What is GDPR and How to Comply and How to Protect Privacy?

When not implemented properly, can lead to havoc for the company.

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A core law concerning the protection of data of all people living in the European Union (EU) is the General Data Protection Regulation (GDPR). The GDPR, which is codified as Regulation (EU) 2016/679, has been formulated to fulfil two important purposes:

  • Placing the control of personal data in the hands of citizens and residents of the EU
  • Easing the regulatory process and environment and standardizing and unifying data protection regulations across the EU with the aim of making global business within the EU easier.

The legislative and secretarial bodies of the EU, i.e., the European Parliament, the Council of the European Union and the European Commission, consolidate and strengthen all aspects relating to data protection for all individuals within the European Union (EU) through the GDPR regulation.  The GDPR also addresses the area of export of personal data to regions outside the EU.

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Gain complete understanding of the GDPR

With the GDPR now being the law that companies that want to do business in the EU have to comply with; it is necessary for them to get proper and thorough understanding of all its elements. This learning is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance. Please visit http://bit.ly/2JurJbE to enroll for this webinar and get a full and proper understanding of the GDPR and how it matters to your business.

Explanation of the advantages and disadvantages of the GDPR

Derk will explain all the aspects of the GDPR, including its benefits and drawbacks. Among the advantages it carries are the greater and clearer insight it offers into Personally Identifiable Information (PII) processing within the company, the boost and synchrony it gives to security controls across the 27 EU members, the increased customer confidence that accrue from stronger safeguards for data protection, and the simplification of the process of doing business in the EU.

However, the GDPR, when not implemented properly, can lead to havoc for the company. It can result in unimaginably high levels of penalties, up to two percent of violating companies’ worldwide revenues, fines of up to € 20 million, complicated lawsuits, loss of reputation, and many liability cases.

The insights that Derk will offer at this webinar will help participants understand how to comply with the regulation in such a manner that their organizations fully derive the benefits of this regulation and neutralize the negative effects of not doing it right.

He will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

This webinar is of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers.

http://data.consilium.europa.eu/doc/document/ST-9565-2015-INIT/en/pdf

http://mlawgroup.de/news/publications/detail.php?we_objectID=227

http://www.eugdpr.org/

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What is FDA regulation of combination products?

Different parts of the combination product meet different proprietary purposes or serve different kinds of benefits.

First, what is a combination product? FDA’s 21 CFR 3.2 (e) describes a combination product as a product that has any of these combinations: a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

Lines of distinction are blurring

With the recent technological advancements in the way drugs are combined; there has been a steady increase in the number of combination products the FDA has been getting and expects to receive for review. Historically, the FDA’s medical product centers, such as the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) have been tasked with the approval of combination products. However, in the near future, FDA regulation of combination products is likely to undergo a vast change, as strict segregation of these bodies has given rise to challenges related to regulation, policy, and review that need to be addressed.

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FDA regulation of combination products covers all aspects of the development and management of combination products, such as clinical investigation, pre-clinical testing, manufacturing and quality control, marketing applications, promotion and advertising,adverse event reporting, and post-approval modifications.

Marketing applications are the backbone of FDA regulation of combination productsFDA regulation of combination products requires all combination products to fulfill marketing applications. This is what enables it to be certified as fit for marketing. A single marketing application or separate one can be made for different parts of the combination product, for its marketing application to get approved.

In most cases, more than one marketing application gets filed when the different parts of the combination product meet different proprietary purposes or serve different kinds of benefits. It is also possible that when any of the individual parts making up a combination product has already been approved for another use, multiple marketing applications are made out as part of FDA regulation of combination products.

An understanding of Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

pharmaceuticalRegulatoryAffairsThe primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process of the manufacturing and subsequent activities with the appropriate laws and regulations that apply to the industry.

Pharmaceutical Regulatory Affairs has evolved over a long time

Pharmaceutical Regulatory Affairs, like Rome, was not built in a day. The earliest attempts at making an activity or profession like Regulatory Affairs a discipline in itself can be traced to at least a century. The Diphtheria Epidemic of 1902 and a few other continental and global pharmaceutical disasters in subsequent years, such as the vaccine tragedy, sulfanilamide and thalidomide events made the authorities realize the need for framing initiatives to check the occurrence of such events. Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

pharmaceuticalRegulatoryAffairsEssentially, Pharmaceutical Regulatory Affairs is about providing direction and focus to the strategy, tactics and operations aspects of the industry. It can be termed as a scientific system of surveillance. Pharmaceutical Regulatory Affairs concerns itself with every activity from start to finish and puts regulations in place to ensure that each activity is technically correctly carried out in accordance with these regulations and is in tune with sound scientific principles and practices.

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All round and comprehensive

The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production, starting with procurement of the raw materials or molecules needed for developing the drug, the clinical trial process, the manufacturing process, the packaging, the marketing and even post-consumption of the product by patients, ensuring that along every step, scientific methods and best practices are adhered to and are in accordance with rules, regulations and requirements set out by the regulatory authorities.

Different set of regulations in different markets

In most cases, it is not only one regulatory body whose regulations and requirements need to be adhered to. When a pharmaceutical product has to be marketed globally, it has to meet the regulatory requirements of all the countries or markets in which it is being sold, individually, unless the rule specifies otherwise.

pharmaceuticalRegulatoryAffairsIn the process of working on all these, the Pharmaceutical Regulatory Affairs profession entails having to take steps to see to it that the product is in some way different from what already exists in the market. All these make Pharmaceutical Regulatory Affairs a challenging profession.

This being the case, Pharmaceutical Regulatory Affairs professionals have their own clearly defined roles on what they need to do in order to ensure that they carry out these activities.

Here the references :

http://www.ijprr.com/File_Folder/127-131%28ijprr%29.pdf

http://www.abpi.org.uk/our-work/mandi/Pages/regulatory.aspx

Biocompatibility testing and evaluations for medical devices

It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient’s body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.

When medical devices and/or materials come into contact with the patient’s body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body. These effects, called acute to chronic, can result in mutagenic effects. It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient’s body, such as cells, tissue or body fluids. Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.

ISO standard for biocompatibility testing and evaluations for medical devices

The International Standards Organization (ISO) has a specific standard for carrying out and ensuring biocompatibility testing and evaluations for medical devices. It is called ISO 10993-1: 2009, and makes biological evaluation part of a structured biological evaluation program that comes under a risk management process. All these are carried out in accordance with ISO 14971.

ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 The basis for biocompatibility testing and evaluations for medical devices is the Risk Management Process. This is the most prevalent standard for assessing biocompatibility testing and making evaluations for medical devices. In requiring biocompatibility testing and evaluations for medical devices to be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025 and requiring the consideration of evaluation of local and systemic risk factors; the ISO 10993-1 is considered the basis for determining the subsequent, necessary biocompatibility testing and evaluations for medical devices.

What factors are tested? In line with the principles set out in ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices, specific testing is prescribed based on two factors: a) the type and the intended use of a medical device or related material, and b) the kind, tenure and extent of contact the medical device makes with the body.

ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices requires assessment to be made for the following among others:

  • Cytotoxicity
  • Genotoxicity
  • Sub chronic toxicity
  • Sensitization
  • Irritation or intra-cutaneous reactivity
  • Implantation
  • Haemocompatibility
  • Systemic toxicity, etc.

3D Printing: FDA Finalizes Guidance for Medical Devices

FDA has now reviewed more than 100 3D printed medical device applications.

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The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance “will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology.”

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a “leap-frog” guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

Enhanced here to continue http://snip.ly/4kybn

The role of Quality Agreements in Contract Manufacturing Organizations (CMO)

Ensuring that they comply with the GMP regulations is at the core of these requirements and expectations.

The role of contract manufacturing in the pharmaceutical and life sciences industries cannot be overlooked. It has gained favor with organizations in these industries, as it allows them the luxury of outsourcing their processes relating to manufacturing or other activities to a third party, saving them costs and hassles in the short and long terms. Entrusting their processes to Contract Manufacturing Organizations (CMO’s) enables them to concentrate on their core activities such as research and new drug discovery.

With the global economy more open than it perhaps has been at any other point of time in history, and with almost no economy of any country being isolated from the forces of globalization; CMO’s are a very viable option for pharmaceutical and related companies. As long ago as 2010; the global CMO size was put at over $26 billion, with a healthy CAGR of over 10 percent. With the global pharma market having crossed a trillion dollars in 2015; there is heavy optimism for the growth of CMO in the coming years.

While these figures look encouraging; a whole lot of issues need to be considered before embarking on contract manufacturing. The most important of these is quality. Ensuring that the supplier maintains the high quality standards set out by the contracting company is a major challenge for the client company.

The Quality Agreement

Quality Agreements are a very strong tool in addressing this issue. A Quality Agreement is a contract reached between a pharmaceutical firm and a GMP Contract Manufacturer, in which the responsibilities each of these parties has towards assuring the quality, safety and efficacy of the manufactured drug, are spelt out in detailed and clear terms. This is the only real means to ensure oversight of the processes and the quality of the products. Ensuring that they comply with the GMP regulations is at the core of these requirements and expectations.

How do contracting pharmaceutical and life sciences firms draft Quality Agreements that comply with the regulatory requirements and ensure the quality of products from the supplier? What are the elements of a Quality Agreement? What due diligence and scrutiny does the contracting organization need to keep in mind when drafting a Quality Agreement?

Complete learning on all aspects of the Quality Agreement

The nitty-gritty of these elements will be taught at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This webinar’s speaker, Roger Cowan, is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. The experience he has gained in the industry after having worked in it for 37 years will be in full flow at this webinar.

Please register for this webinar by visiting Contract Manufacturing Arrangements for Drugs

In-depth look at the two recent FDA and EU guidelines

Roger will explain the dynamics of a CMO Quality Agreement at this webinar. He will discuss the two recent regulatory guidelines: the EU GMP Chapter 7 “Outsourced Activities” (Revised) issued by the EU, and the Draft Guidance for Industry – “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, which was issued by the FDA in May 2013. These two guidelines are important from the CMO perspective, as they offer greater depth of understanding and clarity on quality contracts.

Roger will explain what aspects of Quality Agreements need to be taken care of from a regulatory perspective. Both the FDA and the EU have laid sufficient emphasis on the control of suppliers such as CMO’s. It is expected that these new these new regulatory documents will introduce written documentation of this control. Evidence of this kind of control can be presented to FDA/EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

Writing a Quality Agreement in line with the new guidelines

The speaker will help participants gain a thorough understanding of the Quality Agreement by fully analyzing each proposed section. He will suggest how to write it keeping the new guidelines in mind. He will also detail the comparisons between the two regulatory documents and will highlight their differences. Topics of critical importance in the Quality Agreement, such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc., will be examined. He will also present an analysis of the current status of the FDA draft guidance and will review the comments that this guidance has received from the industry.

Roger will cover the following areas at this session:

o  The Who and What of a good Quality Agreement

o  What a Quality Agreement is – and is not

o  Responsibilities of the owner vs. contract facility

o  GMP responsibilities

o  A comparison of the new guidelines from the FDA and the EU.

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Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

We cover the regulatory status and official requirements start with ICH Q7 and follows by the FDA and the European Medical Agency (EMA) regulations.

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; this guidance amends the International Council for Harmonization (ICH) codification from Q7A to Q7.

All aspects of API manufacture are addressed by this revised guidance. These include:

o  The principles set out for Quality Management

o  The quality unit’s responsibilities

o  Activities relating to production

o  Internal audits

o  Product quality reviews

o  Qualifications expected from personnel

o  Their hygiene standards

o  The qualification that consultants need to have.

The GMP requirements for facility design and construction and equipment used are also included in this FDA Q7 GMP guidance for API revision. Several other API manufacturing topics are also part of this revision. Some of these include:

o  Management of materials

o  Process controls

o  Laboratory controls

o  Packaging

o  Storage and distribution

o  Validation

o  Change Control.

Clarity on the FDA’s revised standard

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain the FDA’s API Quality System revision in detail.

Eyal Lerner, owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues, will be the speaker at this webinar. To gain understanding of how to apply the FDA’s revised API Quality Systems GMP requirements; please register for this webinar by visiting API (ASM) GMP

Explanation of API quality requirements

This webinar will explain the basic requirements and fundamentals of API QS. It will review the quality requirements for API in accordance to global API GMP- ICH Q7. The explanations will be based on practical experience and other relevant guidelines. Eyal will review the requirements of FDA and EMA. All the areas such as materials, Active Pharmaceutical Ingredient and Advanced Starting Materials (ASM) will be discussed along with their definitions. He will also explain the distinctions between these.

Administrative issues such as registration issues concerning filling, annual review and change report to file would be discussed. In this section, Eyal will lay emphasis on the section: “Registration standard: Common Technical Document (CTD)”, as it relates to the ICH M4.

Anyone, whose work concerns the area of development and manufacture of API, such as those in R&D, Regulatory Affairs, Quality Assurance and Quality Control, who wish to get an in-depth background and understanding of API QS; will find this webinar valuable.