Journal Articles related to Regulatory Affairs and CMC

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Health authorities are turning to digitalization to streamline their processes in response to global crises (such as the COVID-19 pandemic) that have affected the supply chain. The growing complexity of information and data in regulatory submissions has encouraged health authorities to implement structured data submissions and centralized e-submission processes through shared workspaces (1, 2). Some ongoing initiatives seek to simplify review and assessment processes through increased global cooperation and harmonization.
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Development of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.
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Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
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Efforts to improve the regulatory review process through standardization, harmonization, and digitalization have gathered steam in recent years with regulators and industry alike pushing forward with data-driven initiatives. Guest contributors from PharmaLex discuss what these mean for 2023 and beyond.
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With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
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The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again cosponsored the 2022 PDA/FDA Joint Regulatory Conference with the theme, “Quality Evolution/Technology Revolution: Modern Quality Management Solutions.” Due to the COVID-19 pandemic, there became a pressing need to address the public health crisis, which led to some introspective thinking among industry and regulators about improving communication and embracing innovation and technology. This emphasis on improvement was the overarching message from the PDA/FDA conference.
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Like the previous workshops, this event was characterized by a mix of presentations on specific Annex 1 topics combined with interactive workshops, whereby participants had the opportunity to ask the panel of experts about the presented subjects. Above all, it provided the opportunity to discuss the participant’s interpretation, challenges and possible solutions with peers from the industry. Based on the number of questions asked of the panel, this turned out to be a very successful workshop with a high level of interaction between participants and presenters and during round-table discussions.
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It has long been communicated to the UK pharmaceutical industry that the Prescription Medicines Code of Practice Authority (PMCPA) welcomes all input and feedback on the ABPI Code of Practice. But what does this actually mean, what does the PMCPA do with such feedback, and what motivates feedback or prevents it from being given?
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The Prescription Medicines Code of Practice Authority (PMCPA) has received at least nine complaints to-date about the use of LinkedIn, indicating that its use, which is not specifically addressed in the ABPI Code of Practice (Code), may benefit from guidance on how to adhere to existing principles whilst also respecting the purpose of LinkedIn. This should help ensure the LinkedIn accounts and activities of pharmaceutical companies and pharmaceutical/agency employees, comply with the Code.
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Rina Newton shares her top tips for ensuring agencies comply with the ABPI Code of Practice. Agencies are engaged by pharmaceutical companies because the expertise they offer may not be available in-house or because there is insufficient resource or time for in-house creation and development.
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How does the ABPI Code apply to congresses? Mitigating the risks of breaching the Code. The ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements.
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