This document is a letter from researchers to the European Commissioner for Health and Consumer Policy and a Scientific Committees Management Officer. The researchers welcome new guidance from SCENIHR on performing risk assessments but raise concerns about the "Klimisch loophole" which allows industry studies following GLP and OECD guidelines to be weighted more strongly than independent studies. They ask the Commission to remove references to Klimisch and OECD guidelines from guidance documents and instead prioritize peer-reviewed, independent studies.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
The Laboratory of Mathematical Chemistry (LMC) was established 30 years ago, in Burgas, Bulgaria, within the University ‘Prof. Dr. Asen Zlatarov’.
Nowadays, the Laboratory is one of the most influential molecular modelling labs worldwide.
This document provides an overview of local biotech companies in Hong Kong Science and Technology Parks (HKSTP). It summarizes 15 diagnostic companies from local universities in HKSTP, including those from Chinese University (CUHK), University of Hong Kong (HKU), University of Science and Technology (UST), and Hong Kong Baptist University (HKBU). It highlights several local high-fliers, including Prof. Dennis Lo from CUHK who founded Arbele and Xcelom, and Prof. Michael Yang from CityU who founded Multigene Diagnostics and Genetel Pharmaceuticals. It also discusses trends in personalized medicine, obstacles, and examples of novel designs and a start-up biotech company to illustrate
Marike Kolossa-Gehring: The Chemical Challenge - How HBM4EU Can HelpTHL
Marike Kolossa-Gehring, Coordinator of HBM4EU, German Environment Agency, at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
This document summarizes a method for identifying counterfeit pharmaceuticals using isotopic fingerprinting. It discusses how stable isotope analysis can provide evidence of a product's manufacturing process or raw materials. Specifically, it describes two methods for measuring stable isotope ratios: IRMS and SNIF-NMR. The combined data from these methods creates a unique isotopic fingerprint that can be used to authenticate products and track them along the supply chain. Eurofins has experience with this technique and can help clients with challenging testing projects.
Finding Optimal Compound Dosage for Anti-Aging DrugsWenlan Hu
Anti-aging compound becomes a very integral part of the compound market. However, the lack of experience in this field makes it very hard for testing CROs to fully understand the mechanism of actions as well as efficacy of the compound, particularly the optimal dosage for anti-aging use. In the following slide we are trying to share with you the best way to do testing on the substances that are designed for anti-aging use.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
The Laboratory of Mathematical Chemistry (LMC) was established 30 years ago, in Burgas, Bulgaria, within the University ‘Prof. Dr. Asen Zlatarov’.
Nowadays, the Laboratory is one of the most influential molecular modelling labs worldwide.
This document provides an overview of local biotech companies in Hong Kong Science and Technology Parks (HKSTP). It summarizes 15 diagnostic companies from local universities in HKSTP, including those from Chinese University (CUHK), University of Hong Kong (HKU), University of Science and Technology (UST), and Hong Kong Baptist University (HKBU). It highlights several local high-fliers, including Prof. Dennis Lo from CUHK who founded Arbele and Xcelom, and Prof. Michael Yang from CityU who founded Multigene Diagnostics and Genetel Pharmaceuticals. It also discusses trends in personalized medicine, obstacles, and examples of novel designs and a start-up biotech company to illustrate
Marike Kolossa-Gehring: The Chemical Challenge - How HBM4EU Can HelpTHL
Marike Kolossa-Gehring, Coordinator of HBM4EU, German Environment Agency, at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
This document summarizes a method for identifying counterfeit pharmaceuticals using isotopic fingerprinting. It discusses how stable isotope analysis can provide evidence of a product's manufacturing process or raw materials. Specifically, it describes two methods for measuring stable isotope ratios: IRMS and SNIF-NMR. The combined data from these methods creates a unique isotopic fingerprint that can be used to authenticate products and track them along the supply chain. Eurofins has experience with this technique and can help clients with challenging testing projects.
Finding Optimal Compound Dosage for Anti-Aging DrugsWenlan Hu
Anti-aging compound becomes a very integral part of the compound market. However, the lack of experience in this field makes it very hard for testing CROs to fully understand the mechanism of actions as well as efficacy of the compound, particularly the optimal dosage for anti-aging use. In the following slide we are trying to share with you the best way to do testing on the substances that are designed for anti-aging use.
This document proposes predictive toxicology and toxicogenomics services from Accommodator Consultancy Services. It discusses the need for predictive toxicology due to bans on animal testing and advances in computational modeling. The company has infrastructure for molecular modeling and data analysis. Services proposed include data processing, toxicology data integration, text mining, expert systems, and assisting with carcinogenicity tests. Benefits include reducing animal testing and speeding safety assessments. Challenges and trends in the field are also reviewed.
Re-Engineering Early Phase Cancer Drug Development: Decreasing the Time from ...mconghuyen
The document summarizes efforts to decrease the time required to develop novel cancer therapeutics from target identification to clinical use. It describes how most oncology drugs fail in late stages of development, particularly phases 2 and 3, due to lack of efficacy. To address this, the National Cancer Institute has created programs like the Experimental Therapeutics Program and Chemical Biology Consortium to streamline the discovery and development process. This includes providing resources from target validation through early clinical trials to support academic and biotech projects focusing on areas of unmet medical need. The goal is to rapidly translate discoveries into treatments to benefit public health.
In its third year, “PEGS China: Protein and Antibody Engineering & Development Summit” returns to Shanghai for 3 days of inspiring presentations and case studies featuring the latest trends and future potential of China’s biotech industry.
This year’s event comprises four content-driven conferences with over sixty global speakers, plus a new 1-day seminar on clinical & regulatory strategies for global and domestic IND and BLA filings. In addition, dedicated exhibit hall and poster viewing hours will provide invaluable opportunities for networking, deal-making and ideas exchange.
