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GDPR 2018 - Summary of new EU regulation
 
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GDPR 2018 is General Data Protection Regulation that will take in effect on 25th of May 2018. In this video I'll explain what GDPR is and why should you care about it. This EU regulation is set to increase user privacy and punish companies that neglect personal data safety. In this video I'll give you a summary of GDPR and the main points that might interest you as a company or private person. In GDPR will be big topic for companies as this will require some changes to the websites so that they comply to the new regulation. If companies are not GDPR compliant then there are some severe fines.The new EU data protection regulation will affect any company that sells to EU citizens, this means in the US or UK GDPR will be followed as well. useful links: GDPR examples: https://youtu.be/bVap-DYWKjg Full regulation doc in pdf: http://ec.europa.eu/justice/data-protection/reform/files/regulation_oj_en.pdf GDPR Summary by EU: https://www.eugdpr.org/key-changes.html Comprehensive video about the topic: https://www.youtube.com/watch?v=NxgZ57BTkFQ General Data Protection Regulation is a long document that describes how companies should use and protect consumer data. It will take an effect on 25 May 2018. It will impact your company if you handle any data from EU citizen. So no matter where your company is based, if you collect data from EU citizens this will apply to you. Now to consumers this is not that bad of a deal. This regulation gives power back to the people. As EU sees privacy as human right. Now for companies this means that they need to look into their process and infrastructure. Analyze what is collected, where is it collected and how the data is used and how it is secured. This will give transparency to consumers, as we will know what is collected and why. There is also small benefits to companies as this will be one regulation across whole europe and not per country, as it is now. Tracking is still allowed but you have to make sure it's done the right way. You need to get user's explicit consent in simple language and ability to opt out at any time. What might be challenging is that current data has to oblige to the new regulation. So you need to make sure that old data has user's consent. I think this regulation will be taken seriously as penalties are severe. At most, 20 million dollars or 4% of global turnover (whichever is higher). There is no one entity that will monitor this regulation, however if you get too many complaints from consumers, you might get sued. There are 7 key rights that GDPR emphasizes: 1. User consent to tracking and ability to opt out 2. Data breach notification within 72h after breach 3. Rights to access your own data 4. Right to be forgotten, so at any point you can ask the company to permanently delete your data 5. Data portability, you have the right to reuse the data elsewhere 6. Privacy by design, companies do out most to secure personal data 7. Data protection officer needs to be appointed if you are companie with 250+ employees
Views: 8202 tipswithpunch
GDPR: What Is It and How Might It Affect You?
 
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The European Union's General Data Protection Regulation on data privacy will come into force on May 25, 2018. This video explains how it could affect you, even if you don't live in the EU. Don’t miss a WSJ video, subscribe here: http://bit.ly/14Q81Xy More from the Wall Street Journal: Visit WSJ.com: http://www.wsj.com Visit the WSJ Video Center: https://wsj.com/video On Facebook: https://www.facebook.com/pg/wsj/videos/ On Twitter: https://twitter.com/WSJ On Snapchat: https://on.wsj.com/2ratjSM
Views: 95223 Wall Street Journal
[Webinar] EU RoHS Directive
 
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The European Union’s Restriction of Hazardous Substances (RoHS) Directive is far-reaching in its scope and requires a robust program to meet its compliance requirements. In this video, we delve into RoHS compliance in 2017 and reveal key information you need to know in order to comply with this directive. In this webinar, you will: -Learn what substances are restricted under RoHS, including new substances added in 2016 -Determine whether or not your products are in scope of the RoHS Directive -Understand RoHS exemptions and how they apply to your products -Learn how to demonstrate compliance, including documentation and labeling -...and more! Compliance with the RoHS Directive can be a challenge for the most robust teams. Watch this video to gain actionable insights into your restricted substances program and RoHS compliance initiatives. To learn about Assent's RoHS compliance software, visit the website here: http://www.assentcompliance.com/rohs/ To experience our webinars live, visit the Events page here: http://www.assentcompliance.com/events/
Views: 3511 Assent Compliance
How DOES the EU Function?
 
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Do you KNOW how the EU is governed? What are the important institutions? How they work together? You probably only have a vague idea how it works, but probably know more about US politics than about European politics. Do you know who is the European president? Trick question! There are around a dozen. This episode will look at how the European government works but also show many of its flaws. This is not to say that the EU is necessarily ruled poorly, but I will address many of the concerns average citizens have. And I think we can ALL agree that governments could be run more efficiently in general. ----------------------------------------------------------------------- Support Europe: https://www.facebook.com/mycountryeurope/ Facebook: https://www.facebook.com/averythingchannel/ ----------------------------------------------------------------------- The European Council is comprised of the 28 chancellors, presidents, and prime ministers of the European member states. At the council the European leaders meet 4 times per year to define the EU’s policy, to push forward European integration, and to serve as an ‘emergency brake’ where it can cancel EU plans if it convinces at least half the EU leaders to vote against that plan. So to whom does the European Council give direction? To the European Commission. The commission is responsible for drafting all the laws of the European Union. It is comprised of 28 commissioners, one for each country, who are in charge of one aspect of European law. There is a commissioner of Transport, a commissioner of Regional Policy, a commissioner of Research, Science, and Innovation, and so forth. In this way, the Commission acts like a cabinet: It’s led by a president, nominated by the European Council and approved by the European Parliament. The other 27 commissioners are chosen by each member country. This way, every member state has 1/28th say in creating the laws of the European Union. The European Court of Auditors sees to it that the taxpayer’s money is spent effectively in the EU. The European Court of Justice is the judicial arm of the European Union. It is comprised of 28 judges, one from each of the member states. Its role is to see to it that the EU laws are applied in all states and to settle legal matters between institutions and countries. It is the highest court in the EU. And that is only inside the EU. Then there are countries outside who want access to the vast EU market but don’t want to adhere to all EU legislation, notably fishing regulations for Norway and Iceland and Banking regulations for Switzerland. They are part of the European Economic Area and Schengen, meaning that they can trade freely with the EU countries and you can move between them, never realizing you left the EU. But the countries don’t have any say in their rules, meaning that if the Schengen or EEA treaties are changed, they can either sign the treaty or leave. So here you have it, a complete overview of the important institutions and how they work. ------------------------------------------------------------------------------------------------- Support Europe: https://www.facebook.com/mycountryeur... Facebook: https://www.facebook.com/averythingch...
Views: 23186 Avery Thing
The European Union Explained*
 
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The European Union with a lot of asterisks. Support these videos: https://www.patreon.com/cgpgrey
Views: 7104251 CGP Grey
The EU Benchmarks Regulation
 
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Rick Sandilands, Senior Counsel, Europe, at ISDA, highlights the key requirements of the EU Benchmarks Regulation.
Views: 1684 ISDA
The EU makes things More Expensive
 
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A segment from Brexit The Movie showing that the EU makes things more expensive for consumers, by protecting inefficient firms, restricting trade with non-EU countries, and forcing firms to meet expensive regulations. Brexit The Movie: https://www.youtube.com/watch?v=UTMxfAkxfQ0
Views: 6865 Man Against The State
EU Law - Direct Effect
 
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Direct effect allows rights under EU law to be enforced within a domestic court system. Vertical direct effect allows rights to be enforced against an emanation of the state while horizontal direct effect allows rights to be enforced against other individuals or against companies. Direct effect is also conditional on the type of EU law that is being enforced. Treaties are a form of primary legislation and have vertical and horizontal direct effect so long as the relevant treaty article matches the conditions set out in Van Gend en Loos (1963): Clear and unconditional Prohibition Not dependent on member state implementation Regulations are directly applicable and as such also have vertical and horizontal direct effect. Directives, in principle, only have vertical direct effect because they are an obligation for member states to implement them. Even then they can only be enforced when they grant rights to individuals (Defrenne v SABENA (No. 2) (1979)) and the time limit for implementation has passed (Pubblico Ministero v Ratti (1979)). However there is a way that directives can have horizontal direct effect and this is known as indirect effect. This works because the courts themselves can be considered as emanations of the state and so in their judgments have to enforce EU law between individuals. This concept first arose in Von Colson v Land Nordrhein-Westfalen (1984) and was applied in the UK through Lister v Forth Dry Dock [1989]. An emanation of the state was defined in Foster v British Gas plc [1990] as a body that: Provides a public service Under the control of the state Has special powers beyond those of individuals
Views: 35996 marcuscleaver
Article 13 and EU Copyright Law explained: This is how Europe will destroy the Internet
 
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The new EU copyright law is going to have drastic affects on the freedom and openness of the Internet. Beyond banning memes, Article 13 of the European Copyright Directive 2018 will result in automated surveillance and centralized control of the Internet. The directive makes online platforms liable for the content generated by their users. That means that on top of punitive and vaguely worded terms of services, Internet gate-keepers like Facebook, Google, or Twitter will be required by law to proactively monitor and censor content. These online platforms will be required by law to create automated mechanisms to filter infringing content. Such technology would essentially turn into “upload filters”. These automated filters won’t be recognizing between infringing and legitimate content, like parodies, satire, commentary or other instances of fair use. To balance the flaws of automated upload filters, the directive also requires platforms to build staffed systems for filing complaints for illegitimate takedowns. I make these videos because I believe standing up against power and illegitimate authority is a moral duty. I believe all humans are fundamentally free. But this freedom won't take care of itself. If you too believe this cause and want to help in this pursuit, you can donate to any of my cryptocurrency wallets. Bitcoin: 1C7UkndgpQqjTrUkk8pY1rRpmddwHaEEuf Dash Xm4Mc5gXhcpWXKN84c7YRD4GSb1fpKFmrc Litecoin LMhiVJdFhYPejMPJE7r9ooP3nm3DrX4eBT Ethereum 0x6F8bb890E122B9914989D861444Fa492B8520575 Credits: Music 'A System of Numbers' by CO.AG music https://www.youtube.com/channel/UCcavSftXHgxLBWwLDm_bNvA Sources: Text of the EU Copyright Directive https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52016PC0593 EFF on the EU Directive https://www.eff.org/deeplinks/2018/09/today-europe-lost-internet-now-we-fight-back https://www.eff.org/deeplinks/2018/09/fake-compromises-real-threats-next-weeks-eu-copyright-vote https://www.eff.org/deeplinks/2018/09/new-copyright-powers-new-terrorist-content-regulations-grim-day-digital-rights https://www.eff.org/files/2018/06/13/article13letter.pdf News Coverage https://www.theverge.com/2018/9/12/17849868/eu-internet-copyright-reform-article-11-13-approved http://www.europarl.europa.eu/news/en/press-room/20180906IPR12103/parliament-adopts-its-position-on-digital-copyright-rules https://www.theverge.com/2018/6/19/17480344/eu-european-union-parliament-copyright-article-13-upload-filter https://www.theverge.com/2018/6/20/17482554/eu-european-union-copyright-filter-article-11-13-passes-juri-vote https://arstechnica.com/tech-policy/2015/07/new-study-shows-spains-google-tax-has-been-a-disaster-for-publishers/ https://www.politico.eu/article/plan-to-make-google-pay-for-news-hits-rocks-copyright-reform-european-commission/ https://www.politico.eu/interactive/copyright-reform-power-matrix-gunther-oettinger-european-commission-eu-policy/ https://www.theguardian.com/technology/2018/jun/20/eu-votes-for-copyright-law-that-would-make-internet-a-tool-for-control https://www.theguardian.com/technology/2018/jun/20/music-industry-wins-key-vote-in-youtube-copyright-battle https://www.theguardian.com/business/2017/apr/15/music-industry-youtube-video-streaming-royalties https://www.bloomberg.com/news/articles/2018-09-20/silicon-valley-and-publishers-fight-on-after-eu-copyright-vote https://www.billboard.com/articles/business/8474706/eu-copyright-vote-music-sector-final-lobbying-push https://qz.com/1387581/article-11-the-eus-copyright-law-could-give-publishers-power-over-google-and-facebook/ https://qz.com/1389385/article-11-and-article-13-axel-voss-is-surprised-by-eu-copyright-law/ Opposition https://juliareda.eu/eu-copyright-reform/censorship-machines/ https://juliareda.eu/2017/03/study-article13-upload-surveillance/ https://juliareda.eu/wp-content/uploads/2017/03/angelopoulos_platforms_copyright_study.pdf https://drive.google.com/file/d/0B7NZMlL3kj5qQzN0RXd2Z0JaR1JmemxhNDd2VmgzSjhFQXdj/view https://juliareda.eu/eu-copyright-reform/extra-copyright-for-news-sites/ https://juliareda.eu/2017/04/copyright-reform-kills-eu-startups/ https://www.youtube.com/watch?v=z6EMOTLwYLM https://europeancopyrightsocietydotorg.files.wordpress.com/2015/12/ecs-opinion-on-eu-copyright-reform-def.pdf http://www.locusmag.com/Features/2008/11/cory-doctorow-why-i-copyfight.html Follow me: https://twitter.com/The_HatedOne_ https://www.bitchute.com/TheHatedOne/ https://www.reddit.com/user/The_HatedOne/ https://www.minds.com/The_HatedOne The footage and images featured in the video were for critical analysis, commentary and parody, which are protected under the Fair Use laws of the United States Copyright act of 1976.
Views: 48642 The Hated One
EU Trade Policy explained
 
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http://ec.europa.eu/trade/policy/ EU trade policy sets the direction for trade and investment in and out of the EU. The EU aims to play a key role in keeping markets open worldwide and helping Europe to exit from the economic crisis. EU trade policy is working to: create a global system for fair and open trade, open up markets with key partner countries, make sure others play by the rules and ensure trade is a force for sustainable development
Views: 65017 European Commission
EU Regulation - a definition
 
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A rule that, when issued by an EU body, can become law throughout the EU without national governments needing to introduce their own laws first.
Views: 457 easyeu
Introduction to the EU Regulatory System
 
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Course Description: This course provides a review of the different classification levels within the medical device directive in Europe, including a review of the related regulatory requirements and regulatory routes possible to CE-mark. In this course we point out how important a quality system is and how a well designed quality system setup early on can help the manufacturer ensure compliance and improve efficiency. Last but not least, the course emphasizes on the need for good documentation practices and that a technical file setup and maintenance throughout the lifecycle of a medical device is required. Learn more at: http://www.wmdo.org//course-detail.aspx?id=90
Views: 878 WMDO
EU-lawmaking
 
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Green Members of the European Parliament work on better EU regulation. Problems that cross borders need a cross border solution. That is why the Greens in the European Parliament are constantly working on better EU regulation: laws that put citizens and our environment in first place. In this video we explain how European laws are made and in which political context this happens.
Views: 1299 Greens EFA
The Fed Explains Bank Supervision and Regulation
 
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Healthy banks and healthy economies go hand in hand. The latest in the Atlanta Fed’s animated video series explains how the Federal Reserve ensures banks are doing business safely and providing fair and equitable services to their communities.
Views: 25072 AtlantaFed
Cosmetics labelling requirements EU (Regulation 1223/2009)
 
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http://www.ceway.eu This clip presents which information about the product needs to appear on a cosmetic product label in the EU, in order for it to be compliant with the regulation 1223/2009. Labelling is a very important part of the product both in terms of sales as well as in terms of being compliant with the relevant legislation. EU regulation 1223/2009 some poses specific requirements for the labelling of cosmetic products placed on the EU market. The following information has to appear on the labels: name and address of the responsible person, product's country of origin (if the manufacturer is from outside of the EU), nominal quantity or content, expiration date, particular precautions for use, batch number, function of the cosmetic product, list of ingredients. Ingredients have to be written in a descending order by concentration and according to their INCI names. What is also worth remembering is that certain things on the label (nominal content, expiration date if wording "best used before the end of" is used, particular precautions for use, function of the cosmetic product) have to be translated into the official languages of the countries where the product is going to be sold. Certain countries, like Belgium, request even more than one language on the label. Cosmetic manufacturers also write various claims for their products on the labels. They have to make sure that the claims made are in line with the definition of the cosmetic products in the EU, and that any claim made is also substantiated.
What is Euro 6  The new EU emissions standard explained in simple terms
 
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A directive of the European Union, this new emission standard primarily sets lower maximum values for vehicle emissions of particulates and nitrogen oxide. For diesel engines, the old standard stipulated a maximum of 180 mg per kilometer. As of September 1, 2015, diesel engines will be restricted to just 80 mg of nitrogen oxide emissions per kilometer (gasoline engines: 60 mg per kilometer).
Views: 25851 Car-engineer media
BIORIUS - EU COSMETIC REGULATION   How to register in EU?
 
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If you are a none-European cosmetic brand or manufacturer, this video is for you. Learn about the complex EU Cosmetic Regulation EU 1223-2009 in a comprehensive way.
Views: 9820 BIORIUS
What is European Market Infrastructure Regulation
 
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~~~ European Market Infrastructure Regulation ~~~ Title: What is European Market Infrastructure Regulation Created on: 2018-08-25 Source Link: https://en.wikipedia.org/wiki/European_Market_Infrastructure_Regulation ------ Description: The European Market Infrastructure Regulation is a body of European legislation for the regulation of over-the-counter derivatives. It was originally adopted by the EU legislature on July 4, 2012 and came into force on August 16, 2012. Its full technical standards were adopted by the European Commission on December 19, 2012 and came into effect on March 15, 2013. The regulations include requirements for reporting of derivative contracts and implementation of risk management standards. It established common rules for central counterparties and trade repositories. The objective of the legislation is to reduce systemic counterparty and operational risk, and help prevent future financial system collapses. ------ To see your favorite topic here, fill out this request form: https://docs.google.com/forms/d/e/1FAIpQLScU0dLbeWsc01IC0AaO8sgaSgxMFtvBL31c_pjnwEZUiq99Fw/viewform ------ Source: Wikipedia.org articles, adapted under https://creativecommons.org/licenses/by-sa/3.0/ license. Support: Donations can be made from https://wikimediafoundation.org/wiki/Ways_to_Give to support Wikimedia Foundation and knowledge sharing.
Views: 97 Audioversity
Which products are cosmetic products? EU cosmetic products definition
 
