The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices.
Documentation Requirements for Combination Products EU - Combination Products...John Robinson
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.
Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.
The document provides information about a candidate's skills and qualifications for a position. It includes summaries of their education history with modules completed in areas like DNA analysis and protein purification. It also lists work experience in microbiology and quality control roles. Key skills mentioned are proficiency in lab techniques and IT programs as well as providing private tuition classes. Research projects are summarized covering evaluation of drug regulation in Europe and developing a business plan for a biofertilizer company.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
This document describes the cell and gene therapy development services offered by Covance, including expertise across preclinical, clinical, and post-approval phases to help reduce time and risks. Services include in vitro and in vivo studies, biomarkers, clinical trials, regulatory consulting, and commercialization support. Covance has experience helping develop the first two FDA-approved gene replacement therapies and both approved CAR-T therapies.
Dear students get fully solved assignments
Send your semester & Specialization name to our mail id :
help.mbaassignments@gmail.com
or
Call us at : 08263069601
This document provides a summary and market analysis of potential vaccines to treat opioid use disorder (OUD). It contains a 140-slide presentation and accompanying Excel workbook forecasting the potential market size and revenues for OUD vaccines in major western markets through 2045 under three scenarios. The document reviews the global OUD epidemic, current treatments, prevention strategies, vaccine technologies in development, and competitive landscape. It models vaccine uptake, pricing, and revenues to inform those seeking to understand the business potential for an OUD vaccine.
Presentation: Advertising therapeutic goods to consumers TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices.
Documentation Requirements for Combination Products EU - Combination Products...John Robinson
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.
Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.
The document provides information about a candidate's skills and qualifications for a position. It includes summaries of their education history with modules completed in areas like DNA analysis and protein purification. It also lists work experience in microbiology and quality control roles. Key skills mentioned are proficiency in lab techniques and IT programs as well as providing private tuition classes. Research projects are summarized covering evaluation of drug regulation in Europe and developing a business plan for a biofertilizer company.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
This document describes the cell and gene therapy development services offered by Covance, including expertise across preclinical, clinical, and post-approval phases to help reduce time and risks. Services include in vitro and in vivo studies, biomarkers, clinical trials, regulatory consulting, and commercialization support. Covance has experience helping develop the first two FDA-approved gene replacement therapies and both approved CAR-T therapies.
Dear students get fully solved assignments
Send your semester & Specialization name to our mail id :
help.mbaassignments@gmail.com
or
Call us at : 08263069601
This document provides a summary and market analysis of potential vaccines to treat opioid use disorder (OUD). It contains a 140-slide presentation and accompanying Excel workbook forecasting the potential market size and revenues for OUD vaccines in major western markets through 2045 under three scenarios. The document reviews the global OUD epidemic, current treatments, prevention strategies, vaccine technologies in development, and competitive landscape. It models vaccine uptake, pricing, and revenues to inform those seeking to understand the business potential for an OUD vaccine.
Presentation: Advertising therapeutic goods to consumers TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
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.
This document discusses the information available to patients once a medicine is authorized, including the product information and European Public Assessment Report (EPAR). It outlines the involvement of patients and consumers in reviewing elements of product information like package leaflets and EPAR summaries. The review process aims to ensure information is clear, understandable, and meets public needs. Patient and consumer organizations provide input on draft documents to assess language use, explanations, and identify unnecessary or missing information from a lay perspective. Their comments notably differ from other reviews and often lead to text changes or revisions for future documents.
The Committee for Orphan Medicinal Products (COMP) is an agency of the European Union that provides opinions on orphan drug designation. COMP is composed of one elected chair, a vice chair, one representative from each EU member state, three patient representatives appointed by the European Commission, and three members appointed by the Commission. COMP is responsible for designating orphan drugs, advising the Commission on orphan drug policy, assisting with international cooperation, and contributing to guidelines. Orphan designation criteria include a disease affecting fewer than 5 in 10,000 people in the EU, the drug providing a clinically relevant advantage over existing treatments, and insufficient profit from standard sales to justify investment costs. Over 100 orphan drugs have received marketing authorization in the EU since 2000
The document discusses the role of Notified Bodies in evaluating combination products that contain both medical devices and medicinal substances. It describes the consultation process where the Notified Body reviews the dossier and audits the manufacturer, but must also receive scientific advice from a drug regulatory agency. The process involves several steps including acceptance review, team selection, Notified Body review of the complete dossier, and a parallel consultation with the drug agency. The goal of the consultation procedure is to verify the safety, quality and usefulness of the medicinal substance. The document provides experiences working with various drug agencies and recommendations to help streamline the lengthy approval process.