EUGM15 - George Papadatos, Mark Davies, Nathan Dedman (EMBL-EBI): SureChEMBL:...ChemAxon
SureChEMBL is a new resource provided by the European Bioinformatics Institute (EMBL-EBI) that annotates, extracts and indexes chemistry from full text patent documents by means of continuous, automated text and image mining. SureChEMBL is perhaps the only open, freely available, live patent chemistry resource available, in a field that has been traditionally commercial.
Since its launch last September, the SureChEMBL interface provides sophisticated keyword and chemistry-based querying and exporting functionality against a corpus of more than 16 million compounds extracted from 13 million patent documents. Both the interface and the underlying data pipeline leverage extensively ChemAxon technologies for name to structure conversion, as well as compound standardisation, registration and searching.
In addition to providing an overview of the system, recent developments and improvements will be described. These include the introduction of various data interexchange and exporting options, such as flat files and a data feed client. Furthermore, our future plans for the SureChEMBL system will be outlined. To date, such plans include complementing the chemical annotations with biological ones, covering genes, proteins, diseases and indications. Furthermore, we are planning to further enrich the chemical annotations with a relevance score, indicating their importance in the patent document.
The compound characterization market is growing increasingly profitable and competitive at the same time. In order to develop a new compound product, the testing step is indispensable. Unlike drug discovery, compound testing is not as restrictive, but understanding the main workflow is still necessary to excel in the market. In order to help you improve both the efficiency and safety of compound testing, we developed the protocol to assist you in your findings.
This document provides an overview of careers in drug discovery and development. It discusses the multi-stage process of discovering new drugs, from identifying drug targets through clinical trials and regulatory approval. The document notes that drug development is a highly time-intensive and costly process involving many disciplines. It also aims to dispel common myths about careers in the pharmaceutical industry, emphasizing that industry scientists have opportunities for publication, innovation, and interesting work.
CRO Company for Mode of Action & Efficacy Test for Drugs | InvivoBiosystemsWenlan Hu
Compound testing takes shares of a huge part of the drug development and health-related compound market. In order to find a CRO that is both friendly for budget saving and efficient at the same time is not easy. IVB uses a three staged compound assessment which includes RNAseq, whole transcriptome analysis, and other techniques to help our clients better understand the mode of action and efficacy of a particular compound.
How to model longevity and health effect in 3 monthsWenlan Hu
Healthspan analysis is a huge part of longevity study, which is heavily looked at by many aging labs in recent years. The older we grow, our health will be affected accordingly, and this influence what type of compound we use. To better picture what effects compounds brings to us and to extend lifespan as a goal. A three stage compound assessment is developed by IVB to solve this question.
This document discusses presentations made by independent researchers at scientific conferences highlighting the advantages of Pressure Cycling Technology (PCT) developed by Pressure BioSciences, Inc. It notes that PCT allows faster and improved sample processing for applications such as biomarker discovery. Pressure BioSciences believes increased awareness and acceptance of PCT will lead to increased revenue in the second half of 2011 compared to the first half. The company is working to commercialize new PCT-based instruments and raise capital to support sales and marketing efforts.
The document is a program of events for the University of Illinois at Urbana-Champaign Innovation & Start-Up Showcase on October 8, 2015. It includes a schedule of faculty presentations on their research and related start-up companies, as well as sessions on poster presentations and start-up pitches. Some of the faculty presentations will cover developing new cancer therapeutics through natural products, targeted drug delivery, and T-cell therapies.
Methods used to assure high quality study for ERAEFSA EU
This document discusses methods for assuring high quality studies for environmental risk assessments of transgenic plants. It outlines principles for early-tier testing of non-target arthropods, including selecting relevant test species, characterizing the test substance, choosing appropriate exposure levels and durations, including suitable negative and positive controls, and evaluating study results to avoid false positives or negatives. The goal is to generate reliable data that risk assessors can interpret consistently and use robustly in the risk assessment process.
Using open bioactivity data for developing machine-learning prediction models...Sunghwan Kim
Presented at the 256th American Chemical Society (ACS) National Meeting in Boston, MA (August 22, 2018).
==== Abstract ====
The retinoid X receptor (RXR) is a nuclear hormone receptor that functions as a transcription factor with roles in development, cell differentiation, metabolism, and cell death. Chemicals that interfere the RXR signaling pathway may cause adverse effects on human health. In this study, open bioactivity data available at PubChem (https://pubchem.ncbi.nlm.nih.gov) were used to develop prediction models for chemical modulators of RXR-alpha, which is a subtype of RXR that plays a role in metabolic signaling pathways, dermal cysts, cardiac development, insulin sensitization, etc. The models were constructed from quantitative high-throughput screening (qHTS) data from the Tox21 project, using various supervised machine learning methods (including support vector machine, random forest, neural network, k-nearest neighbors, decision tree, and naïve Bayes). The performance of the models was evaluated with an external data set containing bioactivity data submitted by ChEMBL and the NCATS Chemical Genomics Center (NCGC). This study showcases how open data in the public domain can be used to develop prediction models for chemical toxicity.
Istvan Sebestyen - Workers operators bystanders and residentscropprotection
The document provides background on EFSA's efforts to develop guidance on pesticide exposure assessment. It summarizes EFSA's process of gathering input, conducting public consultations, and drafting the guidance document and related scientific opinion between 2006-2010. The main contents of the scientific opinion are outlined, including defining the scope, reviewing legal requirements, current risk assessment methods, and proposed new approaches for assessing acute risk and accounting for statistical variability.