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http://www.ceway.eu This clip presents the definition of cosmetic products in the EU and which products are considered to be cosmetic products in the EU. Cosmetic products definition in the EU is provided in the EU cosmetics regulation 1223/2009: "'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;" Besides giving the definition, the cosmetics regulation also lists some categories of cosmetic products. These are: creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases, make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, bath and shower preparations, toilet waters and eau de cologne, depilatories, deodorants and anti-perspirants, hair colorants, hair setting products, products for waiving, straightening and fixing hair, hair cleansing products, hair conditioning products, hairdressing products, shaving products, make-up products and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, skin-whitening products, anti-wrinkle products. Products intended to be ingested, inhaled, injected or implanted into the human body do not fall under the definition of cosmetics. Cosmetic products should also conform with the requirements regarding prohibited substances, restricted substances, colorants, preservatives and UV filters, and claims made for cosmetic products should be in line with the definition of the cosmetic products in the EU as written above. If a product has properties of cosmetic products as well as certain other types of products, it's called a borderline product, and in that case a case-by-case assessment has to be made to determine which legislation this product has to comply with.
EU objective international private law: it's like dating
 
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Brussels 1 and Rome 1 briefly explained in a three step approach (EU Regulation 1215/2012 and 593/2008)
Views: 2611 DrWernaart
What the New ESMA Leverage Rules Mean for European Traders
 
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200:1 Leverage for Eurozone Traders: https://www.daytradingforexlive.com/day-trading-forex-lives-recommended-forex-broker/ Learn to trade with the banks: https://www.daytradingforexlive.com/day-trading-forex-education-course/ Roughly a week ago, the ESMA (European Securities & Markets Authority) passed a new regulation that would require forex brokers to limit the leverage they offer to 30:1 MAX! For minor pairs, gold, and major indices the leverage will be 20:1, 10:1 for commodities other than Gold and non-major equity indices, 5:1 on individual equities, and 2:1 on Cryptocurrencies. This video is mainly geared towards the 30:1 and 20:1 leverage limits as that is what will affect forex traders. This video walks through how you can calculate leverage on your own, and in doing so, we illustrate that the new regulation is not as restrictive as you might initially think. Having run a forex education service for the last decade, I see traders get wiped out time and time again because of over-leveraging. While I'm never one for government intervention, a reduction in leverage will no doubt help the majority of struggling retail traders succeed. -Sterling
Views: 13601 Day Trading Forex Live
BEREC role in net neutrality Regulation in EU
 
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Since 2010 BEREC has supported the EU institutions and the National Regulatory Authorities to deal with net neutrality by investigating it before many others. BEREC was asked by EU legislators to write the net neutrality guidelines. During the consultation process in 2016, around half a million responses were received. These guidelines help the National Regulators to implement the single European net neutrality Regulation in a coherent way as they got the powers and the obligation to assess internet traffic management, commercial practices and agreements; and to effectively enforce the Regulations. It will help National Regulators, consumers and businesses in measuring the performance of Internet access services and for detecting traffic management practices applied to or impacting those services. What is next? BEREC has further ongoing activities in place to support the National Regulators to implement the net neutrality rules and will continue its work in this area diligently
Views: 3589 berec.europa.eu
Post Market Surveillance requirements under the new European Medical Device Regulations
 
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In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action requiring Medical Device Manufacturers to “proactively collect and review experience gained from their devices placed on the market.” With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR. While Post Market Surveillance was always a regulatory requirement, the new measures introduced require that manufacturers follow on specific directions, tightening the links between PMS activities and other processes. Few examples of these new measures are: the issuance of Periodic Safety Update Reports (PSURs) to Notified Bodies, the update of the Vigilance and PMS procedures per the new requirements, and the increased involvement of Notified Bodies and authorities in the process.
Views: 2794 GMED
Changes to the Definition of an "Article" Under EU REACH
 
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In 2017, the European Chemicals Agency clarified the definition of an "Article" under EU REACH, which changes the way that your Substances of Very High Concern (SVHC) totals are calculated. Companies affected by EU REACH may declare that their products contain no SVHC substances of more than 0.1%, but if you are still calculating based on the weight of the product as a whole instead of the weight of each individual component, you could be making an inaccurate declaration. This video describes the change and explains how you should be calculating your SVHC values. GreenSoft Technology, Inc. provides data services to help with this process. We collect Full Material Declaration (FMD) data from your suppliers for you and use our GreenData Manager software to store and calculate the data, using the correct formulas to determine whether the product can be declared as SVHC-free or not. Even if you have collected compliance declarations from your suppliers before, it may need to be recollected with this new calculation formula in mind. Learn more and get a free Risk Analysis when you contact us at www.greensofttech.com.
New EU Pharmacovigilance Directive and Regulations
 
