Dataset Information

Data Management in a Regulatory Context.

ABSTRACT: With the implementation of Article 57(2) in 2012 the European Medicines Agency (EMA) embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by both internal and external factors, the EMA have through the European Union telematics strategy laid the foundation for the regulatory-driven services that may be expected from the community the coming years. Supported by standardization initiatives (e.g., ISO Identification of Medicinal Products), the EMA is gradually building an information management-driven approach to data utilization and exploitation within drug evaluation and approval. Primarily driven by the increasing demand for signal detection, the EMA is additionally hoping to leverage the establishment of defined information models and supporting controlled terms to safeguard future activities within the community. Collectively, the overall community may seek to gain from the overall digitalization roadmap proposed by the EMA and interesting opportunities may be sought as part of the transition. Already now pharmaceutical companies are gradually adapting to this new paradigm and actively seeking to explore how they may leverage the future EMA operating model to serve internal business requirements. If successful, the collective efforts from industry and regulators may lead to an unprecedented product oversight and offer regulators the opportunity to proactively drive corrective actions and, therefore, improve patient safety.

SUBMITTER: Gronning N

PROVIDER: S-EPMC5519530 | biostudies-other | 2017

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:Context Big Data Analytics is a rapidly emerging IT practice whose applications offer benefits for a wide variety of business areas across an organisation. Given the wide scope of applications, the many types of processing involved, including those for purposes not yet foreseen, and the inherent privacy concerns resulting from collecting and storing personal data, the newly introduced General Data Protection Regulation (GDPR) poses specific challenges for safeguarding the security and protection of big data. These challenges are not limited to the IT function but extend across the entire organisation. This raises the question whether Enterprise Architecture Management (EAM), as an approach for ensuring the coherence, strategic alignment and focus on value creation of all organisational resources, offers guidance for addressing those challenges in a holistic manner, and thus provides a fruitful ground for developing an approach for complying to GDPR requirements in a Big Data context. Objective This study surveys the state-of-the-art in research on security, privacy, and protection of big data. The focus is on investigating which specific issues and challenges have been identified and whether these have been linked to GDPR requirements. Further, it examines whether previous research has investigated the potential of EAM in addressing those challenges and what the main findings of those studies are. Method We used Systematic Mapping Review (SMR), which is a methodology for literature review aimed at surveying the state-of-the-art in a research field as it is documented in the scientific literature. Further, we used Template Analysis, which is a thematic analysis technique, for coding the texts of the selected papers, classifying the research studies, and interpreting the different themes addressed in the literature. Results Our study indicates that only few researchers have explored the use of EAM practices in relation to data security and protection in a Big Data context. We further identified seven trends within the areas under consideration that could be subjects for further research. Conclusions Our study does not invalidate the potential of EAM to help addressing GDPR requirements in a Big Data context. However, how EAM practices may contribute to risk management and data governance in environments where big data are being processed, is still a huge research gap, which we intend to address in our future research. Supplementary Information The online version of this article (10.1007/s10257-020-00500-5) contains supplementary material, which is available to authorized users.

Project description:In comparison to protein coding sequences, the impact of mutation and natural selection on the sequence and function of non-coding (ncRNA) genes is not well understood. Many ncRNA genes are narrowly distributed to only a few organisms, and appear to be rapidly evolving. Compared to protein coding sequences, there are many challenges associated with assessment of ncRNAs that are not well addressed by conventional phylogenetic approaches, including: short sequence length, lack of primary sequence conservation, and the importance of secondary structure for biological function. Riboswitches are structured ncRNAs that directly interact with small molecules to regulate gene expression in bacteria. They typically consist of a ligand-binding domain (aptamer) whose folding changes drive changes in gene expression. The glycine riboswitch is among the most well-studied due to the widespread occurrence of a tandem aptamer arrangement (tandem), wherein two homologous aptamers interact with glycine and each other to regulate gene expression. However, a significant proportion of glycine riboswitches are comprised of single aptamers (singleton). Here we use graph clustering to circumvent the limitations of traditional phylogenetic analysis when studying the relationship between the tandem and singleton glycine aptamers. Graph clustering enables a broader range of pairwise comparison measures to be used to assess aptamer similarity. Using this approach, we show that one aptamer of the tandem glycine riboswitch pair is typically much more highly conserved, and that which aptamer is conserved depends on the regulated gene. Furthermore, our analysis also reveals that singleton aptamers are more similar to either the first or second tandem aptamer, again based on the regulated gene. Taken together, our findings suggest that tandem glycine riboswitches degrade into functional singletons, with the regulated gene(s) dictating which glycine-binding aptamer is conserved.

Dataset Information

Data Management in a Regulatory Context.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets