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How to Make Money Giving Stuff Away What if I told you it’s possible to make money by just giving stuff away? We are all too prone to base our expectation of today on what happened yesterday, or the past few months, or the past few years. Expect the goodness of God to show up in your life, and expect favor, blessings, and good success.
Get a bigger vision of your life, expect your path to be illuminated and clear, and make room for God to do something amazing for you. Top 10 Takeaways & Tips We just returned from Social Media Marketing World 2016, and this episode is filled with our impressions, some takeaways, and tips. We get into what you can do to make any conference trip better, and how to get the most from your conference dollars. Come now, you who say, a€?Today or tomorrow we will go to such and such a city, spend a year there, buy and sell, and make a profita€?; whereas you do not know what will happen tomorrow.
Talk, send text and photos a€” send live or recorded voice, text messages and photos instantlya€”to one person or an entire group. Listen live or listen later a€” Listen a€?livea€™ while someone is speaking and respond immediately or listen later and reply when ita€™s convenient. Use any network, globally a€” Voxer works on any cellular or Wifi network around the world.
Traditional Media outlets (radio, TV, magazines) are now looking for people with Platforms. The founder of MeetEdgar, a new social media automation tool designed to prevent updates from going to waste.
Laura was named one of the top 100 entrepreneurs under 35 in 2011, 2013 and 2014 and spoke at the White HouseA about the value of entrepreneurship.
Laura has spoken at numerous influential industry conferences including, BlogWorld, The South by Southwest Interactive Conference, Real Estate Connect, The Social Communications Summit and BlogHer, discussing online marketing, social media, and personal branding. This is a special edition of the Ray Edwards Show where I interview the founder of Meet Edgar, Laura Roeder.
It’s a wild-west version of the show, as Sean and Ray are operating on too little sleep and too much caffeine. Today wea€™re releasing the second in a series of four videos that will give you the very best ideas, tactics, and even formulas that we encourage you to borrow and use in your own copy to make more money.
Ita€™s a wild-west version of the show, as Sean and Ray are operating on too little sleep and too much caffeine. The Art of Writing Words That Sell Today’s podcast is filled with action steps you can put to work in your business right away.
How to know it’s time to give up trying to solve the problem you face, and try something crazy. 7A keys to more effective copywriting-you’ll be writing words that sell better, faster, and easier than ever before.
That’s why it says in the book of Proverbs we should trust in the Lord with all your heart, and lean not on your own understanding. Todaya€™s podcast is filled with action steps you can put to work in your business right away.
Proven Methods Produce Instant Income Copywriting is the single most valuable skill you can develop in business. How it’s possible that God is offering you incredible gifts-and you are refusing to take them!
If I offer you a gift, holding out to you with arms extended, but you keep your hands in your pocketsa€¦ To whom does the gift still belong? For instance, if you’re holding bitterness and anger in your heart toward someone, or unforgiveness, that could block your blessing. Today, ask the Lord to help you search your own heart for anything that may be blocking or refusing his power. Today we’re releasing the first in a series of four videos that will give you the very best ideas, tactics, and even formulas that we encourage you to borrow and use in your own copy to make more money. How to Own the Day and Control Your Life Most people live lives of robotic repetition… they are just going through the motions, and about 90% of those motions are the same ones A they went through yesterday. Surely goodness and mercy shall follow me all the days of my life; and I will dwell in the house of the Lord forever. In the Bible, there was another King, David, who was known as a man after Goda€™s own heart.
God says you are a royal priest, a child of the king, and heir to the promises given to Abraham, a co-heir with Christ. Divine connections, restoration of what was lost, favor, grace, and blessings … all in hot pursuit of YOU, wherever you are! Unclutter is a new handy place on your desktop for storing notes, files and pasteboard clips.A Most of the time it hides at the top of your screen. How to have a real separationA between work and family so you can be fully present with your family.
The 10-3-2-1 goodnight formula to guaranteeA a good night’s sleep, and waking up with energy, ready to take on the day.
