Perspectives on the draft ICH-M10 guidance: an interview with John Kadavil

Bioanalysis ◽  
2019 ◽  
Vol 11 (22) ◽  
pp. 2027-2028
Author(s):  
John Kadavil
Keyword(s):  
Bachelor's Degree ◽  
Public Consultation ◽  
Baltimore County ◽  
University Of Maryland ◽  
Scientific Investigations ◽  
School Of Medicine ◽  
The Us ◽  
Good Laboratory ◽  
Us Fda ◽  
The University

Biography Dr Kadavil received his bachelor's degree in biochemistry from the University of Maryland, Baltimore County. He then received his PhD in molecular pharmacology and experimental therapeutics from the University of Maryland, Baltimore, School of Medicine. Following his PhD, he joined the US FDA as a pharmacologist. He first worked in the Office of Scientific Investigations – Division of Bioequivalence & Good Laboratory Practice under the Office of Compliance at CDER. During his 8 years at the Office of Scientific Investigations, he conducted foreign and domestic bioanalytical and clinical inspections for bioequivalence, bioavailability, pharmacokinetic and GLP studies. In 2011, he joined the Division of Human Food Safety at CVM as a pharmacologist, where he conducted reviews of residue chemistry studies and directed method trials. In 2014, he returned to CDER to become the team lead for the Collaboration, Risk Evaluation and Surveillance Team under the Office of Study Integrity and Surveillance. In September 2018, he became the Deputy Director for the Division of Generic Drug Bioequivalence Evaluation in Office of Study Integrity and Surveillance. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (MD, USA).

scholarly journals Learning analytics as a tool for closing the assessment loop in higher education

2012 ◽  
pp. 236-247 ◽  
Keyword(s):  
Higher Education ◽  
Student Success ◽  
Academic Programs ◽  
Future Research ◽  
University Of Michigan ◽  
Baltimore County ◽  
University Of Maryland ◽  
School Of Medicine ◽  
Academic Analytics ◽  
The University

This paper examines learning and academic analytics and its relevance to distance education in undergraduate and graduate programs as it impacts students and teaching faculty, and also academic institutions. The focus is to explore the measurement, collection, analysis, and reporting of data as predictors of student success and drivers of departmental process and program curriculum. Learning and academic analytics in higher education is used to predict student success by examining how and what students learn and how success is supported by academic programs and institutions. The paper examines what is being done to support students, whether or not it is effective, and if not why, and what educators can do. The paper also examines how these data can be used to create new metrics and inform a continuous cycle of improvement. It presents examples of working models from a sample of institutions of higher education: The Graduate School of Medicine at the University of Wollongong, the University of Michigan, Purdue University, and the University of Maryland, Baltimore County. Finally, the paper identifies considerations and recommendations for using analytics and offer suggestions for future research.

scholarly journals Capturing Student Achievement and Learning Pathways at the University of Maryland, Baltimore County

2022 ◽  
pp. 396-417
Author(s):  
Sherri Nicole Braxton ◽  
Collin Sullivan ◽  
Laura A. Wyatt ◽  
Jalisa Monroe
Keyword(s):  
Information Technology ◽  
Chief Information Officer ◽  
Vice President ◽  
Baltimore County ◽  
University Of Maryland ◽  
Maryland Baltimore County ◽  
Learning Pathways ◽  
The University ◽  
Student Achievement And Learning ◽  
Digital Badging

In 2015, the University of Maryland, Baltimore County (UMBC) recognized the need to capture knowledge, skills, and abilities acquired by students in both co-curricular and curricular endeavors not being captured in any identifiable way. The Vice President of Information Technology and Chief Information Officer desired to document competencies gained by students in the variety of contexts on campus and to track student, faculty, and staff achievements in a way that would both benefit each individual while also supporting the mission of the institution. This vision led to the adoption of a digital badging initiative resulting in a scalable process for implementing new badges throughout the university community. UMBC's digital badging program became the springboard for the institution's entrance into the Comprehensive Learner Record (CLR) realm whose objective is to capture all credentials earned by students, whether they be awarded before, during, or following their tenure at the institution.

scholarly journals In Memoriam. Emilio Marticorena y Carlos Battilana: un recuerdo de valiosos miembros del Comité Editorial de Anales

