Presentation at 2016 Fuel Ethanol Workshop, describing U.S. regulatory pathways for approval of use of modified microorganisms in animal feed, and a proposal for making such pathways simpler and more efficient for modified strains of common microorganisms.
David Glass Presentation at 2016 BIO World CongressDavid Glass
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Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
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These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed the U.S. regulatory framework for the industrial uses of genetically modified algae and the scientific issues involved in the risk assessments that determine decision-making under such regulations. I argued that these regulations, particularly the US EPA "TERA" regulations, are not difficult to navigate and are well designed to allow careful, stepwise testing of modified algae strains both in contained reactors and in open ponds. I also discussed the roles that academic, industry and government researchers can play in developing the research database to support regulatory decision-making.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
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David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
Challenges and Opportunities in Industrial Biotech RegulationDavid Glass
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Presentation at Society for Biological Engineering Workshop, "Technology Challenges and Opportunities in Commercializing Industrial Biotechnology", San Diego September 29, 2015.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
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Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass BIO World Congress Algae Regulation July 2015David Glass
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Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
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Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
David Glass Presentation at 2016 BIO World CongressDavid Glass
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Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
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These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed the U.S. regulatory framework for the industrial uses of genetically modified algae and the scientific issues involved in the risk assessments that determine decision-making under such regulations. I argued that these regulations, particularly the US EPA "TERA" regulations, are not difficult to navigate and are well designed to allow careful, stepwise testing of modified algae strains both in contained reactors and in open ponds. I also discussed the roles that academic, industry and government researchers can play in developing the research database to support regulatory decision-making.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
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David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
Challenges and Opportunities in Industrial Biotech RegulationDavid Glass
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Presentation at Society for Biological Engineering Workshop, "Technology Challenges and Opportunities in Commercializing Industrial Biotechnology", San Diego September 29, 2015.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
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Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass BIO World Congress Algae Regulation July 2015David Glass
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Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
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Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
David Glass World Biofuels Markets Conference Presentation, March 2011David Glass
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Presentation by David Glass at 2011 World Biofuels Markets Conference, Rotterdam, the Netherlands, March 22, 2011. This presentation describes approaches being taken to use advanced biotechnology to improve the plant species being used as biofuel feedstocks. This was part of the "Energy Crops" sessions at the conference, which Dr. Glass moderated.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
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Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
This is a presentation I made on February 2, 2010 at the EUEC 2010 conference in Phoenix. The talk included an overview of the approaches being pursued to use biotechnology to improve microorganisms, algae and plants for biofuel production and the companies pursuing these strategies, and discussion of the impact of biotech regulations on these projects and the prospects for use of engineered organisms in commercial biofuel production. You can find more detailed information on the topics discussed in this talk on my blog at http://dglassassociates.wordpress.com.
Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014" Dr. Ravi Dhar
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An overview of Intellectual Property Barriers in Generic Vaccines & how to circumvent these. Issues of affordability in tough Patent regime has also been mentioned.
Do you need consultation on the classification of biological active substances? Are you familiar with the documentation requirements? Do you need help in writing the documentation?
These slides studies the 2018 report by CDER on New Drug Therapy Approvals. Novel drugs were approved at an all time high of 59 (in contrast to the annual average of 33). Among notable approvals include monoclonal for HIV infection, non-opioid drugs for withdrawal symptoms, marijuana based drugs for seizures, and even contraceptive for women that can be used up to a year.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
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Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
Dr. Ray Matulka, Director of Toxicology at Burdock Group, presents the hurdles of probiotics when being classified from a regulatory standpoint. Dr. Matulka discusses when a probiotic is considered a food, supplement or drug, as well as a potential path forward for the U.S. FDA to implement a probiotic monograph system for probiotics, similar to Health Canada's system.
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
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The field of Gene Therapy is moving at a fast pace providing promise of lifesaving medicines to previously unmet clinical needs. Of significant importance in the development of these novel therapies is the ability to demonstrate their safety including freedom from adventitious agents originating from raw materials or introduced during the manufacturing process.
It can be challenging, in such a fast moving field, to identify and navigate the relevant regulatory requirements and expectations for biosafety testing of such therapies. So too it can be difficult to select the optimal test methods in light of limited product availability and shelf life. Encompassing current biosafety testing approaches for bacteria, fungi, mycoplasma and viruses on starting materials to drug product, this webinar will provide you with the fundamentals to design your own Gene Therapy testing strategy.
In this webinar, you will learn:
⢠The most up to date regulatory expectations for Gene Therapies
⢠How to design a testing strategy to meet US FDA and EMA requirements
⢠How selecting the right biosafety test can overcome some of the unique challenges with Gene Therapies
go to www.medicaldump.com to download this file and check out other medical powerpoints, medical powerpoint templates, medical pdfs and all other medical documents.
David Glass World Biofuels Markets Conference Presentation, March 2011David Glass
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Presentation by David Glass at 2011 World Biofuels Markets Conference, Rotterdam, the Netherlands, March 22, 2011. This presentation describes approaches being taken to use advanced biotechnology to improve the plant species being used as biofuel feedstocks. This was part of the "Energy Crops" sessions at the conference, which Dr. Glass moderated.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
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Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
This is a presentation I made on February 2, 2010 at the EUEC 2010 conference in Phoenix. The talk included an overview of the approaches being pursued to use biotechnology to improve microorganisms, algae and plants for biofuel production and the companies pursuing these strategies, and discussion of the impact of biotech regulations on these projects and the prospects for use of engineered organisms in commercial biofuel production. You can find more detailed information on the topics discussed in this talk on my blog at http://dglassassociates.wordpress.com.
Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014" Dr. Ravi Dhar
Â
An overview of Intellectual Property Barriers in Generic Vaccines & how to circumvent these. Issues of affordability in tough Patent regime has also been mentioned.
Do you need consultation on the classification of biological active substances? Are you familiar with the documentation requirements? Do you need help in writing the documentation?
These slides studies the 2018 report by CDER on New Drug Therapy Approvals. Novel drugs were approved at an all time high of 59 (in contrast to the annual average of 33). Among notable approvals include monoclonal for HIV infection, non-opioid drugs for withdrawal symptoms, marijuana based drugs for seizures, and even contraceptive for women that can be used up to a year.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Â
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
Dr. Ray Matulka, Director of Toxicology at Burdock Group, presents the hurdles of probiotics when being classified from a regulatory standpoint. Dr. Matulka discusses when a probiotic is considered a food, supplement or drug, as well as a potential path forward for the U.S. FDA to implement a probiotic monograph system for probiotics, similar to Health Canada's system.
Latest Updates in Biosafety Testing for Gene TherapyMilliporeSigma
Â
The field of Gene Therapy is moving at a fast pace providing promise of lifesaving medicines to previously unmet clinical needs. Of significant importance in the development of these novel therapies is the ability to demonstrate their safety including freedom from adventitious agents originating from raw materials or introduced during the manufacturing process.
It can be challenging, in such a fast moving field, to identify and navigate the relevant regulatory requirements and expectations for biosafety testing of such therapies. So too it can be difficult to select the optimal test methods in light of limited product availability and shelf life. Encompassing current biosafety testing approaches for bacteria, fungi, mycoplasma and viruses on starting materials to drug product, this webinar will provide you with the fundamentals to design your own Gene Therapy testing strategy.
In this webinar, you will learn:
⢠The most up to date regulatory expectations for Gene Therapies
⢠How to design a testing strategy to meet US FDA and EMA requirements
⢠How selecting the right biosafety test can overcome some of the unique challenges with Gene Therapies
go to www.medicaldump.com to download this file and check out other medical powerpoints, medical powerpoint templates, medical pdfs and all other medical documents.
Enhancing Satellite & Terrestrial Networks Integration through NFV/SDN techno...Harilaos Koumaras
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This presentation discusses the ambitious goal to transform convergence between SatCom and terrestrial networks, leveraging the SDN/NFV paradigm. While the SDN/NFV concepts are starting to pave its way into the carrier network domain, allowing more flexible control of communication networks, it is not yet explored within the SatCom domain. Furthermore, the integrated network management infrastructure to achieve flexible and easier hybrid inter-networking between the two domains and in combination with the intelligent NFV infrastructure will create an innovative step in the terrestrial-satellite interworking space with opportunities to create applications offering seamless delivery across the domains. Standards bodies like ETSI, IETF and ONF dealing with SDN/NFV technologies have acknowledged the priority and interests of seeking innovative approaches to address multi-domain network infrastructure management. The presentation is prepared within the framework of VITAL project and delivered at NCSR Demokritos Summer School 2015 and Panhellenic Conference on Informatics (PCI) 2015.
