Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the government’s outlook and stance in these matters.

There are two aspects of the export, import and trade compliance principle:

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General export, import and trade compliance principles

 

As can be understood from the description of the concept of export, import and trade compliance principle; export, import and trade compliance principles laid out by the government and requiring compliance with their guidelines are fixed. Organizations cannot manipulate or tamper them. Doing so, naturally, invites penalties.

However, the export, import and trade compliance principles set out by individual companies are conditioned by their own ethics and culture. These are a reflection of how organizations carry out their export, import and trade compliance principle, something that they themselves have laid out.

export-import-and-trade-compliance-principleAdapting the right export, import and trade compliance principle and implementing it is a reflection of how well the organization understands the business and the market and how well it is able to maintain its integrity among its circles. Needless to say, an organization that says one thing and does another is seen in a negative light by its peers.

 

Organizations specialize in helping to implement export, import and trade compliance principle

 

Just as there are many organizations which are in the business of ensuring many complex fields such as governance, risk and compliance (GRC) and technology compliance; several organizations specialize in helping organizations implement both the export, import and trade compliance principle as laid out by the government, and their own export, import and trade compliance principles.

export-import-and-trade-compliance-principleWhether an organization gets its export, import and trade compliance principle implemented through an outside, third party or does it on its own; there is no escaping the fact that export, import and trade compliance principle is something that is mandatory to state and implement accordingly.

Overlaps and alignments of organizational, governmental and trade bloc requirements

export-import-and-trade-compliance-principleEven when organizations draw up their own export, import and trade compliance principle; they are bound to include the latest and relevant regulations, policies and procedures as laid out by the government. Many internal export, import and trade compliance principles and external (those prescribed and required by the government) overlap on many occasions with those of trade blocs such as the North American Free Trade Agreement (NAFTA), European Union Preferential Trade Agreement, Association of Southeast Asian Nations (ASEAN), Mercosur, etc. Export, import and trade compliance principles from these different sources should align with each other.

Reasons for export, import and trade compliance principle implementation

 

The export, import and trade compliance principles laid out by respective governments are in place because of many important reasons.

 

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Data Mining and Signal Detection in Pharmacovigilance

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the subject, and it could be either new or one with a precedent.

Data mining can be described as the method of obtaining data from target groups to help the clinical study come to important assessments and conclusions. Many a time, it is not clear whether a drug’s expected benefits outweighs the potential risks it brings about or vice versa, till the drug goes for marketing authorization. In order to assess this to the extent possible, clinical pharmacologists weigh the benefit and risk evaluation of medicines using tools such as data mining. Data mining is done both at the individual level of a subject and at the macro level of the population at large. These two methods are usually inseparable from each other, in that almost no study is done exclusively for one group.

Given its ability to help pharmacologists discern the various patterns that emerge from a clinical study; data mining is acquiring a position of importance of late and is being used in almost all stages of drug development. This could range from the earliest stage, namely drug discovery and could go up to post-marketing surveillance.

The WHO’s Uppsala Monitoring Centre

Data Mining and Signal Detection in Pharmacovigilance1

In order to make the results of very clinical study done in every part of the world accessible to everyone – a formidable task without doubt – the WHO has formulated the Uppsala Monitoring Center. This is a universal database of all the results obtained from clinical research the world over. Although voluntary and missing data from a many studies; the UMC is a comprehensive attempt at establishing a data mining and signal detection system that is accessible to everyone concerned. The UMC can thus be considered the universal data mining and signal detection database.

With over 2.5 million case reports of various clinical studies done all around the world, the UMC has evolved over time as a data mining and signal detection database. It initially started by requiring principals of clinical studies to generate new drug and Adverse Drug Reactions (ADR) combinations every three months. With the growth in the number of studies and the variety of issues they threw up; this was no longer considered feasible.

The UMC then started out to create its own method, by which the principles of making an objective initial assessment of all new drug and ADR combinations started getting implemented as they emerged. To this were added the requirements of bringing about a transparent selection of drug – ADR combinations for review, as well as suggest a quantitative aid to data mining and signal detection.

