When companies are in the formative stages, owners focus on getting work and building teams. And typical of many companies, people resist the efforts of owners and managers to put policies and procedures in place to create accountability as an expectation. But for an organization, it’s a learned behavior. Everyone wants it, everyone needs it and most can easily identify when there is a lack of it.įor a number of people, accountability is a natural behavior. Accountability, or lack of it, is the elephant in the room at many companies. Their full potential in the interest of the Nation.One of the more elusive elements of company culture is accountability. Mission more persuasively and to facilitate its members to apply Recommends ways to strengthen the Voice of NIPTE to advocate its Reflects on strategic directions emphasized by NIPTE in 2016. Next? Do better? Do more -be the third leg of the stool? This report,įrom Roadblocks to Roadmap 2017, with 2020 Vision, reviews and Quality, Cures and the Voice of Patients? What can/should NIPTE do Should be the next steps that optimally integrate 21st Century How will the Nation’s life-science research priorities change? What Transformation underway since the beginning of this century. Juxtaposed to re-shape, perhaps radically so, the Critical Path Novel pharmaceutical technologies, the aspirational 21st CenturyĬures Act (5), and the President-elect Trump’s Administration are (OPQ) and added an emphasis on One Quality Voice (4). In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality Today NIPTEĬontinues to collaborate with FDA to facilitate this transformation. Initiative” to transform the way FDA-regulated products areĭeveloped, evaluated, manufactured, and used (3). Later these merged with the “Critical Path Risk-based Approach initiatives were launched at the beginning of The FDA’s Process Analytical Technology and the PharmaceuticalĬurrent Good Manufacturing Practices (CGMP) for the 21st Century: A The industry to improve their policies and practices. She suggested that, ideally,Īcademia should be “the third leg of the stool” - to nudge the FDA and Janet Woodcock, Director FDA/CDER, reemphasized this missionĪt the NIPTE Conference 2016. Mission - which NIPTE continues to pursue today (see sidebar).ĭr. His introductory remarks described the need and the “Pharmaceutical Technology and Education Enhancement Act” to the In May 2006 Senator Lugar introduced a draft legislation Research and education in addressing some of the most significantĬhallenges that repeatedly plague the Nation’s pharmaceutical (NIPTE), began a journey to improveĪwareness of the need and the value of pharmaceutical technology Over a decade ago, the National Institute for Pharmaceutical NIPTE 2016: From Roadblocks to Roadmap 2017, with a 2020 Vision 2.Directional Vectors, Aligning Themes, FDA PrioritIes,& NIPTE’s Strategic Interests.24 NIPTE Certification: Continuing Education and New Prior Knowledge. Need for proactive practice of Team-based science.18 Description of the product quality challenge –then and now.16 Translational Needs, One Quality Voice & Voice of NIPTE.16 Roadblocks to Roadmap 2017: A Commentary.16 NIPTE Presentations at Regulatory Science Initiatives Part 15 Public Meetings (2014-2016).15 Observations: NIPTE’s recommendations & OGD Priortzation FY 2017 GDUFA Regulatory Science Program.14 Observations on the proposed NIPTE Center of Excellence Concept.13 OPQ perspective on how can NIPTE assist.12 FDA/CDER/OPQ Challenges and focus areas.11 Office of Pharmaceutical Quality: Challenges & Focus Areas.11 Launch of NIPTE-Sun Pharma Education and Certification Program.10Ģ016 Observations and Assessment of impact made by NIPTE.11 NIPTE Recommendation: FY 2017 GDUFA Regulatory Research. NIPTE’s recommendations on research priorities FY 2017 GDUFA Regulatory Science Program. NIPTE’s Center of Excellence (CE) in Pharmaceutical Formulations. Table 2: Overview: From Roadblocks to Roadmap 2017, with a 2020 Vision. Table 1: List of significant NIPTE discussions in 2016. NIPTE 2016: From Roadblocks to Roadmap 2017, with a 2020 Vision 1.From Roadblocks to Roadmap 2017, with a 2020 Vision
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