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Regulatory Submissions Trends Survey 2002

Ellen Semple
1969 Journal of Commercial Biotechnology  
The results specifically present a baseline measure on how pharmaceutical, biotechnology and medical device companies (a) view future increased demand for e-Submissions technology usage, (b) anticipate  ...  This Regulatory Submissions Trends Survey, conducted by CDC Solutions in December 2002, takes the first steps to gauge how regulatory departments of US and European life sciences companies are using technology  ...  One-third of respondents chose not to answer this question.  ... 
doi:10.5912/jcb44 fatcat:fgqlav4thvhknjcjqpcvavtzgi

Lynx D1.1 Functional Requirements Analysis Report

Jorge González-Conejero, Emma Teodoro, Pompeu Casanovas
2018 Zenodo  
The main purpose of this document is to collect business requirements from industry related to needs and expectations regarding a smart and multilingual regulatory compliance information system.  ...  The survey consists of 24 questions, containing different paths based on the profiles of the respondents.  ...  Table 6 . 6 Answers related to Q10.Question 10 of the online survey offers a very common response on which tool is used for storing and sharing relevant digital regulatory compliance documents.  ... 
doi:10.5281/zenodo.1256836 fatcat:i24ltfujzjhwxeksmwauzeroim

Building problem domain ontology from security requirements in regulatory documents

Seok-Won Lee, Robin Gandhi, Divya Muthurajan, Deepak Yavagal, Gail-Joon Ahn
2006 Proceedings of the 2006 international workshop on Software engineering for secure systems - SESS '06  
regulatory documents.  ...  Establishing secure systems assurance based on Certification and Accreditation (C&A) activities, requires effective ways to understand the enforced security requirements, gather relevant evidences, perceive  ...  ACKNOWLEDGMENTS: This work is partially supported by the grant (Contract: N65236-05-P-3672) from the Critical Infrastructure Protection Center (CIPC), Space and Naval Warfare (SPAWAR) Systems Center, Department  ... 
doi:10.1145/1137627.1137635 dblp:conf/icse/LeeGMYA06 fatcat:dwhgos566zgxjbpqfbmhdsz6yu

REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

Achin Jain, Venkatesh M. P., Raja Mohan Reddy.G, Pramod Kumar T.M.
2018 International Journal of Drug Regulatory Affairs  
The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.  ...  One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country.  ...  From Sponsor a. Question and Answers between the chosen reference agency and sponsor - the Answers should include supporting documents used in response to the Questions; b.  ... 
doi:10.22270/ijdra.v3i1.158 fatcat:bx65ux2kdfewfgqwq6lv2uxw5e

Chatbot for Applicants on University Admission Issues

Liudmila Shchegoleva, Grigorii Burdin
2021 Zenodo  
The prototype of the question-answer system is implemented in the form of a chatbot for a social network.  ...  The article discusses a prototype of a question-answer system for automating work with applicants during the admission campaign of Petrozavodsk State University.  ...  The choice of approach for creating a question-answer system should be based on the content of the subject area of questions and answers.  ... 
doi:10.5281/zenodo.4770832 fatcat:lsv3fhtiybahdahmv5shh75rne

Configuration Challenges: Implementing Translational Research Policies in Electronic Medical Records

Michael G. Kahn, David Kaplan, Ronald J. Sokol, Robert P. DiLaura
2007 Academic Medicine  
However, combining clinical research and clinical care activities into one unified electronic information system requires integrating a substantial body of regulatory requirements and institutional policies  ...  The authors highlight these configuration challenges by presenting a list of questions that must be answered unambiguously before implementing translational research capabilities into an operational EMR  ...  Acknowledgments The authors acknowledge the EREX implementation team at The Children's Hospital, led by Dena Somers, Michelle Akey, Patricia Wimmer, and Chris Poppy, who are responsible for implementing a  ... 
doi:10.1097/acm.0b013e318065be8d pmid:17595562 pmcid:PMC3888786 fatcat:bznrgbha45gd3cvues63mstfu4

Assessing Investigator Site Systems for Originating Source Data for Regulated Clinical Research

Suzanne Bishop, Cheryl Tucker McClung, Yvonne Rollinger, Yiannis Karageorgos, Kelley Olree, Ludger Bührmann, Martijn I Griep
2019 Acta Scientific Pharmaceutical Sciences  
eSRA questions as would be needed when updates are made to the underlying documents and/or new pertinent documents are released from any of the regulatory authorities listed above.  ...  The eSource Readiness Assessment (eSRA) contains questions based on regulations and regulatory agency guidelines for clinical research data sources from FDA, EMA, PMDA, and ICH as identified in the eClinical  ... 
doi:10.31080/asps.2019.03.0321 fatcat:kxbu24jdanaptia4d2tistjrjy

Analysis of Questionnaire Results in the Use of BP and ND in Public Administration