Linde Gas whitepaper 'Drug discovery advances inextricably linked to specialt...Linde Gas Benelux
The development and commercialisation of new medical drugs is a complex and costly process, but increasing pressure is being placed on drug companies to accelerate the timeline from discovery of new drugs, through to clinical trials and then to their release onto the market. The pharmaceutical industry continues to demand ever more advanced products aimed at improving health and the quality of modern-day life.
Research and development take place in pharmaceutical laboratories using analytical instruments such as gas chromatographs with multiple detectors, liquid chromatographs coupled with mass spectrometers (LC-MS), ultraviolet/visible (UV/VIS) spectrometers and nuclear magnetic resonance (NMR) spectrometers. These significantly accelerate research and development cycles, ultimately bringing beneficial drugs onto the market faster than ever before. The effective operation of these instruments depends on the use of the appropriate gases or gas mixtures.
GlobeImmune is a biotechnology company founded in 1995 by three University of Colorado faculty to commercialize their inventions from the lab. The company developed recombinant yeast-based immunotherapies and vaccines, with an initial focus on HIV. After hiring a professional CEO in 2002 and obtaining venture capital financing, the company shifted its focus to cancer immunotherapy. GlobeImmune has raised over $180 million in financing to date and completed multiple clinical trials. Its lead products are whole, heat-killed recombinant yeast immunotherapeutics for various cancer indications.
The document provides information about the Organization for Economic Co-operation and Development (OECD). It discusses the history and establishment of the OECD, its objectives to promote policies that improve economic and social well-being, and how it provides a forum for governments to work together on issues like economic growth, employment, financial stability, and trade. The document also summarizes OECD's toxicity testing guidelines, which provide standardized methods for testing chemicals and their potential hazards. This allows data to be shared between countries and avoids duplicative testing.
The document discusses the International Council for Harmonization (ICH). ICH aims to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan, and the United States to reduce duplication of testing and make the development of new medicines more efficient. It outlines the structure of ICH, including its steering committee and expert working groups. ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics. The overall goal is to streamline drug development while maintaining high standards for safety, quality and efficacy.
EU REACH regulation changed the way to do chemical risk assessment. All chemicals marketed or manufactured in the EU must have its own dossier. Non standard methods including alternatives to animal testing are accepted.
Half Italian, half English
The Dictionary of Substances and Their Effects (DOSE): Volume 01 A-Bkopiersperre
This document provides information about the second edition of "The Dictionary of Substances and Their Effects" (DOSE). Some key details include:
- DOSE is a reference work that collects and collates chemical and biological data on over 4,000 substances from peer-reviewed literature to help with risk assessment.
- The second edition has been expanded and updated from the first edition, which covered around 4,000 substances. It includes more recently studied chemicals and updated toxicological data.
- In addition to basic chemical properties and toxicological information, the second edition includes data on occupational exposure limits, endocrine disrupting chemicals, and carcinogenicity assessments from IARC and NTP.
Alternative methods to animal toxicity testingpriyachhikara1
This document discusses alternative methods to animal toxicity testing, including in silico computer simulation methods, in vitro cell culture techniques, using fewer animals, microdosing, and epidemiological and clinical studies. It provides details on regulatory agencies that promote alternative testing methods, as well as specific alternative tests that have been developed and validated according to OECD guidelines to replace or reduce animal use.
1. The document discusses approaches to evaluating the toxicity of industrial chemicals in a humane manner. It examines using laboratory animals versus alternative in vitro methods.
2. Currently, there are no immediate alternatives to using animals for assessing acute toxicity of chemicals through ocular, systemic, and cutaneous toxicity tests. Complex biological systems are difficult to replicate entirely in vitro.
3. Society demands high certainty in toxicity assessments to minimize risk to humans. Toxicologists must be cautious not to reduce predictive quality by replacing animal tests prematurely with alternatives that have not been fully validated.
This document proposes predictive toxicology and toxicogenomics services from Accommodator Consultancy Services. It discusses the need for predictive toxicology due to bans on animal testing and advances in computational modeling. The company has infrastructure for molecular modeling and data analysis. Services proposed include data processing, toxicology data integration, text mining, expert systems, and assisting with carcinogenicity tests. Benefits include reducing animal testing and speeding safety assessments. Challenges and trends in the field are also reviewed.
Re-Engineering Early Phase Cancer Drug Development: Decreasing the Time from ...mconghuyen
The document summarizes efforts to decrease the time required to develop novel cancer therapeutics from target identification to clinical use. It describes how most oncology drugs fail in late stages of development, particularly phases 2 and 3, due to lack of efficacy. To address this, the National Cancer Institute has created programs like the Experimental Therapeutics Program and Chemical Biology Consortium to streamline the discovery and development process. This includes providing resources from target validation through early clinical trials to support academic and biotech projects focusing on areas of unmet medical need. The goal is to rapidly translate discoveries into treatments to benefit public health.
In its third year, “PEGS China: Protein and Antibody Engineering & Development Summit” returns to Shanghai for 3 days of inspiring presentations and case studies featuring the latest trends and future potential of China’s biotech industry.
This year’s event comprises four content-driven conferences with over sixty global speakers, plus a new 1-day seminar on clinical & regulatory strategies for global and domestic IND and BLA filings. In addition, dedicated exhibit hall and poster viewing hours will provide invaluable opportunities for networking, deal-making and ideas exchange.
EUGM15 - George Papadatos, Mark Davies, Nathan Dedman (EMBL-EBI): SureChEMBL:...ChemAxon
SureChEMBL is a new resource provided by the European Bioinformatics Institute (EMBL-EBI) that annotates, extracts and indexes chemistry from full text patent documents by means of continuous, automated text and image mining. SureChEMBL is perhaps the only open, freely available, live patent chemistry resource available, in a field that has been traditionally commercial.