Most people live lives of robotic repetitiona€¦ they are just going through the motions, and about 90% of those motions are the same ones A they went through yesterday. 5 Steps to More Profits, More Often You probably know it’s good to care about your audience. Because God loves you, He longs to shower us with natural and supernatural blessings: healing, restoration, opportunities, favor, increase, and peace.
Daddy, thank you that your hand is with me, and thank you for pouring out your blessing, grace, and favor on my life. He helps people discover their vision, write their story, and speak their vision into existence using his proven VisionSpeakera„? System. Your Backstage Pass to Our Private Launch Recap Meeting It’s another first for the Ray Edwards Show.
The good, the bad, and the ugly of a real-life product launch – complete with the numbers.
Copywriting insights from one of the very few copywriters I have ever hired to write copy for me, Marshall Bone. The single most effective way to turn total strangers into a tight-knit community of raving fans. The single most effective way to lower your a€?dropouta€? rate, and cause your customers to get the most out of your product. Little known secrets that can eliminate failure completelya€¦even when it feels like everything is falling apart at the seams. Why good intentions arena€™t enough: We share our secret process that creates grateful customers who cana€™t wait to buy from us again.
Plus a€“ Ia€™ll share the a€?3 Pa€™sa€? that serve as the lever to move your business to the next level. Little known secrets that compel your JV partners to keep their commitmentsa€¦and get them to raise their hand to promote you again and again.
How to Stop Drifting and Get the Life You Want I’m so excited to offer you this special bonus episode of the Ray Edwards Show. Born in 1972, Danny Alexander grew up in the Highlands and Islands and went to Lochaber High School in Fort William.
In 2003 he was appointed the Head of Communications for the recently formed Cairngorms National Park Authority before becoming an MP for the newly created seat of Inverness, Nairn and Badenoch & Strathspey in the 2005 election. Danny joined the shadow Work and Pensions Team in 2005 and in July 2007 was appointed Shadow Secretary of State for Work and Pensions, holding the post until June 2008.
He played a key role in the negotiating team and in the drawing up of the coalition document for the new Government.
Born in 1964, John Swinney joined the Scottish National Party in 1979 and went on to graduate from Edinburgh University with an MA (Hons) in Politics. Prior to his election as Westminster MP for North Tayside in 1997, he held a number of posts in the SNP at local and national level. Lesley joined SCDI from Glasgow Chamber of Commerce where she was the first female Chief Executive appointed in its 300 year history. She is a non-Executive Board member of the Scottish Environmental Protection Agency and a member of the Scottish Trade and Economic Growth Board established by the Secretary of State for Scotland. 1999-2001 Special Adviser in the Policy Unit of the Scottish Executive for the First Minister of Scotland. 1999 Head of Policy Research at the Scottish Labour Party prior to the 1999 election for the Scottish Parliament. Stephen Boyle is Head of Group Economics at the Royal Bank of Scotland (RBS) Group and a director of RBS Pension Trustees Ltd, the Group’s main pension scheme. Richard Beamish is Interim Chief Officer at the Alliance of Sector Skills Councils, following eight years as Chief Executive of Asset Skills, the Sector Skills Council for the Cleaning Services, Facilities Management, Property and Housing sectors. Professor Russel Griggs  was born and educated in Edinburgh and has a degree from Heriot Watt University.
Since then he has had a number of non executive positions in the private, public and third sector as well as running his own consultancy business which does a variety of strategic work for public bodies and private companies. From 2007 - 2010 he was also Chair of the CBI’s UK SME Council, and from that was a member of various other Government Committees. He was also until recently a Board member and Chair of the Audit Committee of VisitScotland, a Board member of Scottish Enterprise, a Non Executive Director of the Scottish Government, and a Board member and Chair of the Audit Committee of the Department for Employment and Learning in Northern Ireland.
He is honorary Professor of the University of Glasgow and was awarded an honorary doctorate by the University of Glasgow in 2002 for services to industry and the University. Prior to this, Anne was Operations Director for the EMEA (Europe, Middle East and Africa) region of SDI, managing SDI's overseas sales & marketing teams and directly working to both attract inward investors and support Scottish companies to successfully trade internationally.
