EU Regulation 1223/2009 replaces Directive 76/768/EC as the governing regulation for cosmetic products in the EU. It requires companies to maintain a Product Information File for each cosmetic product containing information such as a product description, safety report, manufacturing details, proof of claims, and animal testing data. The responsible person must keep the file for 10 years and make it available in electronic or other format to competent authorities in the Member State where the file is kept. The regulation took effect in July 2013.
Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and managing post-approval challenges.
E2B(R2) and E2B(R3) are standards for electronic transmission of individual case safety reports (ICSRs). E2B(R3) was developed through a new collaborative approach between several international organizations, whereas E2B(R2) was developed by ICH alone. E2B(R3) uses a hierarchical data structure and is more standardized and interoperable compared to E2B(R2). The increased standardization of E2B(R3) allows for better exchange of safety information.
Digital forensics is a branch of forensic science encompassing the recovery and investigation of material found in digital devices, often in relation to computer crime. A Pilot study on methodology and complexity of digital forensics and how digital forensics can be applied in a live environment without the loss or spoilage of valuable data and evidence.
This document summarizes a presentation on biological medicines and monoclonal antibody therapeutics. It discusses regulatory guidelines for biosimilars in Korea and ASEAN countries. The presentation provided an overview of global biosimilar guidelines, noting that the EU implemented the world's first well-organized biosimilar legislation and guidelines. It also noted that Korea has issued biosimilar guidelines since 2009, and Malaysia and Singapore are leading implementation of biosimilar guidelines in ASEAN countries.
Many times we hear people talk about Data Analytics and how it can benefit your business. No more jargon, let's talk specific business real world applications
EU Regulation 1223/2009 replaces Directive 76/768/EC as the governing regulation for cosmetic products in the EU. It requires companies to maintain a Product Information File for each cosmetic product containing information such as a product description, safety report, manufacturing details, proof of claims, and animal testing data. The responsible person must keep the file for 10 years and make it available in electronic or other format to competent authorities in the Member State where the file is kept. The regulation took effect in July 2013.
Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and managing post-approval challenges.
E2B(R2) and E2B(R3) are standards for electronic transmission of individual case safety reports (ICSRs). E2B(R3) was developed through a new collaborative approach between several international organizations, whereas E2B(R2) was developed by ICH alone. E2B(R3) uses a hierarchical data structure and is more standardized and interoperable compared to E2B(R2). The increased standardization of E2B(R3) allows for better exchange of safety information.
Digital forensics is a branch of forensic science encompassing the recovery and investigation of material found in digital devices, often in relation to computer crime. A Pilot study on methodology and complexity of digital forensics and how digital forensics can be applied in a live environment without the loss or spoilage of valuable data and evidence.
This document summarizes a presentation on biological medicines and monoclonal antibody therapeutics. It discusses regulatory guidelines for biosimilars in Korea and ASEAN countries. The presentation provided an overview of global biosimilar guidelines, noting that the EU implemented the world's first well-organized biosimilar legislation and guidelines. It also noted that Korea has issued biosimilar guidelines since 2009, and Malaysia and Singapore are leading implementation of biosimilar guidelines in ASEAN countries.
Many times we hear people talk about Data Analytics and how it can benefit your business. No more jargon, let's talk specific business real world applications
This document discusses biologics and biosimilars. It begins by explaining that biologics are large protein molecules derived from living cells that are used to treat diseases. Examples include human growth hormone, insulin, and monoclonal antibodies. Biosimilars are similar but not generic versions of innovator biologic products. The document outlines key differences between biologics and small molecule drugs, challenges in developing biosimilar monoclonal antibodies, and regulatory guidelines for approving biosimilars from organizations like WHO. It also discusses benefits and concerns regarding the use of biosimilars.
Biosimilars are biological drugs that are similar to already approved biologic reference drugs. They are produced through biotechnology methods involving genetic engineering. While biosimilars hold promise to increase access to biologic treatments, they differ from traditional generics in important ways due to the complex nature of biologics. Biosimilars must undergo rigorous testing and demonstration of similarity to the reference product to ensure similar safety and efficacy profiles. Regulatory frameworks for approving biosimilars have been established by the EMA and FDA, with guidelines outlining requirements for comprehensive characterization, clinical trials, and pharmacovigilance to ensure patient safety.
In May 2017, the updates to the EudraVigilance system were approved for release and the changes went into effect on 22 November 2017, implemented by the European Medicines Agency (EMA). **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Natural Language Processing for Games ResearchJose Zagal
This document discusses how natural language processing (NLP) techniques can help analyze large amounts of text data from games to aid research in game studies. It provides examples of using NLP for part-of-speech tagging, syntactic parsing, and analyzing game reviews and player language to study gameplay descriptions. The document argues that NLP allows researchers to verify hypotheses and explore new questions at a scale not previously possible by automatically processing vast amounts of game text data.
