FDA Requirements for ensuring Premarketing Clinical Trial Safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 2

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks and benefits that go into the clinical trial, and errors need to be identified and corrected at this stage. Wrong data could lead to disastrous consequences for the study, the subjects that are part of it, the organization and eventually, patients.

Basic nature of FDA requirements for premarketing clinical trial safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 1

The FDA has a set of requirements for premarketing clinical trial safety, but these are mostly informal and loose. They are more of an advisory nature than being stringent regulatory requirements that are legally enforceable. Most FDA guidance is on a case-by-case nature.

FDA Requirements for ensuring Premarketing Clinical Trial Safety 4

Basically, the FDA’s guidance is based on its working with large to very large clinical trials. It has thus far not seriously considered working with small groups for assessing premarketing clinical trial safety. At its barest, the FDA seeks to:

  • Advise sponsors or organizations undertaking the clinical trial about ways by which their data collection can be simplified so as to ensure that it is neither too huge nor too small, and should lead to giving insights about the drug’s safety. Essentially, the FDA guideline on premarketing clinical trial safety seeks to prevent sponsors from collecting data that is not relevant.
  • Get sponsors to consult the FDA’s review division for its premarketing clinical trial safety.
The FDA has different requirements for different kinds of studies that relate to clinical trials. For example:

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The FDA’s requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products

The FDA's requirements for non-IND Foreign Clinical Studies 2

that are permitted under this system of foreign clinical studies include:

  • A human drug
  • A biological drug
  • A medical device

The guidelines for foreign clinical studies requirements

The guidelines under which the FDA accepts medical products for approval when they are the result of foreign clinical studies are spelt out in various sections of 21 CFR.

Any foreign clinical study has to be meet requirements of 21 CFR Part 312or 21 CFR Part 812, which relate to studies conducted under an Investigational New Drug Application (NDA) or Investigational Device Exemption (IDE) respectively, just the same way in which American companies too have to

In case a foreign clinical study is not conducted under an IND; the FDA will still accept it, so long as it fulfills the ethical principles set out in the Declaration of Helsinki, or is in accordance with the laws of the respective country from which the study originates, based on whichever of these two offers stronger protection of the subjects of the study.

Highlights of the Helsinki Declaration

The FDA's requirements for non-IND Foreign Clinical Studies 1

The World Medical Association adapted the Helsinki Declaration from the time it was passed in 1964. In 1975, given the popularity of the Declaration in guaranteeing humane protection of human subjects in a clinical study; the FDA adapted the principles of the Helsinki Declaration as the basis for accepting non-IND compliant drugs. This Declaration has been revised a few times, although the FDA is yet to include the latest of these, that of October 2000, into its regulations.

Points of significance

The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

The increasing role of the social media in healthcare 4

The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

The increasing role of the social media in healthcare 3

The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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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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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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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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