The Pharmaceutical Regulatory Science Team (PRST) was founded in 2005 in response to the drive for a paradigm shift in quality from the international regulatory community.
PRST actively engages with global industry and regulators to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. PRST research emphasis is on the development of patient-focused strategies, frameworks, models and tools to enable those involved in the manufacture of drug products to meet the evolving international regulatory expectations ensuring the availability of high-quality medicinal products.
Since it’s inception, the PRST has continued to progress research on quality risk management (QRM), knowledge management (KM), operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.
The PRST journey from Q9 through Q9(R1) is depicted below.
Recent research by the PRST has highlighted the value of a team approach to research, where benefits are evident through convergence of disciplines. In this case, a joint study on quality risk management and knowledge management has inspired the creation of a novel framework, the Risk-Knowledge Infinity Cycle, which defines the interrelationship between QRM and KM, with the opportunity to reduce risk and help protect patients.
The PRST members actively seek opportunities to collaborate with other Industry, Regulatory and academic bodies. Shown below are examples of such bodies.
Academic research team focused on practical implementation of ICH Quality Guidelines supporting paradigm shift in quality since 2005
PRST actively engages with global industry and regulators to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches, with a focus on developing patient-focused strategies to ensure the availability of high-quality medicinal products.
The division of Production Management is one of the four sections within the Institute of Technology Management (ITEM-HSG) at the University of St.Gallen.
Founded in 1898, the University of St.Gallen is one of the leading business schools in Europe and worldwide. The division of Production Management is led by Prof. Dr. Thomas Friedli. 14 researchers on PhD and Post-Doc level extend the frontiers of science in our three competence centers:
Global Production Networks
Smart Manufacturing & Services
Member-based industry organization, creating industry best-practices and aligning industry position
Create an environment where the global biopharmaceutical industry can collaborate and accelerate their rate of progress, for the benefit of all…
by bringing leaders together; mobilising communities; creating partnerships and replacing isolation.
Industry organisation connecting stakeholders to advance the industry, implement regulatory guidelines & develop good practices
ISPE provides a neutral environment where our individual Members and experts belonging to Regulatory Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.
Industry organisation connecting stakeholders to advance the industry, implement regulatory guidelines & provide industry guidance
PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high quality, relevant education to the industry…to assist the advancement of pharmaceutical science and technology in the interest of public health.