Packaging research artefacts with RO-Crate

An increasing number of researchers support reproducibility by including pointers to and descriptions of datasets, software and methods in their publications. However, scientific articles may be ambiguous, incomplete and difficult to process by automated systems. In this paper we introduce RO-Crate, an open, community-driven, and lightweight approach to packaging research artefacts along with their metadata in a machine readable manner. RO-Crate is based on Schema.org annotations in JSON-LD, aiming to establish best practices to formally describe metadata in an accessible and practical way for their use in a wide variety of situations. An RO-Crate is a structured archive of all the items that contributed to a research outcome, including their identifiers, provenance, relations and annotations. As a general purpose packaging approach for data and their metadata, RO-Crate is used across multiple areas, including bioinformatics, digital humanities and regulatory sciences. By applying “just enough” Linked Data standards, RO-Crate simplifies the process of making research outputs FAIR while also enhancing research reproducibility. An RO-Crate for this article11 https://w3id.org/ro/doi/10.5281/zenodo.5146227 is archived at https://doi.org/10.5281/zenodo.5146227.

Needs driven talent and competency development for the next generation of regulatory scientists in Africa

There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long-term strategy for training and professional development of African regulatory personnel. Capacity building programs for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gap and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.

FIP VIRTUAL 2020 Regulatory Sciences

Accepted abstracts under the theme: REGULATORY SCIENCES (n=10)

Medical staff perceptions of risk communication needs for the public and comparison with the needs expressed by the public

Risk communication programs about radiation exposure should be conducted continuously and rigorously by healthcare workers in the Tohoku region in order to reduce the stress caused by radiation exposure. This study aimed to compare the perception by medical staff of the public need to the public need as defined in a previous study, as well as examine the level of perception among healthcare workers of the two concepts “as low as reasonably achievable” (ALARA), and Regulatory Sciences. These two concepts were expected to be the ones to impart information regarding the effect of radiation on the human body during risk communication. The results showed differences between the public perception of risks and belief of what the public risk perception was by the medical staff. In addition, only 23.5% and 16.5% medical doctors had accurate perception of ALARA and Regulatory Sciences in Japan, respectively, even after the great East Japan Earthquake., ALARA and Regulatory Sciences should be added to healthcare workers’ education curriculums to enhance their knowledge level of these concepts. From the viewpoint of laypersons, public health awareness programs conducted by the local and central governments ranked fourth and fifth respectively as sources of information. One of the reasons was that, to some extent, the attitude of the central government seemed apt to be overbearing to laypersons. Therefore, we also believe that medical doctors are expected to be intermediaries between central/local governments and laypersons.

Coda

The coda closes Becoming Human with a consideration of recent developments in the biological sciences and biotechnology that have turned their attention to narrating the problem of “racial health disparity” in reproductive health. I suggest that work on the epigenome, mostly housed in the regulatory sciences—epidemiology and public health—possesses contradictory potential and thus uncertain possibilities with respect to (dis)articulating the antiblack logics that have conditioned the symbiosis of teleological determinism and evolutionary thought (whereby a developmental conception of “the human” is only one of its most obvious instantiations). Bringing the epigenome in conversation with my theory of ontologized plasticity, I argue that Mutu’s aesthetic strategies, along with those of Legae, Douglass, Morrison, Hopkinson, and Lorde featured in Becoming Human, reveal a potential (with neither guarantee nor a manifest horizon of possibility—but a potential, nonetheless) for mutation beyond a mode of thought and representation that continually adheres to predefined rules and narratives that legitimate antiblack ordering and premature death.

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product development shared their experiences with in vitro dissolution and in silico modeling approaches to establish clinically relevant dissolution specifications. The regulators shared their perspectives on the acceptability of these different strategies for the development of acceptable specifications. The meeting also reviewed several collaborative initiatives that were relevant to regulatory biopharmaceutics. Following the scientific presentations, a roundtable session provided an opportunity for delegates to discuss the information that was shared during the presentations, debate key questions, and propose strategies to make progress in this critical area of regulatory biopharmaceutics. It was evident from the presentations and subsequent discussions that progress continues to be made with approaches to establish robust CRDS. Further dialogue between industry and regulatory agencies greatly assisted future developments and key areas for focused discussions on CRDS were identified.