Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

As a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

Other developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

In a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Why Trade Compliance and Logistics Must Work Together

Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

There is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

For many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

Another important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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200+ followers. WOWWWWWW…

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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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:

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.

Adapting 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.

Whether 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

Even 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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Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses need to understand the nuances of the regulatory expectations and do what it takes to meet these.

Professionals and organizations that work in these areas must familiarize themselves with the existing regulations and their latest updates. This is the foundation to ensuring that their products comply with regulatory requirements and meet quality standards, which ensures that the consumer consumes products that are of the set scientific standards.

The regulations in the two markets have evolved differently. The fact that the regulatory agencies in the two markets, namely the US FDA and the European Medicines Agency (EMA) work to ensure the quality of drugs and thus the wellbeing of their consumers is the commonality between the two.

While the US FDA is a centralized agency that regulates food and medicinal products across the vast US market; the EMA, synchronizes the regulations of the 28 countries that are members of the European Union. While the FDA was primarily created to be a consumer protection agency; the regulations from the EMA came about to harmonize the commercial and technological interests of the Member States.

The EU’s new update

In September 2016, the EU, through its two major legislative organs -the European Commission and the European Council, reached a compromise on a major area concerning combination products. Reached four years after a deal was made; the compromise relates to medical devices and invitro diagnostic (IVD) devices.

High risk combination devices, such as implants, will from now be assessed and authorized by the EMA. Brought in to replace the existing EU legislation on medical devices and in-vitro diagnostics; the new regulation seeks to make these products more consistent and uniform in terms of their assessment and approval process across the EU.

Thorough and sound learning of the US and EU regulations on combination products

This is the case of just one regulation in the EU concerning combination products. When the regulations and their updates from both the US and the EU are taken together, a regulatory professional or anyone in manufacturing is up against a mountain. It is to help gain clarity on this wide array of topics that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar.

This seminar, which is aimed at giving professionals who work in areas concerning regulation in the combination products area, will have Salma Michor, founder and CEO of Michor Consulting Schweiz GmbH, as the Director.

Please visit Regulations in the US and EU Dealing with Combination Products to register for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity about combination products

Over two days of intense learning, Salma will offer a thorough understanding of the complexities involved in the regulations about combination products in the EU and the US. She will offer in-depth explanation of all the relevant regulations and guidelines. She will reinforce this learning by offering real life examples of how to register and maintain various types of combination products.

Salma will also help participants explore Interfaces, at which Change Management and LCM will be taken up for explanation. Other important aspects relating to the subject of combination products, namely compliant safety reporting for combination products and documentation requirements and interfacing, will be described in detail at this session.

Over the two days of intense learning, Salma will cover the following areas:

Documentation requirements and interfacing

• Documentation requirements for combination products EU
• Documentation requirements for combination products US
• Interfacing, development, quality, regulatory
• Managing third parties and document control.

This seminar is of high value to professionals whose work is related in one or another way to combination products, such as Regulatory Affairs, Medical Officers, and Clinical Trial Managers.

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GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.

A training session that will give complete understanding of these aspects

Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advice on the GMP guidance document

At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few cases, these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.

Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.

Over these two days, Dr. Kuwahara will cover the following areas:

• Very Early Stages
• GLP requirements
• Early Pre-IND Studies
• Meetings and Preparing for the IND
• GMPs for Phase 1 IND products
• Requirements for Phase 2 INDs
• Preparing for IND Meetings.

 

To continue GMP updates

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

• Physiological and Pharmacokinetic Principles
• Drug Dissolution Testing
• Linking Dissolution Results to Plasma Drug Levels.

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

• The aging population
• The huge spending power of one of the world’s largest economies
• The infusion of new technologies into the field of medical devices, which pushes up costs initially
• The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

• The registration system for manufacturers
• QMS conformity assessment system
• Formats for pre-market certification and pre-market approval applications

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

• Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
• In Japan, are medical devices required to be registered before they can be sold?
• What are the different regulatory classifications for medical devices?
• What are the different application categories for medical device registration?
• What does the registration pathway look like for each regulatory classification?
• What are the document requirements for notification for the various classes of medical devices?
• What are other requirements that are necessary for approval in addition to the device application?
• Is local testing (type testing/sample testing) required for registration?
• When are clinical studies required for registration?
• Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

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+1-800-447-9407