2016 ◽  
Vol 76 (4) ◽  
pp. 457
Author(s):  
José Pacheco Romero ◽  
Oscar Alejandro Castillo Sayán
Keyword(s):  
San Francisco ◽  
Ductus Arteriosus ◽  
Bachelor's Degree ◽  
The State ◽  
Graduate Studies ◽  
The Us ◽  
National University ◽  
San Marcos ◽  
In Memoriam ◽  
The University

Dr. Emilio Pimentel Achilles Marticorena (1928-2007) was born 20 May 1928, in Villa de Arma in the province of Castrovirreyna, located 3700 m.s.n.m. His studies the school held at the Salesian College Huancayo and Alfonso College Ugarte in Lima. I study medicine at the National University San Marcos (San Marcos), obtaining Bachelor's degree in 1955 with the thesis entitled "Probable influence of great heights in determining the ductus arteriosus: Observations in 3000 school high "and subsequently received the title of Surgeon. He made graduate studies in the US. UU., cardiology at the University of Stanford (1961-1963), University Pennsylvania (1963 and 1964) and Center Presbyterian Medical in San Francisco, 1968; and later in the Institute Cardiology of the State of Sao Paulo, Brazil, in 1974.

scholarly journals Social Responsibility and Civic Readiness as Critical Higher Education Outcomes

2019 ◽  
Vol 30 (4) ◽  
pp. 9-16
Author(s):  
Robert L. Caret
Keyword(s):  
Higher Education ◽  
Workforce Development ◽  
Advanced Degree ◽  
Baltimore County ◽  
Formal Organization ◽  
San Jose ◽  
University Of Maryland ◽  
Metropolitan University ◽  
San Jose State University ◽  
The University

Throughout my 25 years in higher education leadership, overseeing two campuses and two university systems, I have maintained a strong connection to the Coalition of Urban and Metropolitan Universities (CUMU), both philosophically and in practical terms. Early on in my tenure as president of San Jose State University, I established the overarching goal of making San Jose State the Metropolitan University of Silicon Valley. Complementing the institution’s geographic location, size, and mission, all of which positioned it ideally for this role, I also saw a student population, a community role, and an ethos of service that spoke to the institution’s responsibility as an urban citizen. This same perspective was part and parcel of my approach at Towson University (TU). As president, I actively created a vision and an identity for the institution, focusing on its role as the Metropolitan University of Maryland. I established external partnerships with focuses on education, economic and workforce development, arts and culture, and social change. As president of the 5-campus University of Massachusetts System (UMass) I oversaw two CUMU member institutions, UMass Lowell and UMass Boston. The University System of Maryland (USM), where I currently serve as chancellor, is itself a CUMU member, as are several of its component institutions, with Towson and the University of Maryland, Baltimore County (UMBC) “founding members” of CUMU as a formal organization. Throughout these years, I also had a very direct connection to CUMU, serving on several committees, on the Board of Directors, as a vice president, and, from 2006-2011, as CUMU president. With this background, I know first-hand the distinctive perspective and unique tools that our comprehensive institutions can use to address social challenges and bring about meaningful change. In addition, I also recognize the special obligation our comprehensive metropolitan and urban universities have to be active and engaged in the communities they serve. These are the primary, 4-year, “access” institutions, not just in terms of the sheer numbers of students they educate, but also in terms of the composition of those students, serving as a vital higher education pathway for women, underrepresented minorities, and first-generation college students. Beyond that, our comprehensive universities stand as bridges, with numerous graduates going on to advanced degree programs at research universities.

scholarly journals Addressing empathy in intercultural virtual exchange: a preliminary framework

2020 ◽  
pp. 117-126
Author(s):  
Irina Golubeva ◽  
Ivett Guntersdorfer
Keyword(s):  
United States ◽  
Intercultural Communication ◽  
Intercultural Competence ◽  
Online Teaching ◽  
Meta Analysis ◽  
The United States ◽  
Point Of View ◽  
Baltimore County ◽  
University Of Maryland ◽  
The University

