used by industry with the knowledge they are acceptable to industry and regulators in the United States, Europe and around the globe.

For a more thorough look at how we’re explaining what we do and why we do it, please visit our new homepage at www.safe-biopharma.org.

I hope you see the value of the Standard’s benefits and agree with our use of the power of One.


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