Statutory Report on Corporate Social Responsibility 2018
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The Gxp Dictionary 1St Edition
Testo Expert Knowledge The GxP Dictionary 1st edition Definitions relating to GxP and Quality Assurance 1 Note: Some of the information contained in this GxP Dictionary does not apply equally to all countries. Depending on the respective local legislation, other definitions may apply to certain terms and topics. The sections affected are not separately identified. 2 Foreword Efficacy, identity and purity are qual- This GxP Dictionary explains the ity attributes, which are required of majority of terms relating to GxP, products from the GMP-regulated qualification, validation and quality environment. The term “Good Manu- assurance. facturing Practice” sums up the quality assurance requirements from national It is intended as a compact reference and international regulations and laws. guide and aid for all those involved Other GxP forms have now been de- in GMP, and does not purport to be veloped, whose scope also expands complete. to adjacent sectors such as medical devices and life sciences. Testo SE & Co. KGaA The complex requirements of the “GMP compliance” generate a variety of specific concepts and abbrevia- tions. 3 GxP Dictionary Contents Contents 10 Terms and Definitions C 15 Calibration 0-9 15 CAPA 10 21 CFR 210/211 15 Capacity Test 10 483 15 CEP (Certificate of Suitability of Monographs of the European A Pharmacopoeia) 11 Action Limits 15 CFR 11 Active Pharmaceutical Ingredient 15 CFU (Colony-Forming Unit) (API) 16 cGMP 11 ADI (Acceptable Daily Intake) 16 Challenge Test 11 Airlock Concept 16 Change Control 11 Annex 16 Clean Corridor -
Introduction to Medical Device Law and Regulation March 2-4, 2021 | Live Virtual Event Speaker Biographies
Introduction to Medical Device Law and Regulation March 2-4, 2021 | Live Virtual Event Speaker Biographies DEBORAH BAKER-JANIS joined NSF International in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes the development of pre‐clinical testing protocols, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions. Ms. Baker‐Janis has supported the development and commercialization of a wide range of products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices. Her educational background is in biomedical engineering. MAHNU DAVAR is a partner in the Washington, DC office of Arnold & Porter. His practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces. Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations. He has also assisted clients to prepare for and navigate state and federal regulatory inspections. Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India. -
Intertek Pharmaceutical Services
PHARMACEUTICAL SERVICES Laboratory & Assurance Solutions INTERTEK PHARMACEUTICAL SERVICES Total Quality Assurance for Pharmaceutical Development and Manufacturing Across your product lifecycle, our expertise brings you the insight you need to accelerate pharmaceutical, biopharmaceutical or medical device product development. Our assurance solutions allow you to identify and mitigate risks associated with products, processes, operational and quality management systems, assets and supply chains. Our specialists bring many years of experience across a variety of product areas including: • Innovative and Generic Pharmaceuticals • Orally Inhaled and Nasal Drug Products • Peptides, Proteins • Nutritional Products, Dietary • Biosimilars Supplements • Monoclonal Antibodies • Consumer Healthcare and Cosmetics • Antibody-drug Conjugates • Medical Devices • Oligonucleotide Therapeutics • Veterinary Medicines • Vaccines • Over-the-Counter (OTC) Drugs 2 Achieving Total Quality You can rely on our global network of experts, Assurance laboratories and specialists to deliver support We have delivered flexible including analysis, bioanalysis, formulation Our scientists, regulatory experts and auditors development, biologics characterization, contract services to the work with you at every stage of development specialist inhalation development expertise, global pharmaceutical and manufacturing, providing responsive, regulatory consultancy, risk assessment, quality compliant solutions. auditing and supply chain management industry for over 25 years At Intertek, -
From Corporate Responsibility to Corporate Accountability