Her first degree from Glasgow University in French, Spanish and Portuguese and this then led her to apply her business skills to an international setting, through an MBA at Strathclyde Graduate Business School.
Andrew is one of the countries leading lawyers in IT and Outsourcing and is well known for his in-depth expertise on large technology projects principally in the fields of strategic technology transactions, technology outsourcing and BPO outsourcing.
Andy was appointed Executive Director of the Edinburgh Centre for Carbon Innovation in 2010. Previously, Andy worked in the private sector in the emerging international carbon and biofuel markets, working with companies to develop both strategic and practical management responses to emerging opportunities and legislation. His public policy work has focused on developing effective national and regional policy frameworks that support the reduction in dependence on fossil fuels and greenhouse gas emissions. The abovementioned Resolution proposes to simplify the state registration procedure for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. Novelties in materials expertise for the abovementioned category of medicines and requirements to such materials deserve a special attention.
It is worth to mention that despite the fact that the Resolution has not come into effect yet, the text of this legal regulation published on the CMU web-site should be considered as final. Upon the consideration of the provided materials the Antimonopoly Committee has come to the conclusion that given marketing agreement does not contain any signs of the abuse of monopoly and anticompetitive concerted actions conducted by GlaxoSmithKline Ukraine. Moreover, the project team put major efforts into the materials preparation aimed at the justification of Competition Law non-infringement by the drafted marketing agreement concluded with the pharmacies and pharmacy chains. The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union.
The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement. The Regulation proposes to establish the selection procedures (development of the first draft Essential Medicines List by the Expert Committee) and yearly revision of the National Essential Medicines List. Further, upon the approval of the first Draft National Essential Medicines List the Expert Committee shall revise the existing taking into account the abovementioned factors and sources. The Draft Regulation also established the schedule of revision of the National Essential Medicines List. Please note that the Order of the Ministry of Health of Ukraine as of February 11, 2016, a„– 84 approved the Regulation on the National Essential Medicines List and the Regulation on the Expert Committee on the selection and usage of essential medicinal products.
For 28 years, The Legal 500 has been analyzing the capabilities of law firms across the world, with a comprehensive research programme revised and updated every year to bring the most up-to-date vision of the global legal market. The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price. The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector. The Concept shall be implemented with the assistance of international organizations and donors in three stages during 2016—2018.
Stage 1 (2016) – establishment of institutional and legal basis for the reformation of public procurements in healthcare sector. CPO shall fulfill the procurements at local and foreign levels, and if required shall maintain the procurement from international suppliers — import of medicinal products, immunobiological products and medical devices, involve other organizations into customs clearance, storage and distribution, conduct other business activities based on long-term plan principles. The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold. Moreover, the document amends the CMU Resolution as of March 5, 2014, a„– 73 "On the Implementation of Pilot Project on State Regulation of Insulin Products Prices" regarding the definition of the unified mechanism of the state regulation of insulin products prices.
These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark.


Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date.
Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate. Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation. In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market.
State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market.
The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project. The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards  in terms of health and level of funding for health care.
The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education. Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them.
Interested individuals and legal entities can apply with a package of necessary documents  for inclusion of drugs in the National List of Medicines. Notice of tax assessment is developed for each separate tax due together with the penalties, as well as for each penalty and poena for the violation of other legislation being under supervision of regulatory authorities.
Notice of tax assessment is considered to be submitted to the taxpayer – legal entity if such assessment notice is delivered by hand to the official employee of such taxpayer against acknowledgement or forwarded in a letter with notification of the delivery. Notice of tax assessment is considered to be submitted to the taxpayer – individual if such assessment notice is delivered by hand to such individual or his authorized representative or forwarded in a letter with notification of the delivery to the address of residence or of the latest known location of such individual. The new Law provides for the implementation of public procurement with the use of two competitive regulatory procedures: open tendering and competitive dialogue, as well as a non-competitive procedure - negotiating the purchase procedure. An important innovation of the Law is the introduction of electronic procurement (e-auction), the electronic review system, as well as the implementation of the exchange of information, documents, to provide clarifications in the e-procurement system.