Beyond Scaling Up: Prequalification of Medicines IDS
This presentation was given at the 'Beyond Scaling Up: Pathways to Universal Access' workshop which was held at the Institute of Development Studies, Brighton on the 24-25 May, 2010. This event was co-sponsored by the Future Health Systems Research Programme Consortium and the STEPS Centre. Laing presented on the WHO Prequalification of Medicines Programme.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
The document discusses the Paediatric Committee (PDCO) at the European Medicines Agency and its role in regulating medicines for children. It describes how prior to 2007, 50-90% of paediatric medicines lacked testing and evaluation. The Paediatric Regulation of 2007 established the PDCO and incentives like extended exclusivity periods to stimulate research into paediatric medicines. The key tools are Paediatric Investigation Plans which must be approved by the PDCO and outline a medicine's paediatric development. The regulation aims to improve children's health through ethical research while not delaying adult approvals. However, its translation into health benefits requires transparency and coordination between regulators and industry.
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.
Healthcare Professionals' Social Networks: The Beginning of the End of Pharma...Len Starnes
First presented at Digital Pharma Europe, Barcelona, 31st March 2009.
Captures the current status of healthcare professionals' social networks from a global perspective and a pharmaceutical industry marketing & sales perspective
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.
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes
13 european regulatory procedures comprehensive overview of ema and national...GlobalCompliancePanel
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines
Laboratory, medical and device performance and validation followingGlobalCompliancePanel
The document advertises a 2-day in-person seminar on June 15-16, 2017 in Salt Lake City, UT on laboratory, medical and device performance and validation following regulatory and ICH statistical guidelines. The seminar will be led by Dr. Al Bartolucci and will cover topics such as analytical methods validation, quality control, statistical process control, and risk management. The seminar costs $1,295 per delegate but early bird registration before June 13 saves $200. Group rates are available for multiple attendees.
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
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.
This document discusses the information available to patients once a medicine is authorized, including the product information and European Public Assessment Report (EPAR). It outlines the involvement of patients and consumers in reviewing elements of product information like package leaflets and EPAR summaries. The review process aims to ensure information is clear, understandable, and meets public needs. Patient and consumer organizations provide input on draft documents to assess language use, explanations, and identify unnecessary or missing information from a lay perspective. Their comments notably differ from other reviews and often lead to text changes or revisions for future documents.
The Committee for Orphan Medicinal Products (COMP) is an agency of the European Union that provides opinions on orphan drug designation. COMP is composed of one elected chair, a vice chair, one representative from each EU member state, three patient representatives appointed by the European Commission, and three members appointed by the Commission. COMP is responsible for designating orphan drugs, advising the Commission on orphan drug policy, assisting with international cooperation, and contributing to guidelines. Orphan designation criteria include a disease affecting fewer than 5 in 10,000 people in the EU, the drug providing a clinically relevant advantage over existing treatments, and insufficient profit from standard sales to justify investment costs. Over 100 orphan drugs have received marketing authorization in the EU since 2000
The document discusses the role of Notified Bodies in evaluating combination products that contain both medical devices and medicinal substances. It describes the consultation process where the Notified Body reviews the dossier and audits the manufacturer, but must also receive scientific advice from a drug regulatory agency. The process involves several steps including acceptance review, team selection, Notified Body review of the complete dossier, and a parallel consultation with the drug agency. The goal of the consultation procedure is to verify the safety, quality and usefulness of the medicinal substance. The document provides experiences working with various drug agencies and recommendations to help streamline the lengthy approval process.
Beyond Scaling Up: Prequalification of Medicines IDS
This presentation was given at the 'Beyond Scaling Up: Pathways to Universal Access' workshop which was held at the Institute of Development Studies, Brighton on the 24-25 May, 2010. This event was co-sponsored by the Future Health Systems Research Programme Consortium and the STEPS Centre. Laing presented on the WHO Prequalification of Medicines Programme.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
The document discusses the Paediatric Committee (PDCO) at the European Medicines Agency and its role in regulating medicines for children. It describes how prior to 2007, 50-90% of paediatric medicines lacked testing and evaluation. The Paediatric Regulation of 2007 established the PDCO and incentives like extended exclusivity periods to stimulate research into paediatric medicines. The key tools are Paediatric Investigation Plans which must be approved by the PDCO and outline a medicine's paediatric development. The regulation aims to improve children's health through ethical research while not delaying adult approvals. However, its translation into health benefits requires transparency and coordination between regulators and industry.
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.
Healthcare Professionals' Social Networks: The Beginning of the End of Pharma...Len Starnes
First presented at Digital Pharma Europe, Barcelona, 31st March 2009.
Captures the current status of healthcare professionals' social networks from a global perspective and a pharmaceutical industry marketing & sales perspective
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.
