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).

Stephen Hawking’s secret to surviving his terrible condition

The late-night comic had found his perfect straight man. In June 2014, John Oliver sat down with renowned theoretical physicist Stephen W. Hawking for an interview.

“You’ve stated that there could be an infinite number of parallel universes,” the host of HBO’s “Last Week Tonight,” asked Hawking. “Does that mean there’s a universe out there where I am smarter than you?”

“Yes,” Hawking replied from his wheelchair, his lips bending up into a slight smile. “And also a universe where you’re funny.”


Hawking died early Wednesday at his home in England at the age of 76. Throughout his career as one of the world’s most recognizable cosmic thinkers, he regularly threw himself into pop culture’s comedic ring with cameos on programs such as “The Simpsons” and “Late Night with Conan O’Brien.”

These appearances aligned with a plucky wit that defined Hawking’s personal life as much as his universe-shaking theoretical work. Humor, however, was not just one side of his personality, but a key to overcoming the degenerative motor neuron disease he struggled against since 1963.

“Keeping an active mind has been vital to my survival, as has maintaining a sense of humor,” Hawking said in a 2013 documentary. “I am probably better known for my appearances on ‘The Simpsons’ and on “The Big Bang Theory” than I am for my scientific discoveries.”

That humor was deployed against a terrible prognosis.

At 21, Hawking was diagnosed with a condition similar to amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. According to the ALS Association, “Half of all people affected with ALS live at least three or more years after diagnosis. Twenty percent live five years or more; up to ten percent will live more than ten years.”

The disease would eventually shut down Hawking’s motor functions, rendering him speechless and unable to move without a wheelchair. Doctors initially said he would be dead in two years. His condition, however, proved to be a rare slow-acting version.

But Hawking fought through his deteriorating physical state, rising to a position as a celebrated professor of mathematics at the University of Cambridge and altering the popular conception of physics with his 1988 bestseller, “A Brief History of Time.”

To Continue his story

Trump gets gift from Russia panel

The President is now wielding a powerful new weapon in his war of credibility with America’s spy agencies over their view that Russia helped put him in the White House, after House Republicans suddenly shuttered their probe into election meddling.
The committee stunned Washington most by taking direct aim at the assessment by US spy chiefs that President Vladimir Putin engineered the Russian election meddling operation specifically to hurt Hillary Clinton and benefit Trump.
That finding squares with Trump’s view that the Russia story is nothing but a hoax and a witch hunt designed by Clinton sympathizers to explain the Democratic nominee’s shock election defeat in 2016.
Trump supporters are certain to use the finding, issued with the imprimatur of a House committee, to argue that it is time for America to move on from the endless recriminations of the election, which have cast an unmovable cloud over Trump’s White House.
While Monday’s report is clearly a partisan, political document — committee Democrats were not briefed before its release — it is all but certain to be used by Trump to discredit intelligence assessments and to proclaim his innocence.
Details of the Republican conclusions also contradict an account laid out by special counsel Robert Mueller of a campaign by Russian entities to disparage Clinton and support Trump, shown in the indictment of 13 Russians issued last month.
With that in mind, the House panel’s move may spur calls by Trump allies for the dismissal of Mueller and the further politicization of the entire Russia question, which is fueling doubts that the GOP-led Congress would ever hold the President to account should the special counsel eventually find wrongdoing by him or his campaign team.
“I think this will reignite those who want to take out Mueller after they were undercut in the wake of those indictments,” CNN analyst and former CIA and FBI official Phil Mudd said on “The Situation Room” on Monday night.
In the light of recent attacks on Mueller, Deputy Attorney General Rod Rosenstein, who is overseeing his work, mounted a firm defense of the special counsel in an interview with USA Today on Monday.
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Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense

The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.

The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the field of pharmaceuticals. In being used for anything from production to processing to cleaning to formulation to Quality Control water is the most widely used and critical substance in the pharmaceutical industry. Its varied grades are used in nearly all stages of the pharmaceutical manufacturing process.

Designing pharmaceutical water systems properly is of great importancePharmaceutical water systems thus acquire extreme importance for this reason, because inefficiency or ineffectiveness in the system could lead to faulty final products, which can affect the lives of individuals, apart from causing harm to the reputation of pharmaceuticals companies.


What are the principles of pharmaceutical water systems design?

  • Ensuring the pharmaceutical water system operates within its capacity is the first principle of pharmaceutical water systems, because any underutilization or overutilization of capacity can affect the quality of the water system
  • Working in tandem with Quality Assurance allows approval of use after installation and subsequent maintenance. A sound pharmaceutical water system has to enable this
  • The entry at any stage, be it production, storage or distribution, of unacceptable chemical, physical and microbial contamination should be prevented at all costs
  • An effective pharmaceutical water system should ensure consistency and reliability in the quality of water production
  • An effective pharmaceutical water system should help commission, install, qualify/validate, operate, perform and maintain itself. Making all these aspects of the water systems industry happen is a core characteristic of pharmaceutical water systems.
  • Pharmaceutical water systems must facilitate the easy and regular monitoring of chemical, microbiological and endotoxin levels in water sources.

Statement from FDA Commissioner Scott Gottlieb, M.D.,

Some of my most important time as Commissioner is spent speaking directly to patients and their families about significant health issues that affect their lives, from the devastating opioid crisis to the current flu season. Overseeing a wide array of medical products, the U.S. Food and Drug Administration plays a vital role in providing consumers with up-to-date, evidence-based information to help them make the most informed medical decisions. The products we regulate touch people’s lives in meaningful ways.con-con-1

Last month I had the opportunity to meet with consumers who have been affected by the medical device Essure to listen and learn about their concerns. This device is used as a method of permanent birth control. The product’s manufacturer, Bayer, estimates that more than 750,000 women worldwide have received the device implant since it was first approved by global regulatory authorities. Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product. As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion. Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously.

I would like to outline the steps we’ve taken, to date, regarding this product, and the additional steps that are underway. I also want to reiterate my commitment to regularly communicating with patients and physicians about this device as more information is made available and additional steps are taken.

Since Essure’s approval in 2002, the agency has continued to monitor the product’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. We convened a panel of medical experts in the fall of 2015 to provide us with advice on how we could better understand concerns about the device, such as patients who experienced abdominal pain, abnormal uterine bleeding and device migration.

In February 2016, we ordered the manufacturer of Essure, Bayer, to conduct a postmarketing (522) study to better evaluate the safety profile of this device when used in the real world. We also required a boxed warning to be added to the product labeling as well as a Patient Decision Checklist. The aim is to help make certain that a woman considering Essure receives and has full access to information about the benefits and risks of this type of device prior to undergoing treatment with this product.

As part of the FDA’s ongoing efforts to monitor Essure adverse events, we continue to review medical device reports submitted to our public database and provide updates about our ongoing analysis of the reports on our website. At the current time, the FDA is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year.

Detailed Statement enhanced here

Top 7 Ranking Signals: What REALLY Matters in 2018?

Every year it seems Google gives us a new ranking signal.

In 2014, HTTPS became a ranking signal.

In 2015, mobile usability became a ranking signal.

Then, 2016 shifted content development as RankBrain came onto the scene.

And, in 2017, there was a more significant push for more HTTPS websites.

Now, in 2018, mobile page speed looks to be the next big ranking signal to focus on.

All that said, John Mueller assures us that “awesomeness” is the key to ranking in Google.

But, with over 1 billion websites online today, how do you create awesomeness?

One thing I know for sure is that all of these ranking factors are all shaped to create a better, more awesome user experience.


With Google evaluating sites based on hundreds of ranking factors, knowing where to aim your SEO strategy in 2018 for the biggest bang might seem impossible.

But good news: Ranking signals are going to continue to adapt to the user.

This means that new SEO trends already surviving have roots in the current algorithm — and with a little creativity and SEO savvy, it’s entirely possible for you to rank well in 2018.

While ranking signals are far from limited to just seven, the factors highlighted in this post are ones I consider to be the most important for this year.

Here are the ranking factors that will really matter in 2018, and why.

1. Publish High-Quality Content

“I don’t need quality content on my website to rank,” said no one ever.

The quality of your website and blog content is still crucial for 2018. Content still reigns as king.

As Rand Fishkin pointed out in a Whiteboard Friday, content that is optimized for keywords still holds valuable SEO power.

Your content needs to provide valuable information. Creating pages with no real value can come back to haunt you, thanks to Google’s Panda and Fred algorithm updates.

Pages like this portal site.