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Upon completion of this Video, Viwers will have a thorough knowledge of the updated framework surrounding Good Pharamcovigilance Practices (GVP). This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation. The content of this Video is designed to simplify the understanding of the new requirements and to provide attendees with the latest information on what the European Commission believes is a significant area of improvement in the region. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/No9e/
European DataWarehouse on the Securitisation Regulation (condensed version)
 
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European DataWarehouse answers key questions surrounding the Securitisation Regulation (EU) 2017/2402: What are the key changes that will impact clients of European DataWarehouse? What is ED doing to help?
European Regulations Tutorial
 
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Tutorial for the Android App "EU Regulations" Link: https://play.google.com/store/apps/details?id=com.ptowngames.euverordnungen
Views: 144 PTown Games
Medical Device Usability: Highlights of European Regulations and the Latest Standards
 
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Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can lead to severe harm to the patients. What process is in place to limit these failures and are these avoidable? Usability Standards (IEC 62366:2007, IEC 62366:2007+A1:2014, IEC 62366-1:2015, IEC 62366-2:2016) specifies a process for analysis, design, verification and validation of usability throughout the design and development cycle of medical devices to mitigate risked caused use/user error and poor interface design. Medical device manufacturers marketing in Europe may apply Usability standards in order to demonstrate compliance with essential requirements of the European Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC) as well as in near future the new Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR). This webinar discuss Usability Engineering Process, its link to Risk management and Quality management system and highlights European requirements: - Usability - Usability and European Regulations and Standards - Overview of Usability Standards and the latest changes - Usability and Medical Device QMS
Views: 1841 GMED
European Environmental Regulation for SMEs
 
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Small and medium-sized enterprises (SMEs) find it harder to comply with environmental legislation than larger companies. In general, the smaller the company, the more difficult it is. Often SMEs are not aware of their environmental obligations - but they are also unaware of the benefits of being green: new market opportunities and cost savings. The European Commission proposed an Environmental Compliance Assistance Programme (ECAP) to make it easier for SMEs to comply with their obligations and improve their environmental performances. The following links are mentioned throughout the video: - ECAP website section dedicated to EU legislation (4’30): http://ec.europa.eu/environment/sme/l... - ECAP website section dedicated to best practices (12’50): http://ec.europa.eu/environment/sme/c... - Environmental footprinting (14’20): http://ec.europa.eu/environment/eussd... - Environmental Impact Assessment (14’20): http://ec.europa.eu/environment/eia/h... - ECAP website section dedicated to funding opportunities (15’50): http://ec.europa.eu/environment/sme/f... - LIFE programme (16’00): http://ec.europa.eu/environment/life/ - Horizon 2020 programme (16’00): http://ec.europa.eu/programmes/horizo... - COSME programme (16’00): http://ec.europa.eu/enterprise/initia...
Views: 4116 EU Environment
Impact Assessments in EU Policy Making
 
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Vesna Valant, DG MOVE, European Commission, presents at the ITF Roundtable on Assessing Regulatory Changes in the Transport Sector held in Stockholm, Sweden on 6-7 October 2016.
Views: 281 IntTransportForum
The European Medical Device New Regulation 2017/745
 
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Course Description: This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics: Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities) Structure of the EU MDR and other related regulations Definition and classification of medical devices (MEDDEV 2.4/1 Rev 9) Conformity assessment procedures and routes Quality system requirements General safety and performance requirements in Annex I and the use of harmonized standards Clinical evaluations, including references to MEDDEV 2.7.1/Rev 4 and clinical investigations Technical file and design dossier requirements Medical device vigilance Designation and oversight of notified bodies by the Medical Device Coordination Group (to be released in Q1 2019) UDI-DI requirements in Annex VI (to be released in Q1 2019) Learn more at: https://wmdo.org/course-detail.aspx?id=180
Views: 52 WMDO
The EU's approach to financial regulation
 
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Presentation Session
Views: 97 Naratam Poudel
FDA Regulation of Medical Devices (Part 1 of 3)
 
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(Part 1 of 3) General overview of medical device regulation.
Story by L'Oréal - The New European Cosmetics Regulation
 
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Transforming a constraint to an opportunity: On July 11 2013, the European Commission strengthened the safety of cosmetics by streamlining the framework for all operators in the sector. Story by L'Oréal - The New European Cosmetics Regulation Subscribe now for the latest content from L'Oreal: http://bit.ly/YqZUxj Like Careers at L'Oréal on Facebook: http://goo.gl/5L1Ifm Follow L'Oreal on LinkedIn: http://linkd.in/Yt0wmi Follow Careers at L'Oreal on Twitter: http://bit.ly/ZadYRP Follow L'Oreal on Twitter: http://bit.ly/YX2bm3 Get to know more about L'Oreal on our official site: http://careers.loreal.com Giving meaning to beauty, by sharing growth, underlies L'Oreal's citizen commitment. The Group's initiatives illustrate the commitment of all its employees and partners around the world, who are willing to support projects that benefit communities, are consistent with the Group's activities and meet real social needs. Story by L'Oréal - The New European Cosmetics Regulation http://www.youtube.com/watch?v=vbUuxVb1z-k&feature=youtu.be
Views: 1455 L'Oréal Talent
The EU Funds Transfer Regulation 2015 – Chapter 2: Scope and requirements
 
