An inclusive Ukrainian education

An inclusive Ukrainian education

Education is one of the few areas nowadays that is still considered a purely sovereign matter, an issue over which national governments – and, in many countries, even local authorities – should have control. But, in today’s world, it seems that no issue is immune to political manipulation. That is the case with Ukraine’s new framework law on education, which has become the target of harsh opposition not so much from within the country, but rather from some neighbouring countries.
The law, adopted last month by Ukraine’s parliament, reflected a long and inclusive policymaking process. Among its provisions is Article 7, which specifies that students in schools and universities should study in the national language. Article 7 seems to be in accord with European norms. Perhaps more important, it will benefit all Ukrainian citizens, including minority-language speakers, who will be better equipped to integrate fully into Ukrainian society.
Under the previous education system, some students would receive their entire 11 years of schooling (to be raised to 12 under the new law) in a minority language, mostly Russian, but sometimes Hungarian and Romanian. About 400,000 students are currently on such a track, which has usually ended with students graduating high school lacking even a working knowledge of Ukrainian – the language in which the country conducts its business.
In fact, just this year, more than half of all graduates of Hungarian-language schools failed tests of Ukrainian. Unable to attend a Ukrainian university, these students have little choice but to find local work in Hungarian that requires only a secondary-school education, or move to Hungary.
The education reform will change this. From 2020, after a three-year transitional period, a minority language can be used as the main teaching language only in kindergarten and elementary school, from which point (after the fourth year of school) most instruction should be in Ukrainian. Some schools for indigenous people, such as Crimean Tartars, will be allowed to keep the old system, but for the most part, graduates of Ukrainian high schools will, under the new system, be adept in the Ukrainian language.
This change will help to eliminate de facto segregation of minority-language speakers, thereby unifying Ukrainian society – critical to a strong and vibrant democracy. It will also equip all students, including ethnic and linguistic minorities, not just to thrive in the labour market, but also to participate more fully in Ukrainian democracy, potentially securing government positions that enable them to advance further the interests of their fellow ethnic minorities.
It should also be noted that, while the rule will lead to less minority-language instruction, it does not preclude it. Education in minority languages will be provided through separate classes and groups, with some programmes allowing for instruction in multiple languages. For example, if a Hungarian speaker were studying Hungarian literature, they would be able to do so in their native tongue.
All in all, the case for Ukraine’s new education law could not be stronger. Yet neighbouring countries are deliberately distorting the legislation’s significance, claiming that it is somehow a threat to ethnic minority groups. And they are prepared to punish Ukraine for it.
Hungarian Foreign Minister Peter Szijjarto has declared that, if the law is not changed, his country will block further Ukrainian integration into Europe. “We can guarantee that all this will be painful for Ukraine in future,” he added. Szijjarto, along with his counterparts from Romania, Bulgaria, and Greece, also voiced opposition to the Council of Europe and the Organisation for Security and Co-operation in Europe.
Moreover, Romania’s president cancelled a visit to Ukraine scheduled for this month, and withdrew an invitation for the speaker of Ukraine’s parliament to visit Bucharest. And, perhaps most ominous, Russian Foreign Minister Sergei Lavrov accused Ukraine of trying to “Ukrainise” the education system, in violation of the country’s constitution and international agreements.
Beyond being a gross misrepresentation, this approach is blatantly hypocritical, as the countries that are complaining about Ukraine’s new language rules have similar systems in place. Though Hungary is home to some 8,000 Ukrainians, there is not a single Ukrainian-language school in the country. The same is true for Russia, with its Ukrainian minority of over 2mn. In Romania, with its roughly 50,000 Ukrainians, there is only one Ukrainian-language school.

Read More: http://snip.ly/6iem1#http://www.gulf-times.com/story/566224/An-inclusive-Ukrainian-education

Malawi University of Science, DoDMA sign pact on degree course for disaster risk management

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The MoU will see the facilitation of a four year full time Bachelors degree in Disaster Risk Management.

Signing the Mou, Secretary to the Office of Vice President and Commissioner for Dodma Clement Chinthu Phiri said the Mou will enhance studies and research in disaster management to guide policy development and implementation.

On her part, MUST Vice Chancellor Professor Address Malata said the institution is geared to making a difference in as far as disaster risk management is concerned through the initiative.

The specialist science and technology university  degrees in health and medical sciences, applied engineering and technology, and Earth and climate change sciences, among other areas.

The Malawi University of Science and Technology Bill was passed in 2010 after the Chinese government agreed to lend funds to build a new university, on condition of repayment over 20 years. Malawi borrowed US$70 million from the Export-Import Bank of China to build the new institution.

In 2011 late president Bingu wa Mutharika moved the planned university from the capital Lilongwe to his own farm, Ndata Estate, which is in Thyolo in the south of the country. It was part of Mutharika’s ambitious initiative to open five new institutions of higher learning in 10 years.

The five proposed institutions would include the University of Bangula, devoted to cotton research and water resources management, to be constructed in the south. The University of Marine Biology would be built in the western district of Mangochi and would focus on aquaculture. And Mombela University in northern district of Mzimba.

Read More: http://snip.ly/cy30s#https://www.nyasatimes.com/malawi-university-science-dodma-sign-pact-degree-course-disaster-risk-management/

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the activities the company that is being audited is carrying out are within the legal guidelines and frameworks laid out by the respective regulatory authorities.

Two types of audits

Quality Assurance Auditing for FDA-regulated industries3

An organization that is in an FDA-regulated industry is required to carry out internal and external audits. The purpose of this dual type of audit is that one complements the other and the two together reinforce the audits. As the two terms indicate, an internal audit may be thought of as being a tool for self-examination. It is an audit that the organization’s own employees carry out to scrutinize the usefulness of the systems. An external audit, on the other hand, is one that is performed by an independent person who has the qualification and purpose for this kind of work. The purpose of both these types of audits is the same.

Audits based on process

Quality Assurance Auditing for FDA-regulated industries1

The core principle on which audits for the FDA-regulated industries are carried out as part of a Quality System is that since testing alone is not sufficient to ensure quality; quality should be inbuilt into the product. This approach, called the process based to auditing; has to, naturally, be based on an in-depth understanding of the entire set of processes that go into a Quality System before the commencement of the audit. A complete understanding of the processes relating to the business, control and production on the part of the auditors should be the basis to the process-based audit. Auditors then go about defining the criteria for the audit and the scope of the purpose they expect it to serve.

So, what to audit?

Quality Assurance Auditing for FDA-regulated industries

Since Quality Assurance auditing is generic to any FDA-regulated industry; a definition of what has to be audited is quite expansive. Based on the kind of the business, these are the important areas in which audit is carried out:

  • Product
  • Process
  • Quality System
  • Regulatory
  • Supplier
  • System
  • Management

The four phases of auditing

Four self-explanatory phases go into an auditing process:

  • The preparation stage
  • The performance stage
  • The Reporting stage
  • The follow-up and closure stage

Auditing of management systems

The ISO 19011

The ISO 19011

The ISO introduced the ISO 19011 management systems audit. The ISO makes it mandatory for companies to also audit the management systems along with Quality Systems. This is done to ensure completeness of the audit.

Passed in 2011, the ISO 19011 is the guiding principle for auditing a company’s management systems and the ISO standard for auditing a company’s management systems.

Full understanding of all elements of audits

A detailed explanation of the ISO 19011 and all other aspects of an ISO audit will be given at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems; will be the Director.

Please log on to Quality Assurance Auditing for FDA-regulated industries to enroll for this seminar. This webinar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Benefits of participation at this seminar

Participants who attend this seminar will benefit in a myriad of ways. David will offer the following at this seminar:

  • Clear Understanding of Auditing Fundamentals
  • Understand Audit Preparation and Planning
  • Learn best techniques for Audit Performance
  • Learn best practices for Audit Reporting
  • How to address Audit Follow-up and Closure efficiently and effectively
  • Understand the requirements and expectations for being an effective auditor
  • How to develop into an even better auditor
  • How to structure, plan and manage your audits
  • How to develop your technical and non-technical skills
  • How to perform your best audit ever.

He will cover the following areas at this seminar:

 

 

 

Quality by Design using Design of Experiments 2017

The Q8, which is the ICH guidance document on pharmaceutical development, requires a drug product to meet its intended product performance as well as the needs of patients. A drug product is encouraged to adapt a systematic approach for pharmaceutical development in accordance with the steps defined by Quality by Design (QbD) principles, even though the strategy may vary from company to company or from product to product.

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System. Some of these are:

o  Process design

o  Qualification

o  Continued process verification

o  Risk management

o  Validation.

Laxity in implementation is no longer an option

Despite the issuance of guidance on implementation of these requirements; many companies have not yet implemented QbD into their Quality Systems. This will change soon, though. Regulatory agencies have been taking a serious view of non-implementation of these requirements.

The ways in which reviewers will begin to enforce the requirements from these guidance documents have been spelt out in the manual the Chemistry, Manufacturing, and Controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) released on policies and procedures (MAPP).

The zeal with which the regulatory agencies will enforce compliance with the requirements of the QbD requirements has been emphasized also by the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, who detailed the concept and reiterated the importance of using a QbD approach to pharmaceutical development in a paper he co-authored in The American Association of Pharmaceutical Scientists in May 2014.

Understand the ways of implementing QbD

In the light of the fact that a drug product can no longer afford to relax in its adherence to steps defined by Quality by Design (QbD) principles to adapting a systematic approach for pharmaceutical development; a meaningful and educative two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will show the ways of doing this.

At this seminar, Heath Rushing, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director. To gain complete insight into how to implement QbD, please register for this seminar by visiting Quality by Design using Design of Experiments. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Complete learning on QbD using DoE

The core purpose of this session is to demonstrate how to integrate those QbD principles into a pharmaceutical Quality System. Towards this end, Heath will focus on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DoE).

He will also take up the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability for detailed description. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.

A systematic understanding of the process

A QbD approach for pharmaceutical development studies should include a systematic understanding of the process. It should then use this understanding to establish a control strategy as part of a comprehensive quality risk management program. This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical Quality Attributes (CQAs). Heath will discuss these in depth.

Despite the thrust of this seminar on the use of DoE for QbD; it will integrate multiple aspects of QbD. An understanding of the relevant applied statistics will be offered, which will help participants understand how statistics can be used to help in two foundational requirements of QbD: A) Setting specifications, and B) Analyzing measurement systems.

Important tools for facilitating understanding

This seminar will also offer tools to participants, which will help them to derive value out of their designed experiments. Generating and analyzing both screening and response surface designs for QbD studies, the ways of using this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability are among the other constituents of this course. This course uses the point-and-click interface of JMP software for analyses.

Heath will cover the following areas at this seminar:

o  Implement QbD principles from discovery through product discontinuation

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Utilize risk management tools to identify and prioritize potential Critical Process Parameters

o  Identify Critical Process Parameters and develop a functional relationship between those process parameters and your Critical-to-Quality Attributes (CQAs)

o  Establish your design space

o  Develop a control plan as part of a risk management strategy

o  Ensure your process is in (statistical) control and capable.

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4, is the guideline the ICH has set out for analytical methods validation. The aim of this guideline is to identify the validation parameters that are required for a number of analytical methods. This guideline also lays down the characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications.

Likewise, the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B, finalized in November 1996 under Step 4, is the ICH guideline on procedures and acceptance criteria in calibration limits. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

For process and Quality Control, the extant guideline is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

In order to achieve harmonization in Quality, professionals have to meet critical milestones. These include conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Get professionally trained on the areas of Validation in accordance with ICH guidelines

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is necessary and important to undergo professional trainings with which professionals in these areas can clarify a number of doubts.

This is the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting. This training will be led by Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To enroll for this seminar, please register by logging on to Validation in accordance with ICH guidelines . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Depth and clarity of understanding of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, along with ICH Q8 and Q9 will be the main thrust of this seminar.

This seminar is not a course in statistics, but offers an introduction to an applied approach to the statistical techniques used, and how to reasonably interpret them. This learning will help participants address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

In addition, Dr. Bartolucci will also focus on another important area: What the different regulatory agencies expect of the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. He will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.