Common Terms used in Pharmacovigilance

Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well.


  • Adverse Drug Reaction is a side effect (non intended reaction to the drug) occurring with a drug where a positive (direct) causal relationship between the event and the drug is thought, or has been proven, to exist.
  • Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown.
  • Benefits are commonly expressed as the proven therapeutic good of a product but should also include the patient’s subjective assessment of its effects.
  • Causal relationship is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction.
  • Clinical trial (or study) refers to an organised program to determine the safety and/or efficacy of a drug (or drugs) in patients. The design of a clinical trial will depend on the drug and the phase of its development.
  • Control group is a group (or cohort) of individual patients that is used as a standard of comparison within a clinical trial. The control group may be taking a placebo (where no active drug is given) or where a different active drug is given as a comparator.
  • Dechallenge and Rechallenge refer to a drug being stopped and restarted in a patient, respectively. A positive dechallenge has occurred, for example, when an adverse event abates or resolves completely following the drug’s discontinuation. A positive rechallenge has occurred when the adverse event re-occurs after the drug is restarted. Dechallenge and rechallenge play an important role in determining whether a causal relationship between an event and a drug exists.
  • Effectiveness is the extent to which a drug works under real world circumstances, i.e., clinical practice.
  • Efficacy is the extent to which a drug works under ideal circumstances, i.e., in clinical trials.
  • Event refers an adverse event (AE).
  • Harm is the nature and extent of the actual damage that could be or has been caused.
  • Implied causality refers to spontaneously-reported AE cases where the causality is always presumed to be positive unless the reporter states otherwise.
  • Individual Case Study Report (ICSR) is an adverse event report for an individual patient.
  • Life-threatening refers to an adverse event that places a patient at the immediate risk of death.
  • Phase refers to the four phases of development: I – small safety trials early on in a drug’s development; II – medium-sized trials for both safety and efficacy; III – large trials, which includes key (or so-called “pivotal”) trials; IV – large, post-marketing trials, typically for safety reasons. There are also intermediate phases designated by an “a” or “b”, e.g. Phase IIb.
  • Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population.
  • Risk factor is an attribute of a patient that may predispose, or increase the risk, of that patient developing an event that may or may not be drug-related. For instance, obesity is considered a risk factor for a number of different diseases and, potentially, ADRs. Others would be high blood pressure, diabetes, possessing a specific mutated gene, for example, mutations in the BRCA1 and BRCA2 genes increase propensity to develop breast cancer.
  • Signal is a new safety finding within safety data that requires further investigation. There are three categories of signals: confirmed signals where the data indicate that there is a causal relationship between the drug and the AE; refuted (or false) signals where after investigation the data indicate that no causal relationship exists; and unconfirmed signals which require further investigation (more data) such as the conducting of a post-marketing trial to study the issue.
  • Temporal relationship is said to exist when an adverse event occurs when a patient is taking a given drug. Although a temporal relationship is absolutely necessary in order to establish a causal relationship between the drug and the AE, a temporal relationship does not necessarily in and of itself prove that the event was caused by the drug.
  • Triage refers to the process of placing a potential adverse event report into one of three categories: 1) non-serious case; 2) serious case; or 3) no case (minimum criteria for an AE case are not fulfilled).
















Pharmacovigilance (abbreviated PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. (The condition, that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function was excluded with the latest amendment of the applicable legislation.) Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest (even without adverse event itself), because they may result in an ADR.

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.


How do users find Apps?

SEO for App Store

SEO for App Store

Unlike the web, there’s no great way to determine exactly where your download come from? Instead, app marketers rely on studies, anecdotes from other marketers, and data from platform owners (Apple, Google, etc.) to find out what the most effective and used channels are for app distribution.

Inbound, Organic channels in the app store are the biggest drivers for downloads. Search in app store is the single largest channel, with 61% consumers finding apps through app store search.

