This document summarizes the key challenges facing the dietary supplement industry according to the speaker. The three main challenges are: 1) Supplements adulterated with dangerous substances are widely available, putting consumers at risk. 2) Many firms struggle to meet basic Good Manufacturing Practice requirements. 3) There is a disconnect between what regulations require and what consumers expect in terms of product safety and efficacy. If not addressed, these challenges will continue to damage consumer and regulator trust in the industry.
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
This document discusses Where Food Comes From, Inc., a company that provides third-party verification and certification services for food producers. It has three main auditing divisions that verify various product attributes and certifications. The document outlines many of the standards, certifications, and attributes that the company can currently verify. It also discusses the importance of third-party verification and traceability in validating claims about food production practices and meeting consumer demand for transparency.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Welcome to the January Edition of Crisis Management’s RecallRegister, Aon’s monthly recall and product safety newsletter. This publication provides a review of the month’s recalls asreported by the U.S. Consumer Product Safety Commission (CPSC), the U.S Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA), National Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). In addition to recall announcements, RecallRegister provides an update on the product recall and contamination insurance marketplace and environment. Each month, we highlight issues of importance including new markets and capacity, significant recall events and changes in legislation affecting the consumer products industry.
Public Opinion On Prescription Drugs And Their PricesKFF
- According to polls from 2015-2019, around 6 in 10 Americans currently take at least one prescription medication and 1 in 4 take 4 or more. While most say the cost of prescription drugs is unreasonable, around 3 in 4 currently taking medications say affording them is easy. However, those taking more medications report more cost problems.
- Around 3 in 10 Americans have not taken their medication as prescribed at some point due to costs, such as not filling a prescription, cutting pills in half, or taking over-the-counter drugs instead.
- Majorities of the public favor policies to lower drug costs like requiring list prices in ads, easier generics, and government negotiations. However, views on the best approach vary by
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
This document discusses Where Food Comes From, Inc., a company that provides third-party verification and certification services for food producers. It has three main auditing divisions that verify various product attributes and certifications. The document outlines many of the standards, certifications, and attributes that the company can currently verify. It also discusses the importance of third-party verification and traceability in validating claims about food production practices and meeting consumer demand for transparency.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Welcome to the January Edition of Crisis Management’s RecallRegister, Aon’s monthly recall and product safety newsletter. This publication provides a review of the month’s recalls asreported by the U.S. Consumer Product Safety Commission (CPSC), the U.S Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA), National Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). In addition to recall announcements, RecallRegister provides an update on the product recall and contamination insurance marketplace and environment. Each month, we highlight issues of importance including new markets and capacity, significant recall events and changes in legislation affecting the consumer products industry.
Public Opinion On Prescription Drugs And Their PricesKFF
- According to polls from 2015-2019, around 6 in 10 Americans currently take at least one prescription medication and 1 in 4 take 4 or more. While most say the cost of prescription drugs is unreasonable, around 3 in 4 currently taking medications say affording them is easy. However, those taking more medications report more cost problems.
- Around 3 in 10 Americans have not taken their medication as prescribed at some point due to costs, such as not filling a prescription, cutting pills in half, or taking over-the-counter drugs instead.
- Majorities of the public favor policies to lower drug costs like requiring list prices in ads, easier generics, and government negotiations. However, views on the best approach vary by
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
Ethical dilemmas concerning drug pricing-Shrinath GhadgeShrinath Ghadge
There is no straightforward solution to the proper pricing of a pharmaceutical. Numerous factors influence pricing from the company perspective such as return on investment, costs of future R&D efforts, access to federal funding, and size of the patient population, to name a few. In addition the healthcare system in the US is generally much more expensive than other countries, driving up overall costs. A public distrust of pharmaceutical companies' greed has been fueled by recent cases of exorbitant increases in drug prices without clear cause. These instances do raise questions of the ethics employed by some companies
The document discusses the benefits and risks of online pharmacies. It outlines the process of online distribution and notes that while e-pharmacies provide convenience, around 96% do not comply with laws. Benefits include lower prices, large selection and 24/7 access, but risks are self-medication without interaction, improper handling of medicines, and sale of controlled substances. Laws prohibit online pharmacies in India without a valid prescription. While e-pharmacies can increase access, proper rules and patient education are needed to ensure safety.
Dr. Tiffany Lee - Antibiotic Use in the Beef Industry: The Producer PerspectiveJohn Blue
Antibiotic Use in the Beef Industry: The Producer Perspective - Dr. Tiffany Lee, Beef Cattle Institute, Kansas State University, from the 2015 NIAA Antibiotic Symposium - Stewardship: From Metrics to Management, November 3-5, 2015, Atlanta, Georgia, USA.
More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
The document discusses e-pharmacy in India. It notes that the Indian healthcare sector is witnessing positive transformation as the economy grows. E-pharmacies in India are estimated to grow significantly in the coming years. The evolving e-pharmacy market includes players like Medlife, Netmeds, 1MG, and PharmEasy. E-pharmacies offer benefits like lower prices, increased access and convenience to consumers compared to traditional pharmacies. Regulations and recommendations are discussed to help e-pharmacies operate sustainably in India.
This document summarizes a report on antibiotic use policies and practices among the top 25 U.S. burger chains and fast food/fast casual restaurants. Key findings include:
- Only Shake Shack and BurgerFi received "A" grades for sourcing beef raised without antibiotics. Most chains have no publicly available antibiotic use policy.
- Wendy's received a "D-" for a limited policy reducing use of one antibiotic in 15% of its beef supply.
- Few chains use independent audits to verify antibiotic use in their supply chains or make auditing standards public.
- Consumers favor ending routine antibiotic use in meat according to surveys showing most would pay more for antibiotic-free options.
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
That's A Killer Look - A Study of Chemicals in Personal Care Products v2zq
That's A Killer Look - A Study of Chemicals in Personal Care Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~ preventharm.org
- The former head of the European Medicines Agency says that if the UK leaves the EU, the EMA will need to carefully manage issues arising from relocating, such as losing expert input from the UK medicines regulator MHRA.
- The consequences for the EU regulatory system and the EMA will depend on how Brexit negotiations unfold over the next two years as the UK divorces from the EU.
- If the EU insists on completing divorce proceedings before discussing the future UK-EU relationship, it could take years to negotiate new drug regulatory collaboration and the EMA may lose staff during the uncertain transition period.
Medication non-adherence is a costly problem in the US healthcare system, costing over $300 billion annually and contributing to hospital and nursing home admissions. Seniors are especially at risk due to taking multiple medications and increased risk of adverse drug events. Pharmacists can play an active role in improving medication adherence through programs that have increased compliance from below 60% to over 97% with improved health outcomes and reduced costs. New technologies now available can help pharmacists monitor patient medication adherence and safety. Rules need to allow pharmacists to utilize these technologies and take a leading role in medication adherence programs.
Globalization has increased international trade and outsourcing of food and medical products regulated by the FDA. Obtaining FDA approval demonstrates that a company's products have gone through the agency's rigorous review process and quality standards, giving credibility worldwide. Indian pharmaceutical companies recognized that achieving USFDA compliance would allow them to expand beyond local markets and establish themselves as world-class producers meeting the highest safety and efficacy requirements.
Aon Food & Drink Inperspective Winter 2015Graeme Cross
This document summarizes an issue of a magazine focused on risks and insurance issues for the food and drink industry. It discusses how Morrisons supermarket has worked with Aon to improve its business continuity planning across its 25 manufacturing, processing, and distribution sites in the UK. It also discusses proposed changes to EU food safety guidelines and whether these could encourage innovation from food companies while still protecting consumers. Additionally, it examines how food and drink companies can better account for weather impacts on sales through historical data analysis rather than simply blaming poor weather.
The document summarizes findings from interviews with 23 primary sources and 7 secondary sources regarding Teva Pharmaceutical Industries Ltd.'s ability to overcome increasing competition and the impending patent cliff for its top-selling drug Copaxone. Most sources believed Teva's growth initiatives would help, but strategic acquisitions would be key to success. Sources viewed Teva as a strong, innovative leader but said maintaining Copaxone patients and generic sales would be challenges without new blockbuster products or deals. While Teva's generic pipeline and sales were seen as promising, uncertainty remained around fending off competitors and retaining its share of the Copaxone market.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
This document provides an overview of dietary supplement manufacturing and quality assurance/quality control processes at Bluebonnet Nutraceutical Ltd. in compliance with Current Good Manufacturing Practices regulations. It details the company's history and product lines. The manufacturing facility layout and processes are described, including receiving raw materials, mixing, blending, encapsulation, tablet production, coating, and finished product packaging. Quality control procedures involve testing raw materials, in-process materials, and finished products to ensure safety and specifications are met. Maintaining compliance with regulations through qualified personnel, documented processes, and calibration of equipment is emphasized.