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes
13 european regulatory procedures comprehensive overview of ema and national...GlobalCompliancePanel
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines
Laboratory, medical and device performance and validation followingGlobalCompliancePanel
The document advertises a 2-day in-person seminar on June 15-16, 2017 in Salt Lake City, UT on laboratory, medical and device performance and validation following regulatory and ICH statistical guidelines. The seminar will be led by Dr. Al Bartolucci and will cover topics such as analytical methods validation, quality control, statistical process control, and risk management. The seminar costs $1,295 per delegate but early bird registration before June 13 saves $200. Group rates are available for multiple attendees.
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
FDA's GMP Expectations for Phase I and First-in-Man Clinical TrialsGlobalCompliancePanel
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.
Fda's gmp expectations for phase i and first in-man clinical trialsGlobalCompliancePanel
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
This webinar discusses the increasing importance and scope of post-market pharmacovigilance trials. It will cover why the FDA is now mandating larger post-approval studies, the design and goals of phase IV trials, and operational strategies for successful studies. Attendees will learn about FDA guidance on risk evaluation and safety monitoring plans for post-market research. The speaker is an expert in clinical research and drug development regulation who will explain new requirements around pharmacovigilance and rare adverse event reporting.
1) Drug development involves multiple phases of clinical trials in humans (phases I-IV) to test dosing, safety and efficacy in an increasing number of patients before regulatory approval and market access.
2) Patient involvement in clinical research is important to ensure trials address patient priorities and perspectives on risk/benefit, endpoints, and trial design elements like inclusion criteria.
3) Key elements of a clinical trial protocol include type of comparisons, randomization, blinding, endpoints, inclusion/exclusion criteria, schedule of events, informed consent process, and patient reported outcomes.
This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,
(2286) World Orphan Drug Congress USA 2016 A4 32 Page Brochure 1.5 SCREEN SPREADPinky Fadullon
This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
Networks in health overview presentation 1st aug 2013Alexandra Merckx
This document discusses Networks in Health (NIH), a global alliance of 20 physician communities with over 2 million doctor members. It outlines NIH's proposition of providing centralized management and a single point of access to its global physician network. Key details include NIH's local execution with central planning, its ability to target physicians by specialty across many countries, and the products/services it offers like campaigns, market research, and advertising. Case studies demonstrate how NIH has helped pharmaceutical clients effectively engage physicians through digital campaigns.
Similar to The new clinical trials regulation and regulatory affairs (20)
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
New FDA FSMA Rules on the Sanitary Transportation of Human and Animal FoodsGlobalCompliancePanel
Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve,
As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR).
Registration
This document advertises a 2-day in-person seminar on statistical methods and data visualization techniques. It will be held on August 3rd-4th in Raleigh, NC and taught by James Wisnowski. Attendees will learn how to explore and communicate data visually using software like Excel, R, Tableau, and JMP. The seminar agenda covers topics like univariate and multivariate plots, interactive graphs, best practices in data visualization, and more. Early registration saves $200 off the $1,295 individual price. Group discounts are also available for multiple attendees.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
14 new fda fsma rules on the sanitary transportation of human and animal foodsGlobalCompliancePanel
This document summarizes a 2-day in-person seminar on the new FDA FSMA rules for sanitary transportation of food. The seminar will be held on August 17-18, 2017 in Raleigh, NC and cover topics such as definitions and responsibilities under the new rules, adulteration prevention, standards for management, sanitation and training, and how to develop a compliant transportation plan. Attendees will include food shippers, carriers, receivers, importers, handlers, logistics and food safety professionals. Discounts are available for multiple attendees registered together.
The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them.
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR).
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304.
An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks?
What to expect in a federal hipaa audit & how to avoid auditGlobalCompliancePanel
I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes,
If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice.
Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions. Includes costs of preparing the necessary safety documentation.
Modern hipaa compliance managing privacy, security, and breach notification...GlobalCompliancePanel
Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule.
This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.
This document advertises a 2-day in-person seminar on incorporating risk management into HR policies taking place on July 27-28, 2017 in Philadelphia. The seminar, led by Ronald L. Adler, an HR consultant with over 40 years of experience, will cover topics such as conducting HR audits, assessing human capital risks, developing HR metrics, and the components of an HR audit model. Attendees will receive a participation certificate, seminar materials, and special access to future seminars and consulting services. Group discounts are available for multiple attendees.
HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance,
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
-------------------------------------------------------------------------------
Find out more about ISO training and certification services
Training: ISO/IEC 27001 Information Security Management System - EN | PECB
ISO/IEC 42001 Artificial Intelligence Management System - EN | PECB
General Data Protection Regulation (GDPR) - Training Courses - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
-------------------------------------------------------------------------------
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
The new clinical trials regulation and regulatory affairs
1. 2-day In-person Seminar:
Knowledge, a Way Forward…
The New Clinical Trials Regulation and Regulatory Affairs
Aspects of Medicinal Product Development in the EU
Zurich, Switzerland
June 15th & 16th, 2017
9:00 AM to 6:00 PM
Adriaan Fruijtier
Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
The main document from a regulatory perspective in the development
of a medicinal product is the regulatory plan. In this Seminar it is
explained how to write the regulatory plan, and which aspects to
consider.