Hastings Business Law Journal Volume 16 Number 1 Winter 2020 Article 3 Winter 2020 From Corporate Responsibility to Corporate Accountability Min Yan Daoning Zhang Follow this and additional works at: https://repository.uchastings.edu/hastings_business_law_journal Part of the Business Organizations Law Commons Recommended Citation Min Yan and Daoning Zhang, From Corporate Responsibility to Corporate Accountability, 16 Hastings Bus. L.J. 43 (2020). Available at: https://repository.uchastings.edu/hastings_business_law_journal/vol16/iss1/3 This Article is brought to you for free and open access by the Law Journals at UC Hastings Scholarship Repository. It has been accepted for inclusion in Hastings Business Law Journal by an authorized editor of UC Hastings Scholarship Repository. For more information, please contact [email protected]. 2 - YAN _ZHANG - V9 - KC - 10.27.19.DOCX (DO NOT DELETE) 11/15/2019 11:11 AM From Corporate Responsibility to Corporate Accountability Min Yan* and Daoning Zhang** I. INTRODUCTION The concept of corporate responsibility or corporate social responsibility (“CSR”) keeps evolving since it appeared. The emphasis was first placed on business people’s social conscience rather than on the company itself, which was well reflected by Howard Bowen’s landmark book, Social Responsibilities of the Businessman.1 Then CSR was defined as responsibilities to society, which extends beyond economic and legal obligations by corporations.2 Since then, corporate responsibility is thought to begin where the law ends. 3 In other words, the concept of social responsibility largely excludes legal obedience from the concept of social responsibility. An analysis of 37 of the most used definitions of CSR also shows “voluntary” as one of the most common dimensions.4 Put differently, corporate responsibility reflects the belief that corporations have duties beyond generating profits for their shareholders. -
CSR in LEO Pharma - Focus Areas 2013-2016
– Corporate Social Responsibility Report — we help people achieve healthy skin Environment & Safety People & Health Compliance & Ethics Partnerships & Collaboration Corporate Social Responsibility (CSR) LEO Pharma CSR Report 2014 – Corporate Social Responsibility Report LEO Pharma in brief Founded in 1908 Headquarters in Denmark Offering care solutions to patients in more than 4,800 employees 100 Present in countries 61 countries with Owned by the LEO employees LEO Foundation Therapeutic areas Psoriasis Actinic keratosis Skin infections Eczema Acne Thrombosis Other areas of care Page – 2 Contents 5 Statement from the President & CEO 6 The commitment of LEO Pharma 7 LEO CSR Strategy 8 LEO Corporate Social Responsibility (CSR) Policy 9 CSR in LEO Pharma - Focus areas 2013-2016 10 Environment & Safety 14 People & Health 18 Compliance & Ethics 22 Partnerships & Collaboration 26 Appendix: Focus areas, goals and milestones 2013-2016 30 Glossary 31 LEO values 31 Contact This report represents LEO Pharma’s compliance with Section 99a and 99b of the Danish Financial Statements Act Page – 3 – Corporate Social Responsibility Report LEO mission We help people achieve healthy skin LEO vision We are the preferred dermatology care partner improving people’s lives around the world Page – 4 Statement from the President & CEO Dear stakeholders, Our mission in LEO Pharma is to help people achieve healthy skin and in 2014 we have helped 48 million patients. LEO Pharma is committed to changing the impact skin diseases have on people’s lives. In 2014, the WHO resolution on psoriasis was adopted, recognising psoriasis as a chronic and disabling disease – a significant step for patients worldwide – which LEO Pharma We help people achieve supports. -
Eugenics and Domestic Science in the 1924 Sociological Survey of White Women in North Queensland
This file is part of the following reference: Colclough, Gillian (2008) The measure of the woman : eugenics and domestic science in the 1924 sociological survey of white women in North Queensland. PhD thesis, James Cook University. Access to this file is available from: http://eprints.jcu.edu.au/5266 THE MEASURE OF THE WOMAN: EUGENICS AND DOMESTIC SCIENCE IN THE 1924 SOCIOLOGICAL SURVEY OF WHITE WOMEN IN NORTH QUEENSLAND Thesis submitted by Gillian Beth COLCLOUGH, BA (Hons) WA on February 11 2008 for the degree of Doctor of Philosophy in the School of Arts and Social Sciences James Cook University Abstract This thesis considers experiences of white women in Queensland‟s north in the early years of „white‟ Australia, in this case from Federation until the late 1920s. Because of government and health authority interest in determining issues that might influence the health and well-being of white northern women, and hence their families and a future white labour force, in 1924 the Institute of Tropical Medicine conducted a comprehensive Sociological Survey of White Women in selected northern towns. Designed to address and resolve concerns of government and medical authorities with anxieties about sanitation, hygiene and eugenic wellbeing, the Survey used domestic science criteria to measure the health knowledge of its subjects: in so doing, it gathered detailed information about their lives. Guided by the Survey assessment categories, together with local and overseas literature on racial ideas, the thesis examines salient social and scientific concerns about white women in Queensland‟s tropical north and in white-dominated societies elsewhere and considers them against the oral reminiscences of women who recalled their lives in the North for the North Queensland Oral History Project. -
What Is Corporate Accountability?