A Food Ingredientâs Journey to Your Dinner TableFood Insight
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Todayâs foods and beverages contain many different ingredients that perform a variety of specific functions, including to improve our foodâs taste, texture, nutrition, convenience, safety, and affordability. While there is more than one path to determine an ingredientâs safety, their safety mustbe established before they can be added to foods and beverages. Letâs follow a food ingredientâs journey to your dinner table.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
U.S. and International Regulation of Microbial Inoculants and Soil AdditivesDavid Glass
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Presentation at the International Phytobiomes Conference, September 2012, Denver, Colorado. The talk describes US and international regulation that might affect the testing and development of modified microorganisms for nonpesticidal uses in agriculture, such as biofertilizers or certain biostimulants.
Dialogue with Canadaâs leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
Raising Awareness and Discovering the Dirt 12345 .docxrobert345678
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Raising Awareness and Discovering the Dirt
12345 Canyon Dr., Northridge, CA 91344 (818) 555-9089 (818) 555-9222 Radd.com
RADD
What role can the FDA play in regulating GMO
products?
This brief is intended for the United States Food and Drug Administration (FDA) and is
presented on behalf of Raising Awareness and Discovering the Dirt (RADD). RADD is a non-profit
organization committed to promoting the wellness of the environment.
Since the earlier 1990s, commercialization of Genetic Modified Organisms (GMOs) has spread
throughout the U.S. The FDA has promoted a program of self-regulation among the biotech crop and
food developers (www.fda.gov). Many of the biotech food and crop developersâ primary interest is the
development of high-yielding products. For example, Monsanto, a biotech food and crop developerâs
director of corporate communications, Philip Angell was quoted saying; âMonsanto should not have to
vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its
safety is the FDAâs job,â (Antoniou, Robinson, & Fagan, 2012, p. 23).
Finally, research and Monsantoâs own feeding trials revealed health-effects and suggest that
more suitable options are needed to maintain the safety of consumers and the environment. Therefore,
RADD is committed to working with the FDA in creating programs that will ensure the safety of
environment and the use of GMOs.
Statement of Issue:
In order to promote awareness and ultimately protect the health of consumers, the FDA has the
ability to regulate GMOs by establishing new guidelines. There is a growing body of evidence that
connects GMOs with health problems, environmental damage, and violation of rights of farmers and
consumers. Studies show a correlation between GMOs and health problems such as production of new
allergens increased toxicity, decreased nutrition, and antibiotic resistance (Bernstein et al., 2003).
Additionally, since the emergence of GMO crops, there has been an increase in the amount of
agriculture changes. Such changes include the development of âmassive weedsâ and âsuper bugs,â both
requiring an increased dosage of toxins to rid of these unwanted, overgrown organisms. In return,
consumers are now ingesting these increased dosages of toxins.
Background:
Ultimately, the only beneficiaries of products containing GMOs are its producers, such as,
Monsanto, rather than consumers. Monsanto makes an abundant amount of profit on their GMO
products as they have scientifically modified crops, allowing them to have faster results. The âproposedâ
purpose of GMOs was to increase yield and enhance nutritional value, while also lowering the use of
pesticides. (www.nongmoproject.org, 2013). Indeed, the use of GMOs increase yield, but studies show
that GMO products hold no nutritional value and rather, by decreasing the use of pesticides, there has
been an increase .
Biopharmaceutics Classification System (BCS) & Waiver of BioequivalenceAjaz Hussain
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Graduate Lecture at the University of Maryland (August 2012). Learning Objective: Identify and explain how future regulatory applications of BCS may be realized in the context of âQuality by Designâ.
Updated July 2013.
I wish to thank all the viewers of my Slideshare presentation of the development and application of the US FDAâs BCS Guidance 2000. Over 11K views have been recorded making this the 2nd highest viewed presentation. FDA is expected to issue a revised BCS draft guidance in the next few weeks. Expected changes include the following:
1. Addition of âvery rapidâ dissolution criteria (>85% in 15 minutes)
2. Change permeability boundary from 90% to 85%
3. Change the pH solubility range from 1 â 7.5 to 1 â 6.8
4. Possibility of changing paddle speed from 50 to 75 rpm.
5. Additional topics / clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), MR (Modified Release) products.
6. Update the list of model drugs.
7. Strengthen GI stability requirement.
David Glass BIO World Congress Synthetic Biology Regulation july 2015David Glass
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Presentation from July 2015 BIO World Congress on Industrial Biotechnology, assessing the adequacy of government regulatory frameworks to assess the risks of commercial uses of synthetic biology.