The regulatory plan describes the regulatory strategy, as well as
pricing and reimbursement issues in your development. Orphan
medicinal Products will be discussed, and the advantages of having a
status as an orphan medicinal product will be explained.
Scientific advice is a vital element in the development of a medicinal
product, and knowledge of the how to choose between national and
EU scientific advice, as well as the preparation and procedure is vital
for a successful outcome
$8,475.00
Price: $5,085.00 You Save: $3,390.0 (40%)*
Register for 5 attendees
Regulatory Affairs Consultant, CATS Consultants GmbH
ENROLL
Adriaan Fruijtier has graduated as a pharmacist at the University of
Utrecht, The Netherlands.
He is currently Director Regulatory Affairs at CATS Consultants. Until
March 2004 he has been Head of the Oncology Group within Global
Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer
Corporation, West Haven, CT, USA. Between 2001 and 2003 he was
Director of Regulatory Affairs at Micromet AG, a biotech company in
Munich, Germany. Prior to joining Micromet he has worked during
four years as a Project Manager for Oncology Projects at the
European Medicines Agency in London, United Kingdom.
2. Global
CompliancePanel
Agenda:
Day One Day Two
2-day In-person Seminar:
The New Clinical Trials Regulation and Regulatory Affairs
Aspects of Medicinal Product Development in the EU
Lecture 1: Introduction
Elements of development regulatory affairs
The regulatory plan
Overview of the European Medicines Agency
Lecture 2: Regulatory strategy and regulatory plans
(including target SmPC)
Structure of the regulatory plan
Sources for the regulatory plan
Lecture 7: SME status
Advantages of micro-, small- and medium-
sized-enterprise (SME) status
How to apply for SME status
Lecture 3: Pricing and reimbursement
What is Health Technology Assessment (HTA)?
Who decides on pricing and reimbursement:
the HTA bodies
Lecture 4: Orphan medicinal products
Rare diseases: orphan medicinal products?
Main incentives
Applying for orphan medicinal product
designation
Lecture 5: Scientific advice
Why and when is scientific advice needed and
useful?
Topics for scientific advice
Briefing document, timelines and planning:
from submission to final scientific advice by
CHMP
National versus EMA
Joint scientific advice CHMP + HTA bodies:
benefits and issues to consider
Lecture 6: Paediatric development
Research and development programme for
medicines in children: Paediatric Investigation
Plans
Cases in which studies in children are not
needed or will be done later: Waivers/deferrals
What is a paediatric use marketing
authorisation (PUMA)?
Lecture 1: Advanced Therapy Medicinal Products (ATMP)
Definitions
Early scientific evaluation of quality and non-
clinical data: Certification procedure
Guidelines
Practical exercise: Determine for various
products if they fall under the ATMP definition
Lecture 2: Oncology
Why is development of oncology products
different?
Preclinical considerations: Which animal
studies are needed for oncology products?
The new clinical oncology guideline
Lecture 3: Practical session: regulatory plan
Case study: New oncology product
Does it qualify for orphan drug designation?
How to propose the optimal orphan indication
Paediatric studies necessary?
Scientific advice: Topics, selection of
authorities
Lecture 4: How to apply for a clinical trial authorisation in
the EU
The clinical trial directive
Outline of the procedure
Content of the Investigational Medicinal
Product Dossier and important guidance
documents
Lecture 5: Voluntary Harmonisation Procedure (VHP)
Harmonisation of assessment of clinical trial
applications in several EU countries through
the VHP:
Lecture 6: Overview of the process
Advantages and disadvantages
Lecture 7: Future changes to the clinical trial authorisation
process in the EU
The Clinical Trial Regulation
Impact on the pharmaceutical and biotech
Industry
Lecture 8: Interactive discussion: what are the advantages
and disadvantages of the new Regulation?
3. Global
CompliancePanel
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
7
9
1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
3
4
5
6
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
8
Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
10%
20%
25%
30%
2 Attendees to get offer
3 to 6 Attendees to get offer
7 to 10 Attendees to get offer
10+ Attendees to get offer
Group Participation
Payment Option
1 Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
2 Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
support@globalcompliancepanel.com or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
Wire Transfer: Please drop an email to
support@globalcompliancepanel.com or call our
toll free +1-800-447-9407 for the wire transfer
information
3
4
2-day In-person Seminar:
The New Clinical Trials Regulation and Regulatory Affairs
Aspects of Medicinal Product Development in the EU