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Overview: During the webinar Participants will be addresses on the key regulatory provisions for cosmetic products in the major global economies. The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. For the regulations of the USA, Canada, China, Japan, South Korea, Taiwan, ASEAN, India, Brazil, Mercosul/Mercosur and Russia, a general introduction into the key provisions will be given. Some specific difficulties arising from the existing discrepancies in the global frameworks will be depicted. Areas Covered in the Session: The new EU Cosmetics Regulation Basis principles and provisions Experiences and obstacles from the implementation phase Options for compliance approaches and available supporting tools Remaining issues and future perspectives and activities Cosmetics Regulations in Asia China & Hong Kong South Korea Japan Taiwan The ASEAN Cosmetics Directive India Russia Cosmetics Regulation in the Americas - Existing Global Discrepancies and International Harmonization Attempts USA Canada Mercosur / Mercosul South Africa Existing Global Discrepancies Harmonization Attempts The Intern. Cooperation on Cosmetic Regulation (ICCR) Who Will Benefit: Business Owners Managers in manufacturing New staff in manufacturing QA Administrative Managers Regulatory Compliance Associates Customer Service Speaker Profile Dr. Annelie Struessmann is Technical Director with CONUSBAT, a provider of internationalization services for the Fine Chemicals, Cosmetics & Life Sciences Industries: www.conusbat.com. She joined the firm in 2003 and established the service area of regulatory affairs where she is focusing on the European regulatory frameworks for cosmetic products and for chemicals (REACH). The service spectrum includes dossier preparation, safety assessments, registrations, notifications and direct representations, etc. S

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Endoscopy is a procedure that has been developed to assist in the removal of endometriosis from the human body. Endoscopy is also being used to help in the treatment of gallstones, cholecystitis, and gastric reflux disease among a number of other conditions. The recent developments in this industry have been driven by changes in government regulation and legislation. The increase in the number of malignancies and the introduction of fiscal policy in the region has resulted in political will on the part of the governments to strengthen public health services. Rising product approval for endoscopy devices by regulatory authorities is expected to drive growth of the global endoscopic stricture management device market during the forecast period. For instance, in January 2020, Pentax Medical received the U.S. Food and Drug Administration (FDA) approval for its Imagina Endoscopy System, which will be used in performing gastrointestinal procedures, digital image enhancement system with Pentax i-Scan. This endoscopy machine is equipped with an LED touch-screen interface, which removes the need for periodic bulb replacement. Besides, it is far more cost-efficient than the GI endoscopy system such as video endoscopy. Thus. These factors are expected to drive growth of the global endoscopic stricture management device market during the forecast period. Furthermore, increasing incidence of bleeding during surgical procedures combined with growing number of endoscopic procedures is expected to boost the global endoscopic stricture management device market growth over the forecast period. However, the lack of skilled healthcare professionals to perform surgical procedures, especially in emerging economies combined with complications related to endoscopic procedures such as bleeding and infection is expected to hamper the global endoscopic stricture management device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/end

Workplace Safety Regulations : Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more. Governments the world over consider it their duty to provide a safe workplace. Workplace safety can concern any hazard that can happen to either the physical or emotional wellbeing of a worker. National and global workplace safety regulations : Workplace safety regulations are legally stipulated measures that governments require organizations in both the private and public sector to implement in order to ensure safety at the workplace. Almost all countries have their own set of workplace safety regulations. These regulations work in tandem with a few global management systems with the aim of enhancing safety standards at the workplace. A notable global organization that is at the forefront of legislating workplace safety regulations is the International Labor Organization (ILO). These ILO-mandated legislations are meant to supplement the national workplace safety regulations that most countries have. This is done in the belief that many a time, these individual legislations may not be sufficient in themselves. Workplace safety regulations in the US : Like most other countries, the US too has its own set of Occupational Safety and Health (OSH) standards. Owing their origins to the Richard Nixon era in late 1970; workplace safety regulations in the US concretized under what is collectively called the Occupational Safety and Health Administration (OSHA). The major feature of OSHA is that apart from promulgating workplace safety regulations across nearly all conceivable sectors and types of industries; OSHA also has a provision for whistleblow

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

"Endoscopy Devices: Applications and Global Markets"This report provides a comprehensive analysis of the global market for endoscopy services and equipment.