David Glass BIO Pacific Rim Conference presentation.12.09.14David Glass
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Presentation at the 2014 BIO Pacific Rim Summit on Industrial Biotechnology, discussing fuel pathway petition processes under the U.S. Renewable Fuel Standard and the California Low Carbon Fuel Standard. Includes discussion of 2014 changes proposed or implemented to each program.
David Glass Presentation at 6th Annual Biofuels Law and Regulation ConferenceDavid Glass
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This is the presentation I made at the Energy Bioscience Institute's 6th Annual Biofuel Law and Regulations Conference. The talk included discussion of a wide-ranging list of legal, regulatory and policy issues important for the development of the biofuel industry in the US and internationally. Please visit my Biofuel Policy Watch blog for additional content relating to this presentation.
D. Glass Associates: Licensing, Tech Transfer and Strategic Patent ManagementDavid Glass
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D. Glass Associates, Inc. offers expert assistance to academic institutions as well as biotechnology and medical device companies in the management of many aspects of the patent and licensing process and industry-academic relations.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
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Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
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A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
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Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
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It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
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Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
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Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Attending a job Interview for B1 and B2 Englsih learnersErika906060
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It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
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Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, youâll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Memorandum Of Association Constitution of Company.pptseri bangash
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www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujaratâs DholeraAvirahi City Dholera
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The Tata Group, a titan of Indian industry, is making waves with its advanced talks with Taiwanese chipmakers Powerchip Semiconductor Manufacturing Corporation (PSMC) and UMC Group. The goal? Establishing a cutting-edge semiconductor fabrication unit (fab) in Dholera, Gujarat. This isnât just any project; itâs a potential game changer for Indiaâs chipmaking aspirations and a boon for investors seeking promising residential projects in dholera sir.
Visit : https://www.avirahi.com/blog/tata-group-dials-taiwan-for-its-chipmaking-ambition-in-gujarats-dholera/
The effects of customers service quality and online reviews on customer loyal...
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David Glass FEW Presentation.06.21.16
1. Simplifying Regulatory Approvals
for Genetically Modified Yeast in
Distillers Co-Products
David J. Glass, Ph.D.
D. Glass Associates, Inc.
Fuel Ethanol Workshop
June 21, 2016
2. â Over 43 million tons of DDGS produced in the U.S. in
2013-2014 (approx. 33 million used domestically, 10
million exported)1.
â Approximately 98% of the distillers grains used in North
America are a byproduct of fuel ethanol production2.
1. Source: Iowa State University. http://www.extension.iastate.edu/agdm/crops/outlook/dgsbalancesheet.pdf
2. Source: University of Minnesota, Distillers Grains By-products in Livestock and Poultry Feeds, 2007 , cited on FDA
website, http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/Contaminants/ucm190907.htm
Distillers Co-Products
3. Use of Modified Yeast Strains in
Distillers Co-Products
â Growth in the U.S. ethanol industry has
Increased interest in the development
of modified yeast strains to improve
ethanol production.
â This has led to increased interest in the
use of modified yeast strains in
distillers co-products.
4. Researchers are modifying S. cerevisiae in several ways
to improve ethanol production:
â Express enzymes to improve feedstock processing.
â Impart new pathways to utilize C5 sugars,
e.g. from cellulosic feedstocks.
â Metabolic engineering to reduce byproducts
like glycerol.
â Improve ethanol tolerance of strains.
Modified Yeast Strains to Improve
Ethanol Production
5. â Industrial use of modified yeast strains is regulated
by EPA under its TSCA biotechnology rules.
â Although some uses are exempt, there have been at
least 27 Microbial Commercial Activity Notices
reviewed and cleared by EPA for different modified S.
cerevisiae strains1.
â Use of GMO Yeast in DDGs regulated as Animal Feed
Ingredients.
1. Source: https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-notifications-status
Regulation of Industrial Use of
Modified Yeast Strains
6. â FDA regulates food and feed.
â Manufacturers must not introduce foods that are
adulterated.
â Ingredients that have not been used in food are
considered âadditivesâ and must be
reviewed for safety and efficacy.