Empathy is widely perceived and understood as an unquestioned component of Intercultural Competence (IC). The authors see the ability to empathise with others and to see their point of view as an important condition for developing an ethnorelative viewpoint, and therefore consider it important to incorporate activities into the intercultural communication curriculum that addresses the affective side of IC (Calloway-Thomas, Arasaratnam-Smith, & Deardorff, 2017; Guntersdorfer & Golubeva, 2018). In their paper, the authors discuss the importance of meta-cognitive tasks by creating opportunities for students where they can describe, share, and evaluate emotions. Based on the recommendations made by O’Dowd (2016), Byram, Golubeva, Hui, and Wagner (2017) about designing and implementing virtual exchanges (VEs), the authors present a preliminary framework, i.e. a sequence of self-reflective meta-analysis tasks that they developed for the intercultural VE between students at Ludwig-Maximilians University (LMU) in Germany and their peers at the University of Maryland Baltimore County (UMBC) in the United States. This framework can be adapted to a variety of online teaching contexts.

scholarly journals How to Avoid "Unenlightened Sorrow": A Statistical Analysis of Plain Remarriage

2021 ◽  
Vol 2 (1) ◽  
pp. 96-112
Author(s):  
Ben Wesley Beachy
Keyword(s):  
Data Sets ◽  
Marriage Squeeze ◽  
University Of Maryland ◽  
Lancaster County ◽  
Parental Roles ◽  
School Of Medicine ◽  
Maryland School ◽  
The University ◽  
Gender Specific ◽  
Central Data

This article is a basic quantitative analysis of widowhood and remarriage trends among several Plain churches. When compared to past studies of similar topics, a remarkable consistency of findings across both time and sect can be identified. Bereaved Plain spouses have largely experienced widowhood along separate gender-specific paths, in data sets ranging from 1730 to 2019 and from relatively liberal to traditional communities. Positing that much of Amish and Amish Mennonite society is designed to socialize and retain children, this article offers opportunities for deeper study of the parental roles undergirding that society. The primary research suggestions include spousal function in the context of family life, the various factors influencing the health of bereaved spouses, and the "marriage squeeze" present in many churches. The central data sets used in this study were collected from the 2019 edition of the Amish Mennonite Directory and the 2015 Church Directory of the Lancaster County Amish and Outlying Daughter Settlements. These reference books were sampled on a one-in-five and one-in-three basis, respectively. The resultant widowhood cases were contextualized by widowhood cases from studies by Elmer Lewis Smith and researchers at the University of Maryland School of Medicine.

Partners in Storytelling

2011 ◽  
pp. 314-318
Author(s):  
William Shewbridge
Keyword(s):  
New Media ◽  
Teaching And Learning ◽  
Baltimore County ◽  
Media Technology ◽  
University Of Maryland ◽  
Broadcast Network ◽  
Technology In Teaching ◽  
The University ◽  
The Relationship

In 2006, the University of Maryland, Baltimore County (UMBC) entered into a unique partnership with Retirement Living Television (RLTV). Initially driven by the practicalities of bringing a new broadcast network to air, the relationship came to influence the role of new media technology in teaching and learning on the UMBC campus. The Charlestown Project brought university students and senior citizens together to create short digital movies. The project also became a catalyst for creating human connections beyond the campus and across generations. Along the way, students formed new attitudes towards aging and community, and the campus attained an increased awareness of the power of digital storytelling.

scholarly journals In Memoriam

2012 ◽  
Vol 45 (01) ◽  
pp. 128-136
Keyword(s):  
Political Science ◽  
Civil Liberties ◽  
Associate Professor ◽  
Public Affairs ◽  
Professor Emeritus ◽  
Baltimore County ◽  
University Of Maryland ◽  
In Memoriam ◽  
The University ◽  
Science Training

A. Stephen Boyan, Jr., Associate Professor Emeritus of Political Science at the University of Maryland Baltimore County (UMBC), died on November 7, 2010 in Burlington, Vermont, following a long illness. Steve was a much valued member of the UMBC Political Science Department for thirty-one of the forty-four years it has been in existence. Steve's area of political science was constitutional law, with a particular focus on civil liberties and First Amendment issues. Much more than most contemporary political scientists, Steve applied his political science training and expertise beyond the reach of the university and the discipline to the wider world of public affairs and political engagement.

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