The document outlines the Queensland Government's new Regulatory Strategy being implemented by the Department of Environment and Heritage Protection. The strategy aims to streamline approvals processes, focus compliance activities on higher environmental risks, and take strong and consistent enforcement action against non-compliant operators. It emphasizes clear communication with industry to help them better understand and meet their environmental obligations. The department will set standards to protect the environment while providing flexibility for innovative solutions, and monitor performance to ensure standards are achieved.
This document provides guidance on common conditions that may be applied to environmental authorities for prescribed environmentally relevant activities in Queensland. It outlines the obligations under the Environmental Protection Act 1994, common offences, and provides definitions of key terms. The common conditions cover general, air, noise, water, waste, and land issues. The document is intended to help potential environmental authority holders understand the standard conditions they may be subject to and encourage appropriate management of environmental risks.
Consultation on “Guidance on variations to biologicals included in the Register”TGA Australia
An overview of the open consultation on “Guidance on variations to biologicals included in the Register” including a summary of major changes from the previous version of the guidance.
Canadian policy for combination (drug / device) productsJasmin NUHIC
The purpose of this policy is to ensure timely access to drug/medical device combination products by
establishing a single window approach and more efficient submission processing system, while ensuring
that combination products marketed in Canada are safe, effective, and of high quality.
The Trials and Tribulations of Combination Product Developmentsteverabin
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
This document discusses biovigilance, which refers to the science and activities related to monitoring biological products for adverse events and quality issues. It provides definitions for biological products and outlines the regulatory framework in Australia. The responsibilities of sponsors to report adverse events, recalls, and maintain traceability systems are described. Examples of adverse events reported for tissue products are given. The document notes that draft biovigilance guidance has been developed and will undergo public consultation before being finalized.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
International Overview & Future Medical Devices Regulationsmdbio2009
This document provides an overview of medical device regulations internationally, including in Canada, the United States, Europe, Australia, and Asia. It discusses key regulatory bodies and requirements in each region. It also summarizes Canada's 2007-2012 strategies to modernize its regulatory framework and program, strengthen human resources and funding, improve governance, and foster stakeholder partnerships. Recognition of standards and relationships between different quality systems are also covered. The presentation aims to help organizations understand and navigate international medical device regulations.
The Implementation of ICH Development Safety Update Report (DSUR) GuidanceAngelo Tinazzi
The document summarizes a presentation about implementing the ICH Development Safety Update Report (DSUR) guidance. It discusses:
- The background and overview of the new ICH DSUR guidance, including its history and key points.
- Implications for study sponsors, including streamlining multiple reports into a single DSUR and establishing standardized processes.
- Components of DSUR implementation, such as developing a clinical trials inventory, extracting and managing data, and mapping data for analysis outputs.
This document provides guidance on common conditions that may be applied to environmental authorities for prescribed environmentally relevant activities in Queensland. It outlines the obligations under the Environmental Protection Act 1994, common offences, and provides definitions of key terms. The common conditions cover general, air, noise, water, waste, and land issues. The document is intended to help potential environmental authority holders understand the standard conditions they may be subject to and encourage appropriate management of environmental risks.
Consultation on “Guidance on variations to biologicals included in the Register”TGA Australia
An overview of the open consultation on “Guidance on variations to biologicals included in the Register” including a summary of major changes from the previous version of the guidance.
Canadian policy for combination (drug / device) productsJasmin NUHIC
The purpose of this policy is to ensure timely access to drug/medical device combination products by
establishing a single window approach and more efficient submission processing system, while ensuring
that combination products marketed in Canada are safe, effective, and of high quality.
The Trials and Tribulations of Combination Product Developmentsteverabin
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
This document discusses biovigilance, which refers to the science and activities related to monitoring biological products for adverse events and quality issues. It provides definitions for biological products and outlines the regulatory framework in Australia. The responsibilities of sponsors to report adverse events, recalls, and maintain traceability systems are described. Examples of adverse events reported for tissue products are given. The document notes that draft biovigilance guidance has been developed and will undergo public consultation before being finalized.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
International Overview & Future Medical Devices Regulationsmdbio2009
This document provides an overview of medical device regulations internationally, including in Canada, the United States, Europe, Australia, and Asia. It discusses key regulatory bodies and requirements in each region. It also summarizes Canada's 2007-2012 strategies to modernize its regulatory framework and program, strengthen human resources and funding, improve governance, and foster stakeholder partnerships. Recognition of standards and relationships between different quality systems are also covered. The presentation aims to help organizations understand and navigate international medical device regulations.
