Thursday, 30 June 2016

List of Pharmacovigilance Companies in India

List of Pharmacovigilance Companies in India

HYDERABAD: 12

1. NOVARTIS
2. PARAXEL
3. MAKROCARE
4. MAHINDRA SATYAMBSG
5. DR REDDY’S
6. AUROBINDO
7. SRISTEK
8. SHANTHA BIOTECHNICS
9. NEKTAR THERAPEUTICS
10. VIMTA LABS
11. BIOLOGICAL E. LTD
12. MEDHIMALAYAS

BENGALURU: 14

13. QUINTILES
14. SYNOWLEDGE PV SERVICES
15. BIOCON
16. ACCENTURE
17. ASTRAZENECA
18. BLUEFISH
19. SCIFORMIX/STRIDES ACROLABS
20. MMS-HOLDING
21. NORWICH CLINICAL SERVICES
22. HCL
23. OMNICARE CLINICAL RESEARCH
24. MICRO LABS
25. ECRON ACUNOVA
26. G7 INFOTECH

MUMBAI: 11

27. COGNIZANT
28. TCS
29. SIRO CLINPHARM
30. MEDPACE
31. SCIFORMIX
32. PPD
33. SYMOGEN
34. IPCA LABORATORIES
34. RATIOPHARM
35. DIAGNOSEARCH
36. UNIJULES (NAG PUR)

PUNE: 2

37. I 3 GLOBAL DRUG SAFETY
38. SCIFORMIX

CHENNAI: 4

39. ICON
40. ACCENTURE
41. RX MD
42. TAKE SOLUTIONS

DELHI: 5

43. JUBILIANT-BIOSYS
44. APCER, DELHI
45. WIPRO
46. I GATE PATNI COMPUTERS
47. APC PHARMA

GURGOAN: 5

48. KINAPSE
49. MSD (MERCK)
50. I 3 GLOBAL DRUG SAFETY
51. GVK
52. WNS

AHMEDABAD: 2

53. LAMBDA
54. INC RESEARCH
CHANDIGARH: 1
55. QUANTUM SOLUTIONS

What to Do If Unsuccessful in Exams

It is always difficult to forecast the result of the exams; it does not matter whether you are in school or college. It is because exams are scariest part of student life but exams take out the finest ones, predictably or unpredictably. But for some student’s exams results can be a mental disaster and they cannot handle the mental stress of getting failed. Failing is the most disturbing and shocking experience. Only way to manage the mental stress of failure is to talk to the people. Discuss the matter with your family, friends and your mentor who can suggest you with a better approach for future career aspects. Keep in mind that failing in the exam does not mean that it is the end of your life or career opportunities. It is a phase if life which you have to pass through in life sooner or later. We fall to rise again and to rise above failure. Failure gives you strength and makes you stronger. Failures make you understand what it means to fail which was beyond your expectations.
It is always difficult to forecast the result of the exams; it does not matter whether you are in school or college. It is because exams are scariest part of student life but exams take out the finest ones, predictably or unpredictably......
Students worry so much about their failures because they feel that just because of this single failure they are not going to get their dream job or university (college), which is absolutely wrong. Do not let your failures hinder your performance or achieving anything in life. These failures must not convince you that you cannot achieve your goals. Failing in exam does not mean that you are less than anyone who has performed better than you exams.

How to handle such scenario- Advices for students

  • The students should: Consider all possible priorities, resources and problems and Follow a stabilized routine at home.
  • Should not envision extreme consequences and worst circumstances. Should not amplify failure or degrade self.
  • Stay connected with the teachers or counselors when feeling low or worried or disinterested.
  • Cultivate alternative managing strategies and de -emphasis from the pain.
  • Relax your mind. Be positive and hope for the best.
  • Talk to family and friends. Stop worrying. Outcome is not the final influential factor.
  • Go for the options available. Find out and update with wide and diverse choices. Your decision should not be influenced by others.be true to yourself. Don’t forget your strengths and your capabilities and your own choices.

