Presentation by Dana Spinant (DG JUST, European Commission) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)
John Bazill, DG Environment EC, Timber Regulationsbelier
The document outlines the key features of the EU Timber Regulation, which prohibits placing illegal timber in the EU market and requires due diligence checks by operators. It defines legality based on a country's harvesting laws. Products are scoped based on customs codes. The regulation entered into force in 2010 and will be applicable in 2013, with further delegated and implementing acts to be adopted on procedures and risk assessment. Member states will designate authorities and checks may be performed on monitoring organizations that operators can use to demonstrate due diligence.
The document provides an overview of recent and upcoming EU healthcare policy developments. Key points include:
1) Disagreements among MEPs on the clinical trials regulation regarding transparency of results.
2) Plans to adopt new rules on medical devices and in vitro diagnostic devices by November to improve safety.
3) Ongoing negotiations on pricing and reimbursement of medicines and revisions to the Tobacco Products Directive.
4) A new symbol will identify medicines undergoing additional monitoring and rules aim to improve labelling of hazardous chemicals.
5) An animal testing ban for cosmetics has fully entered into force and €144 million in funding was provided for rare disease research.
Overview of the Competition Law Enforcement Practice in UkraineMariya Nizhnik
Ukrainian competition law enforcement has developed over the past few years, with more cartel investigations, greater control over dominant undertakings, bid rigging, and significant increase in monetary penalties.
Mariya Nizhnik, First Deputy Head of the Antimonopoly Committee of Ukraine for Eurolawyer 2015 conference in London on November 24, 2015.
This document summarizes key aspects of quality management and metrology at OAO "MSZ", a major Russian nuclear fuel fabrication facility. It discusses two elements of their quality system - process management to ensure quality during manufacturing and testing of measurement instruments. Specifically, it covers technological equipment qualification and measuring system qualification, which are important for understanding the principles to guide such work at the plant. The information provided can be used to promote OAO "MSZ" products and in negotiations with potential customers.
This publication was prepared in the framework
of the Energy Watchdog Coalition project,
implemented by DiXi Group together with Expert
Forum (Romania) and the Secretariat of the
Steering Committee of the Eastern Partnership
Civil Society Forum with the support of the
European Union. The contents of this publication
can under no circumstances be regarded as
reflecting the position of the European Union
Trainings from net zealous llc on new eu pharmacovigilance directive and regu...NetZealous LLC
NetZealous LLC offers professional trainings on the new EU Pharmacovigilance Directive and Regulation that came into effect in July 2012 and replaces existing guidelines. The trainings provide an in-depth understanding of the seven modules that set out the changes and offer the latest information on related EU legislation, regulations, and directives. The trainings cover all aspects of the new EU Pharmacovigilance system including an overview of the regulatory structure, why the changes were made, how the modules are organized, how it will improve patient safety and affect marketing authorization holders and clinical study sponsors, and implementation expectations.
Practical steps to implement the Integrated Chemical Safety and Security Program in Ukraine were proposed at Ukraine Chemical Security Forum, held in Kielce, Poland, on April 19, 2016, in the framework of CHEMSS2016.
UE : document de travail - priorités législatives pour 2022Société Tripalio
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John Bazill, DG Environment EC, Timber Regulationsbelier
The document outlines the key features of the EU Timber Regulation, which prohibits placing illegal timber in the EU market and requires due diligence checks by operators. It defines legality based on a country's harvesting laws. Products are scoped based on customs codes. The regulation entered into force in 2010 and will be applicable in 2013, with further delegated and implementing acts to be adopted on procedures and risk assessment. Member states will designate authorities and checks may be performed on monitoring organizations that operators can use to demonstrate due diligence.
The document provides an overview of recent and upcoming EU healthcare policy developments. Key points include:
1) Disagreements among MEPs on the clinical trials regulation regarding transparency of results.
2) Plans to adopt new rules on medical devices and in vitro diagnostic devices by November to improve safety.
3) Ongoing negotiations on pricing and reimbursement of medicines and revisions to the Tobacco Products Directive.
4) A new symbol will identify medicines undergoing additional monitoring and rules aim to improve labelling of hazardous chemicals.
5) An animal testing ban for cosmetics has fully entered into force and €144 million in funding was provided for rare disease research.
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Ukrainian competition law enforcement has developed over the past few years, with more cartel investigations, greater control over dominant undertakings, bid rigging, and significant increase in monetary penalties.
Mariya Nizhnik, First Deputy Head of the Antimonopoly Committee of Ukraine for Eurolawyer 2015 conference in London on November 24, 2015.