Moreover, for the conduct of unauthorized concentration, which did not lead to monopolization and significant impediment of competition on Ukrainian market , the AMCU recommends to calculate the basic penalty in accordance with the total revenue (income) received from the sales of products (goods, services) at all commodity markets of Ukraine. The AMCU made the greatest specification regarding the calculation of the basic penalties in the cases of the infringements of informational character. Moreover, the AMCU believes that if the incorrect information has been provided several times during the consideration of the case regarding the violation of informational character, the total penalty charges shall amount to the penalty for one relevant violation. It is worth to mention that the AMCU established the reduced penalty, which may be imposed on the respondent during the investigation of the case of informational character and on the applicant in the case regarding the concentration and the concurrent actions if they provided incomplete case information.
Correction of previously determined penalty taking into consideration the aggravating and mitigating circumstances. Declarations with violation of the deadlines for submission for the reporting period in case the application is submitted within its contents.
The registers are published at the official State Fiscal Service’s web-site on a daily basis. In case the Main Directorates of the State Fiscal Service in regions, or in the city of Kyiv send to the appellant the decision on final or partial denial of the appeal, the appellant has a right to file the subsequent appeal within 10 calendar days upon the receipt of such decision. The document in its new edition, updated and improved in line with the requirements of the Law of Ukraine "On Prevention of Corruption", was recently approved by the  Management Board of AIPM Ukraine. The project was conducted by Oleksii Bezhevets, partner with Legal Alliance Company and senior associate Lidiya Sangarovskaya-Gurlach. The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree a„– 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure). Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF).
An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan. In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports.
In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others.
Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance.
It is to be recalled that  in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market.
Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order a„– 143. The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product.
In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved.
The Project aims to supporting of Ukrainian government in issue of improvement of effectiveness and transparence in public purchasing system for medicinal products, in particular, by complying of National list of main medicinal products and medical devices with international standards. This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities.
In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market. Taking into consideration the composition of the event members many of whom represented the medical devices market, the regulation of the medical devices circulation in 2016 was discussed during a separate interactive session involving Pavel Harchyk, President of the Association of market operators of medical devices, Natalia Serhienko, Health Care Committee Executive Director, European Business Association, and Darya Bondarenko, CEO of Association of market operators of medical devices.
The next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business. Following the traditions of the summery conferences the session on taxation of pharmbusiness was held. The highly topical conference programme did not let the participants to relax and loose focus, just as the regulatory and law-enforcement authorities does not let the sector representatives to relax in the course of the year.
Hygiene requirements  exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods. Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements  vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements. Therefore  amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance . The document designates the mechanism for taxpayers’ appeals against tax assessment notices or any other decisions made by the regulatory authorities in the course of administrative procedure. This Procedure shall not be applied to the appeals against the regulatory authorities’ decisions, actions or inactions of their officers or other employees if the special law establishes other procedures for appeals. Complaints about the decisions of state tax inspection offices are filed to regulatory authorities in Kyiv and regions, to inter-regional territorial agencies. Complaints about the decisions of regulatory authorities of Kyiv and regions, of inter-regional territorial agencies, and of customs offices are submitted to the State Fiscal Service of Ukraine. The decisions of State Fiscal Service of Ukraine made upon the consideration of taxpayers’ complaints are final and without any further administrative appeal, however may be appealed to court. The complaint should be submitted in writing to the higher regulatory authority within 10 calendar days following the taxpayer’s receipt of the respective decision made by the regulatory authority. The complaints for the regulatory authorities’ decisions and actions should be cited and submitted separately. The taxpayers may attach to their complaints all calculations and evidence, which they deem appropriate.
Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported. The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal. The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal. The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period.
The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation. Nevertheless, the tax payers are still obliged to pay advanced corporate profit tax payments for the first three quarters of 2016. The failure to make this payment shall result in imposing on such tax payer the penalty in the amount provided in Article 123 of the Tax Code of Ukraine.
In such a way, the National List of Essential Medicinal Products and Medical Devices has been renamed into the National Essential Medicines List. Since CMU Resolution a„– 333 as of March 25, 2009 adoption, the list has not been amended with any medical device.
