The representatives of state authorities (in particular Maksym Nefyodov, Deputy Minister of Economic Development and Trade, and Olexander Starodubtsev, Head of the Department of the Ministry of Economic Development and Trade), real business representatives – pharmaceutical companies, distributors and pharmacy chains, international organizations and professional associations brought together in order to complexly and comprehensively discuss the given issues.
Dmytro Aleshko, being a leading expert in the area of state (public) procurements, participated in the profile discussion panel, which opened the conference.
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 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.
With high and mid-management personnel in mind, this program is developed to fortify their leadership position as individual and within the organization.
Your vibration by getting content and enabling it to work potential than to have to overcome some. In my last post I reviewed some of the issues I see with Bimodal IT; these include promoting a segregation of techniques when companies really need integration and recommending sequential lifecycles for complex projects. First, we should acknowledge the elegance of its simple design and understand why organizations are drawn to it.
In the book a€?Good to Greata€? Jim Collins popularized the idea of the a€?Tyranny of the OR vs.
The a€?Tyranny of the ORa€? part describes having to choose from two seemingly contradictory strategies a€“ either Mode 1 which is traditional and sequential OR Mode 2 which is exploratory and nonlinear. Jim Collins linked the ability to leverage a€?ANDa€? thinking to high performing companies, but this third alternative or a€?Middle Waya€? has been around for a long time. An example of applying the AND mentality to Bimodal IT would be to execute a couple of Mode 1 and Mode 2 projects and then get the teams together for an improvement workshop.
I am not suggesting these are universal enhancements Mode 1 and Mode 2 projects, they are just examples of things that might be suggested. I am in favor of using established and proven development approaches, they leverage good practice and help prevent common pitfalls. As Alistair Cockburn and Jim Highsmith have been saying for decades, we really need a methodology per project.
The continuous improvement model used could be one already in place at the organization or one that best fits with the mindset or culture. Gartner did a great job creating a framework that is appealing and accessible to organizations slow to adopt adaptive lifecycles. We would like to invite Agile Practitioners to Agile Coach Camp Canada - West, an Open Space Conference to be held in Vancouver, BC on the weekend of June 17-19, 2016.
The annual gathering at Agile Coach Camp creates opportunities for our Agile community to share our successes, our learning, our questions and our unresolved dilemmas a€“ all in an energizing and supportive environment.
The Open Space Technology, Unconference format, encourages participants to join the conversation.
Each of us can make a contribution to the art and science of helping people and teams be their best as they deliver valuable software. As you probably know the Exposure Draft of the PMBOK v6 Guide is making its way through review at the moment.
Looking through my web site visitor statistics it is clear that one of the popular resources is my PMBOK v4 Guide to Agile mappings.
I get the feeling that DSDM is considered by many people outside of the UK as the uncool, out-of-touch great-uncle of agile.
On the one hand I applaud any approach that helps bring the benefits of iterative methods and increased collaboration to organizations, especially those that have previously resisted them. If your project is simple, visual and being undertaken by a small, co-located team then an agile approach is likely a good fit.
Also, given the complexity of large systems, the chance of getting something complicated done right through a sequential process is very small.
These benefits coupled with others around an increased sense of ownership and accountability by the team for having been involved more in the planning and ongoing steering of the project, I believe large complex projects need agile techniques more than small simple projects. I am not saying large projects should be run purely with agile methods, they need additional layers of rigor and communication, but there are some great scaling frameworks like Disciplined Agile Delivery (DAD) that do this without losing the benefits of iterations, adaptation and empowered teams. The next stage after Denial and Anger is Bargaining, where people try to avoid or minimize the impact of a change by making some highly visible or not really substantive bargains.
As an example Gartner states their Mode 1 approach that is traditional and sequential emphasizes safety and accuracy, but I would feel much safer and confident in a system where the highest priority features were developed first and have been reviewed and tested in every iteration since, than an approach that had lots of careful planning and then testing performed towards the end of the project.
