Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges and opportunities for improvement. Methods A questionnaire was completed by the MCAZ. The agency has participated in the Optimising Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize assessment procedures and metrics associated with regulatory agencies and regional regulatory initiatives. Data identifying the milestones and overall approval times for all products registered MCAZ from 2017 to 2019 were collected and analyzed. Results The MCAZ conducts a full review of quality, safety, and efficacy data for generics and biosimilars not approved by a reference agency, an abridged review for products approved by a reference agency and a verification review for World Health Organization prequalified products under the collaborative registration procedure. The highest number of reviewed products is generics manufactured by foreign companies. There has been an improvement in review times for all categories of products over the three-year period. Guidelines, standard operating procedures, and review templates are in place and the majority of indicators for good review practices are implemented. Although quality decision-making practices are implemented, there is no formal framework in place. Conclusion The MCAZ successfully implements three types of review models in line with international standards. Overall, target timelines are realistic and what is achievable with the current available resources. Recommendations made such as the review of available human resources, separation of agency and company time when setting and measuring targets, review of the templates and benefit-risk framework used for abridged review, and development of a decision-making framework present opportunities for an enhanced regulatory review process.

AN EARTHQUAKE CATALOG OF MID-ATLANTIC RIDGE

The Mid-Atlantic Ridge (M-AR), which runs along the centre of the Atlantic Ocean, is one of the best known divergent boundaries. Seismic studies have been a crucial factor in deciphering the structure of the oceanic crust. For their performance a necessary prerequisite is the compilation of a reliable earthquake catalog of the broader area. In this study, an attempt was made to create an earthquake catalog of M-AR that could become a useful “tool” for large-scale seismological studies of this region. For this reason a very large sample of data from several seismological centers, as well as from already published catalogs of strong earthquakes, was collected and examined. ISC was considered as the main reference agency, while as reference magnitude scale the moment magnitude scale, MW was adopted. The main goal was to identify and organize the best and most recent information available for earthquakes falling within the time window 1900-2014 and the space window bounded by the extended coordinates ~ 81 (N) to -51 (S) and 10 (E) to ~ -50 (W). After magnitude homogenization, check of focal depths and definition of completeness magnitude, a reliable and homogeneous earthquake catalog of M AR consisting of 14,211 events was created, available for any seismological use and further study.

SVM-Based Credit Rating and Feature Selection

The assessment of risk of default on credit is important for financial institutions. Logistic regression and discriminant analysis are techniques traditionally used in credit rating for determining likelihood to default based on consumer application and credit reference agency data. We test support vector machines (SVM) against these traditional methods on a large credit card database. We find that they are competitive and can be used as the basis of a feature selection method to discover those features that are most significant in determining risk of default.

Implications of translational shifts in interpreter-mediated texts

The aim of this study is to examine the nature and extent of translational shifts in interpreter-mediated texts. 10 professional interpreters with 11-30 years experience participated in the study. A corpus of 10 source texts (full-length speeches) and 10 target texts (interpreter-mediated versions) recorded during international conferences is analyzed. Shifts in the following linguistic phenomena are assessed: Personal reference, agency, mood and modality, threats to face. Our findings reveal a significant trend of distancing, de-personalization and the mitigation of illocutionary force.