Data Mining and Signal Detection in Pharmacovigilance3

Today, the UMC uses several methodologies to carry out its task of being at the forefront of data mining and signal detection. It uses the Bayesian Confidence Propagation Neural Network, which uses Bayesian statistics within the architecture of a neural network for data mining and signal detection.

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What are the components of a Financial Audit Program?

What are the components of a Financial Audit Program5

There are various core components of a financial audit program. First, an understanding of a financial audit:

  • A financial audit is a regular exercise carried out by qualified professionals from within or outside, to check the financial health of an organization
  • It involves having to verify, examine and analyze the various data pertaining to the organization’s finance, such as financial records and financial statements
  • This exercise is carried out to assess the company’s financial status, its profit and loss, growth prospects, investments needed to achieve those prospects, and most importantly, compliance with prescribed regulatory requirements

Components of a financial audit program

What are the components of a Financial Audit Program

Components of a financial audit program can be described in a number of ways. While on the one hand, components of a financial audit program could include the exact processes and steps that financial experts take to carry out the financial audit; on the other, components of a financial audit program can include those steps and processes that companies have to implement in order to ensure the smooth conduct of a financial audit.

So, components of a financial audit program could include at least two different, but related areas. In the first of these, the financial expert(s) look into many records, primarily these:

  • The profit and loss statements;
  • Balance sheet.
One of the core components of a financial audit program is the profit and loss statement, which reflects how the company is placed financially. A good financial expert can discern the exact health of the company by analyzing the profit and loss statement.

A balance sheet constitutes another of the components of a financial audit program, as it is in this that the financial activities of the company for a fixed period of time -usually a financial year -are measured and assessed.

Other components of a financial audit program

What are the components of a Financial Audit Program3

Among other components of a financial audit program; it is important for companies to know how to conduct itself during an audit. This is all the more important during external audits. The company has to comply with regulatory requirements to ensure that it supplies all the records and data that the independent auditor may ask. Failing to provide them, or proof of fudging of accounts is a serious offence and can attract major penalties. So, it is crucial for companies to keep note of the components of a financial audit program, so that it stays compliant and maintains a name in the industry.

 

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What is logistics and supply chain management?

What is logistics and supply chain management

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

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What is logistics and supply chain management?Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:

Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.

Another way of understanding logistics and supply chain management 

logistic-and-supply-chain-managementAnother way of understanding logistics and supply chain management is this:

Logistics can be understood as being a discipline in which the following activities are involved:

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On the other hand, supply chain management can be said to include more extended activities, which include:

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Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.

Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:

logistic-and-supply-chain-managementA sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

 

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The FDA’s Adverse Event Reporting Requirements

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The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.

The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing surveillance program for all its approved products that fall in the category of therapeutic biologics and drugs. So, this database has a record of the adverse event reporting done by all individual and sponsors of their clinical trials. It is a catalog of all the error reports that get generated at various times and stages of the clinical research program.

Voluntary in nature

The FDA's Adverse Event Reporting Requirements4

The outstanding aspect of the FDA’s adverse event reporting requirements is that these reporting requirements are not mandatory. Yet, those involved in clinical research, such as sponsors, healthcare and pharmaceutical organizations, institutions and individuals strictly adhere to adverse event reporting requirements in order to steer clear of legal entanglements that could come their way in the future, and to help other players keep track of all adverse events.

Some of the core adverse event reporting requirements

The FDA's Adverse Event Reporting Requirements1

Applicants should electronically submit all Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products in xml format. Among the adverse event reporting requirements, this has been in place from 2000.

The FDA has been amending rules relating to adverse event reporting requirements from time to time. According to the amendment passed in June 2015; the following adverse event reporting requirements apply:

All applicants should submit all ICSRs, ICSR attachments, and periodic safety reports electronically. They can do this using either of these options:

The E2B method specifies that the files should be in xml format, and the attachments in pdf.

The FDA's Adverse Event Reporting Requirements3

The Safety Reporting Portal (SRP) is meant for those applicants that do not have the database-to-database capability. To fulfill this among the FDA’s adverse event reporting requirements, the applicant needs to have an account with which to access the portal site. FDA’s adverse event reporting requirements state modes and criteria that applicants have to meet to request an SRP account, to activate the account, to add attachments, and for submitting Periodic Safety Reports (PSR).