% of app users who find apps via each channel:

(1)    Sync Software (iTunes) – 17

(2)    Media – 17

(3)    App Discovery Apps – 21

(4)    Web Sites – Third Party – 21

(5)    Friend / Family – 61

(6)    App Store Search – 63

(7)    Web Sites – Blog -  7

(8)    Web Search – 14

(9)    Social – 19

(10) Pre Installed Apps – 20

Moreover, some of best data, if not fully complete, comes from the platform owners themselves. Google Play’s Head of Search and Discovery, Ankit Jain, recently shared a wonderful quote about the magnitude of app store search in his presentation at Google I/O:

“For the average app, search actually makes up the vast majority of installs.”

Yes exactly, whatever applications you upload in Google Play Store and Amazon Store should be optimized properly. Like, there are some factors which we need to take care of before uploading the app, below are some of the factors which we need to concentrate on:

On- Meta Data:

App Title

An app’s title is the single most important metadata factor for rank in ASO. Its equivalent to the <title> tag in your HTML, and is a great signal to the app stores as to what your app is about. On the web, you want your title to include both a description of what you do (including keywords) as well as some branding; both elements should also exist in the app store. Be sure to include the keywords, but don’t be spammy. Make sure it parses well and makes sense. Example: “Strava Run – GPS Running, Training and Cycling Workout Tracker”


Patrick Haig, our VP of Customer Success, likes to break descriptions down into two sections: above the fold and below the fold (sound familiar?). He says, “Above the fold language should be 1-2 sentences describing the app and its primary use case, and below the fold should have a clear and engaging feature set and social proof.” We’ll dig into some of the differences about the description field across platforms below.

Keyword Field

The Keyword Field in iOS is a 100 character field which you can use to tell iTunes search for which keywords you should show up. Since you only get 100 characters, you must use them wisely. A few tips:

  • When choosing your keywords, just like on the web, focus on relevancy, search volume, and difficulty.
  • Don’t use multiple word phrases; break out to individual words (Apple can combine them for you).
  • Don’t repeat keywords that are already in your title (and put the most important ones in your title, leaving the keyword field for your secondary keywords).
  • Separate keywords with commas, and don’t use spaces anywhere.


Consumers are finicky. They want apps which are beautiful, elegant, and simple to understand. Your icon is often their first interaction with your app, so ensure that it does a great job conveying your brand, and the elegance and usefulness of your app. Remember, in search results, an icon is one of the only ways you can convey your brand and usefulness. Think of it as part of the Meta description tag you’d create in SEO. For example, SoundCloud does a great job with their icon and branding.



The most important rule to remember when creating your screenshots is that they should not be screenshots. They are, instead, promotional graphics. That means you can include text or other graphics to tell your app’s story in an interesting, visual way.

Especially in iOS, where the card layout shows your first screenshot, it is incredibly helpful when an app displays a graphic which explains the app right up front, increasing conversions from search results to viewing the app page and, ultimately, installing the app.

The best app marketers also use their screenshots promotional graphics together to create a flow that carries the user through the story. Each graphic can build off the previous graphic, giving the user a reason to continue scrolling and learning about your app.


Outside of your direct control, you’ll also want to focus on a few things to ensure the best performance in ASO.


Every app has a rating. Your job as a marketer is to ensure that your app gets a great overall rating. Rating is directly tied to performance in app store search, which leads us to believe that rating is a factor in app store search rankings.


Similar to ratings, you want to ensure that the reviews your users write about your app are positive. These reviews will help increase your conversion rate from app page views to downloads.

For a great product to help you increase your rating and reviews, check out Apptentive.

How do iOS and Google Play Differ In App Store Search?

The differences in the platforms mean that there are different levers to pull depending on the platform. Google Play and iOS act completely independently, and often, quite differently. The differences are wide-ranging, but what are a couple of the main differences?

In general, the way to think about the differences is that Google is Google and Apple is Apple. Duh, right? Google has the built the infrastructure and technology to learn from the web and use many different data points to make a decision. Apple, on the other hand, doesn’t have indexes of the web, and comes from a background in media. When in doubt, imagine what you’d do if you were each of them and had the history each of them has.