WHAT IS CORPORATE ACCOUNTABILITY? BACKGROUND AND OVERVIEW Since the 1990s, the world has witnessed the growing importance and visibility of a range of initiatives led by businesses, social organisations and governments, with the stated aim of pressuring companies to behave in more socially responsible and accountable ways. This is a new development for many parts of the business world. Previously, the state (or government) was assumed to lead standard setting and behavioural norms for businesses in relation to most categories of stakeholders. When community organisations and interest groups wanted to change business behaviour, they focussed on changing the law. From the 1990s the focus changed, reflected in the emergence of new alliances and regimes of influence over business norms, linking together consumers, communities, workers and producers. What is the difference between corporate social responsibility (CSR) and corporate accountability? Corporate responsibility, corporate social responsibility (CSR) and corporate accountability are sometimes confused or seen to be synonymous. However, corporate responsibility and corporate accountability are typically distinguished from one another along several lines. Corporate responsibility in its broadest sense refers to varied practices that reflect the belief that corporations have responsibilities beyond generating profit for their shareholders. Such responsibilities include the negative duty to refrain from harm caused to the environment, individuals or communities, and sometimes also positive duties to protect society and the environment, for example protecting human rights of workers and communities affected by business activities. Such responsibilities are generally considered to extend not only to direct social and environmental impacts of business activity, but also to more indirect effects resulting from relationships with business partners, such as those involved in global production chains. -
The Challenge of Compliance in Life Sciences Moving from Cost to Value
The challenge of compliance in life sciences Moving from cost to value To start a new section, hold down the apple+shift keys and click to release this object and type the section title in the box below. Contents Foreword 1 Executive summary 3 Overview of compliance 4 Compliance insights 6 The future of compliance 18 Glossary 19 Contacts 20 The Deloitte Centre for Health Solutions The Deloitte Centre for Health Solutions, part of Deloitte UK, generates insights and thought leadership based on the key trends, challenges and opportunities within the healthcare and life sciences industry. Working closely with other centres in the Deloitte network, including the US centre in Washington, our team of researchers develop ideas, innovations and insights that encourage collaboration across the health value chain, connecting the public and private sectors, health providers and purchasers, and consumers and suppliers. In this publication, references to Deloitte are references to Deloitte LLP, the UK member firm of DTTL. To start a new section, hold down the apple+shift keys and click to release this object and type the section title in the box below. Foreword Welcome to the Deloitte UK Centre for Health Solutions’ report on The challenge of compliance in life sciences: Moving from cost to value. Seeing the challenges that life sciences clients face in responding to an increasingly complex regulatory environment led us to launch an independent research initiative which set out to identify: • how well the industry understands the totality of its compliance risks • how compliance is managed and implemented within life sciences companies • what the future of compliance looks like. -
How to Replace
REPLACING GDP BY 2030 CAMBRIDGE UNIVERSITY PRESS BY RUTGER HOEKSTRA METRICSFORTHEFUTURE.COM The creation of the “GDP-multinational” The Ascent Golden Age Contested Hegemony Demise? 200 180 160 140 120 Studenski 100 United Nations 80 60 40 20 0 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 What happened in the “Golden Age”? Community Features Macro-economics (GDP multinational) Goal Economic Growth Community Policy Science Macro-economics Structure Accounting Framework System of National Accounts Key Indicator Gross Domestic Product Common Language System of National Accounts Institutionalisation √ But GDP is not a measure of well-being, inequality or sustainability “Beyond-GDP cottage industry” A selection of the many terms Adjusted Savings, Affect, A-growth, Basic Needs, Beyond-GDP, Carbon footprint, Capabilities, Capital Approach, Circular Economy, Comprehensive Wealth, Corporate Social Responsibility (CSR), Cradle-to-Cradle, Current Wellbeing, Degradation, Depletion, De-Growth, Distribution, Ecological footprint, Economic wellbeing, Eco-System Services, Environmental Accounts, Footprint, Functionings, Genuine Progress Indicator (GPI), Genuine Savings, Green Economy, Green Growth, Human Capital, Human Development Index (HDI), Human wellbeing, Inclusive Growth, Index of Social Economic Welfare (ISEW), Inclusive Wealth, Industrial ecology, Industrial Symbiosis, Inequality, Integrated Reporting, Investment, Life cycle analysis, Life satisfaction, Material flow analysis, Natural Capital, Natural Capital Accounting, Needs, Planetary -
Corporate Social Responsibility (CSR) 2016