The document provides an overview of genetic toxicology and genotoxicity assessment. It discusses what genetic toxicology is, why genotoxicity is evaluated, common assays and testing paradigms used, and key industry regulations and requirements. The agenda covers definitions of genetic toxicology, why we evaluate genotoxicity, common assays, and regulations from bodies like ICH, ECHA, and FDA.
This document provides an overview of artificial intelligence in drug discovery. It discusses three main challenges: 1) determining the best data to use for training models, 2) obtaining well-characterized patient data to pair molecular mechanisms with clinical indications, and 3) the lack of skilled AI researchers in big pharma. It also reviews the competitive landscape and growth of companies selling patient data and those applying AI in healthcare. Examples of AI applications discussed include using deep learning to predict drug approval and quantum molecular dynamics simulations.
THE PRESENTATIONS DESCRIBES THE ICH GUIDELINE FOR RESIDUAL SOLVENTS i.e Q3C.
IT contains the basic of ICH and the complete description about the ICH guideline Q3C and its classification,limits,acceptance criteria in Pharma industries and the standards.
#Pharmaceuticalguideline
#medicine
#healthandmedicine
Tizen is an open source, standards-based software platform supported by leading mobile operators, device manufacturers, and silicon suppliers. It can be used for multiple computing platforms including smartphones, In-vehicle infotainment (IVI), smart TV, notebooks, tablets, and more. In this session, we will outline the vision and goals of the project, and give pointers to the technical details, architecture and building blocks needed to develop Tizen OS based solutions. We'll also give you an understanding of the native and Web/HTML5 based development environment offered by Tizen.
Nitrosamine Impurities in Human Drugs.pdfTuhinReza5
This document discusses nitrosamine impurities in human drugs. It begins by classifying impurities into organic, inorganic, and residual solvent categories. It then provides background on nitrosamines, explaining that they are probable carcinogens that can form during manufacturing through nitrosation reactions between amines and nitrous acid. The document identifies seven common nitrosamine impurities and discusses acceptable intake limits. It provides guidance for manufacturers on controlling nitrosamine impurities, including risk assessment, testing, validation methods, and specification limits.
This document provides an introduction and overview of natural language processing (NLP). It discusses what NLP is, how machines can process human language, the history and importance of NLP, and the typical components and processes involved, including morphological/lexical analysis, syntactic analysis, semantic analysis, discourse integration, and pragmatic analysis. The document also compares natural language to computer languages, discusses the future of NLP being linked to advances in artificial intelligence, and summarizes that NLP involves disambiguation at various linguistic levels through statistical learning methods.
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
The document discusses key principles and guidelines for regulated bioanalysis including validation of quantitative bioanalytical methods. It covers validation of both non-chromatographic and chromatographic assays. Some of the main points covered include validation criteria for calibration curves, quality controls, selectivity, accuracy, precision, reproducibility, recovery, and stability. Examples of validation results are also provided to illustrate concepts like matrix effects, column ruggedness, and recovery.
This document provides an overview of the Android operating system. It discusses that Android is an open-source, Linux-based software platform built for mobile devices. The document then reviews Android's history from its founding in 2003 by Andy Rubin to its acquisition by Google in 2005. It also examines the Open Handset Alliance consortium and describes Android's multi-process architecture and key features. The rest of the document outlines the various versions of Android released since 2008 and their new features, as well as advantages and disadvantages of the Android platform.
This presentation provides an overview of the Android operating system. It discusses that Android is an open-source, Linux-based software platform developed by Google and the Open Handset Alliance. The key points covered include the history and founding of Android, its features such as support for various wireless technologies and advanced media formats, the different versions released over time, and comparisons to other mobile operating systems. Examples of applications for controlling devices like Arduino and robots from Android are also presented.
- The list of services offered by firebase
- What is machine learning
- Types of machine learning
- How firebase helps to achieve ML with ML Kit
- What is AutoML Vision Edge and how to use it to train model
The document discusses Transformer models BERT and GPT. BERT uses only the encoder part of Transformers and is trained using masked language modeling and next sentence prediction, allowing it to consider bidirectional context. GPT uses the decoder part and is trained with autoregressive language modeling, allowing it to generate text one word at a time by considering previous words. While both can be adapted to various tasks, their core architectures make one generally better suited for certain tasks like text generation versus language understanding.