National Essential Medicines List should be formed with due consideration of world-wide practices of rational pharmacotherapy and pharmacotherapeutic approach to primary health care of patients with priority pathologic conditions taking into consideration disease burden and mortality rate, and health care sector standards. In the majority of countries this function is fulfilled by the WOH Model List of Essential Medicines, which has been elaborated as a core document for ensuring public health care at government expense.
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Since 2009, shea€™s been teaching entrepreneurs how to harness the power of social media marketing and create their own fame at LKR Social Media.
Would you like to learn how to write copy that sells like crazy, but doesna€™t sound sleazy or pushy? We have to do the most counterintuitive thing: turn off the logic machine, stop researching our problem on Google, stop overanalyzing the problem, and stop looking for answers in the natural realm. But sometimes, your mind will try to distract you, so you don’t even notice that God is speaking to your heart all the time. It’s the only skill you can use to create more sales, out of thin air, without spending more on ads or changing your product or delivery. There are gifts that are right in front of us, we have our hands firmly stuffed in our pockets, oblivious to what life is offering us.
There may be something else that God is asking you to do or suggesting to you that you are ignoring. Is the equivalent of having your hands in your pockets when someone’s trying to give you a gift. Would you like to learn how to write copy that sells like crazy, but doesn’t sound sleazy or pushy? Creating valuable products, with a view to the future, and having lifelong relationships with your customers. In this case, I tied the benefit of instant income to the action of listening to this episode. Ita€™s the only skill you can use to create more sales, out of thin air, without spending more on ads or changing your product or delivery. In seconds, you’ll be recording audio from any application or from audio inputs like microphones. Imagine sitting in on one of our private team meetings in which we discuss a product launch.
Skip these and you better have a large supply of aspirin nearby, a€?cause the headaches are a comina€™.
You may have the greatest product in the world, but if you cana€™t communicate your message effectively your launch is over before it starts. This free bonus will also identify the people who are ready, willing, and able to go to the next level with you. In 1999, he became the MSP for Tayside North, remaining as the constituency’s MP until standing down from Westminster at the 2001 General Election. He lives near Blairgowrie in his constituency and his hobbies include cycling and hill walking.
Lesley is also a non-Executive Board member of Glasgow City Marketing Bureau and Chairs BusinessClub Scotland, the network established to drive forward business engagement in the 2014 Commonwealth Games. He started his business life in marketing in the pharmaceutical industry and then moved to the consumer flooring industry before becoming CEO of an industrial textile company in England in the 1980s.
Currently he is a Group Board member and Chair of the Audit Committee of Lenlyn Group, a large regulated financial services company, Chair of PureLifi, a technology spin out company from Edinburgh University, Chair of the Scottish Mines Restoration Trust, and a Board member of the BE Group, a business support and publishing company.
He also Chairs the Scottish Government’s independent Regulatory Review Group who advise and work on better regulation in Scotland. He also reviewed the Lending Code (the voluntary code that banks use to state how they will lend to consumers and micro businesses) which will bring new lending standards for both the consumer and SME sector.
He has been also associate Professor at Boston University and a member of the board of the Business School at Georgia Southern University.
SDI is the Trade and Investment arm of the Scottish Government, Scottish Enterprise and Highlands & Islands Enterprise.


Prior to this, Anne lived and worked for two years in Madrid and for 3 years near Toulouse, France, as a management consultant to the French Chambers of Commerce network, and as part of a national private Spanish consultancy, Soluziona. Fully fluent in both French and Spanish, Anne has a track record of international business and is passionate about "selling" Scotland internationally.
His primary focus involves the financing, advisory and transaction support services across the oil & gas service and wider energy sector. For the first time in their history, Assistants are starting to get the recognition that they deserve as strategic business partners and not just as a support mechanism. Thus, the term for materials expertise conducted by the State Expert Center has been reduced to 20 business days. The Resolution proposes the Ministry of Health to establish the expertise procedures for the abovementioned products, but with an approval of the Ministry of Economic Development. This Draft Law also proposes to establish the simplified registration procedures for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU.
In particular, the team made a comprehensive research on medicinal product markets, which may be affected by the concluded marketing agreement, conducted social and marketing studies, analyzed the experience of GlaxoSmithKline group of companies regarding the relevant agreements in other countries, developed internal standard operating procedures for the Client with regard to pharmacies and pharmacy chains cooperation. We would also like to express our gratitude to the project team members representing GlaxoSmithKline Ukraine for the fruitful collaboration. The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session. This Regulation belongs to the package of documents drafted in order to implement the new model of Essential Medicines List. The difference lies in the fact that all individuals intending to include a particular medicinal product into the List shall have an opportunity to submit a corresponding application including the documents confirming the comparative efficiency, safety and cost-effectiveness of the product. The Regulation Annexes formalize the application execution Instruction for amending the National Essential Medicines List. The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations (hereinafter - CPO) in Ukraine, which requires some time and incremental actions. CPOs shall be established under the Health Ministry decision and shall operate under its supervision. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration.
Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market. The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO. An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package  on this matter.
Such persons shall not present a real conflict of interest, in particular,  they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. At the same time, the Law provides a number of cases to which the provisions of the latter do not apply. In addition, the AMCU has specified the meaning of such aggravating circumstances as the obstruction of case investigation. This method is recommended in case the respondent did not provide any information on the total revenue at the market where the concentration took place and at adjacent markets. Thus, previously the basic penalty equaled up to 5% of the revenue from the sales of the products (goods, works, services) of economic entity in the last reporting year prior to the year the penalty was charged, and if there was no revenue or the respondent did not provide any information on the total revenue – the penalty equaled to 10 000 of non-taxable incomes of the residents. The written appeal should contain all data outlined in the Procedure, it should be signed by the appellant-physical entity or by the authorized person, for other appellants – the appeal should be signed by the director or a legally authorized representative and sealed (if available).
Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant.
At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person). Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine. In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it. It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e.
The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments. The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection  for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness. Being an annual event for the pharmaceutical sector representatives, the Conference focuses on the regulatory aspects of the pharmbusiness and other legal tendencies of the pharmaceutical market. Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr. The discussion was held around the current status, potential problems and roadmaps in this sphere.
The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements. Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session. Nevertheless, all the attendees remained satisfied with a quantity and quality of the information received at the event and expressed a desire to meet in such a format at least twice a year. Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission.
The opportunity to track  dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation.
According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their  authorized representative. In addition the mentioned procedures shall not be applied to the appeals against decisions made in the course of administrative violations proceedings. Prior to this Resolution adoption the list approved by the CMU Resolution a„– 400 March 29, 2006 was in force containing 783 products among which only 1 product was a medical device – test system. The essential medicines are selected with regard to the morbidity rate, comparative effectiveness and safety evidence, economic efficiency.
Laura Roeder isa€¦ The founder of MeetEdgar, a new social media automation tool designed to prevent updates from going to waste. And best of all, would you like to get access to these information-packed, professionally-produced, and incredibly helpful tutorials absolutely free? It’s easy to drag items from other applications to the top of screen to store them in Unclutter.
Keep your heart open and your mind open and your eyes open… today could very well be the day you experience the abundant life Jesus promised! She is a member of the Advisory Board of Glasgow University Business School and acts in an advisory capacity to the Board of The Big Partnership, the UK’s fifth largest independent PR agency. In 1990 he joined Scottish Enterprise in a business development role and became an Executive Director of Scottish Enterprise where he ran the investment banking and business development arms, as well as spending some years in the USA looking at outward investment for Scottish companies.
He is about to review the branch closure programme for those banks that agreed a protocol with Government in 2015 on how these would be done. He was awarded an OBE in the Queen’s Birthday Honours list in 2008 for services to Scottish Industry. She has a strong interest in international education, and is an active participant in the activities of the International School in Sevres, near Paris.
Prior to that he led Scottish Enterprise Glasgow in its role as Glasgow’s business led economic development agency.
Before joining Campbell Dallas in September 2010, Tom gained over 15 years experience in the sector from both an advising and financing perspective through his time in the Corporate Finance team of a Big 4 firm and the leveraged finance team of a leading UK based bank. The term for making the decision on or the rejection of the state registration has been reduced to 10 business days. Please note, that the Ministry of Economic Development is mentioned for the first time in the context of the state registration of medicinal products and previously was not involved into any step of the registration process. In addition, we would like to mention a substantial expertise and due attention to this issue expressed by Antimonopoly Committee specialists. The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine. The patients shall receive their medication for a lowered price or for free in accordance with these categories. Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month.
An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs. This Order updates the mailing procedures for tax assessment notices to be sent to taxpayers by regulatory authorities. Today the AMCU increased the penalty up to 30% of the revenue from the sales of the products (goods, works, services) that violated the legislation on the protection against unfair competition.
In the end of the session the Legal Alliance senior associate Alexander Bondar presented a report on the new public procurements law, which practically implements the electronic procurements (electronic auction), electronic system of appeal, and the exchange of information, documents, submission of explanations in the electronic procurements system.
In the course of his report the delegated had an opportunity to discuss the plans and implementations of 2015 and to share their expectations and forecasts for the coming year. After he passed the floor to the special guests of the conference - Aliona Kushnova, Judge at the regional Kiev administrative court, and Jonas Triggvason, Managing Partner, UPharma Consulting. The session was traditionally opened with an analytical report on the status of the pharmaceutical market in 2015 presented by Irina Gorlova, General Director, SMD. Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry.
Before 2006 the list approved by the CMU Resolution a„– 1482 as of November 16, 2001 was acting. The show includes interviews with well-known experts like Michael Hyatt, Jeff Goins, Dan Miller, Cliff Ravenscraft, Michael Stelzner, Amy Porterfield, Donald Miller, and many others.
Instead you ought to say, a€?If the Lord wills, we shall live and do this or that.a€? But now you boast in your arrogance. Trust Him, because in the final analysis, He’s the only one you can totally trust, every time.
We invite you to listen in, as we recap what happened in the product launch we conducted in October. He also ran Scotland the Brand, the Scottish Science Trust, and was in charge of designing and building the Scottish Pavilion at Disney’s Epcot Theme Park in Florida for the Millennium celebrations. He was responsible for co-ordinating the investment of Scottish Enterprise resources in the growth of the city’s economy.
They celebrate and recognise the role and its importance while encouraging Assistants to take control of their personal development, and drive their own career agendas. Our joint efforts led us to the implementation of the project that only yesterday seemed to be almost impossible”. The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt. In addition to a lot of interesting facts the reporter highlighted that the total volume of the medicinal products market in Ukraine amounted to 2.1 billion USD in 2015. In this weeka€™s episode, youa€™ll finda€¦ Why you are about to experience more favor, abundance, and a€?happy accidentsa€? than you have ever imagined.
He has devoted much of his career to the economic transformation of Glasgow and has served in many partnership roles over twenty years. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD. And they’ll even send you photos of it so you can breathe easy that ita€™s on its way. Andrew has increasingly been involved in offshore outsourcing projects for a number of companies and organisations and he has also been consulted by various Governments including the UK Cabinet Office, the UK Department for Trade and Industry, the Argentinean Government and the Cayman Islands Government. In the framework of this session the participants discussed the adjustments in the personal data protection, as well as promotional activities and programs of the pharmaceutical companies. Therefore, the National Essential Medicines List did not function properly from the very beginning of its development. He has had many years of direct experience of the licensed bar and restaurant trade in the city and he can just about manage a game of tennis if provided with suitable energy drinks. The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics. Session speakers - Zoya Zamikhovska, Junior associate, Lidiya Sangarovskaya-Gulach, Senior associate, and Andrii Gorbatenko, Associate partner, who presented to the audience their reports on medicinal products advertising, marketing agreements in the pharmacy sector, and distribution contracts. Andrii Gorbatenko emphasized the types of law infringements foreseen by the competition law, and paid the attendees attention to the provisions of distribution contracts, which are attracting a close attention of the Antimonopoly Committee of Ukraine, in particular the provisions regulating the reports, discounts and bonus payments.



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