Platelet-rich plasma is a coagulated blood-rich polymer, made from extracted platelets. Extracted platelets are normally coagulated by monocytes or lymphocytes with fibrin. Platelets are also commonly injected into the body's bloodstream to support tissue healing following tissue surgery. Platelet-rich plasma has been found effective against bleeding disorders. It also helps reduce the risk of deep vein thrombosis (DVT) in patients with high blood pressure and in those taking anticoagulants. It may also reduce the risk of pulmonary embolism (PE), which is blood clots that enter the lungs and pulmonary system. In the chest, the clot can stop or limit the flow of blood to the heart. PE often leads to cardiac arrest and death. Increasing cosmetic surgeries is expected to drive growth of the global platelet rich plasma market during the forecast period. Cosmetic surgeries refer to surgical specialty involving the restoration, alteration, or reconstruction of the human body. According to the International Society of Aesthetic Plastic Surgery (ISAPS), in 2018, around 128,398 cosmetic procedures in Thailand and 1,036,618 procedures in Mexico were carried out. Hence, these factors are expected to drive growth of the global platelet rich plasma market during the forecast period. Furthermore, increasing prevalence of cosmetic surgeries is expected to boost the global platelet rich plasma market growth over the forecast period. Read more @ https://sachinbhombe.blogspot.com/2021/03/platelet-rich-plasma-market-is-witness.html

Autoclaves are also known as steam sterilizers and are used to expose each item to direct steam contact at the required temperature and pressure for the specified time. They are used for healthcare or industrial applications to eliminate the protein structure of the bacteria and spores. Compatible of steam autoclaves for crisis strategy decontamination of N95 respirators is expected to propel growth of the global steam autoclave market. For instance, in October 2020, 3M, a U.S-based multinational conglomerate corporation, announced that Belimed steam autoclaves are compatible for crisis strategy decontamination of specific single-use N95 Respirators. Moreover, launch of biological indicators for steam autoclaves is also expected to aid in growth of the market. For instance, in December 2020, Steris Corporation, a U.S-based medical equipment company, launched Spordex Self-Contained Biological Indicator Ampoules to confirm sterilization of liquids in steam autoclave cycles. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global steam autoclave market. For instance, globally, as of 4:03pm CET, 1 March 2021, there have been 113,820,168 confirmed cases of COVID-19, including 2,527,891 deaths, reported to the World Health Organization. Moreover, high prevalence of hospital-acquired infections is also expected to aid in growth of the market. For instance, according to an observational epidemiological study of intra-abdominal infections published in December 2019, in NEJM Journal Watch, of the 2621 critically ill adults with intra-abdominal infections at 309 international centers between January and December 2016, 32% were community-acquired, while 68% were hospital-acquired. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/emergence-of-covid-19-and-lunch-of-new.html

Enteral feeding devices technological advanced medical device used to deliver nutrition food directly to the stomach to the bedridden patient suffering from chronic diseases such as cancer and neurological disorder. The increase in the cases of malnutrition and premature birth cases around the globe is a prime factor driving growth of the enteral feeding devices market. Moreover, the growing prevalence of chronic diseases such as cancer and cardiovascular disease is another key factor fostering the market growth of the enteral feeding devices. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths occur due to cancer. Around 70% of deaths from cancer occur in low- and middle-income countries. Furthermore, increasing global expenditure on the healthcare sector for improving the patient care is further projected to augment the growth of the enteral feeding devices market. From the geographical perspective, North America is projected to gain significant growth over the forecast period and this is attributed to the high presence of the geriatric population prone to chronic disease that leads to digestive ailments. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/enteral-feeding-devices-to-gain.html

An N95 mask is a commonly-used, shortened name for N95 respirators, which is actually a particulate-filter respirator that meting the U.S. national institute for Occupational Safety and Health (NIOSH) standards. Respirators are designed to protect you from inhaling harmful dust particles and fumes. But when it comes to choosing a respirator for use in the home or on the job, there are certain features you need to look for. The first and most important feature to look for is that it is safe for you to wear. Respirators are generally divided into two types. The first is the full-face respirator, while the other type is the full-body respirators. While there are some differences between these two types of respirators, both have the same main functions. High prevalence of infectious diseases is expected to propel growth of the global N95 grade medical protective masks market over the forecast period. For instance, according to the World Health Organization, in 2018, India reported around 2.69 million cases of tuberculosis. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global N95 grade medical protective masks market. For instance, globally, as of 3:33pm CET, 17 November 2020, there have been 54,771,888 confirmed cases of COVID-19, including 1,324,249 deaths, reported to the World Health Organization. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/emergence-of-covid-19-to-augment-growth.html