The Implementation of ICH Development Safety Update Report (DSUR) GuidanceAngelo Tinazzi
The document summarizes a presentation about implementing the ICH Development Safety Update Report (DSUR) guidance. It discusses:
- The background and overview of the new ICH DSUR guidance, including its history and key points.
- Implications for study sponsors, including streamlining multiple reports into a single DSUR and establishing standardized processes.
- Components of DSUR implementation, such as developing a clinical trials inventory, extracting and managing data, and mapping data for analysis outputs.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
5 Critical Areas of Combination Drug CompliancePeter Dellva
This slideshare walks through five critical areas of combination drug compliance including: What is 21 CFR Part 4, FDA’s Office of Combination Products, Compliance for legacy combination products, Stability study strategy and more
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Presentation: The Australian and International landscape - keynote forumTGA Australia
This document summarizes a keynote forum on the Australian and international regulatory landscape presented at the 2017 ARCS Annual Conference. It discusses several topics, including an increasing number of oncology drugs and trials, new pathways for priority and provisional drug approvals in Australia and comparisons to other countries, regulation of biosimilars and orphan drugs, clinical trial complexity, and developments in medical device and software regulation. It also touches on issues of regulatory transparency and uncertainties from Brexit.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
How PerkinElmer became world's market leader?, Marika KaseBusiness Turku
PerkinElmer has become the world leader in newborn screening through long-term investments, partnerships focusing on customer needs, and expanding their product range and geographic coverage. They have screened over 522 million babies cumulatively. Currently, PerkinElmer screens 37 million babies annually and helps save around 24,000 babies per year from various treatable conditions. PerkinElmer provides a complete solution for newborn screening including sample collection, processing, measuring, data processing and consulting services to support screening programs around the world.
Adoption of the pics guide to gmp pe009 13TGA Australia
The document discusses the adoption of the latest version of the PIC/S Guide to GMP by the Australian regulatory authority. Key points include:
- Australia aims to adopt the latest international GMP standards to maintain equivalence and assurance for international markets.
- The timeline for adoption includes notifying industry in 2017/2018 and full implementation by January 2019.
- Major changes in the new PIC/S Guide include new requirements for quality manuals, increased emphasis on senior management involvement, additional responsibilities for quality roles, and clarification of document and data integrity standards.
- Annex 15 on validation was expanded to provide more detail on validation master plans and checks to ensure data integrity.
Cutter PTCA catheter Regulatory strategy for PMDA submission_12-7-11_FINAL-1Prajakta Buva
This presentation discusses the regulatory strategy for obtaining approval of the Cutter PTCA dilation catheter in Japan. It outlines goals of obtaining the fastest approval as possible. Key steps include obtaining Foreign Manufacturer Accreditation licenses, preparing a submission dossier, conducting audits, and consulting with the PMDA. Challenges include missing technical data and non-compliance with some Japanese standards. Options to expedite approval include partial change application or pre-consultation meetings. The timeline aims for approval by June 2012 but risks delay depending on the pathway chosen and ability to resolve issues. Launch of the improved Cutter catheter could significantly increase sales and operating income for 2012.
Complying with Wearable Health Device RegulationTGA Australia
The document discusses regulations for wearable health devices in Australia. It provides an overview of the Therapeutic Goods Administration (TGA), which regulates medical devices to ensure safety, quality and performance. The TGA evaluates devices before and after market access. It also outlines what classifies a device as medical and subject to regulation, and the process for including a device on the Australian Register of Therapeutic Goods (ARTG). Higher risk devices receive more scrutiny. Manufacturers must comply with essential principles for design and safety, and report any issues with devices.
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
The document discusses proposed expedited pathways for prescription medicines in Australia, including a Priority Review pathway. It outlines proposed eligibility criteria focusing on serious conditions with unmet needs where the medicine provides a major therapeutic advantage.
A draft designation process is presented involving assessment of eligibility criteria within 6-8 weeks. Designations would lapse if no registration submission is made within 3 months. Appeals of designation decisions are proposed.
Priority Review is aimed to complete assessments in 150 working days through flexible business processes and expert advice. Provisional Approval could grant earlier conditional registration based on early safety and efficacy data, with enhanced post-market monitoring required. Public consultation on
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
The document outlines the regulatory strategy for a new drug to treat onychomycosis. The goals are FDA approval in the US and determining proper dosing for human use. Assumptions are made about manufacturing, efficacy, safety, and testing. A risk management plan is presented. Current activities include dossier review and market analysis. The timeline outlines chemistry, manufacturing, controls, preclinical testing including toxicology and animal studies, and regulatory submissions.
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Mar...NAMSA
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets is the first of many Remote Training Series that NAMSA does. This first series discusses and evaluates emerging markets and the opportunities and challenges that follow.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
5 Critical Areas of Combination Drug CompliancePeter Dellva
This slideshare walks through five critical areas of combination drug compliance including: What is 21 CFR Part 4, FDA’s Office of Combination Products, Compliance for legacy combination products, Stability study strategy and more
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
Presentation: The Australian and International landscape - keynote forumTGA Australia
This document summarizes a keynote forum on the Australian and international regulatory landscape presented at the 2017 ARCS Annual Conference. It discusses several topics, including an increasing number of oncology drugs and trials, new pathways for priority and provisional drug approvals in Australia and comparisons to other countries, regulation of biosimilars and orphan drugs, clinical trial complexity, and developments in medical device and software regulation. It also touches on issues of regulatory transparency and uncertainties from Brexit.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
How PerkinElmer became world's market leader?, Marika KaseBusiness Turku
PerkinElmer has become the world leader in newborn screening through long-term investments, partnerships focusing on customer needs, and expanding their product range and geographic coverage. They have screened over 522 million babies cumulatively. Currently, PerkinElmer screens 37 million babies annually and helps save around 24,000 babies per year from various treatable conditions. PerkinElmer provides a complete solution for newborn screening including sample collection, processing, measuring, data processing and consulting services to support screening programs around the world.
Adoption of the pics guide to gmp pe009 13TGA Australia
The document discusses the adoption of the latest version of the PIC/S Guide to GMP by the Australian regulatory authority. Key points include:
- Australia aims to adopt the latest international GMP standards to maintain equivalence and assurance for international markets.
- The timeline for adoption includes notifying industry in 2017/2018 and full implementation by January 2019.
- Major changes in the new PIC/S Guide include new requirements for quality manuals, increased emphasis on senior management involvement, additional responsibilities for quality roles, and clarification of document and data integrity standards.
- Annex 15 on validation was expanded to provide more detail on validation master plans and checks to ensure data integrity.
Cutter PTCA catheter Regulatory strategy for PMDA submission_12-7-11_FINAL-1Prajakta Buva
This presentation discusses the regulatory strategy for obtaining approval of the Cutter PTCA dilation catheter in Japan. It outlines goals of obtaining the fastest approval as possible. Key steps include obtaining Foreign Manufacturer Accreditation licenses, preparing a submission dossier, conducting audits, and consulting with the PMDA. Challenges include missing technical data and non-compliance with some Japanese standards. Options to expedite approval include partial change application or pre-consultation meetings. The timeline aims for approval by June 2012 but risks delay depending on the pathway chosen and ability to resolve issues. Launch of the improved Cutter catheter could significantly increase sales and operating income for 2012.
Complying with Wearable Health Device RegulationTGA Australia
The document discusses regulations for wearable health devices in Australia. It provides an overview of the Therapeutic Goods Administration (TGA), which regulates medical devices to ensure safety, quality and performance. The TGA evaluates devices before and after market access. It also outlines what classifies a device as medical and subject to regulation, and the process for including a device on the Australian Register of Therapeutic Goods (ARTG). Higher risk devices receive more scrutiny. Manufacturers must comply with essential principles for design and safety, and report any issues with devices.
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
The document discusses proposed expedited pathways for prescription medicines in Australia, including a Priority Review pathway. It outlines proposed eligibility criteria focusing on serious conditions with unmet needs where the medicine provides a major therapeutic advantage.
A draft designation process is presented involving assessment of eligibility criteria within 6-8 weeks. Designations would lapse if no registration submission is made within 3 months. Appeals of designation decisions are proposed.
Priority Review is aimed to complete assessments in 150 working days through flexible business processes and expert advice. Provisional Approval could grant earlier conditional registration based on early safety and efficacy data, with enhanced post-market monitoring required. Public consultation on
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
The document outlines the regulatory strategy for a new drug to treat onychomycosis. The goals are FDA approval in the US and determining proper dosing for human use. Assumptions are made about manufacturing, efficacy, safety, and testing. A risk management plan is presented. Current activities include dossier review and market analysis. The timeline outlines chemistry, manufacturing, controls, preclinical testing including toxicology and animal studies, and regulatory submissions.
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Mar...NAMSA
Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets is the first of many Remote Training Series that NAMSA does. This first series discusses and evaluates emerging markets and the opportunities and challenges that follow.
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
BA401 Eli Lilly And Company Drug Development Strategytbsmali
The document summarizes Eli Lilly and Company's drug development strategy in the mid-1990s. It provides context on the global pharmaceutical industry and Lilly's position as one of the largest pharmaceutical companies at the time. It then describes Lilly's focus on developing drugs for central nervous system diseases like depression, insomnia, and migraine. Specifically, it outlines Lilly's project using combinatorial chemistry to develop a new migraine drug to target serotonin receptors without vasoconstriction side effects, like their existing drug Imitrex. The summary highlights Lilly's innovation in combinatorial chemistry and focus on developing new drugs for major diseases affecting many people.
