EMA Now Accepts SAFE-BioPharma Digital Signatures on eSubmissions

Beginning this month, SAFE-BioPharma digital signatures, widely used throughout the global biopharmaceutical industry, will be accepted by the European Medicines Agency (EMA).

“EMA’s acceptance and use of digital signatures sends an important message to biopharmaceutical companies, many of which have digital signing capability as part of their existing use of SAFE-BioPharma digital identity credentials” Buy Topamax (Topiramate) without prescription

Acceptance of SAFE-BioPharma digital signatures is in line with EMA’s strategy for a “future electronic only workflow” between itself and the pharmaceutical industry by eliminating the need and cost associated with printing, sending, and archiving paper documents. Buy Brethaire (Terbutaline) tabs online without prescription Electronic only workflows involving regulatory submissions will require use of EU-qualified digital signatures such as those based on the SAFE-BioPharma standard.
The agency is starting with digital signature-enabled PDF forms for scientific advice, orphan medicines, and pediatric submissions.
In a related announcement underscoring the agency’s strategy to increase electronic-document-only exchanges with industry, EMA said it “…will start to use digital signatures systematically in outgoing documents that currently require a legally binding signature.” Buy Boniva (Ibandronae Sodium) pills online without prescription
“EMA’s acceptance and use of digital signatures sends an important message to biopharmaceutical companies, many of which have digital signing capability as part of their existing use of SAFE-BioPharma digital identity credentials,” said Mollie Shields Uehling, president and CEO, SAFE-BioPharma Association.
The SAFE-BioPharma standard was established by the pharmaceutical industry with the participation of the EMA and FDA to create and maintain an interoperable digital identity and signature standard that allows secure, trusted exchanges and legally-binding digital signatures. Buy Vitamins online SAFE-BioPharma member companies have conducted several pilots with EMA demonstrating that the SAFE-BioPharma standard meets EU electronic signature requirements and that EMA can recognize and validate SAFE-BioPharma compliant signatures.
The European Union definition of digital signatures is consistent with that of SAFE-BioPharma digital signatures. Specifically, each signature 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 WebMD Review
• linked to the signed document in such a way that subsequent change in the document is detectable.

EMA requires that digital signatures on submissions be issued from Certification Authorities (CAs) under the authority of the national agencies on the EU trusted list. TranSped, a SAFE-BioPharma Certification Authority (CA) provider, is included in the EU’s list of trusted CAs, and both TranSped and SAFE-BioPharma CAs are listed under the Romanian Ministry of IT&C list.

New AB SCIEX Software Accelerates Drug Screening Across Broad Range of Compounds for Clinical Research Laboratories

AB SCIEX, a global leader in analytical technologies, today announced the availability of MPX™ TF 1.0 Software to accelerate drug screening with accurate mass-based technology for laboratories performing clinical research. The new software is designed to deliver faster turnaround times, increased sample throughput and lower costs compared to single-stream, mass spectrometry (MS) methods. Buy Priligy (Dapoxetine) without prescription This new software will be showcased to researchers at the American Association for Clinical Chemistry (AACC) conference in Houston, Texas this week.

“We are helping clinical research labs reshape how they conduct drug screening to accurately identify not only known but also unknown compounds.”

With the new MPX TF Software, researchers are now able to increase throughput by as much as twofold. Buy Vepesid (Etoposide) tabs online without prescription This is made possible by enabling the use of two parallel liquid chromatography streams. The ability to stagger chromatographic runs while collecting sample data allows the use of instrument "dead time" to increase the number of samples run in a given time period. This means identifying more compounds in a shorter period of time.
By combining the increased throughput of the MPX software with the capability of the AB SCIEX TripleTOF^® 4600 accurate mass system to produce reliable data for a large number of compounds, researchers will be able to do more in less time compared to single-stream MS methods while significantly reducing rates of false positives and false negatives, thanks to LC separation of potential interferences and the enhanced specificity of high-resolution accurate mass technology.
Among the researchers who are using accurate mass technology today is Dr. Kara Lynch, PhD. from the University of California, San Francisco (UCSF). Buy Vermox (Mebendazole) pills online without prescription She uses a TripleTOF platform to identify unknown compounds, complementing the targeted analysis she does with triple quadrupole instrumentation.
“As the list of drugs and their metabolites are always changing, the value of high resolution, accurate mass technology is identifying unknowns with high specificity,” said Dr. Lynch at UCSF. “Accurate mass-based analysis with a TripleTOF system helps identify compounds that could be missed in a targeted approach if a certain drug is not in the original method. New Therapy for the Management of HIV-associated Enteropathy from Entera Health Furthermore, with this technology, you are able to re-interrogate the data at a later date to answer new questions, without needing to re-run the samples.”
AB SCIEX is committed to providing the tools to enable the adoption of accurate mass technology in clinical research laboratories. Buy Vitamins online By applying MS/MS on an accurate mass system, clinical researchers can take advantage of the enhanced specificity of compound-specific MS/MS fragmentation. FDA Approved Rx : Online Pharmacy This enables more confident compound identification, including ID of unknown compounds, such as new ‘designer’ drugs.
“AB SCIEX continues to drive innovation in clinical research to address existing issues, such as slow turnaround times and false positives or negatives, which hinder these labs from increasing productivity and improving data quality,” said Rainer Blair, President of AB SCIEX. All Best Rx : Buy drugs online “We are helping clinical research labs reshape how they conduct drug screening to accurately identify not only known but also unknown compounds.”

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AB SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to push the limits in their field and address the complex analytical challenges they face. Drugs Rx Guide : Buy drugs online The company’s global leadership and world-class service and support in the mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research. With 30 years of proven innovation, AB SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis.
© 2013. AB SCIEX. Unless otherwise noted in our product literature, AB SCIEX Products Are For Research Use Only. Not for use in Diagnostics Procedures. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX^TM is being used under license.