Since its launch last September, the SureChEMBL interface provides sophisticated keyword and chemistry-based querying and exporting functionality against a corpus of more than 16 million compounds extracted from 13 million patent documents. Both the interface and the underlying data pipeline leverage extensively ChemAxon technologies for name to structure conversion, as well as compound standardisation, registration and searching.
In addition to providing an overview of the system, recent developments and improvements will be described. These include the introduction of various data interexchange and exporting options, such as flat files and a data feed client. Furthermore, our future plans for the SureChEMBL system will be outlined. To date, such plans include complementing the chemical annotations with biological ones, covering genes, proteins, diseases and indications. Furthermore, we are planning to further enrich the chemical annotations with a relevance score, indicating their importance in the patent document.
The compound characterization market is growing increasingly profitable and competitive at the same time. In order to develop a new compound product, the testing step is indispensable. Unlike drug discovery, compound testing is not as restrictive, but understanding the main workflow is still necessary to excel in the market. In order to help you improve both the efficiency and safety of compound testing, we developed the protocol to assist you in your findings.
This document provides an overview of careers in drug discovery and development. It discusses the multi-stage process of discovering new drugs, from identifying drug targets through clinical trials and regulatory approval. The document notes that drug development is a highly time-intensive and costly process involving many disciplines. It also aims to dispel common myths about careers in the pharmaceutical industry, emphasizing that industry scientists have opportunities for publication, innovation, and interesting work.
CRO Company for Mode of Action & Efficacy Test for Drugs | InvivoBiosystemsWenlan Hu
Compound testing takes shares of a huge part of the drug development and health-related compound market. In order to find a CRO that is both friendly for budget saving and efficient at the same time is not easy. IVB uses a three staged compound assessment which includes RNAseq, whole transcriptome analysis, and other techniques to help our clients better understand the mode of action and efficacy of a particular compound.
How to model longevity and health effect in 3 monthsWenlan Hu
Healthspan analysis is a huge part of longevity study, which is heavily looked at by many aging labs in recent years. The older we grow, our health will be affected accordingly, and this influence what type of compound we use. To better picture what effects compounds brings to us and to extend lifespan as a goal. A three stage compound assessment is developed by IVB to solve this question.
This document discusses presentations made by independent researchers at scientific conferences highlighting the advantages of Pressure Cycling Technology (PCT) developed by Pressure BioSciences, Inc. It notes that PCT allows faster and improved sample processing for applications such as biomarker discovery. Pressure BioSciences believes increased awareness and acceptance of PCT will lead to increased revenue in the second half of 2011 compared to the first half. The company is working to commercialize new PCT-based instruments and raise capital to support sales and marketing efforts.
The document is a program of events for the University of Illinois at Urbana-Champaign Innovation & Start-Up Showcase on October 8, 2015. It includes a schedule of faculty presentations on their research and related start-up companies, as well as sessions on poster presentations and start-up pitches. Some of the faculty presentations will cover developing new cancer therapeutics through natural products, targeted drug delivery, and T-cell therapies.
Methods used to assure high quality study for ERAEFSA EU
This document discusses methods for assuring high quality studies for environmental risk assessments of transgenic plants. It outlines principles for early-tier testing of non-target arthropods, including selecting relevant test species, characterizing the test substance, choosing appropriate exposure levels and durations, including suitable negative and positive controls, and evaluating study results to avoid false positives or negatives. The goal is to generate reliable data that risk assessors can interpret consistently and use robustly in the risk assessment process.
Using open bioactivity data for developing machine-learning prediction models...Sunghwan Kim
Presented at the 256th American Chemical Society (ACS) National Meeting in Boston, MA (August 22, 2018).
==== Abstract ====
The retinoid X receptor (RXR) is a nuclear hormone receptor that functions as a transcription factor with roles in development, cell differentiation, metabolism, and cell death. Chemicals that interfere the RXR signaling pathway may cause adverse effects on human health. In this study, open bioactivity data available at PubChem (https://pubchem.ncbi.nlm.nih.gov) were used to develop prediction models for chemical modulators of RXR-alpha, which is a subtype of RXR that plays a role in metabolic signaling pathways, dermal cysts, cardiac development, insulin sensitization, etc. The models were constructed from quantitative high-throughput screening (qHTS) data from the Tox21 project, using various supervised machine learning methods (including support vector machine, random forest, neural network, k-nearest neighbors, decision tree, and naïve Bayes). The performance of the models was evaluated with an external data set containing bioactivity data submitted by ChEMBL and the NCATS Chemical Genomics Center (NCGC). This study showcases how open data in the public domain can be used to develop prediction models for chemical toxicity.
Istvan Sebestyen - Workers operators bystanders and residentscropprotection
The document provides background on EFSA's efforts to develop guidance on pesticide exposure assessment. It summarizes EFSA's process of gathering input, conducting public consultations, and drafting the guidance document and related scientific opinion between 2006-2010. The main contents of the scientific opinion are outlined, including defining the scope, reviewing legal requirements, current risk assessment methods, and proposed new approaches for assessing acute risk and accounting for statistical variability.
Linde Gas whitepaper 'Drug discovery advances inextricably linked to specialt...Linde Gas Benelux
The development and commercialisation of new medical drugs is a complex and costly process, but increasing pressure is being placed on drug companies to accelerate the timeline from discovery of new drugs, through to clinical trials and then to their release onto the market. The pharmaceutical industry continues to demand ever more advanced products aimed at improving health and the quality of modern-day life.
Research and development take place in pharmaceutical laboratories using analytical instruments such as gas chromatographs with multiple detectors, liquid chromatographs coupled with mass spectrometers (LC-MS), ultraviolet/visible (UV/VIS) spectrometers and nuclear magnetic resonance (NMR) spectrometers. These significantly accelerate research and development cycles, ultimately bringing beneficial drugs onto the market faster than ever before. The effective operation of these instruments depends on the use of the appropriate gases or gas mixtures.