This document summarizes key aspects of quality management and metrology at OAO "MSZ", a major Russian nuclear fuel fabrication facility. It discusses two elements of their quality system - process management to ensure quality during manufacturing and testing of measurement instruments. Specifically, it covers technological equipment qualification and measuring system qualification, which are important for understanding the principles to guide such work at the plant. The information provided can be used to promote OAO "MSZ" products and in negotiations with potential customers.
This publication was prepared in the framework
of the Energy Watchdog Coalition project,
implemented by DiXi Group together with Expert
Forum (Romania) and the Secretariat of the
Steering Committee of the Eastern Partnership
Civil Society Forum with the support of the
European Union. The contents of this publication
can under no circumstances be regarded as
reflecting the position of the European Union
Trainings from net zealous llc on new eu pharmacovigilance directive and regu...NetZealous LLC
NetZealous LLC offers professional trainings on the new EU Pharmacovigilance Directive and Regulation that came into effect in July 2012 and replaces existing guidelines. The trainings provide an in-depth understanding of the seven modules that set out the changes and offer the latest information on related EU legislation, regulations, and directives. The trainings cover all aspects of the new EU Pharmacovigilance system including an overview of the regulatory structure, why the changes were made, how the modules are organized, how it will improve patient safety and affect marketing authorization holders and clinical study sponsors, and implementation expectations.
Practical steps to implement the Integrated Chemical Safety and Security Program in Ukraine were proposed at Ukraine Chemical Security Forum, held in Kielce, Poland, on April 19, 2016, in the framework of CHEMSS2016.
UE : document de travail - priorités législatives pour 2022Société Tripalio
Document de traavil publié par l'Union Européenne fixant son programme de travail législatif pour 2022. Ce document énumère les différents projets de la Commission Européenne
The document discusses the challenges of complying with legislation controlling substances across different countries and regions. It describes the Controlled Substance Compliance Service (CSCS) project led by Pistoia Alliance to address this issue. The project defined requirements, issued a request for proposals, and selected two vendors - ChemAxon/Patcore and Scitegrity - to develop controlled substance identification solutions using different technologies. The project helped establish a need for such solutions and a community of experts to address the global controlled substance compliance problem.
This document summarizes the key principles and regulations of pharmacovigilance in the European Union. It discusses the basis and definitions of pharmacovigilance, the major milestones in EU pharmacovigilance legislation, and the roles and responsibilities of the European Medicines Agency, national competent authorities, marketing authorization holders, and other stakeholders in monitoring the safety of medicines in both pre- and post-authorization phases.
The document discusses the history and current state of chemicals policy and regulation in the European Union, specifically the REACH regulation. It provides background on the development of EU chemicals legislation over time, from early directives on classification and labeling in the 1960s to the adoption of the REACH regulation in 2006. It describes the key elements and objectives of REACH including registration, evaluation, authorization and restrictions for chemicals. It also discusses the role of the European Chemicals Agency and provides an overview of the implementation of REACH to date.
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
How E-Cigarettes Should be Regulated - Professor Jean-François ETTER - E-Ciga...Lindsay Fox
1) E-cigarettes are mostly used by smokers and help some quit or reduce smoking. Regular use by non-smokers has not been documented. E-cigarettes are less toxic than cigarettes.
2) Regulations of e-cigarettes vary by country and are currently evolving. The document discusses potential regulations as tobacco products, medications, or consumer products.
3) Regulating e-cigarettes as medications poses several problems and may stifle innovation, give the market to big tobacco, and result in fewer smokers quitting. Consumer product regulation with additional safety standards may better balance public health and individual freedom.
The document discusses how e-cigarettes should be regulated. It presents evidence that e-cigarettes are safer than cigarettes and are used mostly by smokers to help quit smoking. It analyzes the current regulations in the US, UK, and EU and argues that regulating e-cigarettes as tobacco products or medicines would be disproportionate and could negatively impact public health goals. Instead, it advocates for regulating e-cigarettes as consumer products, with additional product standards and restrictions on youth access, similar to other consumer goods. The goal of regulation should be to balance public health benefits with limiting risks, without making e-cigarettes less competitive than cigarettes.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
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Indian Pharmaceutical Industry; its Challenges WHILE Exportation of pharmaceu...Manukonda sravani Reddy
The Indian pharmaceutical industry is currently the largest provider of generic drugs globally, accounting for 20% of global exports. It is expected to expand rapidly to reach $55 billion by 2020. The industry meets 70% of India's domestic drug demands and includes over 8,000 small companies and 250 large companies. India is the third largest pharmaceutical market by volume and exports over $16 billion worth of drugs annually, with the largest importer being Europe. Pharmaceutical companies in India are regulated by the Drugs and Cosmetics Act and must obtain regulatory approval through various procedures to market drugs in India and other countries.