â Certain products, like traditional DDGs,
considered GRAS due to long history of use;
others can achieve GRAS status as well.
U.S. Regulation of Animal Feed
Ingredients
7. FDA Biotechnology policy is not clear on the extent of genetic
changes to an organism that would trigger need for new review.
FDA Genetic Engineering Policy
Comments questioned whether a substance (including microbes)
that is GRAS could lose its GRAS status solely because it was
produced or modified by new biotechnology. The answer is yes, if
the substance (and its contaminants) has been altered in such a way
that it can no longer be generally recognized by qualified experts to
be safe. In this instance, the substance would be a food additive.
Source: FDA Statement in Coordinated Framework for Biotechnology Regulation, 1986
8. Although overseen by FDA CVM there are several
options for approval of new feed ingredient:
â GRAS Self-determination
â GRAS Self-determination, notification to FDA
â FDA Feed Additive Petition
â AAFCO New Ingredient Definition
U.S. Regulation of Animal Feed
Ingredients
9. Different Paths to Approval
â The different pathways all generally require the same
types of data.
10. â Manufacturing Chemistry; Analytical Methods
â Identity
â Manufacturing process and controls
â Product specifications
â Stability (product and in feed)
â Analytical methods: product, quantification in feed
â Utility
â Intended Use
â Feeding studies to show efficacy?
â Safety
â Target Animal â white paper or studies
â Human food -- Toxicology and Residue Chemistry â white paper or studies
â Environmental â Assessment or Categorical Exclusion
Adapted from K. Smedley presentation at 2016 AAFCO Midyear Meeting, January 2016
Data Requirements for FDA, AAFCO
Approval Pathways
11. Different Paths to Approval
â The different pathways all generally require the same
types of data.
â The same group at FDA CVM conducts the technical
review under all the pathways.
â There are pros and cons to each approach, but â
â The track record to date for approvals of modified
yeast strains has been very limited.
12. â Under U.S. law, a product for use in food or feed can be
determined to have GRAS status in two ways:
â Experience based on common use in food or feed or
â âScientific principlesâ â that, based on publicly available
information, there is a consensus among qualified experts
that those data and information establish that the substance
is safe under the conditions of its intended use
â A manufacturer can make such determinations itself, usually
based on the advice of an expert scientific panel.
GRAS Self-Determination
13. â Established 2010, modeled after
successful program for GRAS substances
in human food.
â Applicant makes its own GRAS
determination, submits dossier to obtain
FDA concurrence.
â FDA responds either âno questionsâ or
âdoes not support GRAS statusâ.
â To date, 20 submissions, only 7 of which
received favorable âFDA has no
questionsâ ruling.
FDA CVM GRAS Notification Program
14. GRAS Notification Process: No
Successful Yeast Strain Requests
Submitter Product Purpose Status
Gevo Inactivated
modified S.
cerevisiae
Component of animal feed when
used in the fermentation and
distillation of corn to produce
isobutanol
Notice does not provide a
basis for a GRAS
determination
Gevo Isobutanol distillers
grain
Component of animal feed At notifier's request, FDA
ceased to evaluate the
notice
DSM Inactivated
modified S.
cerevisiae
Component of animal feed when
used in the fermentation of corn
to produce ethanol
At notifier's request, FDA
ceased to evaluate the
notice (Resubmitted
4/29/16, pending)
http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm
15. â AAFCO established a process to
add approved new ingredient
definitions to their Official
Publication.
â Applicants submit dossier to
AAFCO Investigator, for review by
FDA CVM.
â New definitions approved by
Ingredient Definition Committee
and full AAFCO membership.
AAFCO New Ingredient Definition
Process
AAFCO: Association of American
Feed Control Officials
16. Successful AAFCO Requests for
Novel Yeast Strains
Source: 2016 AAFCO Official Publication, pp. 443-444.