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Risk Management and Compliance in the Healthcare Industry

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Risk management and compliance in the healthcare industry requires a high degree of foresight, observation and knowledge of the regulatory rules and principles. Apart from being aware of the regulations, risk management and compliance in the healthcare industry is a lot about being smart, inventive and observative about the day-to-day aspects of the workings of the industry, as this highly operationalized activity is changing at a rapid pace.

Risk managers in charge of risk management and compliance in the healthcare industry need to equip the Board of Directors of the healthcare settings in which they work with much more than just the regulations that need to be put in place. They also need to impart insights into how this is to be done while keeping the costs low and at the same time, improving business.

These are the most important factors that make risk management and compliance in the healthcare industry extremely important:

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Regulatory pressure is too much to bear

 

In the current scenario of highly reinvigorated regulatory oversight in the healthcare industry, there is heavy pressure on risk managers to implement risk management and compliance in the healthcare industry in an optimal manner. The fervor of regulatory requirements and level of supervision from the regulatory bodies have gone up so drastically of late that in a recent survey, PriceWaterhouseCooper found out that half the people on the corporate board governance in hospitals said that they regard risk management as their greatest priority for the next few years.

This trend is triggered by a host of factors, all of which could contribute to making risk management and compliance in the healthcare industry all the more critical in the years ahead. Some of the factors that have accelerated this sense of urgency and criticality are:

Burgeoning cost of healthcare: 

risk-management-and-compliance-in-the-healthcare-industryAs the US healthcare industry grows into a multi-trillion dollar industry; there is a need for ensuring risk management and compliance in the healthcare industry.

Rapid increase in many diseases: Many diseases in the US are mostly a result of undisciplined and profligate lifestyles. This has placed a heavy burden on the healthcare sector to both implement preventive measures and improve standards in healthcare administration.

Technological improvements: History has shown that every improvement in technology has brought about more and more illnesses and disease, as technology makes people more sedentary. This has increased the pressure of risk management and compliance in the healthcare industry, as they are under higher pressure to implement strategies aimed at containing these.

Need to reinvent to stay ahead of the curve

 

All these factors are pushing corporate boards in healthcare to take a relook at the way risk management and compliance in the healthcare industry has been functioning. They have realized the need to implement these with a fresher and more urgent, yet intuitive approach. They need not just the judiciousness needed for grasping the present state of affairs in the industry; they need to also have sufficient foresight in anticipating the kind of change the industry is likely to undergo in the next few years.

risk-management-and-compliance-in-the-healthcare-industryThe proper understanding and implementation of risk management and compliance in the healthcare industry sits at the core of this need for hospitals to stay abreast and ahead of the competition. Relying on traditional models of risk management and compliance in the healthcare industry is likely to take them only that far. The risk managers need to have the ability to develop enterprise-wide risk management strategies that withstand the onslaught of rapid changes and absorb them into the system.

 

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Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing careerWith over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.

Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech and pharma. This is why:

  • The US is the world’s largest market for pharmaceuticals, as well as being the world leader in biopharmaceutical research
  • Research by Pharmaceutical Research and Manufacturers Association (PhRMA) has revealed that the majority of the world’s research and development (R & D) in pharmaceuticals is conducted by U.S. firms
  • These firms hold the intellectual property (IP) rights on most new medicines.

Huge in every sense

Biotech and Pharmaceutical Courses2

Around 5,000 new medicines with approximately 3,400 compounds are currently being studied in the United States, the longest pipeline in any region in the world. The pharmaceutical industry employs nearly a million people and supports more than three times that number in related and supplementary industries. All these place a high demand on biotech and pharmaceutical courses.

What should those aspiring for courses look for?

Biotech and Pharmaceutical Courses4

Certification is the primary criterion to look out in those seeking a biotech and pharmaceutical courses. Whether it is classroom or online courses that are opted for; certification by a certifying authority should be the determining admission to biotech and pharmaceutical courses.

CFPIE or the Center for Professional Innovation and Education Inc., BioPharma Institute and Center for Professional Advancement (CFPA) are some of the better known providers of certified biotech and pharmaceutical courses. This is a partial list of the areas on which courses are offered by these institutes/centers:

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

biotechandPharmaceuticalCoursesThese three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

 

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