Roadshow Presentation Barry Callebaut's 9-month / Q3 ResultsBarry Callebaut
This document provides an overview and financial highlights of Barry Callebaut for Q3 2013/14. Key points include:
- Strong volume growth of 15.8% driven by recent cocoa acquisition. Standalone growth was 2.4%.
- Integration of recently acquired cocoa business from Petra Foods is on target.
- Mid-term financial targets are confirmed.
- Growth was seen in emerging markets, gourmet products, and outsourcing.
- Financial information shows increased sales, volume, and assets due to the cocoa acquisition.
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
Ethical dilemmas concerning drug pricing-Shrinath GhadgeShrinath Ghadge
There is no straightforward solution to the proper pricing of a pharmaceutical. Numerous factors influence pricing from the company perspective such as return on investment, costs of future R&D efforts, access to federal funding, and size of the patient population, to name a few. In addition the healthcare system in the US is generally much more expensive than other countries, driving up overall costs. A public distrust of pharmaceutical companies' greed has been fueled by recent cases of exorbitant increases in drug prices without clear cause. These instances do raise questions of the ethics employed by some companies
The document discusses the benefits and risks of online pharmacies. It outlines the process of online distribution and notes that while e-pharmacies provide convenience, around 96% do not comply with laws. Benefits include lower prices, large selection and 24/7 access, but risks are self-medication without interaction, improper handling of medicines, and sale of controlled substances. Laws prohibit online pharmacies in India without a valid prescription. While e-pharmacies can increase access, proper rules and patient education are needed to ensure safety.
Dr. Tiffany Lee - Antibiotic Use in the Beef Industry: The Producer PerspectiveJohn Blue
Antibiotic Use in the Beef Industry: The Producer Perspective - Dr. Tiffany Lee, Beef Cattle Institute, Kansas State University, from the 2015 NIAA Antibiotic Symposium - Stewardship: From Metrics to Management, November 3-5, 2015, Atlanta, Georgia, USA.
More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
The document discusses e-pharmacy in India. It notes that the Indian healthcare sector is witnessing positive transformation as the economy grows. E-pharmacies in India are estimated to grow significantly in the coming years. The evolving e-pharmacy market includes players like Medlife, Netmeds, 1MG, and PharmEasy. E-pharmacies offer benefits like lower prices, increased access and convenience to consumers compared to traditional pharmacies. Regulations and recommendations are discussed to help e-pharmacies operate sustainably in India.
This document summarizes a report on antibiotic use policies and practices among the top 25 U.S. burger chains and fast food/fast casual restaurants. Key findings include:
- Only Shake Shack and BurgerFi received "A" grades for sourcing beef raised without antibiotics. Most chains have no publicly available antibiotic use policy.
- Wendy's received a "D-" for a limited policy reducing use of one antibiotic in 15% of its beef supply.
- Few chains use independent audits to verify antibiotic use in their supply chains or make auditing standards public.
- Consumers favor ending routine antibiotic use in meat according to surveys showing most would pay more for antibiotic-free options.
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
That's A Killer Look - A Study of Chemicals in Personal Care Products v2zq
That's A Killer Look - A Study of Chemicals in Personal Care Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~ preventharm.org
- The former head of the European Medicines Agency says that if the UK leaves the EU, the EMA will need to carefully manage issues arising from relocating, such as losing expert input from the UK medicines regulator MHRA.
- The consequences for the EU regulatory system and the EMA will depend on how Brexit negotiations unfold over the next two years as the UK divorces from the EU.
- If the EU insists on completing divorce proceedings before discussing the future UK-EU relationship, it could take years to negotiate new drug regulatory collaboration and the EMA may lose staff during the uncertain transition period.
Medication non-adherence is a costly problem in the US healthcare system, costing over $300 billion annually and contributing to hospital and nursing home admissions. Seniors are especially at risk due to taking multiple medications and increased risk of adverse drug events. Pharmacists can play an active role in improving medication adherence through programs that have increased compliance from below 60% to over 97% with improved health outcomes and reduced costs. New technologies now available can help pharmacists monitor patient medication adherence and safety. Rules need to allow pharmacists to utilize these technologies and take a leading role in medication adherence programs.