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The Banker’s Joy Macknight and Deutsche Bank’s head of regulatory management, institutional cash management, Stefan Fruschki, discuss the FTR 2015’s requirements and scope in greater detail.
Views: 4599 The Banker
GDPR  Capsule 1 - Intro & Definition
 
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You probably heard about GDPR that replaces EU Directive 95 But do you really know what it is? Explanation with Kris Vansteenwegen of NRB
Views: 323 NRB
CSDR - a new regulatory framework for European CSDs and their clients
 
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New rules set to come into effect as part of The CSD Regulation will create a more consistent and efficient approach to securities settlement in Europe. But they also entail changes to the way you work today. In this video, Paul Symons, Euroclear's Head of Government Affairs, explains what CSDR aims to achieve and where the main impacts are for you, for example in the areas of settlement discipline and buy ins.
Views: 1760 Euroclear Group
EU Treaty - a definition
 
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A written and legally binding agreement between member states that outlines the basic principles and laws of the EU, for example the Maastricht Treaty of 1992 and the Lisbon Treaty of 2007.
Views: 911 easyeu
EU European Commission - a definition
 
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The civil service that supports the European Union by proposing legislation, developing programmes and public campaigns and taking to the Court of Justice any organisations (including companies) and member states that it believes are not following EU law. It is based in Brussels, Belgium.
Views: 1520 easyeu
European directives
 
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A brief explanation of EU directives and whether they have direct effect
Views: 5584 35cheeba
RoHS Directive 2011/65/EU & WEEE Directive 2012/19/EU
 
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Course Description: This course provides an overview of the requirements of the RoHS and WEEE Directives for medical devices (enforced in 2014). Both directives have caused major implications for manufacturers of electric and electronic medical devices. This course explains what these changes mean for manufacturers, sub-contract manufacturers, and national distributors. Learn more at: http://www.wmdo.org/course-detail.aspx?id=200
Views: 1292 WMDO
EU Regulatory Framework Objectives and Principles | Alexandre de Steel
 
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Recorded at FSR C&M Training 2017-18: Block 1 on Competition and Regulation in the Electronic Communications http://fsr.eui.eu/communications-media/ The FSR C&M Annual Training on Business Models, Innovation and Regulation in the Digital World is a state-of-the-art course combining high academic standards with a deep and direct contact with actual and present regulatory problems and trade-offs. The course is open to the staff of FSR Institutional Partners (national Regulatory Authorities and European Commission) and Market partners (private companies supporting the research activities of the Florence School) as well as to academics. The training course is opened by a five-day block on Competition and Regulation in the Electronic Communications, which is characterized by an interdisciplinary approach to the major competition and regulatory topics that will transversally be relevant in the following blocks.
in-cosmetics 2010: EU Cosmetics Regulation
 
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The Cosmetics Regulation new EU Law was published in December 2009. It affects all companies that manufacture or import into the European Union and came into force January this year. Dr Annelie Struessmann from CONSUBAT discusses. The 'New European Regulation on Cosmetic Products' Seminar will take place on 14 April 2010 at in-cosmetics.
Views: 379 in-cosmetics
EU Law - Freedom of Establishment and Services
 