17. AAFCO Process is manageable but time-consuming
12-18 mos 3-6 mos 6 mos 12 mos minimum
Submission
CVM Review
CVM
Letter
AAFCO
Ingredients
Definition
Cmte Vote
Good case scenario: 36 months from submission to publication
Biannual meeting cycle Annual publication cycle
CVM & AAFCO MOU: The 2 organizations work together under a
Memorandum of Understanding that currently expires Sept 2017
Publication in the
ânextâ Official
Publication
AAFCO General
Membership
Vote
Slide courtesy of Kevin Wenger, Mascoma/Lallemand, used with permission
18. Pros Cons
GRAS Self-determination Does not require agency
review
Not recognized by many
states, Canada
GRAS Notification through
FDA
When successful, GRAS
status clearly established
Program has not worked
well, especially for biotech
products
Feed Additive Petition
through FDA
If approved, legal status
clear at FDA and AAFCO
Time-consuming, requires
rule-making, no precedent
for yeast
AAFCO Ingredient
Definition
Iterative review process,
approval clears marketing
in all states
Time-consuming,
dependent upon AAFCO
meeting schedule
Different Paths to Approval
19. â For modifications to microorganisms with a long
history of use in food and feed, including
Saccharomyces cerevisiae yeast, why should animal
feeding studies be needed to show safety?
â Shouldnât comparison to naturally-occurring species
(or ingredient containing naturally-occurring
organism) be sufficient?
â A better model is the Voluntary Consultation program
in place since 1996 for GMO crop plants.
Use in Feed of Yeast and other
Familiar Microorganisms
20. â Limited to plant species:
microorganisms excluded by definition.
â Process:
â Initial consultations.
â Submission of companyâs safety
and nutritional assessment.
â Review by Biotechnology Evaluation
Team with members from FDA CFSAN
and CVM.
â FDA may request a meeting, or
submission of more data.
FDA Voluntary Consultation for GMO
Crops
21. â FDA may conclude:
â No further questions
â The product requires review as
a food additive
â There are other regulatory issues
(e.g. labeling requirements) to be
addressed.
â Consent given to > 170 cases to date.
â Average time to decision has been
increasing over time, but is approximately 20-24 months.
FDA Voluntary Consultation for GMO
Crops
22. Adapting the Voluntary Consultation
Process for Microorganisms (1)
FDA Voluntary Consultation Program Proposed New Process
The name of the bioengineered food and the crop from which it
is derived.
The name of the modified feed ingredient and the microbial
species from which it is derived, including documentation of
taxonomy.
A description of the various applications or uses of the
bioengineered food, including animal feed uses.
A description of the applications or uses of the modified feed
ingredient in animal feed, including any use limitations, and the
identity of the target animal species. Identification of current or
prior uses of the selected microbial species in animal feed, to
which the proposed use(s) can be compared.
Information concerning the sources, identities, and functions of
introduced genetic material.
Information concerning the sources, identities, and functions of
introduced genetic material.
Information on the purpose or intended technical effect of the
modification, and its expected effect on the composition or
characteristic properties of the food or feed.
Information on the purpose or intended technical effect of the
modification, and its expected effect on the composition or
characteristic properties of the modified feed ingredient derived
from the modified microorganism.
23. Adapting the Voluntary Consultation
Process for Microorganisms (1)
FDA Voluntary Consultation Program Proposed New Process
The name of the bioengineered food and the crop from which it
is derived.
The name of the modified feed ingredient and the microbial
species from which it is derived, including documentation of
taxonomy.
A description of the various applications or uses of the
bioengineered food, including animal feed uses.
A description of the applications or uses of the modified feed
ingredient in animal feed, including any use limitations, and the
identity of the target animal species. Identification of current or
prior uses of the selected microbial species in animal feed, to
which the proposed use(s) can be compared.
Information concerning the sources, identities, and functions of
introduced genetic material.
Information concerning the sources, identities, and functions of
introduced genetic material.
Information on the purpose or intended technical effect of the
modification, and its expected effect on the composition or
characteristic properties of the food or feed.
Information on the purpose or intended technical effect of the
modification, and its expected effect on the composition or
characteristic properties of the modified feed ingredient derived
from the modified microorganism.
24. Adapting the Voluntary Consultation
Process for Microorganisms (2)
FDA Voluntary Consultation Program Proposed New Process
Information concerning the identity and function of expression
products encoded by the introduced genetic material, including
an estimate of the concentration of any expression product in
the bioengineered crop or food derived thereof.
Information concerning the identity and function of expression
products encoded by the introduced genetic material, including
an estimate of the concentration of any expression product in
the modified feed ingredient.
General description of the manufacturing process of the
modified feed ingredients.
Information regarding any known or suspected allergenicity and
toxicity of expression products and the basis for concluding that
foods containing the expression products can be safely
consumed.