GlobeImmune is a biotechnology company founded in 1995 by three University of Colorado faculty to commercialize their inventions from the lab. The company developed recombinant yeast-based immunotherapies and vaccines, with an initial focus on HIV. After hiring a professional CEO in 2002 and obtaining venture capital financing, the company shifted its focus to cancer immunotherapy. GlobeImmune has raised over $180 million in financing to date and completed multiple clinical trials. Its lead products are whole, heat-killed recombinant yeast immunotherapeutics for various cancer indications.
The document provides information about the Organization for Economic Co-operation and Development (OECD). It discusses the history and establishment of the OECD, its objectives to promote policies that improve economic and social well-being, and how it provides a forum for governments to work together on issues like economic growth, employment, financial stability, and trade. The document also summarizes OECD's toxicity testing guidelines, which provide standardized methods for testing chemicals and their potential hazards. This allows data to be shared between countries and avoids duplicative testing.
The document discusses the International Council for Harmonization (ICH). ICH aims to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan, and the United States to reduce duplication of testing and make the development of new medicines more efficient. It outlines the structure of ICH, including its steering committee and expert working groups. ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics. The overall goal is to streamline drug development while maintaining high standards for safety, quality and efficacy.
EU REACH regulation changed the way to do chemical risk assessment. All chemicals marketed or manufactured in the EU must have its own dossier. Non standard methods including alternatives to animal testing are accepted.
Half Italian, half English
The Dictionary of Substances and Their Effects (DOSE): Volume 01 A-Bkopiersperre
This document provides information about the second edition of "The Dictionary of Substances and Their Effects" (DOSE). Some key details include:
- DOSE is a reference work that collects and collates chemical and biological data on over 4,000 substances from peer-reviewed literature to help with risk assessment.
- The second edition has been expanded and updated from the first edition, which covered around 4,000 substances. It includes more recently studied chemicals and updated toxicological data.
- In addition to basic chemical properties and toxicological information, the second edition includes data on occupational exposure limits, endocrine disrupting chemicals, and carcinogenicity assessments from IARC and NTP.
Alternative methods to animal toxicity testingpriyachhikara1
This document discusses alternative methods to animal toxicity testing, including in silico computer simulation methods, in vitro cell culture techniques, using fewer animals, microdosing, and epidemiological and clinical studies. It provides details on regulatory agencies that promote alternative testing methods, as well as specific alternative tests that have been developed and validated according to OECD guidelines to replace or reduce animal use.
1. The document discusses approaches to evaluating the toxicity of industrial chemicals in a humane manner. It examines using laboratory animals versus alternative in vitro methods.
2. Currently, there are no immediate alternatives to using animals for assessing acute toxicity of chemicals through ocular, systemic, and cutaneous toxicity tests. Complex biological systems are difficult to replicate entirely in vitro.
3. Society demands high certainty in toxicity assessments to minimize risk to humans. Toxicologists must be cautious not to reduce predictive quality by replacing animal tests prematurely with alternatives that have not been fully validated.
Significance of BA/BE studies in drug research and evaluation of different as...inemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
This document provides a summary of recent literature on endocrine disrupting chemicals (EDCs) published between April and June 2012. It describes papers on human exposure measurement and modelling of EDCs, health effects of EDCs, biological mechanisms of EDCs, environmental effects of EDCs, and risk assessment of EDCs. Several studies measured concentrations of bisphenol A, phthalates, and flame retardants in human samples like urine, hair, and tissues to characterize exposure levels. Other reviews discussed health impacts of UV filters and links between male reproductive disorders and environmental toxicants.
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
Good Model Organism for Anti Aging TestingWenlan Hu
Drug testing is taking more attention than ever before in a fast growing market for longevity compounds. In order to succeed in a competitive market and develop a pipeline method for quick drug development, we need to understand and choose the most suitable model organism for aging studies. The following content is intended to provide information on how to choose the best model for anti-aging drug testing.
Trends April 2015 book review scope issueLinda Gross
The U.S. Centers for Medicare & Medicaid Services announced an oncology payment model intended to reward quality care and reduce costs. The model aims to set bounds on oncology costs by rewarding oncologists who meet quality benchmarks for Medicare beneficiaries undergoing chemotherapy. It is a five-year pilot program that combines quality benchmarks within six-month episodes of care with fee-for-service reimbursement. The program requires practices to provide 24/7 patient access and use of electronic health records to better manage complex cancer care.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
This document discusses defining the objectives of a product safety evaluation program. It outlines five key steps:
1) Defining how the product will be used and manufactured to understand potential exposures
2) Quantifying expected exposure levels based on use and manufacturing processes
3) Identifying potential health hazards based on chemical properties and anticipated exposures
4) Gathering existing toxicity data from literature reviews
5) Designing a testing program to fill data gaps based on intended use and potential hazards
The testing program may involve a tiered approach starting with basic toxicity tests and progressing to more
comprehensive studies depending on exposure potential and initial findings. The goal is to understand health risks
and ensure product safety.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Biological Monitoring of Workers Exposed to Pesticides - Guidelines for appli...Saide OER Africa
This guideline was produced for those persons responsible for the maintenance of health and safety measures at agricultural workplaces handling potentially hazardous organophosphate and carbarnate chemicals. It is primarily aimed at professional nursing and other medical staff charged with monitoring workers for pesticide exposure, but will be useful to all personnel involved in workplace health and safety wishing to understand the principles behind monitoring workers for pesticide exposure.