Globalization has increased international trade and outsourcing of food and medical products regulated by the FDA. Obtaining FDA approval demonstrates that a company's products have gone through the agency's rigorous review process and quality standards, giving credibility worldwide. Indian pharmaceutical companies recognized that achieving USFDA compliance would allow them to expand beyond local markets and establish themselves as world-class producers meeting the highest safety and efficacy requirements.
Aon Food & Drink Inperspective Winter 2015Graeme Cross
This document summarizes an issue of a magazine focused on risks and insurance issues for the food and drink industry. It discusses how Morrisons supermarket has worked with Aon to improve its business continuity planning across its 25 manufacturing, processing, and distribution sites in the UK. It also discusses proposed changes to EU food safety guidelines and whether these could encourage innovation from food companies while still protecting consumers. Additionally, it examines how food and drink companies can better account for weather impacts on sales through historical data analysis rather than simply blaming poor weather.
The document summarizes findings from interviews with 23 primary sources and 7 secondary sources regarding Teva Pharmaceutical Industries Ltd.'s ability to overcome increasing competition and the impending patent cliff for its top-selling drug Copaxone. Most sources believed Teva's growth initiatives would help, but strategic acquisitions would be key to success. Sources viewed Teva as a strong, innovative leader but said maintaining Copaxone patients and generic sales would be challenges without new blockbuster products or deals. While Teva's generic pipeline and sales were seen as promising, uncertainty remained around fending off competitors and retaining its share of the Copaxone market.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
This document provides an overview of dietary supplement manufacturing and quality assurance/quality control processes at Bluebonnet Nutraceutical Ltd. in compliance with Current Good Manufacturing Practices regulations. It details the company's history and product lines. The manufacturing facility layout and processes are described, including receiving raw materials, mixing, blending, encapsulation, tablet production, coating, and finished product packaging. Quality control procedures involve testing raw materials, in-process materials, and finished products to ensure safety and specifications are met. Maintaining compliance with regulations through qualified personnel, documented processes, and calibration of equipment is emphasized.
Roadshow Presentation Barry Callebaut's 9-month / Q3 ResultsBarry Callebaut
This document provides an overview and financial highlights of Barry Callebaut for Q3 2013/14. Key points include:
- Strong volume growth of 15.8% driven by recent cocoa acquisition. Standalone growth was 2.4%.
- Integration of recently acquired cocoa business from Petra Foods is on target.
- Mid-term financial targets are confirmed.
- Growth was seen in emerging markets, gourmet products, and outsourcing.
- Financial information shows increased sales, volume, and assets due to the cocoa acquisition.
What Every Dietary Supplement Business Should Know About Protecting Brands a...memangelson
The document is a presentation about protecting trademarks for dietary supplement businesses. It discusses selecting distinctive trademarks, registering trademarks with the USPTO, and protecting trademarks through proper usage and enforcement against infringers. Key points include conducting trademark searches, building brands through consistent trademark use, fighting genericide, monitoring third party use, and taking action such as sending demand letters or filing oppositions. The overall message is that trademarks are important for branding and companies should take appropriate steps to secure rights in their marks.
A Quick Overview of the US Health & Wellness Market. Find out about Dietary Supplement use in the United States, and various consumer trends for the US Market.
Successfully Navigating U.S. FDA Requirements when Importing a new Dietary Supplement into the U.S. Presented by Nutritional Products International,Scott Gould and Rosemarie Sunderland on a live Webinar. For more information on marketing your product in the US visit www.nutricompany.com
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
The document discusses government regulation of food and drug safety in the United States. It notes that responsibility is divided between multiple agencies, including the Department of Agriculture (USDA) which regulates meat and poultry, and the Food and Drug Administration (FDA) which regulates all other foods. However, the FDA has a smaller budget and less regulatory authority than the USDA despite regulating most foods. The document also outlines various food and drug safety measures, controversies around clinical drug trials and dietary supplements, and politics around the FDA approval process.
Presented by David Rosenthal, President, Cashew/Commodity Concern Certification, on January 19th at the Peanut and Tree Nut Processors' Association Meeting held in Freeport, Grand Bahama
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
Welcome to the 38th edition of The Authentication Times.