Here are a couple concrete examples.

Description versus Keywords

In iOS, there’s a keywords field. It’s easy to see where this came from, especially when you think of iTunes’ background in music: a song has a title (app title), musician (developer name), and then needs a few keywords to describe the song (“motown,” “reggae,” etc.). When Apple launched their app store, they used the same technology that was already built for music, which meant that the app title, developer name, and keywords were the only fields used to understand search for an app. Note that description isn’t taken into account in iOS (but I expect this to change soon).

On the other hand, there is no keyword field in Google Play; there is only a description field. Thus, while iOS doesn’t take the description into account, in Google Play the description is all you have, so be sure to do exactly the same as you do on the web: cater your content towards your keywords, without being spammy.

Leveraging PageRank in Google Play

Another big difference in iOS and Google Play is that Google has access to PageRank and the link graph of the web, while Apple does not. Thus, Google will take into account the inbound links to your app’s detail page (for example, as a factor in Google Play search, while Apple has no such factor.

How to Measure Success in App Marketing

Search Rankings

Just like on the web, a great way to measure your success in app store search is to track your ranking for specific search terms you care about over time and versus your competition. Rank tracking is incredibly valuable for ASOs to understand their progress.

Top Charts

Top Charts, especially Top Charts within a particular category, do a great job of allowing you to understand your success in relation to the rest of the apps in your category.

Ratings and Reviews

Just as ratings and reviews will help your ASO, they are also great metrics to track over time for how you’re doing with your app marketing. Keep track of what users are saying, how they’re saying it (pro tip: listening to their language is a great way to do keyword research!), and what they’re rating your app.


Taking it one step further, correlating your search rankings to download will allow you to understand the effect your increased ASO is having on your app performance. One way we do this is to integrate with iTunes Connect and overlay your search rankings with your downloads so you can visually see how closely related any one keyword is with your downloads. It’s not perfect, but it helps!

Conversion and Revenue

At the end of the day, revenue is the most important metric you should understand. Of course, you should be tracking your revenue and doing the same correlation with search performance. In addition, you should watch your conversion rate over time; we often see apps whose conversion rate soars with an increase in ASO because the users are so much more engaged with the app.

Happy New Year 2014



“New year comes to give us a fresh hope,
For a better future and success,
New Year gives us dream for that
We will face challenges with confidence,
On this new year
may your dreams and hopes Succeed
with the blessings of god Happy New Year”

Team Designing Wishes all followers and visitors of this blog a Very Happy New Year!


Social Media Marketing Strategies

Social media marketing refers to the process of gaining website traffic or attention through social media sites. Social media marketing programs usually center on efforts to create content that attracts attention and encourages readers to share it with their social networks. The resulting electronic word of mouth refers to any statement consumers share via the Internet about an event, product, service, brand or company. When the underlying message spreads from user to user and presumably resonates because it appears to come from a trusted, third-party source, as opposed to the brand or company itself, this form of marketing results in ‘earned media’ rather than ‘paid media’.

Designing | Share your knowledge

Designing | Share your knowledge

Social media itself is a catch-all term for sites that may provide radically different social actions. For instance, Twitter is a social site designed to let people share short messages or “updates” with others. Facebook, in contrast is a full-blown social networking site that allows for sharing updates, photos, joining events and a variety of other activities.

Why would a search marketer — or a site about search engines — care about social media? The two are very closely related.

Social media often feeds into the discovery of new content such as news stories, and “discovery” is a search activity. Social media can also help build links that in turn support into SEO efforts. Many people also perform searches at social media sites to find social media content.

Social Media For Marketing: Developing Your Goals, Social media marketing can help with a number of goals, such as:

  • Website traffic
  • Conversions
  • Brand awareness
  • Creating a brand identity and positive brand association
  • Communication and interaction with key audiences

According to the 2014 B2B Content Marketing Benchmarks, Budgets and Trends report, content marketing is on the rise, with 93 percent of marketers using content marketing, compared to 91 percent last year. For most, this is not all that surprising.

