Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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62 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m ularly monitors progress on each working group within its portfolio, and all activities are reviewed annually by the IQ Consortium Board of Directors. IQ members designate volunteer SMEs to join the working group and execute the project. Depend- ing on the project, the results may be reported as a peer-reviewed publication, oral presentation, sym- posia, white paper, webinar, case study, or other method. Finally, to ensure that there is an effective oper- ating model that enables scientists to focus on and drive innovation and quality, the IQ Consortium's Secretariat, Faegre Drinker Biddle & Reath, LLP ("Faegre Drinker"), provides legal support, over- sees compliance with antitrust laws, and effectively serves as the "back office" for the Consortium, al- lowing IQ participants to focus on the scientific and technical projects within the IQ Consortium. To deliver on its mission statement, the IQ Con- sortium established five strategic objectives: • Collaborate across IQ member companies to create cross-functional data sets, scientific posi- tions, and conclusions with greater scope and impact than possible by any member company alone • Advance relationships with global professional organizations, other consortia, academics, and government research institutes to ensure scien- tific excellence and harmonization • Proact ively bui ld consensus w it h g loba l regulators on issues and opportunities to advance innovation and quality in pharmaceu- tical development • Share the results of IQ initiatives with interna- tional scientific and regulatory communities • Ensure the continued value of IQ through com- mitted leadership, focused and clear priority- setting, productive cross-disciplinary collabora- tions, and active engagement by a diverse talent pool to plan for leadership succession. All leadership groups and working groups map their projects to these objectives. On an annual basis, these objectives are reviewed by the Board of Directors to measure the IQ Consortium's success in delivering on its mission and vision. Collectively, these objectives serve to enable innovation, preserve high-quality science, improve probabilities of tech- nical success, and speed the delivery of innovative treatments to patients. This viewpoint highlights the unique attributes that enable the IQ Consor- tium's success and allow it to advance its mission. A summary of case studies demonstrating IQ Con- sortium working groups activity is planned for a Pharmaceutical Technology publication in 2021. Value through collaboration and transformational change The IQ Consortium has advanced scientific inquiry and understanding on a range of issues. Through- out its 10-year history, IQ has generated significant scientific output and publications, and engaged in direct scientific exchange and targeted workshops with global regulators (Table I). In 2015, the IQ Con- sortium added a Data Sharing Framework agree- ment that allows IQ members to create a unique database of voluntarily contributed data, shared in a blinded fashion, to complete research projects and formulate scientific positions, conclusions, and recommendations. The Secretariat assists with the combination of data sets across companies for use in these defined research projects, the results of which are shared with all IQ Consortium members. The IQ Consortium has ongoing dialogue with FDA through scientific roundtables and work- Quality

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