This document discusses post-Brexit implications for research and cooperation in Europe. It outlines how Brexit may impact the movement of staff in research and health industries, future data protection and clinical trial frameworks, and authorization of new medicines. It also summarizes several ongoing EU research initiatives on neurodegenerative diseases, including the Joint Programme for Neurodegenerative Disease Research (JPND) and Innovative Medicines Initiative (IMI), and EU Joint Actions on Dementia.
This document discusses the establishment of Single Points of Contact (SPOCs) systems globally to facilitate cooperation against counterfeit medical products. It describes the Council of Europe's work establishing SPOC networks, including providing training to authorities and maintaining a database. The European Directorate for the Quality of Medicines & HealthCare has trained officials from over 40 countries. The document also outlines provisions in the MEDICRIME Convention supporting cooperation between competent authorities through SPOCs.
The new EU regulatory landscape - How might it impact digital advertising?Nick Stringer
The GDPR will have a significant impact on the media industry. It expands the definition of personal data, applies globally if targeting or monitoring EU individuals, increases penalties for noncompliance up to 4% of revenue, and makes using personal data harder commercially. While compliance will be easier for companies with direct user relationships, preparation is needed as the GDPR takes effect in May 2018 and a new ePrivacy law is also proposed to align with its strict consent standards.
I (Legislative acts) REGULATIONS REGULATION (EU) 2.docxsheronlewthwaite
I
(Legislative acts)
REGULATIONS
REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 April 2016
on the protection of natural persons with regard to the processing of personal data and on the free
movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) The protection of natural persons in relation to the processing of personal data is a fundamental right.
Article 8(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’) and Article 16(1) of the
Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of
personal data concerning him or her.
(2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal
data should, whatever their nationality or residence, respect their fundamental rights and freedoms, in particular
their right to the protection of personal data. This Regulation is intended to contribute to the accomplishment of
an area of freedom, security and justice and of an economic union, to economic and social progress, to the
strengthening and the convergence of the economies within the internal market, and to the well-being of natural
persons.
(3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the protection of
fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow
of personal data between Member States.
4.5.2016 L 119/1 Official Journal of the European Union EN
(1) OJ C 229, 31.7.2012, p. 90.
(2) OJ C 391, 18.12.2012, p. 127.
(3) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the Council at first
reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016.
(4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(4) The processing of personal data should be designed to serve mankind. The right to the protection of personal
data is not an absolute right; it must be considered in relation to its function in society and be balanced ag ...
The document is the 2008 Annual Activity Report for the European Union Agency for Fundamental Rights. Some of the key achievements and activities in 2008 included:
1) Completing the EU-MIDIS survey, the first EU-wide quantitative survey on immigrant and ethnic minority experiences of discrimination and victimization.
2) Publishing the Agency's Annual Report on fundamental rights, which examined racism, xenophobia and related issues and provided conclusions and recommendations.
3) Organizing a major conference on freedom of expression with the EU Presidency that explored challenges to this right.
The document summarizes the potential impact of the European Union's new General Data Protection Regulation (GDPR) on the use of machine learning algorithms. The GDPR, set to take effect in 2018, will restrict automated individual decision-making by algorithms and create a "right to explanation" for algorithmic decisions. It poses challenges for industry and highlights opportunities for machine learning researchers to design interpretable algorithms that avoid discrimination and satisfy the right to explanation.
In this edition of our policy brief, we provide an update of some key regulatory and policy changes under way or anticipated in coming months in relation to the newly released digital agenda, to the on-going implementation of the energy strategy, to financial services, and to taxation.
Learn about the latest policy developments with this monthly alert from our team in Brussels. For real-time updates, follow @MSL_Brussels or reach out to us on Twitter @msl_group.
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Nick Stringer - Five Key Things EU General Data Protection Regulation (GDPR) ...Nick Stringer
The EU General Data Protection Regulation (GDPR) aims to update existing EU data protection laws to reflect today's digital world, give citizens greater control over personal data, and streamline rules across EU markets. Key aspects of the GDPR include a broader definition of personal data, new obligations for transparency and accountability, tougher user consent requirements, and fines of up to 20 million euros or 4% of annual global turnover for non-compliance. The GDPR will apply directly in all EU markets from May 2018 and have global significance by applying to individuals located in the EU regardless of where data is processed.