If it has a redeeming feature it is that it could lead to the introduction of some iterative based projects, that then open the door to more agile projects, in organizations that had up until then resisted agile methods.
Following the update to the PMI-ACP Exam with the addition of the new a€?Agile Principles and Mindeseta€? domain I updated my PMI-ACP Exam Prep book and have now just finished the new questions for FASTrack Exam simulator.
As an early release bonus you can receive 30% discount off my book and the FASTrack exam simulator. 2) Your upcoming project will be the organization's first use of agile, and the sponsor asks you about tailoring the new methodology. Adapting the new methodology will be a good way for the team to learn about agile practices.

The team should become comfortable with the new methodology before we consider changing it.
We should wait to adjust our practices until we see where the team runs into difficulties applying them. In trying out the product increment, the customer thought of another feature to add to the backlog. In the demo, the customer decided that the team hadn't completed one of the items selected from the backlog for that iteration. 4) Your cutting-edge project has several major risks that the team wants to eliminate as quickly as possible. 5) You ask the product owner to allocate the financial return expected from the project across all the product features.
Just make up some numbers as a starting point, we'll refine the exact amounts as we proceed. We need this information to do a cost-benefit analysis of the product features and prioritize the backlog. 8) If your progress toward the sprint goal is being threatened because you haven't yet gotten the website copy from marketing, what should you do? 10) After several months, the agile team you are leading has finally reached the Performing stage.
11) As team coach, what should be your attitude toward your team membersa€™ individual goals and personal motivations?
Cultivate them; personal goals are an important reason why people want to be successful at work. Understand them; try to align personal motivations with the teama€™s progress toward the project goals.
Leverage them; use individual goals to persuade team members to raise their performance level.
12) The developers have just finished building a product increment and will present it to Sara in a demonstration tomorrow. 13) A few months ago the members of the delivery team seemed to be arguing constantly, and they needed a lot of guidance from their team leader. 14) For iterations 1 through 6, the teama€™s velocity tracking chart shows 20 points, 35 points, 18 points, 23 points, 25 points, and 22 points.
16) You mention in a meeting that agile teams focus on people rather than processes and tools. If we get the right people on the team, the processes and tools they are using won't matter.
Having an empowered team is more important for project success than the processes and tools being used. A project's chances of success are heavily dependent on whether we can get the best people on the team. 17) When you are working with a Scrum team, who is primarily responsible for ensuring that value is delivered by the project?
18) The business representative for your lean team hasn't been available for a few weeks due to a crisis in a foreign subsidiary. 19) In the iteration retrospective, the team's coach reminds the pair programming teams that everyone owns the code, and it is important that all of that knowledge be shared.
20) You've found a more efficient way to analyze the lab test results that you and your teammates are evaluating in the current spike. Explanation: Daily stand-up meetings are typically the earliest source of warning signs or indications of potential problems, since these meetings occur every day.
Explanation: Agile practices should be mastered and fully understood before we attempt to customize them.
Explanation: To understand this question you need to think about why we ask the product owner for this information. Explanation: Ideal time refers to how long it will take to complete a work item if there are no interruptions, impediments, delays, or distractions. Explanation: Since sprints are timeboxed, when a sprint ends we stop working and return any incomplete work to the backlog for replanning. Explanation: One of the key functions of a daily stand-up meeting is to share information about problems and impediments to progress.
Explanation: Agile leaders try to align their team membersa€™ individual goals and personal motivations with the teama€™s progress toward the project goals. Explanation: This scenario describes a team that is moving from the Storming stage to the Norming stage. Explanation: The model that describes the stages of adult skill acquisition is the Dreyfus model.
Explanation: Agile teams follow Agile Manifesto value 1, a€?individuals and interactions over processes and tools,a€? because experience has shown that having an empowered team is more important to the success of an agile project than the processes and tools they choose to use.
Explanation: The product owner has the primary responsibility for ensuring that value is delivered by a Scrum project. Here is a link to my slides from the recent PMI-SAC Professional Development Conference.
It was great to catch up with old friends at the conference and receive such positive feedback about my presentation. It is interesting to note that sub-steps 2 and 3, a€?Benefits Analysis and Planninga€? and a€?Benefits Deliverya€? are iterative. This is an aside, but a repeating pattern we often encounter is something I call the a€?Thick Sandwicha€?. Middle managers and their processes are created to optimize the process, add rigor and controls, but often just hinder the process. Removing or lessening this layer of management interference is critical to ensuring benefits are delivered. So it is the outcome a€“ the benefits and not the outputs a€“ the project deliverables that we should be focused upon. While numerical approaches do exist for trying to convert these benefits into financial measures (For instance: a€?Negative press around the Product X launch may deflate share price by 5%a€?) by definition these measures are harder to quantify. We have to be careful when using agile for projects targeting Reputation and Safety benefits. The team may push rapidly ahead on new components and even on trying new approaches to development, but these are not the final solutions. Projects undertaken primarily for Goodwill and Learning benefits are great candidates for agile approaches.
Benefits management focusses on the bigger picture view of why we undertake projects and programs. Benefits Management takes the longer term, not just scope, schedule and budget criteria view to track the Whya€™s of projects to delivered benefits. I ran a couple of Calgary based PMI-ACP courses three years ago when the exam first came out. In October 2015 the PMI rolled out the updated version of the PMI-ACP exam, based on feedback from hundreds of existing credential holders and agile practitioners.
I was a founding member of the steering committee that designed and developed the exam content outline.
The course will be capped to 15 people for better Q&A and will take place at historic Fort Calgary which is close to downtown on 9th Avenue and has free parking. The course has a 100% pass rate and uses Turning Technologies audience response technology.
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.
Origin This training programme was designed initially for a multinational industrial corporation in 2005 Assignment: to design a programme to train operations supervisors (production team leaders) in people management skills and train internal trainers to qualify them to deliver the training locally. While it is easy to poke holes in ideas, it is more useful and rewarding to fix and improve things. The simplicity of an If-This-Then a€?Aa€?, If-Not-Then a€?Ba€? approach is appealing and it allows companies to try agile-like approaches without making a full commitment. The a€?Genius of the ANDa€? part refers to instead embracing both ends of the continuum and simultaneously making the best decision for the unique circumstance at hand. We could ask them about their experiences and suggestions for cross-pollination of the best techniques.
The real power of the process comes from getting people thinking about how to improve the process and caring about the outputs.
However, since organizations vary in function, organization and culture it is naA?ve to assume different companies should use the same one (or two) processes to execute their projects. If they were to now follow it up with some guidelines for tailoring and evolution within organizations adopting it they would have a winning strategy for engaging participants and driving better results. I have been working with the PMI on some iterative, adaptive and agile content and look forward to when the non-disclosure agreements are lifted and I can tell you all about it.
These were created many years ago to support a training course I used to run for project managers operating in environments governed by PMBOK v4 Guide processes.
It is NOT a how-to-do-agile in a PMBOK based company, a project executed only through the steps discussed in the guide would be a nasty Franken-process that is neither agile or plan based. While somewhat related to modern agile, it is kind of forgotten about or dismissed as outdated or not applicable. Despite helping create DSDM 22 years ago I still sometimes struggle explaining its origins and role in the Agile Manifesto to people who are not familiar with it.
However, big, complex, embedded systems undertaken by large and distributed teams also benefit from an iterative approach to the early identification of risks, confirming true requirements and surfacing gaps in understanding.
Likewise, we cannot expect a project manager to understand all the technology portions, project dependencies and estimation outliers.
However, Bimodal IT steers companies away from many of the tools ideally suited for large projects. The first stage is Denial, we refuse to believe this is real, is happening to us, or applies to us.
For example, a€?OK, I will use an iterative approach, how about I make my iterations 6 months long?a€? Here, the resistor is negotiating or bargaining terminology a€?I will use an iterative approach whena€¦a€? for an excuse to continue operating pretty much as they were before.
It appeals to organizational leaders who do not really understand or believe in the benefits of an agile approach, but are under pressure to keep up with the times, offer agile projects to their teams, appear responsive to their business community. The Atkins diet was very popular because a rule like a€?No Carbsa€? is simple and people liked that. Simple rules like Mode 1 traditional and Mode 2 agile-ish are appealing since they are easy to follow.
It polarizes project selection when we should be looking more at hybrid models for large projects.
I think Gartner should not end with the Bimodal framework, but use it as a foot-in-the-door primer for the Next Steps of continued evolution. Feedback from people taking the exam indicated more difficult and more scenario based questions were wanted.

The new FASTrack exam features over 500 PMI-ACP questions with answers and explanations to get you ready for passing your PMI-ACP exam as quickly as possible. But now they seem to have worked through their issues and their team leader isn't as involved on a daily basis. After doing the job for a little while, she is now gaining confidence and is able to make independent decisions. Fortunately, the team has a good sense of the backlog priorities and has been able to continue making progress in her absence. Apparently there were some inconsistencies in the refactoring that was done between different teams, and as a result, there are some unnecessarily complex structures that will need to be reworked and simplified.
The third question in that meeting asks about impediments to progress, which could be signs of problems. If we change the practices first and then encounter problems, we won't be able to tell if those problems are due to the changes we made or other causes. Although the customer might also think of another feature to add to the backlog, they would still approve the iteration if the work that was done meets the goal that was set. The team could also use risk-based spikes for their risk reduction efforts, and their latest risk-adjusted backlog would reflect the currently expected monetary value of the remaining risks. The team needs to assign a financial value to each product feature as a starting point for creating a risk-based backlog, where the anti-value of the risks is ranked along with the value of the product features. Since this meeting is held every day, it gives the ScrumMaster almost immediate information about any issues the team is facing, which replaces the need for separate meetings to discuss issues. They do this by managing the product backlog and making sure the team has a correct understanding of the project vision, the project goals, and the product requirements. Although this team might conceivably be using a Scrum-XP hybrid, there is nothing in the scenario to indicate that.
The theme for the conference was Back to The Future and my presentation explained how projects throughout history have managed uncertainty and how we do it today.
It was a bit of a departure for me, delving into history, but an enjoyable one and I learned lots researching it.
Work is prioritized with the highest business value items done early and definitions of a€?donea€? that focus on acceptance rather than completion of work help ensure benefits are truly delivered. It describes the situation where workers want to do the right thing and executives and senior managers want business benefits, but placed between them is a layer of middle management who, while well intentioned, tend to obstruct common sense and efficient delivery. In many large organizations too much emphasis is given to a€?are you following process?a€? rather than a€?are you creating value?a€? This is largely because it is easier to measure if a project is following process than if they are adding value. Gate reviews, retrospectives and PMOa€™s have to be careful to focus on these outcomes and not the outputs to keep returning focus to benefits. We can have projects to build transport infrastructure, create attractions and hire employees, but the benefits of opening a theme park only come about when all are accomplished at the appropriate times. They engage the business frequently and work iteratively towards what the business wants which may be different from what was first asked for. The longer and larger an endeavor, the more likely it is that business, the market and sponsors will change. Rather than slicing a project horizontally into activities and doing all the requirement gathering, then all the analysis, and then all the design; agile projects slice vertically developing and delivering small increments of functionality.
I firmly believe the iterative nature of agile that delivers candidate solutions early, bakes the most significant elements in up front and employs far more review and feedback cycles leads to higher quality solutions. They go fast to uncover gaps in understanding sooner to build a better product in the long run. The frequent lookbacks at the benefits and process being used themselves foster goodwill and learning opportunities.
Often project managers, who are rightly close to their projects, cannot see the bigger picture of what success looks like. Agile projects take a business value driven approach that usually aligns with benefits but still needs higher level coordination.
Since then the certification has grown in popularity from niche to mainstream with over 10,000 people now holding the credential.
The new Exam Content Outline has been restructured with the addition of a new domain a€?Agile Principles and Mindseta€? to focus on thinking and acting in an agile way as opposed to simply implementing agile processes and hoping for improved results. We based the exam on what agile practitioners with a year or twoa€™s experience should know to be effective. Following the course each participant receives a personalized follow-up study plan based on their sample question performances.
They gave the participants the opportunity to make the most objective opinion on the changes in the field of public procurements. During another session he presented a report on “Law Labyrinth of Legal Support and Appeal of Procurements Outcomes. 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. Most organizations are ruled by the tyranny of the a€?ORa€?, whereas Great organizations find a third way to satisfy both and leverage the Genius of the a€?ANDa€?.
Maybe Mode 1 projects could benefit from a monthly Show-and-tell review of project outputs and planned work for the next period with the wider project community? Giving people input into how we undertake work and the ability to improve it moves them from un-invested-followers of a process to engaged-workers with some autonomy and say in how things get done. The impacts of failure in air traffic control are quite different from pop-culture web sites and they should use different development approaches. I think I can state, without saying too much, that people can expect to see a natural evolution of mainstreaming techniques that are now considered common practice. Instead, it is a thinking tool and discussion guide only for people operating in environments with both plan-driven and agile type.
While some Not Invented Here (NIH) prejudice is natural, there is a cruel irony in DSDM first being criticized for being too large and bureaucratic to be truly agile because it includes architectural elements and program management guidance, then 20 years later SAFe, LeSS and DAD adding these elements for large enterprise suitability.
In Gartnera€™s words a€?Bimodal IT is the practice of managing two separate, coherent modes of IT delivery, one focused on stability and the other on agility.
Engaging the team more through collaborative practices to better estimate, plan and identify risks produces much more robust plans. Traumatic loss or change is often accompanied by a surreal, outside-observer feeling as we struggle to accept what has happened or is happening. By publicly adopting Bimodal IT, they can push the small, trivial projects through an agile methodology - appeasing critics while clinging to their more comfortable traditional, sequential model. Ask a nutritionist though and they will do two things, first they will explain that while it has some truth to it, the real makeup of good nutrition is more complex and varies depending on a large number of factors. However, like any restrictive diet, they are at best an over simplification and at worst are potentially harmful. You can plan in detail and analyze requirements with reviews and tools a€“ I spent 10 years of my software career working on very formal military projects a€“ but, I believe the best way to discover if software works is by working the software. It promotes more of a bargaining adoption of iterative methods and empowered teams than a serious acceptance of where these approaches can help all project types. So, while it currently has some use as a gateway or stepping stone to deeper thinking about project approaches, it should not be considered a destination for IS policy as it stands today. The FASTrack exam simulator complements the book and provides references to which page in the book to read if you need more information about a topic. However, there are now two work packages that haven't been approved yet--and at the end of this week there will be three. Someone suggests that the code standards should be updated once the differences are worked out, and you all nod your heads in agreement. Problems might also be uncovered in retrospectives and demos, but usually that isn't the earliest opportunity to discover them.
The other two options (missing refactoring, user testing, and QA testing) describe activities that should have been done during the iteration. For this purpose, it is most important to get the relative value of the product features right. So here the team leader would have changed her style from Coaching to Supporting, rather than vice versa--but that switch would have been in response to the team, not the cause of the change. Also, although the business representative has switched to another focus, that isn't the main point being illustrated here.
I also introduced a half-serious idea that the PMI accidently removed most of the theory on managing uncertainty in their attempt to simplify and serialize project management so they could document it in the PMBOK Guide and create multiple choice questions based on it. So, we need to get benefits from them, or at least think we will get benefits from them, to start projects in the first place. This aligns them well for benefits tracking and management, but there is more to understand to truly integrate agile projects with effective benefits management. Agile is well aligned at CMMI levels 1 (Initial), 2 (Defined) and 3 (Managed), it also perfectly aligns with CMMI level 5 (Optimizing) that focuses on process improvement but runs afoul on the documentation and controls layer of CMMI level 4 (Quantitatively Managed).
Usually, this is a good thing, however for larger programs of work, we need to ensure these local optimizations do not compromise the integration and global optimization of benefits. Terminating a waterfall project 50% of the way through might yield lots of documentation but no usable solution.
Critical elements have more review, testing and usage within the project environment than waterfall developed components. They are human-centered, adaptive, collaborative endeavors and work well on humanitarian and process improvement initiatives that naturally follow progressive rollout and adaptation.
We wanted a methodology agnostic credential that captured the agile practices used on most projects most of the time. The book is currently available for 30% off from RMC here and is also included in the course. 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. However, true to its namesake personality disorder, organizations using Bimodal IT exhibit large swings in the execution approach that are not natural or optimal. Maybe Mode 2 projects would benefit from the development of RACI charts before distributing work between team members and part-time supporting roles? There are lots of free frameworks available to engage their team members in continuous improvement of their methodology. Describe opportunities you see emerging as we seek to improve the organization of knowledge work.
Then through the iterative approach of developing real, executable slices of the application, the validity of these estimates can be checked and refinements made to model the likely outcomes.
Since most organizations have significantly more small projects than large ones it may even appear that half or more of the projects being undertaken are Mode 2, agile projects when this represents only a small proportion of the project work being undertaken. The second thing they will do is to start explaining the large number of factors and either confuse you, send you to sleep, or make you wish you never asked them in the first place.
Finally, it propagates dangerous sequential process models for large and complex projects that really need iterations more than small, simple projects. The team can keep going for a while, but the longer they have to wait for feedback and approval the more likely it is that they will get off track. You definitely wouldn't wait and work around the issue, since agile emphasizes early detection and resolution of problems, whether internal or external. We can't really tell from this scenario how negotiable the story is, but the description of a online store is broad so it sounds like there is room for discussion. Many of the questions on the PMI-ACP exam will be ambiguous like this; in that case, read the question carefully, rule out the wrong answers, and look for the option that fits BEST. Often the benefits of a project are not fully realized until after the project is finished. Here again the well-intentioned layer of rigor and control can act as a value delivery inhibitor if we are not careful. A perfectly executed project that completed every document and passed every gate review but failed to deliver benefits is a colossal waste of time and resources. We know that people learn better when the training is relevant to their needs, made as enjoyable as possible and learners feel they are achieving their goals.The WHS Diploma course comprises 9 modules. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD.
Organizations often find themselves trying to harvest what they can (if anything) from long-running initiatives that need to change.
The team at Rose Training Australia consists of expert trainers that are trained to help students to develop the skills you need to effectively develop work priorities, manage meetings and apply time management techniques.
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. Agile Manifesto principle 6 states that the most efficient way of conveying information within a development team is a face-to-face conversation. Sitting a level higher than individual projects and operating over longer timelines, programs are better positioned to identify, track and transition benefits from individual projects or groups of related projects.
Obviously they do not call this a€?salvaginga€?, a€?rescuinga€? or a€?trying to get something useful from all that money we spenta€? since there are reputations and facades of leadership at stake. Believe me, the way we deliver it, it’s easier than you think!Online courseThis is a fully supported web based course that allows you to set the pace at which you work. The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics.
You are given 12 months to finish the Cert IV course, however, we have had many students who have completed this in under a fortnight! At Rose Training Australia we do everything we can to help you shape your future. 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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