Statutory report on Corporate Social Responsibility (CSR) 2016 Statutory report on Corporate Social Responsibility for the financial year 2016 cf. Section 99a and 99b of the Danish Financial Statements Act1. This report is a supplement to the Management’s review in the Annual Report 2016 covering the period January 1 – December 31, 2016. 1In Danish ‘Lovpligtig redegørelse for samfundsansvar, jf. årsregnskabsloven §99a og 99b’ Zealand Pharma A/S Smedeland 36 2600 Glostrup Denmark Corporate Social Responsibility (CSR) Report for 2016 Acting as a responsible part of society is a cornerstone in the way we conduct our business. Our behavior should benefit the patients we strive to help, our employees, shareholders and the wider community. Zealand and CSR Our Corporate Social Responsibility (CSR) work is an integrated part of Zealand’s business, and the efforts in this area are based on our core values. We believe that Zealand has an obligation to be socially responsible in order to benefit not only our main stakeholders, mainly shareholders, patients and employees, but also society. A key focus for us across our business is to have open, engaging and respectful communication with all our stakeholders. Our CSR efforts are based on the most common elements of some of the most widely implemented CSR initiatives in the world, notably the Global Reporting Initiative (GRI) and the United Nations Global Compact. Within these two systems, Zealand has found complementary frameworks for both guiding and reporting its CSR activities, along with several principles in the areas of labor, e environment, human rights and anticorruption. In addition to these, we have added a provisional category for animal rights, given the unique requirements of our industry. -
Social Responsibilities of Business and Business Ethics
CHAPTER 6 SOCIAL RESPONSIBILITIES OF BUSINESS AND BUSINESS ETHICS LEARNING OBJECTIVES After studying this chapter, you should be able to: • explain the concept of social responsibility; • discuss the need for social responsibility; • identify the social responsibility towards different interest groups; • analyse the relationship between business and environmental protection; and • define the concept of business ethics and state the elements of business ethics. 2021-22 Chapter 6.indd 139 31-12-2020 11:55:58 140 BUSINESS STUDIES Mani is a young newspaper reporter and has been writing for almost six months on malpractices by business enterprises including such issues as misleading advertisements, supply of adulterated products, poor working conditions, environmental pollution, bribing government officials, and so on. He has started believing that business people tend to do anything to mint money. He happens to take an interview of Mr. Raman Jhunjhunwala, chairman of a leading truck manufacturing company which is known for its fair dealing with customers, employees, investors as well as other social groups. Through this interview, Mani develops the understanding that it is possible for a business enterprise to be socially responsible and ethically upright and, at the same time, be highly profitable. He then gets busy with studying more about the social responsibility of business and business ethics. 6.1 INTRODUCTION working conditions, honestly paying taxes prevention/installing pollution A business enterprise should do devices in the factory, and sincerely business and earn money in ways that attending to customer complaints are fulfill the expectations of the society. examples of socially desirable practices Every individual living in society has which improve the image of enterprises certain obligations towards society. -
Psychological Well-Being of College Students: Validation of the Personal-Social Responsibility and Wellness Module
Journal of Educational and Human Resource Development 8:59-70 (2020) Southern Leyte State University, Sogod, Southern Leyte, Philippines Psychological Well-Being of College Students: Validation of the Personal-Social Responsibility and Wellness Module *Gino A. Cabrera, Helene D. Daya Noreen P. Echague Southern Luzon State University Lucban, Quezon, Philippines Abstract The present study is the second phase of an earlier study that identified the psychological well-being (PWB) of college students in a state university in Quezon Province, Philippines. The findings of the previous study served as the basis for formulating and developing the Personal-Social Responsibility and Wellness (PSRW) course module, which is integrated into the new college curricula as a 3-unit subject. The course module aims to increase wellness and well-being among the students to cope with the demands of college life positively. This present study is the validation of the developed module. The validation is carried out using a combination of an ex post facto research that intends to measure the effectiveness of the course module in enhancing the PWB of the students and a predictive cross-sectional study to ascertain the socio-demographic predictors of PWB. This research involves 676 first-year students from six colleges of the main campus and eight satellite campuses of the university. Using Ryff’s PWB scale as pre- and post-test, paired sample t-test indicated a significant change in the six PWB dimensions such as autonomy, environmental mastery, personal growth, positive relations, purpose in life, and self-acceptance, and overall PWB of the students. Henceforth, results suggest the continued use of the developed evidence-informed module.