Also not surprising: 42 percent of B2B marketers consider themselves effective at content marketing, up from 36 percent last year.


Getting marketing value out of content

Content marketing has existed in offline marketing for many years; the modern term “Soap Opera” derives from the fact that this popular format was sponsored by washing-powder companies. The contrast to this is modern commercial breaks, which have become increasingly less effective as modern recording devices have developed features that allow viewers to essentially to bypass advertising.

The lesson to take away from this contrast is that most users instinctively understand that quality content has to be paid for somehow. Thus, they are unlikely to object to a sponsor’s name being referenced as having enabled the posting. They are less likely to engage with blatant advertising or with badly-disguised advertising such as the “infomercials” used on shopping channels.

Getting content noticed

The second key point about content marketing is that it only works if people can actually find the content. If your plan is to host it on your own website, then you have full responsibility for making sure that users know both what is there and how to access it. This means that you will also need to look at your social media strategy and your direct contact strategy. It is highly recommended that you pro-actively make users aware when fresh content is added, which should be regularly, rather than relying on them to remember to check.

Target Audiences

Developing a content marketing plan without identifying the target audiences is like shooting an arrow in the dark. If you don’t know who you are trying to reach, then regardless of how remarkable your content is, it will have little chance for success.

In identifying the target audience, don’t jump immediately to your current customers. They may or may not be the right customers for your business and offering, and they may or may not be the customers you aspire to work with.

During this part of the process, you should be asking questions like:

  • Who are your best customers?
  • What types of issues are they concerned with?
  • What types of information do they consume to address those issues?
  • Where do they get that information now?
  • How do they typically interact with information, and the companies that produce that information?


Look beyond the statistics

A blog may hit the right notes in terms of raw statistics, which is to say, visibility and traffic, but may still be a bad match for your business. Conversely smaller blogs, which are still establishing themselves, may provide more value. Have a look at what is being said about you already and see if there are bloggers who look like they might be actively interested in engaging with you or even promoting you.

Competitive & Aspirational Benchmarking

You’ll want to get an understanding of what your competition is doing with regards to content marketing, as they are competing for your buyers and influencers’ mindshare on a daily basis. Anyone in the decision-making seat has limited time to consume information, and therefore they will select only the most remarkable content.

Don’t forget about your aspirational peers, though. Your industry may be behind the times, and your competition may be doing things the wrong way. Make sure you include a company that you know is executing content marketing successfully, and benchmark against it.

Process, Team & Tools

All the cool content ideas in the world will mean nothing if you’re not able to establish the right team and process to execute content marketing, and give them the right tools to support it.

Process and team decisions are driven by goals and objectives. To address some of these issues, you first have to decide whether you are insourcing, outsourcing, or executing in a hybrid model. Staffing and operating a content marketing team is no easy task, even if you’ve assembled a dream team. Trying to assign content creation tasks to an existing and possibly already overworked staff is an even more difficult way to execute a successful content marketing strategy. Consider your team structure carefully.

For maximum content marketing effectiveness, you’ll also need a little technology. In particular, your plan should include an exploration of:



Authorship markup, in particular, is my number one tactic for local SEO this year, enabling proprietors’ photos to appear as icons next to their listings in SERPs, drawing in consumers’ eyes and clicks., the Twitter Cards protocol allows tweets containing links to display in a richer format, with more content visible and integrated as part of the tweet.

Twitter provides a number of types of Cards: Summary, Product, Photo, Summary Large Image, Player, App and Gallery. Twitter also recently released a Lead Generation Card for a select group of brands.

For small business blogs, Twitter cards can be great for online brand development. Similar to rich snippets in search engine results, the enhanced layout makes the account’s tweets more noticeable and engaging, causing their links to appear more legitimate, thereby reducing consumers’ hesitancy to click through. This treatment likely will correlate to increased click-through.

Social media is a powerful and affordable marketing tool if it’s taken seriously. Instead of a shotgun approach, follow these steps to create a social media marketing plan with a focused, refined strategy that can generate results.