Gouty arthritis is a type of arthritis that causes inflammation, typically in one joint, which begins suddenly. Gouty arthritis is caused by the deposition of needle-shaped crystals of uric acid in a joint. The primary symptoms of gouty arthritis include severe pain, swelling, and redness in joints, often in the big toe. Increasing prevalence of gout with rising alcohol consumption is expected to drive growth of the global gouty arthritis market. According to the Centers for Disease Control and Prevention (CDC), from 2013-2015 around 54.4 million adults in the U.S. have some form of arthritis, gout, rheumatoid arthritis, or fibromyalgia. According to the Arthritis Foundation, 8 million people in the U.S. suffer from gout arthritis every year. According to the same source, high intake of sugary or alcoholic drinks is one of the major risk factors for gout arthritis. Alcohol is a major source of purine, which produces uric acid. High levels of uric acids in the body can result in the formation of crystals of uric acid, eventually leading to gout. Hence, such factors are expected to drugs market is expected to drive growth of the global gouty arthritis market. Furthermore, increasing adoption of biologics and increasing R&D activities in regenerative medicines is expected to propel the global gouty arthritis market growth in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/gouty-arthritis-market-is-gaining.html

Biostimulants are natural or synthetic substances that aid in reducing the dependency on fertilizers. These substances are applied to seeds, plants, and soil in order to increase plant growth, resistance to water and abiotic stresses. Increasing global population has led to focus on boosting crop yield. According to projections by Population Reference Bureau (PRB) included in the 2018 World Population Data Sheet, the world population is expected to reach 9.9 billion by 2050, up 2.3 billion or 29% from an estimated 7.6 billion people in 2018. Moreover, according to according to Food and Agriculture Organization, worldwide food demand is expected to increase by 70% by 2050. Decrease in arable land in various regions has led to has led to various challenges in the agricultural sector. According to the study 'Will Limited Land, Water, and Energy Control Human Population Numbers in the Future', published in the journal Human Ecology, the amount of arable land available per person will decrease to 1500m² by 2050 from 4000m² in 1961. In July 2020, the government of India was expected to announce guidelines to regulate the biostimulants market in the country. Earlier, in July 2019, Europe witnessed several changes regarding definition and classification of these substances. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/increasing-global-population-and-focus.html

"Microbiology Testing: Granular Analysis of the Global Market" This DataPack contains 800 tables from Venture Planning Group's new 7-country study, "Global Microbiology Testing Market: US, Europe, Japan," including supplier shares, and forecasts for over 100 tests.

Pepgra offers global regulatory and clinical writing services. The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies. Contact us at : IND:+91 8754446690 US:+1-972-502-9262 UK:+44-1143520021 info@pepgra.com http://pepgra.com/what-we-do/global-regulatory-clinical-writing-services/

In this report, the global GPS Receiver market is valued at USD XX million in 2016 and is expected to reach USD XX million by the end of 2022, growing at a CAGR of XX% between 2016 and 2022. Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), market share and growth rate of GPS Receiver in these regions, from 2012 to 2022 (forecast), covering North America Europe China Japan Southeast Asia India

Nurse call system makes an all-in one solution for both your nurse call needs as well as wireless nurse phone calls. These systems have been some of the best in the market these days in that they can incorporate any old piece of hospital equipment into a single unified call center system. With an integrated system, you can now use your pager, digital radio, or even your cell phone to dial in, and you can get live access to your nurses through a large LCD screen. Nurses can use this system at the reception desk or even while on the job. For those who wish to be constantly on the go, the system also features an LCD screen with a large touch pad that makes it easy to navigate and input data. A digital radio, headset, and other necessary hardware are all included in the package for the best experience possible. There are many options to choose from in this type of system, depending on how much you want to spend. The biggest thing to consider is how much you need and whether you want a more basic system, or a more advanced system like a fully integrated one. Each system comes with a long warranty, so if ever there was a time when you needed a system to replace, you are covered. High prevalence of chronic disorders is expected to propel growth of the global nurse call systems market. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/high-prevalence-of-chronic-disorders-to.html

Patient monitoring refers to the collection and analysis of medical data from one or more health settings (such as in hospitals or doctor's offices) for use by health care providers and other professionals in order to detect changes in an individual's medical status and to provide treatment options as needed. In health care, patient monitoring is generally the measurement of one or more medical parameters over extended periods of time, usually at different health care settings (such as in doctor's offices or hospitals). Patient monitoring may be implemented in many different health care settings including primary care offices, emergency rooms, doctors' offices, nursing homes, private practices, and government agencies. Most patient monitoring systems contain software that collect and store medical data in a database that is accessible to multiple health care providers and to health care facilities. High prevalence of chronic disorders is expected to propel growth of the global remote patient monitoring devices market over the forecast period. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read More @ https://coherentmarketinsights-blog.blogspot.com/2020/11/high-prevalence-of-chronic-disorders-to.html

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl