The EU’s Pharmacovigilance Directive

Pharmacovigilance is a major public health initiative of the EU. It is aimed at reducing the risk attendant in any part of the production, marketing and supply chain of medicinal products. Monitoring is done not only before the medicinal products enter the market; it is done at every stage after, too.

The aim of putting a strict vigilance regimen is to help detect any aspect of a medicinal product that could compromise on its safety. This whole system of monitoring is called pharmacovigilance.

The EU’s Pharmacovigilance Directive is the legal structure that spells out the objectives and implementation plans for the EU’s pharmacovigilance system. The Pharmacovigilance Directive is part of the EU’s efforts to enforce very stringent assessment of all medical products for their safety, quality and efficacy before they become authorized.

Regulation on all areas of medicineIn essence, the Pharmacovigilance Directive lays out the conditions and rules by which medicinal products have to be marketed within the EU and beyond. It prescribes the manner in which products have to be manufactured, labelled, marketed, recalled and destroyed. The Pharmacovigilance Directive, which applies to products for human use, bans any medicinal product that is not authorized by any member state of the EU from being marketed.

The review of 2010The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect. The legislation passed that year further fortifies and streamlines the system relating to the safety of medicines that enter the European market.

The Pharmacovigilance Directive of 2010 strategizes areas relating to preventing, detecting and assessing of adverse reactions in patients to ensure improved patient safety and with it, public health. One of the major features of this amendment is that patients are empowered to directly report adverse drug reactions to the designated competent authorities. Another important aspect is that the definition of an adverse reaction has been widened to include issues like overdose and medication errors.

Important features of the Pharmacovigilance Directive of 2010The Pharmacovigilance Directive of 2010 seeks to take concrete steps to enhance its core objectives of patient safety and public health. It is built on these foundations:

  • It puts in place a robust, proportionate and proactive risk management regimen
  • It enhances safety data quality
  • It strengthens the link between safety evaluations and actions from regulatory authorities
  • The Pharmacovigilance Directive of 2010 has led to greater communication, transparency and patient involvement
  • It assigns clear-cut responsibilities and tasks for everyone concerned
  • It facilitates the decision-making apparatus within the EU
  • The Pharmacovigilance Directive of 2010 has established The Pharmacovigilance Risk Assessment Committee, a new scientific committee to be based at the European Medicines Agency (EMA).

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”

Does this mean that the FDA regulation on medical device packaging design is simple, plain and broad, and can be bypassed? Not really. Compliance with the medical device packaging design has to be seen in relation to two factors:

Medical Device 3

Sits with device labeling requirements

FDA regulation on medical device packaging design has to be seen in conjunction with its twin regulation, namely Sec. 820.120 device labeling. This is the first of the two sections on medical device labeling and packaging. This section has elaborate details on how medical devices need to be packaged and labeled. The FDA has requirements in this section on the integrity, inspection, storage, operations, and control number of labeling. FDA regulation on medical device packaging design has to be complied with collectively with this section.

Scope for creativitySecondly, FDA regulation on medical device packaging design is only a set or regulations that require adherence to the device packaging design elements. Medical device packaging design manufacturers are free to use their creativity in designing device packaging. Adherence to FDA regulation on medical device packaging design does not mean that there should be no innovation; it only means that the medical device packaging design has to be complied with. As long as this is met, manufacturers are free to design imaginatively. Perhaps because there is enough scope for innovation, FDA has left this area general and nonspecific, with the only requirements being that the medical device packaging design adhere to guidelines aimed at protecting it.

An understanding of Pharmaceutical Regulatory Affairs

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.


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 :

The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and important unit operations in the field of pharmaceutical engineering.

Development and adaption of technology is one of the major bottlenecks of pharmaceutical process engineering. The major changes that digitization has brought into areas such as say, education and automobiles are yet to be fully realized in pharmaceutical process engineering. The benefits of digitization are yet to be felt and fully put into use in the crucial areas of pharmaceuticals, such as manufacturing -which, being a high precision area, offers tremendous scope for the use of conceptualizations such as the Internet of Things (IoT)- supply chain management, and Quality Control.

Lack of integration between the core functions and regulatory pressures are often cited as major reasons for which pharmaceutical process engineering is yet to catch up with the drastic changes wrought by technology.

Full understanding of the area of Pharmaceutical Process Engineering

A complete assessment of the present scenario in the pharmaceutical process engineering field, along with the its prospects for the future will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this session, Co-founder and CEO of CGMP University Inc. Training and consulting organization and well-known author of several books relating to GMP; David Muchemu, will be the speaker.

Want to understand the importance and the prospects of this very vital area of pharmaceutical process engineering? Then, please register for this webinar by visiting Choosing process variables to control

Preventing flare-up of issues

David will help participants understand how to avoid being in situations where issues arise after scale up. The main reason this happens is that process variables and their parameters are never established based on hard data and engineering realities. David will offer a solution that combines engineering factors and scientific data collected in the lab into process control to counter such problems. He will explain the following major topics relating to these:

o  The process concept

o  Design of Experiment: DOE

o  Choosing process variables to control

o  Process validation

o  Process scale-up

o  Batch reactors

Of high value to professionals in pharmaceutical process engineering, such as Quality Engineers, Manufacturing Engineers and Line Managers; this webinar will cover the following areas:

o  Quality Risk Management Defined

o  Compliance Requirements for Quality Risk Management

o  The Quality Risk Management Model

o  Quality Risk Management Life Cycle.

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Current and future USFDA food import and export safety regulations

The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.

Since foods from almost every country in the world are brought in into the US to be sold in this huge market; the FDA has put in place very strict regulations for ensuring the food items that enter the US market are of set quality standards. To do so, it sets stringent standards that relate to the critical attributes of food, such as safety, sanitation, healthfulness and labeling.

The FDA coordinates with agencies across the country

The FDA’s coordination with other agencies is gargantuan, given the fact that about seven-tenths of seafood and 35% of all the food items consumed in the US are imported. It works with a number of agencies to carry out its functions. These are some of the agencies with which the FDA works in close association:

o  Homeland Security

o  Customs and Border Protection

o  The FDA and the USDA

o  Center for Disease Control

o  Food Safety Inspection Service

o  Agricultural and Marketing Services

o  Food and Nutrition Services

o  The U.S. Department of Commerce

o  Department of Defense, and

o  The Federal Trade Commission (FTC).

Thorough understanding of the FDA’s work on food imports

A proper understanding of the way the FDA works with food imports, the regulations it has in place, and its expectations from importers is necessary for individuals and organizations that are connected with FDA food imports in one or another way. This knowledge is needed to help them ensure that their products reach US shores without trouble and get regulatory approval from the FDA.

This is the learning a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

John Ryan, who began Ryan Systems a decade ago and who has been involved in the manufacturing, food, transportation and Internet industries over the past 30 years; will be the speaker at this webinar. please visit Current and Future Safety Regulations

To register for this learning session and get a thorough understanding of the FDA’s rules and thinking on food imports to the US.

Thorough familiarity of the FDA’s work on food imports

An understanding of the ways in which the various agencies work with the FDA in respect to food imports will be offered at this webinar. An in-depth understanding of this aspect is necessary for those who want to import food to the US and gain regulatory approval for their products, as they have to work with the FDA at various levels.

John Ryan will cover the following areas at this session:

o  Global Food Markets drive new import food safety requirements

o  Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things

o  Understand “Prior Notice” requirements

o  Foreign Supplier Verification Program (FSVP)

o  Prepare for the Foreign Facility Inspection Program

o  Learn what is in the “Investigations Operation Manual” (IOM)

o  What can happen to your product when seized

o  Learn what other countries require for food import

o  Review the proposed rules for food safety and quality during transportation processes

o  Learn how much food and what food is imported from different countries

o  Understand what the Imported Seafood Safety Program includes

o  PREDICT & OASIS Systems

o  Other resources available to help you.

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15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.


Some freshmen even might worry about the “freshman 15,” a.k.a. the weight gain that can happen when freshmen come to college. Tanya Bachman, nutrition instructor in the School of Nursing, said weight gain and unhealthy eating habits are common in college.

“I think it’s very common, not every single person is going to experience it but it is common,” Bachman said. “It’s being away from home and learning how to feed yourself, at the same time balancing academic load.”

Whether or not you believe in the freshman 15, everyone can agree that staying healthy in college is hard — both mentally healthy and physically healthy. The Beacon put together a list of 15 ways to stay healthy this semester.

1. Watch what you’re eating

2. Don’t skip meals

3. Avoid unhealthy snacking

4. Avoid sugary coffee drinks

5. Stay hydrated

6. Take vitamins

7. Use the Beauchamp Center

8. Take a fitness class

9. Try yoga and meditation

10. Get active with your friends

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Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing nitinol-based medical devices, the use of these devices has increased rapidly in the recent years.

Covered in this report

The report covers the present scenario and the growth prospects of the global nitinol-based medical devices market for 2017-2021. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.

The market is divided into the following segments based on geography:

• Americas



Technavio’s report, Global Nitinol-based Medical Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

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