Strategies For Regulatory Intelligence
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Regulatory Intelligence As The Basis For Regulatory Strategy And Global Drug Development
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Author : Petra Heyen
language : en
Publisher: GRIN Verlag
Release Date : 2011
Regulatory Intelligence As The Basis For Regulatory Strategy And Global Drug Development written by Petra Heyen and has been published by GRIN Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Health & Fitness categories.
Master's Thesis from the year 2004 in the subject Health - Miscellaneous, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultät), language: English, abstract: The Regulatory Affairs (RA) department is a key discipline in the global network of drug development. During drug development, regulatory strategy is one crucial success factor for the approval of the development candidate. Also, regulatory strategy can optimise labelling in the key countries in order to maximise the market success. No submission and approval would be possible without the appropriate dossier composition and compilation. Without adherence to the respective guidance documents and scientific advice from Health Authorities to design the optimal clinical development plan, optimal labelling would not be feasible. These two examples show some characteristics of the regulatory strategy: it is highly interactive with other disciplines and it is heavily based on a thorough intelligence work which enables the RA Manager to know the "rules of the game" and to develop the optimal regulatory strategy for the current development candidate. The major cornerstone for developing a regulatory strategy is regulatory intelligence. This document focuses on regulatory intelligence. The regulatory contributions to the global drug development from early research to submission are described. Strategies for generic drugs as well as detailed strategies for life-cycle management are excluded. Major components of regulatory intelligence are: - Competitor Information - Information on Regulatory Environment - Information on Legal Requirements Competitor analysis is an essential aspect of the intelligence work. Sources of competitive information as well as relevant items of competitive information are described. Sources of information about the regulatory environment and sources of information about the legal regulatory environment are described and their tremendous impact on setting up and modify
Strategies For Regulatory Intelligence
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Author : Chris Walker
language : en
Publisher:
Release Date : 2001
Strategies For Regulatory Intelligence written by Chris Walker and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with categories.
Intelligence In Regulation
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Author : Neil Quarmby
language : en
Publisher:
Release Date : 2018-11-21
Intelligence In Regulation written by Neil Quarmby and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-21 with Administrative agencies categories.
Written from a practitioner's perspective, Intelligence in Regulation fills a void in international literature on regulation. The wide and largely disparate world of regulators is late to the idea of professionalising decision-making despite this need being well understood and ingrained in national security and, to a lesser extent, law enforcement.The book draws largely from the experience of the author as a former intelligence officer, as a builder of intelligence and decision-systems across many sectors, and as a user of intelligence in leading regulatory operations. The narrative leads the reader through the barriers to effective regulatory decision-making, then to case studies of regulatory failure, and concludes with practical guidance on building and improving intelligence systems. Theoretical references are drawn from a number of sources and, in particular, the book acts as a companion piece to Managing Intelligence: The Art of Influence (Quarmby and Young, 2010) which contains the fundamentals of contemporary intelligence craft.While oriented towards compliance and regulation, the content can be applied across other public and private sectors, especially where consideration of external change agents is important in decision-making. If in doubt, simply insert the name of your organisation or field where you read the word 'regulator' and you may be surprised how many of the observations echo your own organisational circumstance.
Strategic Regulatory Intelligence
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Author : Federico Goodsaid
language : en
Publisher: Academic Press
Release Date : 2018-05-01
Strategic Regulatory Intelligence written by Federico Goodsaid and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-01 with Medical categories.
Strategic Regulatory Intelligence
Regulatory Content And Intelligence A Complete Guide
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Author : Gerardus Blokdyk
language : en
Publisher: 5starcooks
Release Date : 2018-12-03
Regulatory Content And Intelligence A Complete Guide written by Gerardus Blokdyk and has been published by 5starcooks this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-03 with categories.
Who will be responsible for deciding whether Regulatory Content and Intelligence goes ahead or not after the initial investigations? Who will be responsible for documenting the Regulatory Content and Intelligence requirements in detail? Can management personnel recognize the monetary benefit of Regulatory Content and Intelligence? Have you identified your Regulatory Content and Intelligence key performance indicators? How do you ensure that implementations of Regulatory Content and Intelligence products are done in a way that ensures safety? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Regulatory Content and Intelligence investments work better. This Regulatory Content and Intelligence All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Regulatory Content and Intelligence Self-Assessment. Featuring 668 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Regulatory Content and Intelligence improvements can be made. In using the questions you will be better able to: - diagnose Regulatory Content and Intelligence projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Regulatory Content and Intelligence and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Regulatory Content and Intelligence Scorecard, you will develop a clear picture of which Regulatory Content and Intelligence areas need attention. Your purchase includes access details to the Regulatory Content and Intelligence self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard, and... - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation ...plus an extra, special, resource that helps you with project managing. INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
Regulatory Intelligence 101
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Author : Meredith Brown-Tuttle
language : en
Publisher:
Release Date : 2014-08-04
Regulatory Intelligence 101 written by Meredith Brown-Tuttle and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-04 with categories.
Guide to how to conduct regulatory intelligence, available tools and resources.
Regulatory Intelligence 101
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Author : Meredith Brown-Tuttle
language : en
Publisher:
Release Date : 2016
Regulatory Intelligence 101 written by Meredith Brown-Tuttle and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Drugs categories.
Regulatory Intelligence 101 Third Edition
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Author : Gloria Hall
language : en
Publisher:
Release Date : 2021-03-26
Regulatory Intelligence 101 Third Edition written by Gloria Hall and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-26 with categories.
Study To Support An Impact Assessment Of Regulatory Requirements For Artificial Intelligence In Europe
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Author :
language : en
Publisher:
Release Date : 2021
Study To Support An Impact Assessment Of Regulatory Requirements For Artificial Intelligence In Europe written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with categories.
This Study, completed for the European Commission, DG CONNECT, supports the Impact Assessment of the European Commission's proposed Regulation on a European approach to Artificial Intelligence (AI). The study is divided into four main sections. Section 1 of the Study is dedicated to a comprehensive overview of existing evidence and prospective assessments of the risks and harms generated by AI for fundamental rights as well as for safety/security. Section 2 provides a comparative overview of emerging national experiences in developing strategies and regulatory frameworks in this domain, with specific emphasis on risk governance. Section 3 contains a detailed analysis of the results of the public consultation on the European Commission White Paper on Artificial Intelligence. It includes the analysis of 18 free-text questions from the consultation on the White Paper (6,667 free-text responses); and the screening of 408 position papers submitted to the public consultation. Section 4 is dedicated to an assessment of the compliance costs generated by the proposed Regulation on Artificial Intelligence, including both administrative burdens and substantive compliance costs. The cost estimation is built on time expenditures of activities induced by the new requirements under the proposed Regulation. Below, we describe our main findings in each of the sections.
China Medical And Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information Regulations Contacts
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Author : IBP, Inc
language : en
Publisher: Lulu.com
Release Date : 2018-09-03
China Medical And Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information Regulations Contacts written by IBP, Inc and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Business & Economics categories.
2011 Updated Reprint. Updated Annually. China Pharmaceutical Chemicals Producers Directory