The guidelines concentrate on monitoring for organophosphate and carabarnate insecticides because the technology is reasonably readily available, and the methodology well described. These chemicals are widely used, and are the most common cause of acute poisoning by pesticides. The guidelines have also been written bearing in mind the Hazardous Chemical Regulations (Regulation 556 of 25 August 1995 in terms of the Occupational Health and Safety Act) that include agricultural workplaces in addition to industry.
Biological Monitoring of Workers Exposed to Pesticides - Guidelines for appli...PiLNAfrica
This guideline was produced for those persons responsible for the maintenance of health and safety measures at agricultural workplaces handling potentially hazardous organophosphate and carbarnate chemicals. It is primarily aimed at professional nursing and other medical staff charged with monitoring workers for pesticide exposure, but will be useful to all personnel involved in workplace health and safety wishing to understand the principles behind monitoring workers for pesticide exposure.
The guidelines concentrate on monitoring for organophosphate and carabarnate insecticides because the technology is reasonably readily available, and the methodology well described. These chemicals are widely used, and are the most common cause of acute poisoning by pesticides. The guidelines have also been written bearing in mind the Hazardous Chemical Regulations (Regulation 556 of 25 August 1995 in terms of the Occupational Health and Safety Act) that include agricultural workplaces in addition to industry.
The International Conference on Harmonization (ICH) brings together regulatory authorities from Europe, Japan, and the US along with pharmaceutical industry experts to discuss scientific and technical requirements for drug registration. ICH has established guidelines covering quality, safety, efficacy, and other topics with the goals of increasing harmonization and ensuring safe, effective drugs are developed efficiently. The guidelines address issues such as stability testing, impurities thresholds, and quality risk management over the lifetime of drugs.
The document discusses the International Conference on Harmonization (ICH) guidelines. ICH brings together regulatory authorities and pharmaceutical companies from Europe, Japan, and the US to discuss testing procedures for ensuring drug safety, quality, and efficacy. The guidelines cover Quality, Safety, Efficacy, and Multidisciplinary topics. They aim to harmonize technical requirements for drug approval across countries to reduce costs and duplication of testing while making safe, effective treatments more widely available. The Common Technical Document format was also created to standardize the submission of information to regulatory agencies in ICH regions.
The International Conference on Harmonization (ICH) aims to harmonize technical requirements for pharmaceutical registration across Europe, Japan, and the United States to reduce duplication of testing and delays in availability of new medicines. ICH addresses quality, safety, efficacy, and multidisciplinary topics through guidelines developed by experts from regulatory authorities and the pharmaceutical industry in the three regions. The objectives of ICH harmonization are more efficient use of resources and protection of public health while eliminating unnecessary delays in the global development and availability of new medicines.
The Coalition of Mercury-Safe Dentistry aims to end the use of dental mercury amalgam fillings and educate dental professionals and patients about their removal. The coalition seeks to assist those in the dental field and patients in understanding the health risks of mercury from dental fillings. Several organizations agree that the risks of illness from mercury in dental fillings pose unreasonable dangers to patient and dental staff health.
IAOMT dental mercury amalgam position statementDo No Harm, llc
This document provides a position statement from the International Academy of Oral Medicine and Toxicology (IAOMT) against the use of dental mercury amalgam fillings. The statement calls for ending the use of dental mercury amalgam fillings due to health risks from mercury exposure. It recommends that dental practitioners and patients be educated about mercury-free alternatives and that existing fillings be removed safely. The position is based on analyses of scientific data showing dental mercury amalgam fillings are the primary source of mercury exposure for much of the population and pose unreasonable health risks according to principles of risk assessment and precaution.
American Dental Association Talking Points on Amalgam SafetyDo No Harm, llc
An anti-amalgam film will be shown at the Kansas City FilmFest on April 18-19. The film follows three health advocates who inform the public and government about mercury vapor released during dental amalgam removal. A biochemist and mercury-safe dentist explain that peak mercury levels released during removal vastly exceed safety limits. Dental professionals are often unaware of amalgam's toxicity and safety protocols. The public is invited to attend screenings of the film. Talking points are provided to respond to patient inquiries about amalgam safety that reiterate its safety and effectiveness as shown by scientific studies.
1997 epa health_effects_of_mercury_v5___great_resourceDo No Harm, llc
This document is a report from the US Environmental Protection Agency on the health effects of mercury and mercury compounds. It contains five volumes, and this volume (Volume V) focuses specifically on the toxicokinetics and biological effects of elemental mercury, inorganic mercury, and methylmercury. The report summarizes information on the absorption, distribution, metabolism, and excretion of different forms of mercury in the body. It also reviews data on the critical noncancer and cancer health effects of mercury exposure, and discusses susceptible populations, interactions between mercury and other chemicals, and approaches to hazard identification and dose-response assessment.
This document analyzes the real costs of using dental amalgam, which contains mercury, compared to mercury-free alternatives. It finds that while amalgam fillings have a lower direct cost for dentists, the environmental and societal costs of mercury releases from amalgam use are substantial. These costs include pollution control, health impacts, and environmental damage. When these external costs are accounted for, mercury-free composite fillings have a lower total cost than amalgam fillings. The document estimates that the external costs of amalgam use in the US range from $41-67 per filling when considering pollution control costs, or $60-128 per filling when considering health and environmental benefits of phasing out amalgam. It concludes that from a full life-cycle
The document discusses mercury as a problem in indoor air. It provides 3 main points:
1) Mercury vaporizes from spills and contaminates indoor air, posing health risks especially to children and fetuses. Small spills can cause levels exceeding health guidelines.
2) Common sources of indoor mercury include thermometers, thermostats, fluorescent bulbs, and some religious practices.
3) Studies show that even minor spills can cause prolonged elevated indoor air levels, potentially exceeding occupational health standards and persisting for years. Children playing with mercury can be highly exposed.