We hope you are doing well, staying healthy, and, most importantly, taking care of
your loved ones. The pandemic COVID-19 is affecting all of us and we can only face it all together. Let’s all work together to remain calm, be positive and fight this outbreak.
Firstly, we request all stakeholders to #Stayhome and practice social distancing. While there are various myths and rumors are spreading, we would suggest adhering to some practices while forwarding these messages at social media. Various other concerns are increasing among the public including the news of getting fake personal protection equipment’s, including sanitizers & masks. Witnessing a scarcity of sanitizers and
face masks since the COVID-19 outbreak, Counterfeiters and profiteers have offered the bogus public treatments and unfounded advice. These are ideal conditions for
criminals to capitalize on people’s fears by advertising falsified therapies and vaccines and spreading rumors of potential cures. In this challenging situation, being vigilant is the most important thing (Please refer our special page on COVID-19 & counterfeiting).
Secondly, referring to current issue, we are highlighting the issue of “Food & Beverages Safety & Quality – An overview on recent regulation, product recall, authentication & traceability”. Apart from it, you will also find various authentication & traceability initiative various countries are adopting in combating illicit trade, smuggling and counterfeiting. This is a positive step and we hope more and more countries will come together in fighting illicit trade.
We hope you will find this issue informative and interesting and as always, we look
forward to receiving your feedback. If you have any news, contributions or comments for the editorial team, please feel free to email us at info@aspaglobal.com
The document discusses new legislation and regulations around food safety in the United States. It outlines the Food Safety Modernization Act, which aims to modernize the food safety system by shifting from reactive to preventative response. Key points of the new law include increased mandatory inspections of domestic and foreign facilities by the FDA, requiring food safety plans and prevention controls, and more import certification requirements for foreign exporters. The changes are expected to significantly impact Chinese exporters through new registration, record access, inspection and food safety standard requirements.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
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FDA Regulation of Promotion & Advertising Part 7: FTC RegulationMichael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
2011 Food Defense Summit: Legal Risks and Responsibilities for Producing Safe...Bill Marler
Bill Marler of Marler Clark, The Food Safety Law Firm gives a presentation at the 2011 Food Defense Summit in Denver about the legal aspects of food safety in food production and reducing foodborne illness.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
This presentation provides an overview of the history of drug regulations and Good Manufacturing Practices (GMPs) in the United States. It describes how regulations have evolved over time in response to safety issues and tragedies, from the early 1900s to present day, with the goal of ensuring drug products are safe and effective. Key events and acts that shaped regulations are highlighted, including the Federal Food, Drug, and Cosmetic Act of 1938 and amendments requiring proof of efficacy and safety testing.
Fda gmp compliance for the Life Science Industrydmanalan
The document discusses good manufacturing practices (GMP) required by the FDA for life science companies. It provides an overview of GMP regulations for drugs, medical devices, and combination products. It explains that the FDA focuses on a "state of control" during inspections to assess compliance. While drug GMPs and device quality system regulations differ in some details, the overall systems are similar. The document reviews how the regulations address statistical techniques and quality systems. It also outlines the FDA's systems-based approach to inspections.
This document summarizes a discussion draft from the Pew Charitable Trusts providing guidance for industry on selecting experts to conduct Generally Recognized as Safe (GRAS) evaluations. The draft was created to address conflicts of interest identified in Pew's previous research. It outlines four key questions around purpose, exemptions, comparisons to similar programs, and resources. If finalized, the guidance would provide recommendations to the FDA on implementing their 2010 recommendation to develop a strategy to minimize potential conflicts of interest in GRAS determinations.
The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.
1) Recalls and returns are a fundamental element of good manufacturing practices and ensure that defective products are removed from the market.
2) Manufacturers are obligated to initiate a recall if one is necessary to protect public health, and regulatory authorities may order a recall.
3) It is important to monitor a recall closely and maintain thorough records to ensure its effectiveness in removing defective products from distribution and use.
This document summarizes a roundtable discussion between experts on managing regulatory and compliance challenges in the food industry. It discusses the increasing regulatory obligations food companies face related to ingredients, labeling, marketing and data privacy. Enforcement of food safety laws has increased in recent years, and companies can face fines or penalties for non-compliance. Leading practices for managing these challenges include regulatory monitoring, involvement in industry groups, having regulatory expertise, and clear product development processes.
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Similar to Excellence Beyond Compliance: A new path forward for the dietary supplement industry? (20)
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One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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