The document discusses key aspects of developing a global regulatory strategy for drug development and registration. It outlines the long development timeline and costs to bring a drug to market. It also describes the regulatory approval processes in the US, EU and Japan, including application formats, timelines and opportunities to expedite review of important new drugs. Developing an integrated global strategy from early research can help optimize the development plan and registration across regions.
Regulatory framework for new drug developmentDr. Mohit Kulmi
The regulatory framework for new drug development involves a lengthy multi-step process including drug discovery, pre-clinical research, and clinical trials on humans to test safety and efficacy. Key aspects of the framework include guidelines from the International Conference on Harmonisation (ICH) to harmonize technical requirements globally, oversight of clinical trials by institutional review boards, and Good Clinical Practice (GCP) standards to ensure trials are scientifically sound and respect participants. The overall goal is to develop new medications efficiently and ethically while protecting human subjects.
This document is a CV for Leigh Baker that provides information about her qualifications, experience, and objectives. Baker has over 15 years of experience in health, safety, environment, and quality roles. She is currently a Health, Safety and Environment Advisor on contract at the Wellcome Trust in London, where her responsibilities include advising staff, conducting inspections and audits, and managing documentation. Previously she held roles at Johnson Controls and Emcor Facilities Services, where she implemented environmental management systems and led audits and training. Baker has numerous qualifications in areas such as NEBOSH, ISO standards, and environmental management. Her objective is to utilize her experience in health, safety, environmental, sustainability and quality.
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This document summarizes a unit on cleaner production from the Saltillo Technological Institute's distance education program. It discusses the principles and phases of cleaner production, as well as practices, barriers, and benefits. Cleaner production aims to conserve resources and reduce waste and pollution in production processes, products, and services. It can increase efficiency and sustainability. The document also provides several case studies on industries that implemented cleaner production strategies to reduce their environmental impact and become more sustainable and efficient.
This document outlines the Emissions Reduction Fund method for reducing emissions in commercial buildings. It describes how building owners can undertake energy efficiency upgrades like installing more efficient lighting or appliances. Participants earn carbon credits by having the building's energy usage rated before and after upgrades using the National Australian Built Environment Rating System. Eligible commercial buildings must be office, hotel, or shopping center buildings. Participants must keep records of their project and have yearly ratings and a final audit conducted by an approved auditor.
How Sustainability management and the GRI structure can benefit your companyNico Smit
This document discusses sustainability reporting and management. It outlines the advantages of adopting GRI sustainability standards, including risk mitigation and improved performance. It emphasizes the importance of establishing departmental objectives, metrics, and targets to monitor sustainability efforts across an organization. Key benefits mentioned include increased revenues, reduced costs, and less profit erosion from implementing sustainability practices.
The document discusses the benefits of environmental impact assessments (EIAs). It outlines 5 main benefits: 1) better environmental planning and design of projects, 2) ensuring compliance with environmental standards, 3) savings in capital and operating costs, 4) reduced time and costs of project approvals, and 5) increased project acceptance by the public. It also discusses key principles of EIAs, including that they should be purposive, focused, adaptive, participative, transparent, rigorous, practical, credible, and efficient. Finally, it outlines the main stakeholders involved in EIAs, including proponents, government agencies, NGOs, interested groups, and affected communities.
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
Exploring the intricacies of environmental monitoring in Uganda's industrial landscape, this comprehensive guide navigates readers through the crucial steps and considerations for fostering sustainable development. From establishing clear objectives to embracing self-environmental monitoring trends, the article emphasizes the pivotal role of ongoing monitoring practices in safeguarding ecosystems and ensuring regulatory compliance. ASK Eco-Capital Services Uganda Limited leads the discourse, shedding light on emerging trends and best practices, empowering stakeholders to advance environmental stewardship and build a greener, more resilient future.
An environmental management system offers a structured approach to incorporate environmental care into all aspects of business operations. Key benefits include achieving regulatory compliance, improving corporate image and competitive advantage. Factors like legislation, stakeholder pressures, and financial risks motivate organizations to adopt environmental management systems. ISO 14001 provides an international standard for environmental management systems that establishes requirements and guidelines.
The document discusses biodiversity offsets in British Columbia and outlines some of the successes and challenges with the provincial policy. It provides background on drivers of environmental mitigation policy including a lack of consistent standards. General principles of offsets are described such as delivering measurable outcomes additional to existing programs. The trial application led to successes like greater transparency and consistency in mitigation planning. Challenges included ensuring the legal authority to conduct offsets off permitted areas and clarifying what makes offsets additional. Moving forward focuses on addressing challenges through continued engagement and strategic approaches.
The document outlines an environmental management system for a leather tanning industry. It discusses establishing a statement of intent, committing to continual improvement and pollution prevention, complying with environmental regulations, adhering to sector codes of practice, aligning with parent company policies, setting measurable objectives and targets, implementing the system, maintaining it through audits and reviews, communicating it to employees and the public, and making it available publicly. The key aspects of the system are minimizing environmental impacts, promoting sustainability, reducing chemical usage and spillage, implementing safety practices, establishing emergency response plans, investing in prevention technologies, and monitoring and reporting on progress.
A PRACTICAL GUIDE TO ENVIRONMENTAL PERMITS AND LICENSES: NAVIGATING UGANDA'S ...Semakula Allan Kinene
Picture this – Environmental Permits and Licenses as your passport to a world where responsible development harmonizes with Mother Nature. These are not mere documents; they are your commitment to sustainable practices, endorsed by the regulatory authority, NEMA.
In this document, we'll embark on a journey through the lush landscapes of Uganda's environmental regulations, uncovering the secrets behind Environmental Permits and Licenses. Get ready to explore the "what," "why," "by who," "when," and "how" with us!
Understanding the Essence of Environmental Permits and Licenses.
Cleaner Production - it is the major advancement in the chemical industry or in all sectors. I have provided this file its all about TEXTILE INDUSTRIES with CP. So go through it.
Ensuring Environmental Compliance: Debt Collection Agencies in CaliforniaCedar Financial
Discover the imperative need for debt collection agencies in California to align with stringent environmental regulations. This comprehensive analysis highlights the significance of sustainable practices, waste management protocols, and eco-friendly strategies for debt collection operations. Gain insights into the legal requirements, environmental policies, and green initiatives essential for ensuring environmental compliance within the debt collection industry in the state of California.
Green Logistics Why Business Organizations Should Consider it More Often.pdfMr. Business Magazine
Green logistics is the practice when business organizations take a step to minimise the environmental impact when they are distributing their products or services.
Imagine that you are talking to a friend about pursuing a job in tLizbethQuinonez813
Imagine that you are talking to a friend about pursuing a job in the criminal justice system.
Write a 400 word response describing the conflict between due process and crime control models. No works cited page. Address the following:
· Describe the differences between the formal and informal social control.
· Define the 2 models: crime control and due process.
· Describe the conflict between the models.
· Which one do you think your local community represents?
· How might the emphasis on human services impact the conflict between due process and control?
1
Sample Executive Summary: Sunco
I.M. Student
The University of Arizona Global Campus
BUS 123: Principles in Business
Professor Tough
May 15, 2050
*This sample was adapted by the UAGC Writing Center from an original paper by a student. Used by permission.
An executive summary is a concise summary of a business report. It restates the purpose of the report, it highlights
the major points of the report, and it describes any results, conclusions, or recommendations from the report.
An executive summary should be aimed at an audience that is interested in and wants to learn more about the
purpose of the main business report.
An executive summary should…
• Be presented as a document that can stand on its own
• Be one to three pages, depending on the length of the report
Note: For academic purposes, a title page is attached to the executive
summary. In the professional world, however, this is not required.
http://writingcenter.uagc.edu/introduction-apa
2
Sample Executive Summary: Sunco
Through partnering with utility companies and other energy regulators, Sunco can make
renewable energy a dependable option for our customers. The opportunity, recommendation,
timeline, and cost are provided in this report.
Opportunity
In the absence of a national “smart” grid, which would increase “pricing transparency,
as well as enable a host of consumer-producer interactive transactions” (Contreras, 2012, p.
645), we here at Sunco, as producers of renewable energy, have run into the problem of getting
our services to the customers who demand them. Similarly, our consumers who generate
renewable energy on-site from solar panels and wind turbines have also run into the problem of
permits, regulations, and service charges that vary from state to state and utility to utility (Ryor,
2014). Currently, the main challenge is convincing local utilities of the economic viability of
renewable energy, and since the energy supplied is undifferentiated, the general customer base
is unaware that other options exist.
Solution
Since we, as a company, lack the necessary knowledge and authority to enable our
services to be accessed and expedited in a way that would make them economically feasible in
the existing system, we seek to engage in a partnership with utilities and regulators arou ...
Financing Industry Decarbonization: Marcia Yu, IFC.pdfOECD Environment
This document summarizes a workshop on financing industry decarbonization held in April 2022. It discusses two main categories of sustainable finance - "use of proceeds" instruments and "target driven" sustainability-linked financings. For the latter, pricing is linked to achieving sustainability performance targets which are verified and can result in interest rate adjustments. The document also outlines strategic, transactional, and implementation support the International Finance Corporation can provide clients in developing decarbonization strategies and executing sustainable finance deals.
Environmental auditing originated in the 1970s in the US and was initially reactive, focusing on end-of-pipe solutions after environmental damage occurred. It is now a more proactive management tool to evaluate environmental performance, compliance, and management systems. Environmental audits are conducted according to standardized procedures and incorporate reviews, inspections, and reporting to facilitate improvement. They provide benefits like ensuring compliance and anticipating risks while demonstrating environmental awareness.
Michael Ng has over 15 years of experience in operations management, quarantine compliance, and project management across Australia, China, and Southeast Asia. He has a proven track record of establishing efficient operations, ensuring regulatory compliance, developing stakeholder relationships, and delivering projects on time and on budget. Ng's career highlights include managing quarantine operations for a large LNG project in Darwin, restructuring the quarantine program for a company in China, and establishing best practices as a senior quarantine officer in Sydney. He holds various qualifications in financial markets, project management, port security, and supervision.
3. 3
Foreword
The Department of Environment and Heritage Protection is responsible for managing the health of
Queensland’s environment, protecting its unique ecosystems, and conserving the state’s built heritage.
The department is also committed to enabling sustainable long-term economic development in Queensland.
The department’s vision is to be Australia’s most respected and responsive environment and heritage protection
regulator. Fundamental to this vision is strong risk-based regulation. The department’s regulatory approach
is outlined in this Regulatory Strategy, which addresses community expectations of strong environmental
management, as well as industry expectations of faster approvals and reduced regulatory burden.
There has already been a significant shift in the way the department’s environment and heritage regulatory
activities are being undertaken. This strategy builds on that shift by acknowledging that industry is best
placed to identify the most appropriate way to manage their activities to ensure environmental outcomes
are achieved and standards are maintained. This presents industry with a new opportunity to adopt
innovative approaches and to manage their activities to most effectively meet the standards or outcomes
set by government.
This approach will be complemented by the department’s adoption of a sophisticated and targeted
approach to identifying environmental risks, increasing compliance and taking strong enforcement action
where necessary.
The department’s role is to clearly articulate the environmental outcomes industry must achieve. Where the
risk to the environment is greatest, standards will be higher and if necessary, compliance and enforcement
actions stronger. Regulatory effort is directed towards reducing environmental risks through a robust
problem-solving approach to deliver real, measurable results. A wide range of regulatory tools will be used
to solve complex issues, for example the use of economic instruments to achieve environmental outcomes.
The department is focused on communicating with its customers and capitalising on risk-mitigation
opportunities through the establishment of cooperative partnerships. We will also collaborate with other
agencies, particularly with data systems, to enable more efficient delivery of many services.
Implementation of the Regulatory Strategy will ensure industry is able to prosper while ensuring Queensland’s
unique environment and heritage places are well-managed and protected now and into the future.
Jonathan (Jon) PC Black
Director-General
Department of Environment and Heritage Protection
4. 4
Introduction update
This Regulatory Strategy outlines the long-term vision for the Department of Environment and Heritage
Protection’s regulatory, compliance and enforcement activities.
This vision includes a regulatory framework which is responsive to the needs of the government,
industry and the community.
At its core this strategy reinforces the department’s objective of strong environmental management
supporting sustainable economic development.
Over time this strategy will set the direction for a significant cultural and operational change in the way
the department undertakes its role.
These activities will lead to:
ff a significant streamlining in application processes
ff an increased focus on effective and targeted compliance activities
ff a more consistent application of strong but proportionate enforcement activities
ff a formidable specialist knowledge base—linked to industry and academic partners—for all major
activities that pollute.
This strategy also acknowledges the growing importance of building an improved voluntary compliance
culture within industry.
To assist industry improve its compliance practices the department will set clear expectations about
acceptable standards of environmental performance, as well as publish easy to understand guidance
material and information to assist customers to meet their environmental obligations. The department will
not impose restrictive conditions about how environmental risks are to be managed, providing business
with enough scope to develop innovative environmental solutions.
This information will assist industry to better understand its responsibilities in achieving good environmental
practices, and give operators every opportunity to know what their environmental obligations are.
For those industry members who choose not to comply with their obligations, the department will be
consistent in taking prompt, strong enforcement action. This enforcement will provide assurance to the
vast majority of industry members that do act responsibly and meet their environmental obligations that
the department is consistently dealing with those who do not.