The document discusses the neurological and psychological symptoms of mercury poisoning from dental fillings based on numerous medical references. It details how chronic low-level exposure to mercury vapor from "silver" fillings can cause a wide range of nonspecific symptoms like fatigue, anxiety, mood issues, cognitive difficulties and more. Standard toxicology and medical references confirm that long-term mercury exposure can gradually induce neurological and psychiatric effects that are difficult to diagnose due to their variable nature.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Hiranandani Hospital in Powai, Mumbai, is a premier healthcare institution that has been serving the community with exceptional medical care since its establishment. As a part of the renowned Hiranandani Group, the hospital is committed to delivering world-class healthcare services across a wide range of specialties, including kidney transplantation. With its state-of-the-art facilities, advanced medical technology, and a team of highly skilled healthcare professionals, Hiranandani Hospital has earned a reputation as a trusted name in the healthcare industry. The hospital's patient-centric approach, coupled with its focus on innovation and excellence, ensures that patients receive the highest standard of care in a compassionate and supportive environment.
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.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
1. cab-dalli-webpage@ec.europa.eu John DALLI
European Commissioner for Health and Consumer Policy
European Commission
B - 1049 Brussels, Belgium
vladimir.garkov@ec.europa.eu Vladimir Garkov, MD, PhD
Scientific Committees Management Officer
DG SANCO
Unit C7: Risk Assessment Belliard 232/2-9
B-1049 Rue Breydel 4, Brussels, Belgium
by post & by email 16 May 2012
Dear Commissioner Dalli; Dear Dr. Garkov:
We welcome the new guidance of the Commission’s Scientific Committee on Emerging New
Health Risks (SCENIHR), on how to perform risk assessments (RA).1 We hope it represents the
view of all three of the Commission’s non-food safety advisory bodies (SCENIHR, SCHER,
SCCP). However, the guidance contains a flaw that is likely to undermine its intent.
The guidance is a positive step towards making risk assessment as practised realistic, by
minimizing false negative error - i.e. missing toxic effects. Specifically, we commend the
SCENIHR for guiding its RA Working Groups to:
1) perform a thorough review of the peer-reviewed literature at the start of every RA, then
consider the totality of the data using a 'weight of the evidence' approach;
2) rely “primarily on original refereed [peer-reviewed] publications” for RAs.
1
SCENIHR (2012). Memorandum on the use of scientific literature for human health risk assessment purposes -
weighing of evidence and expression of uncertainty
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_s_001.pdf
2. Point (2) is critical. The peer-reviewed toxicity studies that are largely publicly funded and use
flexible, realistic protocols are, according to scientific reviews, far less likely to produce false
negative error than the toxicity studies sponsored by the substance’s manufacturer, which follow
rigid and limited OECD protocols. 2 We commend the SCENIHR for recommending that the
independent peer-reviewed literature (as opposed to studies commissioned by industry, which
generally are not peer-reviewed or published) should be regularly utilized in RA.
However, we are very concerned to see this more scientifically-rigorous approach
undermined, once again, by the “Klimisch loophole”. In SCENIHR’s discussion of criteria for
the acceptability of a study for a RA, the guidance recommends that the Working Groups utilize:
“the criteria proposed by Klimisch et al., (2007) and the OECD Manual for the investigation
of HPV chemicals.”
This is unacceptable. Klimisch and co-authors were employees of the chemical giant BASF and
they published in a journal that was the subject of a US Congressional inquiry due to its industry
sponsorship and perceived lack of independence on chemicals.3 Klimisch et al allow only one
criterion for the most reliable studies: Was it done according to Good Laboratory Practice (GLP)?4
This criterion effectively excludes most independent (non-industry sponsored) studies from
consideration, since only industry studies are done according to GLP. GLP is not a hallmark of
good or reliable science: it is a laboratory management system invented for the purpose of
preventing fraud in industry studies conducted for regulatory purposes. Researchers operating
independently of industry consider GLP to be irrelevant to their research – and thus too expensive
in terms of labour hours to implement without good reason. Crucially, at no point have regulators
informed independent scientists that their study is considered unreliable for not using GLP.
We ask the Commission to immediately delete the “Klimisch loophole” from all RA guidance
(EFSA, EChA and possibly other Commission guidances also use the Klimisch loophole to
exclude independent peer-reviewed data). Risk assessors must not be allowed to dismiss the
valid studies they have just been asked to prioritize.
SCENIHR’s reference to the Organisation for Economic Co-operation and Development (OECD)
HPV Manual compounds the Klimisch loophole. As with GLP, OECD’s toxicity test protocols are
for studies done for regulatory purposes (usually by industry). An increasing number of scientists
operating independent of industry feel the narrow OECD protocols restrict their freedom to
investigate; criticizing them as insensitive and prone to false negative results.5 For example,
2
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. JAMA
2003;289:454e65.
– Fagin D, Lavelle M. Center for Public Integrity. Toxic Deception: How the Chemical Industry Manipulates Science,
Bends the Law and Endangers Your Health. 2nd Edition. Monroe, ME: Common Courage Press, 1999:
– Swaen GM, Meijers JM. Influence of design characteristics on the outcome of retrospective cohort studies. Br J Ind
Med 1988;45:624e9.
– vom Saal FS, Hughes C. An extensive new literature concerning low-dose effects of bisphenol A shows the need for
a new risk assessment. Environ Health Perspect 2005;113:926-
3
RTP was one of several industry-linked organizations that were investigated by a US Congressional Committee in
2008 over their role in the FDA’s decision allowing the chemical bisphenol A in infant formula and other foods. See:
Layton, L. 2008. Studies on chemical in plastics questioned. Washington Post. April 27, 2008.
http://www.washingtonpost. com/wp-dyn/content/article/2008/04/26/AR2008042602126. html?sid=ST2008042602242 ;
Dingell, Rep. J. D. (D-Mich.). 2008. Letter to Jack N. Gerard, president and CEO, American Chemistry Council, April 2.
http://www.ewg.org/release/congress-chemical-industry-you-re-under-investigation
4
Klimisch, H. J., M. Andreae, et al. (1997). A systematic approach for evaluating the quality of experimental
toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25(1): 1-5.