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The distinction between establishment and services is based on the idea that establishment is more permanent whereas services are more temporary in nature. Establishment mainly falls under Art. 49 with 49(1) allowing for primary and secondary establishment and (2) prohibiting unequal or discriminatory treatment. The law in this area is directly effective as per Reyners [1974]. Equivalent qualifications across member states are interpreted broadly as per Heylens [1987] and also Directive 2005/36 Meanwhile article 49(2) has been broadened beyond discrimination to include any unjustified restriction on the freedom of establishment. The main case in this are is Gebhard [1995] that allows for restrictions only if they meet four criteria: 1) Non-discriminatory 2) Justified 3) Needed to secure an objective 4) Don't go beyond what is necessary to achieve that objective A national can rely on Art. 49 with respect to their own member state only when they have exercised the freedom of movement themselves as per Knoors [1979] Article 54 states companies should be treated in the same way as individuals and although company law can vary from state to state the ECJ has placed a lot of focus on achieving the overall objective of freedom of establishment as seen in Centros [1999] and Überseering [2002]. However once a company is established in a Member State they are then subject to that country's rules as regards incorporation etc. as per Daily Mail [1988] and Cartesio [2008] The liberalisation provided by Art. 54 means that it can be difficult to crack down on tax avoidance as seen in Cadbury Schweppes [2006]. Freedom of services is based on the temporary nature of the work rather than the infrastructure or, as per Commission v Portugal [2010], the period of time. Art. 57 loosely defines services and 58 excludes other services that are covered in other parts of the treaty. Art. 56 also has direct effect as per Van Binsbergen [1974]. Similarly there also has to be an inter-state element as seen in Deliège [2000] Also covered is the freedom to receive services; Luisi & Carbone [1984] The service does have to be provided for remuneration and this line can become blurred in relation to certain healthcare systems that are a hybrid between user and government payments Some controversial services such as abortion, gambling and marijuana can still be considered services (Grogan [1991]) but can be subject to national rules that provide a proportional and non-discriminatory restriction (Zenatti [1999]). Taking a broad definition it is even possible that certain social benefits may also fall within the definition; Cowan [1989]. Art. 62 allows for restrictions on policy, security and health grounds. Beyond this Van Binsbergen [1974] sets out the conditions for any restriction imposed by a Member State: 1) Pursuit of a legitimate public interest 2) Applied without discrimination 3) Proportionate 4) Respects fundamental rights (Carpenter [2002]) This freedom can be controversial as it allows greater liberalisation in the labour market at the expense of employee rights. This came to a head in Laval [2007] although this judgment has been tempered somewhat by the Rome I Regulation. Restrictions on tax grounds can be allowed to prevent fraud but not for other, broader reasons; Danner [2002]. Non-discriminatory restrictions can also be caught if they are a hinderance to the freedom of services (Alpine Investments [1995]) and Gebhard [1995] also applies within this context. The Bolkenstein Directive sought to achieve greater harmonisation by focusing on the country of origin but after protest this was watered down and so only mainly deals with a range of procedural and administrative issues.
Views: 9531 marcuscleaver
Steps to the EU market for cosmetic products
 
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http://www.ceway.eu This clip presents the steps which cosmetic product manufacturers need to take in order to be able to sell their products in the EU. The rough steps for placing the cosmetic products on the market are the following: classify your product, assign a responsible person, compile the product information file, notify your product to the CPNP, put your cosmetic product on the EU market. You have to remember that you should also always keep the product information file updated. For the classification of your products you should check the definition of cosmetic products in the EU, which can be found in the EU cosmetics regulation 1223/2009. The second step is to assign a responsible person. This is requested the EU cosmetics regulation by saying: "Only cosmetic products for which a legal or natural person is designated within the Community as "responsible person" shall be placed on the market." Responsible person has to be designated by a written mandate and has to accept this role in writing. Product information file (PIF) is a basis for pre-market notification of cosmetic products. The product information file contains various information about the cosmetic product, including raw material specifications, finished products specifications, packaging specifications, cosmetic product safety report (CPSR), labelling etc. The last step before you can place the cosmetic product on the market is the notification of your product to the CPNP portal. Product notification has to be performed by the responsible person. The links which are mentioned in the clip are the following: - cosmetic product definition: http://www.ceway.eu/is-your-product-even-a-cosmetic-product/ - responsible person: http://www.ceway.eu/european-responsible-person-rp/ - product information file: http://www.ceway.eu/product-information-file-pif/ - cosmetic notification: http://www.ceway.eu/notification-process/
Cosmetic products claims in the EU
 
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http://www.ceway.eu Which claims can you make for cosmetic products in the EU and which are prohibited? Which legislation regulates cosmetic product claims? What do you have to do to prove the claims that you make? This CE.way Regulatory Consultants video clip presents the requirements and guidelines regarding claims that can or can not be made for cosmetic products in the EU. It presents what the EU cosmetics regulation 1223/2009 says about cosmetic product claims, as well as the EU regulation 655/2013, which was specifically published to introduce some common criteria regarding cosmetic product clams in 2013. Cosmetic product claims have to be in line with the definition of the cosmetic products in the EU. Cosmetic product definition in the EU is the following: "'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours" This means that cosmetic products should not claim that they treat or prevent diseases in human beings. Therefore words or phrases such as: cures, heals, treats, restores, prevents, clears, protects against disease, helps control the symptoms of, traditionally used for treatment of, strengthens the immune system etc. are not allowed. As consumers should be protected from misleading claims, each claim made on the cosmetic product, except for the obvious ones (like lipstick colours your lips) or clear exaggerations, have to be substantiated.

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