Critical to the strategy’s success is effective engagement with the department’s customers, their
industry associations and the supporting consulting industry—to ensure the new regulatory approach is
understood. This engagement will also include expanding the use of accredited third party auditors to
ensure that solutions developed by customers are appropriate and effective.
5. 5
What does the department regulate?
The department is responsible for Queensland’s environment and heritage protection laws and regulations
and regulates activities under the:
ff Coastal Protection and Management Act 1995
ff Environmental Protection Act 1994
ff Nature Conservation Act 1992
ff Queensland Heritage Act 1992
ff Sustainable Planning Act 2009
ff Waste Reduction and Recycling Act 2011
ff Water Act 2000 (Chapter 3)
How does regulation work?
The department’s many different types of regulatory activities can sometimes seem complicated.
These activities can be broken down in four simple stages.
They are:
1. Setting the standards that clients must meet.
2. Applying those standards to specific cases by assessing applications for approvals.
3. Monitoring the performance of activities that have been approved.
4. Responding to that performance, including by taking strong, proportionate and consistent
enforcement action.
Focus of
previous
regulatory
framework
Focus of new
regulatory
strategy
Setting the
standards
Applying the
standards
Monitoring
performance
Responding to
performance
6. 6
ff Consult with industry associations, peak bodies and community groups on regulatory matters that
affect their members.
ff Introduce measures to quantify the continued improvement in application processing times and
industry compliance.
ff Adopt new technologies, such as innovative remote sensing platforms, to help identify high risk
activities requiring closer on-ground scrutiny.
ff Publish regular compliance plans which outline priority compliance areas.
What activities will the department implement under its
Regulatory Strategy?
To help achieve the Regulatory Strategy’s vision the department will:
ff Introduce new policies and amendments to legislation to cut red tape and streamline processes
that are focused on strong environmental outcomes.
ff Develop easy to understand education and information material for clients and departmental
staff, including guidance on making and assessing applications, complying with the department’s
expectations and taking enforcement action.
ff Introduction of market-based incentives which will provide clients with greater flexibility to meet
their environmental obligations, for example, water quality offsets.
ff Distribute compliance alerts, prosecution bulletins and other information to clients, industry
associations, peak bodies and the community.
Benefits to industry Benefits to the environment
ff More certainty and consistency in approval conditions
ff Quicker approvals
ff More scope to develop innovative, low-cost
environmental solutions
ff Reduced compliance costs
ff More best practice environmental management measures
are adopted by industry
ff Assessment based on environmental risk
ff Allows increased proactive compliance
ff Greater education about environmental management
7. 7
Stage 1 – how does the department set the standards that
clients must meet?
Queensland’s environment and heritage protection laws outline the standards that different clients
must meet. In addition to these standards set down in law, there are also other standards set by the
department under various policies. These departmental standards are based on the latest available
science and consideration of the community’s expectations that the environment is protected from
undue harm by industry’s activities.
Guidance material will be published to assist clients in making applications and meeting the
department’s standards.
When the department prepares new legislation or amendments to legislation, or when it updates its
policies, it will consult appropriately with industry associations, peak industry groups and the community
to discuss the practical implications of any proposed changes. The department will encourage industries
to take responsibility for their members’ environmental performance and develop their own standards
of practice. The department will explore opportunities for co-regulation, for example, industry-led
development of Codes of Practice.
Department
standards
Consultation
Guidance material
published
Legislation Science
Community’s
expectations
Department’s responsibility Client’s responsibility
Clearly setting environmental outcomes for industry to meet
Implementing actions to meet the environmental
outcomes sought
8. 8
Stage 2 – how does the department assess applications?
To assess a new application the department will:
ff ask for information to assess the risks posed by the activity
ff set the environmental outcomes the client must meet by imposing wherever possible,
non-prescriptive conditions on approvals.
The department encourages clients to hold pre-lodgement meetings so that they can fully understand the
information that they must provide. If the information received is insufficient to assess the risk then the
application will normally be refused.
Information received by the department as part of an application will be accepted at face value. Except for
obvious errors or omissions, the department will not check the accuracy or sufficiency of information provided
by an applicant. If a client is found to have provided inaccurate or misleading information then appropriate
enforcement action, including prosecution, may be taken.
In making its decision on the application the department will either:
ff Approve the application and outline the environmental outcomes that the clients must achieve.
This will include setting release limits for activities with discharges to air, water or land. Except where
there is a high risk of harm occurring, the department will not outline “how” the client must achieve
these environmental outcomes. It is the responsibility of the client to assess the most efficient and
effective way to achieve these outcomes for their own particular circumstance.
ff Refuse the application. An application can be refused because the information supplied was
insufficient to allow appropriate conditions to be imposed or because the proposed activity
represents too great an environmental risk.
