Virtify Simplifies PIM Labeling with New Software Release
Virtify, Inc. today announced the upcoming release of its new software product Virtify PIM Enterprise, part of the Virtify Enterprise Content Compliance (ECC) Software Suite. Virtify PIM is designed to help companies stay compliant with the new EU labeling standard, and is a Web-based product that enables the creation of PIM submissions in a collaborative, "best-practices" environment.
The PIM standard is being implemented to enable the efficient exchange and evaluation of product information for obtaining marketing authorization in Europe. A key goal is to reduce the repetition of content across multiple countries and documents through a single, centralized XML submission. Moreover, electronic authoring and publishing for PIM XML must integrate with existing translation processes and software.
Virtify PIM Enterprise is a software solution designed to enable customers to comply with the PIM standard for submitting product label information in an efficient, consistent and predictable manner. Virtify PIM's structured content approach allows users to operate at the PIM element and PIM fragment level-the same content levels specified by the PIM standard. This capability provides users with unprecedented content control and flexibility, allowing authors and reviewers to "parallel-process" different sections of the PIM submission or submissions. In addition, the software has a rapid deployment and implementation cycle and is not dependent on any third party infrastructure or solution.
The PIM standard is currently in pilot. It is expected to move into production in 2011 for new approvals using the centralized procedure. A full migration of legacy product information will be required in the future.
Virtify PIM is built upon Virtify's structured content management engine. Key capabilities include:
* Comprehensive PIM Lifecycle Management with integrated workflow for rapid status and centralized management of PIM submissions including content creation, review, approval, and translations, as well as bi-directional communication and comments from EMA
* Role-based, granular access control at the PIM document, PIM element, PIM fragment, and language level.
* Automated XML generation with no programming knowledge required
* Integrated Translation Management through standard web services for translation tracking and status reporting through the Virtify PIM dashboard
Virtify is currently exhibiting at the 2nd Successful eCTD Lifecycle Management Conference in Prague, Czech Republic. Virtify PIM Enterprise will be available to customers in October 2010.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