Information regarding any known or suspected allergenicity**,
pathogenicity or toxicity of expression products and the basis
for concluding that modified feed ingredients containing the
expression products can be safely consumed.
Information comparing the composition or characteristics of the
bioengineered food to that of food derived from the parental
variety or other commonly consumed varieties with special
emphasis on important nutrients, and toxicants that occur
naturally in the food.
Information comparing the composition or characteristics of the
modified feed ingredient to that of an ingredient derived from
the parental species or other commonly utilized wild type
strains or species with special emphasis on important nutrients,
and toxicants that occur naturally in the feed product.
**References to allergenicity would likely be relevant only for ingredients intended for food-producing animals.
25. Adapting the Voluntary Consultation
Process for Microorganisms (2)
FDA Voluntary Consultation Program Proposed New Process
Information concerning the identity and function of expression
products encoded by the introduced genetic material, including
an estimate of the concentration of any expression product in
the bioengineered crop or food derived thereof.
Information concerning the identity and function of expression
products encoded by the introduced genetic material, including
an estimate of the concentration of any expression product in
the modified feed ingredient.
General description of the manufacturing process of the
modified feed ingredients.
Information regarding any known or suspected allergenicity and
toxicity of expression products and the basis for concluding that
foods containing the expression products can be safely
consumed.
Information regarding any known or suspected allergenicity**,
pathogenicity or toxicity of expression products and the basis
for concluding that modified feed ingredients containing the
expression products can be safely consumed.
Information comparing the composition or characteristics of the
bioengineered food to that of food derived from the parental
variety or other commonly consumed varieties with special
emphasis on important nutrients, and toxicants that occur
naturally in the food.
Information comparing the composition or characteristics of the
modified feed ingredient to that of an ingredient derived from
the parental species or other commonly utilized wild type
strains or species with special emphasis on important nutrients,
and toxicants that occur naturally in the feed product.
**References to allergenicity would likely be relevant only for ingredients intended for food-producing animals.
26. Adapting the Voluntary Consultation
Process for Microorganisms (3)
FDA Voluntary Consultation Program Proposed New Process
A discussion of the available information that addresses
whether the potential for the bioengineered food to induce an
allergic response has been altered by the genetic modification.
A discussion of the available information that addresses
whether the potential for the modified feed ingredient to induce
an allergic response** has been altered by the genetic
modification.
Any other information relevant to the safety and nutritional
assessment of the bioengineered food.
Any other information relevant to the safety and nutritional
assessment of the modified feed ingredient, including any
information inconsistent with the determination of safety.
Other information needed for AAFCO purposes, including:
proposed Feed Ingredient Definition and proposed label, etc.
Other information needed for GRAS purposes, including
proposed GRAS claim, basis for concluding GRAS status, etc.
27. Adapting the Voluntary Consultation
Process for Microorganisms (3)
FDA Voluntary Consultation Program Proposed New Process
A discussion of the available information that addresses
whether the potential for the bioengineered food to induce an
allergic response has been altered by the genetic modification.
A discussion of the available information that addresses
whether the potential for the modified feed ingredient to induce
an allergic response** has been altered by the genetic
modification.
Any other information relevant to the safety and nutritional
assessment of the bioengineered food.
Any other information relevant to the safety and nutritional
assessment of the modified feed ingredient, including any
information inconsistent with the determination of safety.
Other information needed for AAFCO purposes, including:
proposed Feed Ingredient Definition and proposed label, etc.
Other information needed for GRAS purposes, including
proposed GRAS claim, basis for concluding GRAS status, etc.
28. â A quicker procedure for approval of modified strains of common
food/feed microorganisms is needed, particularly for use of yeast in
DDGs, where there is such a long history.
â For familiar microbial species, comparison of the modified strain to
wild-type should be sufficient to assess safety and avoid the need
for feeding studies.
â However, staffing issues at FDA CVM will continue to be the
bottleneck for all technical reviews of new feed ingredients.
â Can this procedure be adopted as part of ongoing âmodernizationâ
of the Coordinated Framework?
Conclusions
29. David J. Glass, Ph.D.
D. Glass Associates, Inc.
124 Bird Street
Needham, MA 02492 USA
Phone 617-653-9945
dglass@dglassassociates.com
www.dglassassociates.com
More details on this proposal in Advanced
Biotechnology for Biofuels blog: http://wp.me/pKTxe-cn
Thank you!