The document discusses how Brexit may impact criminal law and cooperation in the EU. It describes several EU criminal law frameworks and agencies that the UK currently participates in, such as the European Arrest Warrant, European Judicial Network, Eurojust, and operations they have conducted. Leaving the EU could mean the UK loses access to these systems and procedures, hindering criminal investigations and extraditions between the UK and EU countries.
Presentation by Vito Spinelli (Consultant in the ESCO secretariat, DG EMPL) on the occasion of the EESC Seminar on 'Delivering on Skills' organised in Brussels on 17 November 2014.
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The document discusses the challenges of complying with legislation controlling substances across different countries and regions. It describes the Controlled Substance Compliance Service (CSCS) project led by Pistoia Alliance to address this issue. The project defined requirements, issued a request for proposals, and selected two vendors - ChemAxon/Patcore and Scitegrity - to develop controlled substance identification solutions using different technologies. The project helped establish a need for such solutions and a community of experts to address the global controlled substance compliance problem.
This document summarizes the key principles and regulations of pharmacovigilance in the European Union. It discusses the basis and definitions of pharmacovigilance, the major milestones in EU pharmacovigilance legislation, and the roles and responsibilities of the European Medicines Agency, national competent authorities, marketing authorization holders, and other stakeholders in monitoring the safety of medicines in both pre- and post-authorization phases.
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MILESTONES – FURTHER DEVELOPMENT
How E-Cigarettes Should be Regulated - Professor Jean-François ETTER - E-Ciga...Lindsay Fox
1) E-cigarettes are mostly used by smokers and help some quit or reduce smoking. Regular use by non-smokers has not been documented. E-cigarettes are less toxic than cigarettes.
2) Regulations of e-cigarettes vary by country and are currently evolving. The document discusses potential regulations as tobacco products, medications, or consumer products.
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Indian Pharmaceutical Industry; its Challenges WHILE Exportation of pharmaceu...Manukonda sravani Reddy
The Indian pharmaceutical industry is currently the largest provider of generic drugs globally, accounting for 20% of global exports. It is expected to expand rapidly to reach $55 billion by 2020. The industry meets 70% of India's domestic drug demands and includes over 8,000 small companies and 250 large companies. India is the third largest pharmaceutical market by volume and exports over $16 billion worth of drugs annually, with the largest importer being Europe. Pharmaceutical companies in India are regulated by the Drugs and Cosmetics Act and must obtain regulatory approval through various procedures to market drugs in India and other countries.
This document discusses post-Brexit implications for research and cooperation in Europe. It outlines how Brexit may impact the movement of staff in research and health industries, future data protection and clinical trial frameworks, and authorization of new medicines. It also summarizes several ongoing EU research initiatives on neurodegenerative diseases, including the Joint Programme for Neurodegenerative Disease Research (JPND) and Innovative Medicines Initiative (IMI), and EU Joint Actions on Dementia.
This document discusses the establishment of Single Points of Contact (SPOCs) systems globally to facilitate cooperation against counterfeit medical products. It describes the Council of Europe's work establishing SPOC networks, including providing training to authorities and maintaining a database. The European Directorate for the Quality of Medicines & HealthCare has trained officials from over 40 countries. The document also outlines provisions in the MEDICRIME Convention supporting cooperation between competent authorities through SPOCs.
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REGULATIONS
REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 April 2016
on the protection of natural persons with regard to the processing of personal data and on the free
movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) The protection of natural persons in relation to the processing of personal data is a fundamental right.
Article 8(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’) and Article 16(1) of the
Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of
personal data concerning him or her.
(2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal
data should, whatever their nationality or residence, respect their fundamental rights and freedoms, in particular
their right to the protection of personal data. This Regulation is intended to contribute to the accomplishment of
an area of freedom, security and justice and of an economic union, to economic and social progress, to the
strengthening and the convergence of the economies within the internal market, and to the well-being of natural
persons.
(3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the protection of
fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow
of personal data between Member States.
4.5.2016 L 119/1 Official Journal of the European Union EN
(1) OJ C 229, 31.7.2012, p. 90.
(2) OJ C 391, 18.12.2012, p. 127.
(3) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the Council at first
reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016.
(4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(4) The processing of personal data should be designed to serve mankind. The right to the protection of personal
data is not an absolute right; it must be considered in relation to its function in society and be balanced ag ...
The document is the 2008 Annual Activity Report for the European Union Agency for Fundamental Rights. Some of the key achievements and activities in 2008 included:
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2) Publishing the Agency's Annual Report on fundamental rights, which examined racism, xenophobia and related issues and provided conclusions and recommendations.