Pre-lodgement meeting
Write application
Lodge application
with department
Enforcement action
(including prosecution)
Client
Department of Environment
and Heritage Protection
Client cannot meet
outcomes due to
inaccurate or
misleading information
RefusedRefusedApproved
Environmental
outcomes outlined
Client to assess most
effective and efficient
way to achieve outcomes
Sufficient information
(taken at face value)
Insufficient
information
Too great an
environmental risk
Department’s responsibility Client’s responsibility
ff Make clear what information is required from applicants
ff Ask only for information that is necessary to decide
an application
ff Assess applications in the shortest time possible
ff Provide accurate, complete information to support
an application
9. 9
Stage 3 – how does the department monitor the
performance of individual activities?
To ascertain whether clients are complying with their conditions and other legal obligations, the
department will monitor their performance. The department will increase the amount of time it spends
monitoring client performance, as it reduces the amount of time it spends assessing applications.
Monitoring activities carried out by the department will include desktop audits and inspections of sites
that have an approval from the department. The department will also use new technologies to assist in
identifying those who are not achieving the environmental outcomes.
The department will be targeted and transparent in deciding which industries or activities will be the focus
of its compliance activities. It will be targeted by identifying the areas where breaches of its legislation
pose the greatest risk to the environment or heritage places and taking action to reduce that risk. It will be
transparent by publishing information about which areas it is focusing on and what it is doing about them
in compliance plans.
The department will monitor client performance based on risk. Where individual clients represent a higher
risk to the environment because of their poor performance, the department will check their compliance
more frequently. Where a client consistently demonstrates good performance and manages its risk
appropriately, the department will acknowledge that good performance and lower risk by conducting less
frequent inspections.
Education and information sharing will also be a focus to highlight best practice opportunities to
improve performance.
Frequency of monitoring
Best practice
Unacceptable
performance
Goal
performance
Acceptable
performance
Non-compliance and
enforcement action
Meets departmental
standards
Industry innovation
encouraged to exceed
acceptable performance
High Medium Low
Department’s responsibility Client’s responsibility
ff Identify areas of greatest risk and target its
resources accordingly
ff Reduce the regulatory burden on good performers,
increase the consequences for poor performers
ff Communicate compliance focus and actions
ff Educate and share information on best practice
environmental management
ff Monitor its own performance
ff Respond to risks before they become problems
ff Notify the department of serious incidents
10. 10
Stage 4 – how does the department respond
to performance?
It is the goal of the department to foster a positive culture of compliance within industry.
To ensure clients do the right thing the department will make available easy to understand education
resources and information guidelines to help them better understand their responsibilities.
Whilst the vast majority of clients are responsible and endeavour to achieve or go beyond their
environmental requirements, there will be occasions where some clients fail to meet their obligations.
If the department finds that a client has broken the law, it will take action to bring the client back into
compliance with its obligations. This may mean providing an opportunity for the client to voluntarily fix
the problem, or taking enforcement action in accordance with the department’s enforcement guidelines.
This enforcement action can include warnings, penalty infringement notices and prosecutions.
Where necessary to stop unlawful harm to the environment or a heritage place, the department will require
someone to do, or not do, certain things to prevent harm from occurring. This may include stopping an
activity or suspending an approval until the department is satisfied that the activity will be properly managed.
The department will provide information to industry and the community on its compliance and enforcement
actions by publishing compliance alerts and prosecution bulletins.
Department’s responsibility Client’s responsibility
ff Take enforcement action quickly, fairly and in
accordance with the enforcement guidelines
ff Make clients aware of the consequences of breaking
the law
ff Cooperate with the department
ff Take action to fix the consequences of an incident that
causes harm to the environment or a heritage place
11. 11
How will the department measure whether the Regulatory
Strategy is successful?
The department will introduce a suite of measures to quantify the effectiveness of its
Regulatory Strategy including:
ff obtaining feedback via targeted questionaires from clients in relation to the quality
of information being provided by the department, and provide departments performance
ff monitoring application processing times to ensure a reduction in overall processing time
ff monitoring compliance activities against performance indicators in the department’s
compliance plan
ff monitoring compliance of the activities the department regulates
ff tracking improvements to environmental standards
ff tracking progress of sustainable economic growth.
Where else can I find information on the department’s
regulatory activities?
The department’s website—www.ehp.qld.gov.au—will be continually updated as new activities under
the Regulatory Strategy are implemented, including the delivery of new education and information tools.