A slide series to learn and appreciate the importance and the potential of Personalized/Individualized Genomic Medicine. It briefly goes through the idea of biotechnology and the advancements we have made in biology and technology. A series of applications for genomic medicine is then explored, not failing to mention the challenges we have to overcome as well, for the next medical revolution.
A case for personalized medicine is presented.
Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
This document discusses biologics and biosimilars. It begins by explaining that biologics are large protein molecules derived from living cells that are used to treat diseases. Examples include human growth hormone, insulin, and monoclonal antibodies. Biosimilars are similar but not generic versions of innovator biologic products. The document outlines key differences between biologics and small molecule drugs, challenges in developing biosimilar monoclonal antibodies, and regulatory guidelines for approving biosimilars from organizations like WHO. It also discusses benefits and concerns regarding the use of biosimilars.
Biosimilars are biological drugs that are similar to already approved biologic reference drugs. They are produced through biotechnology methods involving genetic engineering. While biosimilars hold promise to increase access to biologic treatments, they differ from traditional generics in important ways due to the complex nature of biologics. Biosimilars must undergo rigorous testing and demonstration of similarity to the reference product to ensure similar safety and efficacy profiles. Regulatory frameworks for approving biosimilars have been established by the EMA and FDA, with guidelines outlining requirements for comprehensive characterization, clinical trials, and pharmacovigilance to ensure patient safety.
In May 2017, the updates to the EudraVigilance system were approved for release and the changes went into effect on 22 November 2017, implemented by the European Medicines Agency (EMA). **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Natural Language Processing for Games ResearchJose Zagal
This document discusses how natural language processing (NLP) techniques can help analyze large amounts of text data from games to aid research in game studies. It provides examples of using NLP for part-of-speech tagging, syntactic parsing, and analyzing game reviews and player language to study gameplay descriptions. The document argues that NLP allows researchers to verify hypotheses and explore new questions at a scale not previously possible by automatically processing vast amounts of game text data.
The document provides an overview of genetic toxicology and genotoxicity assessment. It discusses what genetic toxicology is, why genotoxicity is evaluated, common assays and testing paradigms used, and key industry regulations and requirements. The agenda covers definitions of genetic toxicology, why we evaluate genotoxicity, common assays, and regulations from bodies like ICH, ECHA, and FDA.
This document provides an overview of artificial intelligence in drug discovery. It discusses three main challenges: 1) determining the best data to use for training models, 2) obtaining well-characterized patient data to pair molecular mechanisms with clinical indications, and 3) the lack of skilled AI researchers in big pharma. It also reviews the competitive landscape and growth of companies selling patient data and those applying AI in healthcare. Examples of AI applications discussed include using deep learning to predict drug approval and quantum molecular dynamics simulations.
THE PRESENTATIONS DESCRIBES THE ICH GUIDELINE FOR RESIDUAL SOLVENTS i.e Q3C.
IT contains the basic of ICH and the complete description about the ICH guideline Q3C and its classification,limits,acceptance criteria in Pharma industries and the standards.
#Pharmaceuticalguideline
#medicine
#healthandmedicine
Tizen is an open source, standards-based software platform supported by leading mobile operators, device manufacturers, and silicon suppliers. It can be used for multiple computing platforms including smartphones, In-vehicle infotainment (IVI), smart TV, notebooks, tablets, and more. In this session, we will outline the vision and goals of the project, and give pointers to the technical details, architecture and building blocks needed to develop Tizen OS based solutions. We'll also give you an understanding of the native and Web/HTML5 based development environment offered by Tizen.
Nitrosamine Impurities in Human Drugs.pdfTuhinReza5
This document discusses nitrosamine impurities in human drugs. It begins by classifying impurities into organic, inorganic, and residual solvent categories. It then provides background on nitrosamines, explaining that they are probable carcinogens that can form during manufacturing through nitrosation reactions between amines and nitrous acid. The document identifies seven common nitrosamine impurities and discusses acceptable intake limits. It provides guidance for manufacturers on controlling nitrosamine impurities, including risk assessment, testing, validation methods, and specification limits.
This document provides an introduction and overview of natural language processing (NLP). It discusses what NLP is, how machines can process human language, the history and importance of NLP, and the typical components and processes involved, including morphological/lexical analysis, syntactic analysis, semantic analysis, discourse integration, and pragmatic analysis. The document also compares natural language to computer languages, discusses the future of NLP being linked to advances in artificial intelligence, and summarizes that NLP involves disambiguation at various linguistic levels through statistical learning methods.