3) Organizing a major conference on freedom of expression with the EU Presidency that explored challenges to this right.
The document summarizes the potential impact of the European Union's new General Data Protection Regulation (GDPR) on the use of machine learning algorithms. The GDPR, set to take effect in 2018, will restrict automated individual decision-making by algorithms and create a "right to explanation" for algorithmic decisions. It poses challenges for industry and highlights opportunities for machine learning researchers to design interpretable algorithms that avoid discrimination and satisfy the right to explanation.
In this edition of our policy brief, we provide an update of some key regulatory and policy changes under way or anticipated in coming months in relation to the newly released digital agenda, to the on-going implementation of the energy strategy, to financial services, and to taxation.
Learn about the latest policy developments with this monthly alert from our team in Brussels. For real-time updates, follow @MSL_Brussels or reach out to us on Twitter @msl_group.
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
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Presentation by Sarah Cook, Director, United Nations Research Institute for Social Development, United Nations, on the occasion of the EESC conference on "Social economy and social innovation as drivers of competitiveness, growth and social well-being - Perspecitves and priorities for the new Commission and the European Parliament" (Brussels, 1 October 2014)
Presentation by Antonella Noya, Senior Policy Analyst, OECD, on the occasion of the EESC conference on "Social economy and social innovation as drivers of competitiveness, growth and social well-being - Perspecitves and priorities for the new Commission and the European Parliament" (Brussels, 1 October 2014)
Presentation by Xavier Le Mounier, Policy Officer (Innovation Policy for Growth), DG Enterprise and Industry, European Commission, on the occasion of the EESC conference on "Social economy and social innovation as drivers of competitiveness, growth and social well-being - Perspecitves and priorities for the new Commission and the European Parliament" (Brussels, 1 October 2014)
Presentation by Apostolos Ioakimidis, Policy Officer (Entrepreunership 2020 Cooperatives, Mutuals, Social Enterprises, Family Businesses), DG Enterprise and Industry, European Commission, on the occasion of the EESC conference on "Social economy and social innovation as drivers of competitiveness, growth and social well-being - Perspecitves and priorities for the new Commission and the European Parliament" (Brussels, 1 October 2014)
Presentation by Peter Lambreghts, EDF Board member & European Network of Independent Living,on the occasion of the EESC SOC section conference on Civil society perspectives on the implementation of the UN Convention on the Rights of Persons with Disabilities (UNCRPD) in Brussels on 2 October 2014.
Presentation by Stefano Palmieri, EESC Europe 2020 Steering Committee, on the occasion of the EESC SOC section conference on Civil society perspectives on the implementation of the UN Convention on the Rights of Persons with Disabilities (UNCRPD) in Brussels on 2 October 2014.
More from European Economic and Social Committee - SOC Section (20)
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
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
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdfrightmanforbloodline
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdf
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdf
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Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Lecture 6 -- Memory 2015.pptlearning occurs when a stimulus (unconditioned st...AyushGadhvi1
learning occurs when a stimulus (unconditioned stimulus) eliciting a response (unconditioned response) • is paired with another stimulus (conditioned stimulus)
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
3. Objectives of EU-level action on NPS
Protect consumers' health and safety.
Eliminate barriers to legitimate trade in NPS and prevent the
emergence of such barriers.
How?
1.- improving speed of action
2.- introducing restrictions proportionate to the risks NPS pose
3.- ensuring free movement for industrial/commercial purposes,
and for R&D
4.- improve links with the EU legislation on internal market
3
4. Legislative package on NPS
1. - Regulation on new psychoactive substances
(information exchange, risk assessment, market
restrictions) – COM(2013)619
2. - Directive amending 2004 Framework Decision
on drug trafficking (criminal law measures on
severe-risk NPS) – COM(2013)618
4
5. How does the new mechanism work?
Regulation
Member States detect a new
psychoactive substance
Member States share info via
EMCDDA/Europol
Early
Warning System
Joint EMCDDA – Europol report
5
6. How does the new mechanism work?
Regulation
Implementing act
Immediate risk
Joint EMCDDA – Europol report
Temporary consumer market
restriction (12 months)
Commission requests a risk
assessment
EMCDDA Risk Assessment
6
7. How does the new mechanism work?
Regulation
No EU action
Permanent consumer market
restriction
Directive
Severe risk
Implementing acts
Moderate risk
Low risk
EMCDDA Risk Assessment
Permanent market restriction
and
criminalisation
National transposition of EU
criminal law measures
Urgency procedure for the adoption of implementing act for immediate risk is possible (measure enters immediately into force, then adopted by MS committee)