Larisa Survilo, Ilze Buksa, Andrejs Gaidukovs, Vira Shendryk
2014 Applied Computer Systems  
This solution includes a good understanding and management of the existing business processes, the use of normative documents and the effective use of information systems in public administration.  ...  As a result of the analysis, hypotheses for further study are set.  ...  The possibility to use IS has a positive impact on development of qualitative documents and processes. 6. The regulatory environment is highly variable. 7.  ... 
doi:10.1515/acss-2014-0019 fatcat:c6a72grrpvcrloggwid7n2pm3e

Lynx Newsletter issue #1: Compliance made easy [article]

Lynx Consortium
2019 Zenodo  
In particular, this solution envisages an ecosystem of smart cloud services to better manage compliance documents, based on a Legal Knowledge Graph, which integrates and links heterogeneous compliance  ...  Lynx will offer a legal knowledge and information one-stop shop service for SMEs and other operating internationally.  ...  Title: Question Answering for Link Prediction and Veri cation. Description: We tackle the problem of knowledge graph population with the help of question answering system.  ... 
doi:10.5281/zenodo.4723442 fatcat:oa7bfcngszaa5db4rx3ukoo5ye

BUILDING DECISION SUPPORT PROBLEM DOMAIN ONTOLOGY FROM NATURAL LANGUAGE REQUIREMENTS FOR SOFTWARE ASSURANCE

SEOK-WON LEE, DIVYA MUTHURAJAN, ROBIN A. GANDHI, DEEPAK YAVAGAL, GAIL-JOON AHN
2006 International journal of software engineering and knowledge engineering  
These decision points are further complicated by natural language specifications of inherently non-functional C&A requirements scattered across multiple regulatory documents with complex interdependencies  ...  Considering the exhaustive nature of C&A activities together with the complexity of software-intensive systems, effective decision making relies heavily on the ways to understand and structure the problem  ...  Acknowledgments This work is partially supported by the grant (Contract #N65236-05-P-3672) from the Critical Infrastructure Protection Center, Space and Naval Warfare (SPAWAR) Systems Center, US Department  ... 
doi:10.1142/s0218194006003051 fatcat:rqcsy72y7bfopb4r6yx32g6wfy

Appendix 1 [chapter]

Claudio M. Radaelli, Fabrizio De Francesco
2013 Regulatory quality in Europe  
One answer only Please attach a copy of the official document containing the objective. Principles of regulatory quality Some countries have defined the guiding principles of regulatory quality.  ...  Does your government set out explicit principles of regulatory quality? Yes Please attach a copy of official documents defining principles. This can be the same document produced for question 1.  ... 
doi:10.7765/9781847792310.00016 fatcat:ru3q755ujbbslbjmtbh56etjzi

Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers' from emerging countries

Katharina Hartmann, Sonia Pagliusi, Alexander Precioso
2020 Vaccine  
A "fit for purpose" pharmacovigilance system may vary as it depends on several factors.  ...  expectations, serving as a basis to further strengthen pharmacovigilance systems, to support accelerated global vaccine supply.  ...  Pagliusi and A. Precioso for data accuracy, then presented to a subset of DCVMN members at the regional PV workshop held in Sao Paulo, 27  ... 
doi:10.1016/j.vaccine.2020.06.016 pmid:32591289 pmcid:PMC7311355 fatcat:bhnmfruitzfclbhqsg26q2qhju

Continuing Professional Development: the role of a regulatory board in promoting lifelong learning

George Konstantinides
2010 INNOVATIONS in Pharmacy  
These questions are challenging to answer, but important considerations for a regulatory body. The second consideration is acceptance of CPD by pharmacists.  ...  A growing body of evidence is being published on the potential role CPD might play in our CE system.  ... 
doi:10.24926/iip.v1i2.197 fatcat:wuuk5eyqe5e3hbizyqhi2nllje

Lynx D5.7 Demonstrator for pilot 3

Pascual Boil, Elsa Gómez, Pablo Calleja
2020 Zenodo  
Section 2 describes our use case in more detail, focusing on the main objectives of a law firm like Cuatrecasas, and how the solution built in Lynx can help its clients and prospects.  ...  This includes a description of th [...]  ...  However, a chatbot-like interface offers the ideal interaction scenario for non-legal experts, relying on a Question Answering (Q&A) system that simplifies the access to regulatory sources and helps them  ... 
doi:10.5281/zenodo.4300691 fatcat:n3euisnky5g2xiq36qbkjjjmb4

COMPARISON OF PHARMACISTS PROFESSIONAL ACTIVITY OF UKRAINIAN PHARMACY ON PROVISION OF INFORMATION ON ADVERSE REACTIONS OF PHARMACEUTICAL PRODUCTS

Oksana Mishchenko, Vasiliy Ostashko, Iuliia Greshko
2020 EUREKA Health Sciences  
documentation on this matter.  ...  Supervision of the State Expert Center of the Ministry of Health of Ukraine and are aware of the regulatory legal documentation on this issue, however they are not active enough to take necessary action  ...  documentation on this matter.  ... 
doi:10.21303/2504-5679.2020.001417 fatcat:6oh3rs45brbllcrf7hwcuhamyi
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