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
The document discusses key principles and guidelines for regulated bioanalysis including validation of quantitative bioanalytical methods. It covers validation of both non-chromatographic and chromatographic assays. Some of the main points covered include validation criteria for calibration curves, quality controls, selectivity, accuracy, precision, reproducibility, recovery, and stability. Examples of validation results are also provided to illustrate concepts like matrix effects, column ruggedness, and recovery.
This document provides an overview of the Android operating system. It discusses that Android is an open-source, Linux-based software platform built for mobile devices. The document then reviews Android's history from its founding in 2003 by Andy Rubin to its acquisition by Google in 2005. It also examines the Open Handset Alliance consortium and describes Android's multi-process architecture and key features. The rest of the document outlines the various versions of Android released since 2008 and their new features, as well as advantages and disadvantages of the Android platform.
This presentation provides an overview of the Android operating system. It discusses that Android is an open-source, Linux-based software platform developed by Google and the Open Handset Alliance. The key points covered include the history and founding of Android, its features such as support for various wireless technologies and advanced media formats, the different versions released over time, and comparisons to other mobile operating systems. Examples of applications for controlling devices like Arduino and robots from Android are also presented.
- The list of services offered by firebase
- What is machine learning
- Types of machine learning
- How firebase helps to achieve ML with ML Kit
- What is AutoML Vision Edge and how to use it to train model
The document discusses Transformer models BERT and GPT. BERT uses only the encoder part of Transformers and is trained using masked language modeling and next sentence prediction, allowing it to consider bidirectional context. GPT uses the decoder part and is trained with autoregressive language modeling, allowing it to generate text one word at a time by considering previous words. While both can be adapted to various tasks, their core architectures make one generally better suited for certain tasks like text generation versus language understanding.
A slide series to learn and appreciate the importance and the potential of Personalized/Individualized Genomic Medicine. It briefly goes through the idea of biotechnology and the advancements we have made in biology and technology. A series of applications for genomic medicine is then explored, not failing to mention the challenges we have to overcome as well, for the next medical revolution.
A case for personalized medicine is presented.
Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
Bu ay Hosting Dergi’de, Yazılım sektörü, istatistik verileri ve teknik anlatımlar yer alıyor. Ayrıca Türkiye ve Dünyadan Hosting sektörü ile ilgili haberleri, alanında uzman yazarların makalelerini dopdolu içeriğimizde bulabilirsiniz.
7. o Kimlik doğrulama
o Hesap yönetimi
Destekledikleri:
o E-mail ve şifre ile giriş
o Sosyal medya hesapları üzerinden giriş
o Var olan kimlik doğrulama sistemi ile
entegrasyon
8. o Bulut tabanlı NoSQL Veritabanı
o Senkronizasyon
o Uygulama üzerinden direkt erişim
9. o Resim vb. statik kaynaklar
o SSL Desteği
o Ücretsiz kendi alan adınızı(domain)
yönlendirme
10. o Kolay dosya depolama
o Düşük bağlantıyla hizmet
o Google Cloud Storage ile yedekleme
ve erişme
11. o A/B test ortamı sunma
o Uygulamanın davranışını değiştirme
o Sunucu konsolunda key-value çiftiyle
kontrol
o Değişiklikleri anında yayınlayabilme
12.
13. o Yayınlamadan önce en popüler cihazlar üzerinde
test imkanı
o Raporlama ve ekran görüntüleri
o Robo & custom test
14. o Crash detaylarını ve etkilerini görüntüleme
o İşletim sistemi ve versiyon bilgisi
o Analytics ile entegre
15.
16.
17. o Tek bir URL ile farklı kullanıcı deneyimlerini
özelleştirme
o Çapraz platformlarda çalışma
o Kullanıcıya uygulama yüklü değilse , kullanıcıdan
uygulamayı yüklemesini isteme
18. o Uygulama paylaşımı için açılır pencere özelliği
o SMS ve Email Destekleme
o Google’dan gelen alıcı önerileri
o Dinamik bağlantılar üzerine kurulmuştur
19.
20. o Evrensel uygulama kampanyaları
o 2 milyar indirme
o Android ve iOS desteği
o Kitleyi yeniden hedefleme
o Dönüşüm izleme ve optimizasyon
21.
22. o Google arama ile entegre
o Uygulama içeriğini indexleme
o Arama sıralamasını artırma
23.
24. o Basit arayüz , sıfır kod
o Cloud Messaging üzerinde
yapılandırılmış
o Kitle hedefleme
25.
26.
27.
28. İlgi çekici formatlar:
Video reklam , geçiş reklamı, native
1 milyardan fazla uygulama AdMob kullanıyor
Firebase SDK ile entegre