Even big names like eBay and Apple aren’t worthy of the content crown. Thin content hurt both brands.

High-quality content is about creating pages that increase time on page, lower bounce rate, and provide helpful content for the user.

Blog pages like this and guides like this are the type of high-quality content search engines, and users want.

High-quality content pages must do more for today’s SEO than just be well-written and long-form. They also have to cover the following areas to increase their presence in SERPs:

Search Intent

Knowing users’ search intent is essential to creating pages that drive organic traffic.

CoSchedule saw a 594 percent increase in traffic by reshaping their SEO content strategy to be more aligned with searcher intent.

To understand what your target searchers intent is, you need to dive into your Google Analytics to see what users are looking for.

Reports like Site Search and User Flow can give you an idea of what your customers are searching for.


You can also view Search Analytics report in Google Search Console. This report will give you insights into what people are clicking on the SERPs to get to your site.

Keyword Research

Despite the word on the street that keyword research is not needed to rank, keyword research still supports quality content creation. Unlike traditional keyword research, today, keywords serve as a content creation roadmap.

Through competitor research and data mining, you can uncover keyword gems that have average search volume, but high click-through rate for your audience.

Check out how Chris Hornack, founder of Blog Hands, saw an 80 percent increase in traffic after performing keyword research.

So, as the industry continues to whisper about the negative impact of keyword research, you need to identify your primary keywords and bucket them into topics suited for your searcher.

Andrea Lehr, Brand Relationship Strategist at Fract, shares insights on how she buckets her keywords here.

Voice Search

According to Google,  72 percent of people who own a voice-activated speaker say that their devices are often used as part of their daily routine.

It’s evident that since the growth of AI assistants like Siri, Alexa, and Cortona, a new way of searching is coming.

Optimizing for the way people speak can feel like going to your first yoga class.

You’re looking around at what other people are doing, trying to breathe deeply while holding your lotus cup above your head, meanwhile, you’re just waiting for savasana. #Awkward.

I get it. And, Dawn Anderson does too. She offers some awesome tips on SEO for voice search, including thinking about how people ask questions and understanding local queries and intent.

And, Brian Dean recently shared his insights into optimizing for voice search after reviewing 10,000 Google Home results.

Rich Snippets

Rich snippets use schema to markup your text and data for better visibility in Google search results.

Rich snippets could mean photos or ratings on your result (which is standard for recipes) like this.

Rich snippets can increase your click-through rate and lower your bounce rate because it gives users more of a preview of your content before they click on it.

If SERPs are the front door to your business, your content pages are the interior, showing users that your website (and therefore, your products or services) are worth their time.

By building high-quality content for your website,  you create a warm and inviting place for your users and search engines to make themselves at home.

Continuation part here it goes

ICH Q10 -the ICH’s Pharmaceutical Quality System

The purpose for which the International Conference on Harmonization (ICH) has issued wide-ranging in ICH Q 10 guidelines is that they help individuals and organizations in the pharmaceutical industry avoid duplication of their work, especially in pharmaceutical research and product registration.

ichQ10PharmaceuticalQualitySystemReduction of double work is the important purpose

Putting in place greater harmonization in the area of pharmaceutical product registration by interpreting and applying technical ICH guidelines was the aim with which the ICH was launched in 1990.

The harmonization the ICH Q 10 aims to bring about seeks to reduce and possibly eliminate repetition of testing and reduce double work of research and development of new human medicines. It uses extensive guidelines to achieve this. These guidelines are given for all areas of ICH Q 10.

Quality Guidelines:

Related to the Quality area; these guidelines include crucial milestones such as doing stability studies, defining appropriate limits for impurities testing, and evolving a malleable approach to GMP risk management based pharmaceutical quality.

Safety Guidelines:

Relates to the safety aspect of carrying out research in the carcinogenic, genotoxic and repro toxic areas, which carry a high risk of danger.

Efficacy Guidelines:

To ensure efficacy in research, ICH guidelines cover areas such as the conduct, design, safety and reporting of clinical trials. Efficacy guidelines also include biotechnological processes and pharmacogenetics or genomics techniques, which are aimed at producing medicines that target disease better.

Multidisciplinary Guidelines:

These are guidelines are for areas left out of the Quality, Safety and Efficacy Guidelines. Core elements of this area of ICH Q 10 guidelines include ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).