5
Makris SL 2011. Current Assessment of the Effects of Environmental Chemicals on the Mammary Gland in Guideline
Rodent Studies by the U.S. Environmental Protection Agency (U.S. EPA), Organisation for Economic Co-operation and
Development (OECD), and National Toxicology Program (NTP). Environ Health Perspect 119:1047-52.
http://dx.doi.org/10.1289/ehp.1002676
3. OECD protocols kill the test animals before most chronic disease can show up, and Ramazzini
Institute’s chronic toxicity tests prove this greatly understates the carcinogenicity of chemicals.
Altogether, not one of several hundred experienced risk assessors asked in plenary at the 2009
Global RA Forum could recall a single pre-marketing RA that did not use an OECD/GLP study as
its key study to set the “safe” dose for human exposure. In post-market RA, this is not much
better. For example, EFSA, in their most recent post-marketing RA of bisphenol A (BPA) appear
to have used OECD/GLP compliance as the criterion to dismiss without further justification 216 of
229 (94%) of recently published studies, of which a substantial number seriously challenged or
contradicted EFSA’s ”safe” daily dose of BPA.6
While the OECD protocols and GLP rules have useful elements, and GLP must continue to be
used for industry studies as a tool to assist fraud detection; industry studies using these protocols
must not be given greater weight than financially disinterested studies using realistic protocols.
If you wish to test whether RAs yield as much false negative error as we claim, we propose that
you perform comparative literature reviews on the chronic toxicity findings for several long-
marketed agents (so that they have a large enough body of peer-reviewed studies), comparing
the findings of GLP/OECD regulatory studies with those of the independent literature. RA theory
requires that there be a valid reason not to use the lowest chronic L/NOAEL known as the key
study. We are asking you to test if RA is currently doing so.
We are confident that you will discover, for any such chemical, falsifications of OECD/GLP
findings in mammalian chronic toxicity models; as well as massive data gaps hinted at by
independent low-dose in vitro and ecotoxicity findings.
EU laws already allow the Commission to designate alternative data quality criteria as equally
valid to the OECD’s. So we ask the Commission to designate: 1) peer-reviewed publication, 2)
high journal impact factor, and 3) researcher financial independence, as those criteria.
EFSA's June scientific colloquium on low-dose toxicity in RA would be a good forum for the EU’s
safety regulators to initiate this discussion on improving RA. Speakers will include Laura
Vandenberg, whose review7 found 840 published studies in which low concentrations were
demonstrated to be more potent than higher ones. Such findings are routine in endocrinology;
and their existence falsifies the fundamental tenet of RA, that “the dose makes the poison” in
linear dose-response fashion.
In conclusion, we ask you to delete the Klimisch loophole from SCENIHR’s and other guidances;
and to initiate discussions with us and financially un-conflicted scientists on how to make RA
more realistic. The director of the USA’s National Toxicology Program and National Institute for
Environmental Health Sciences has just called for such a discussion;8 and several medical
societies have offered their expertise in the effects of contaminants on human disease to assist
risk assessors. 9
We look forward to your response,
– vom Saal FS, Myers JP 2010. Good Laboratory Practices Are Not Synonymous with Good Scientific Practices,
Accurate Reporting, or Valid Data. Environ Health Perspect 118:a60-a60. http://dx.doi.org/10.1289/ehp.0901495
6
http://reseau-environnement-sante.fr/2012/05/03/ressources/veille-scientifique/bisphenol-a-bulletin-de-veille-
scientifique-n-12/
7
Vandenberg LN, Colborn T, Hayes TB, Heindel JJ, Jacobs DR Jr, Lee DH, Shioda T, Soto AM, Vom Saal FS,
Welshons WV, Zoeller RT, Myers JP. Hormones and Endocrine-Disrupting Chemicals: Low-Dose Effects and
Nonmonotonic Dose Responses. Endocr Rev. 2012 Mar 14 ahead of print.
8
http://ehp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.1205179
9
http://www.sciencemag.org/content/331/6021/1136.1.citation
4. Yours sincerely,
(Lucie Daniel, for the absent) Hans Muilerman, hans@pan-europe.info Pesticide Action
Network—Europe, 1 Rue de la Pépinière 1000, Brussels, Belgium Tel. +316-55807255
On behalf of the following NGOs:
ClientEarth 36 Av. de Tervueren 1040 Brussels, Belgium
Earth Open Source 145-157 St John St. (2nd Flr), EC1V 4PY London, UK
European Environmental Bureau Blv. Waterloo 34, 1000 Brussels, Belgium
Health & Environment Alliance (HEAL) 28 Blv. Charlemagne, 1000 Brussels, Belgium
Réseau Environnement Santé (RES), 148 rue du Faubourg 75010 Paris, France
R.I.S.K. Consultancy, PB 10028 Brussels 1080 Belgium
Copies by email to:
Inter-Committee Coordination Group, Sanco-D5-Risk-Assessment@ec.europa.eu
Janez Potočnik, Commissioner for Environment janez.potocnik@ec.europa.eu
Jack De Bruijn, Risk Management unit, EChA, jack.de-bruijn@echa.europa.eu
Bjorn Hansen, Head of Unit--Chemicals, DG Env. Bjorn.Hansen@ec.europa.eu
Hubert Deluyker, Dir., Science Strategy, EFSA, hubert.deluyker@efsa.europa.eu