Steps required to study with concentration:

  1. Eliminate Interruptions: choose a place to study which is interruption free. Where you have lowest noise pollution, your study place is the last place to be interrupted by the guests
  2. You need to utilize the time of the day which suits you the best, in which you feel fresh and can easily grasp whatever you study. Researchers have proved that 60 minutes study at morning is equivalent to 90 minutes study at night.
  3. You need to focus on the ongoing task and it must be given the utmost priority. We should try and keep ourselves away from the distractions. For instance, you must study for the time you had previously decided without peeping into your notifications on your Facebook account.
  4. Set Goals: decide how long you are going to study and what subjects you need to complete before you leave your study table. Always stick to the planned goals.
  5. Positive attitude: keep no phrase in dictionary like “I cannot do it” or it cannot be achieved.
  6. Rest/Stretch time: take breaks to walk around. Short walks pump blood supply to your brains which eventually increases supply of oxygen to your mind and increases understanding and concentration.
  7. Changing the subject: Keep changing the subjects you study. Do not study the same subject for long hours. If you change subject then you absorbs more points than keep studying the same subject and getting fed up of that.
  8. Reward yourself: give yourself small treats for achieving the goal. It will keep you happy and fulfilled
if you set your goals ridiculously high and its a failure, you will fail above everyone elses success ― James Cameron

Memory Improvment : How Self testing can Help and Effects of selftesting

The word ‘test’ itself is enough to strike fear into the heart of even the most nerveless of students. Howeveraccording to some researchers tests can help improve our long-term memory and our ability to retrieve important information when we need it. Every individual have their own study strategies, with specific habits, quirks and routines that work best for them. But there is a mounting body of evidence to suggest that the traditional approach to learning may not be as effective as it was believed earlier. In fact , studying until your eyes are almost ready to pop out of their sockets as you approach exam time is one of the most wrong things to do.
The word ‘test’ itself is enough to strike fear into the heart of even the most nerveless of students. Howeveraccording to some researchers tests can help improve our long-term memory and our ability to retrieve important information when we need it.

The Effects of Testing

We consider them to check our intelligence, that how much we are exactly capable of and how much we know. But Psychologists are improvising the concept more and more that test can rather be far more beneficial to us than this. So, know the question arises HOW? Results shows that they can actually make this happen by improving the long-term memory. This makes tests suitable as well as ideal for language learning or key facts and dates storing.  After this, Under-utilizing, or not utilizing it in a more effective way will be more of a shame .
For example, while students may have their own different study habits, their overall approach to study generally looks quite similar:
prepare, prepareprepare, test.
Or it can look like this:
prepare, test, prepare, test.
However, according to researchers, what it should look like is:
prepare, prepareprepare, test.
Or it can look like this:
prepare, test, prepare, test.
, test, test, test.
That’s because studying in this way is a more effective method. Psychologists call this the ‘Testing Effect’.
 Improvement of memory through testing – some research
The influence of the testing effect can be seen in two recent studies, which are outlined below.

Experiment #1

Jeff Karpicke and Henry Roediger, American psychologists, examined a group of college students by conducting an experiment to show the effects of testing on facts memorization and language learning. Students were asked to learn pairs of Swahili and english words followed by preparation of test in different ways. First group were asked to keep testing themselves on all items without skipping what they were getting right whereas the second groupwere told to stop testing themselves on their correct answers.
Results obtained were outstanding. The students who skipped items from testing, coul recalled about 35% of the word pairs.Those who kept testing themselves even after they had learned them could recall 80% of the word pairs

Experiment #2

CarolaWiklund-Hörnqvist, conducted another remarkable study in 2014 for which he got 83 students to study a series of psychological concepts for four minutesin an undergraduate psychology course. 50% of the students being part of the experiment, continued to study, while each one was presented on a computer screen for 15 seconds.
Remaining students were asked to take six tests in which their task was to suggest concept described on the screen .
At the end of the learning session, all 83 participants who were part of the test, were given a fact and asked to type in the equivalent concept. The same test was given 18 days later and again 5 weeks later.
Tested participants tested outclassed the other students on all three tests.
The students who were tested in the second case were given an additional memory boosterthrough what is known as ‘instant response’ – that is, finding out whether you’ve answered correctly or not straight after you have provided your answer.

Getting how to learn

So if testing improved to be so successful in improving our long-term ability to recall facts, why don’t we use it to implement it in our revision plans? Some commentators have recommended that it may come down to the way that we traditionally feel about tests. It’s probably reasonable to say that most people would view standard study methods as being less intimidating and demanding than tests. As the mind is hard-wired to follow the path of least resistance, learners are more inclined to opt for the easier option.
However, it has also been noted that people show a lack of awareness when it comes to the ways we think and how they can be enhanced upon. These are what psychologist Tom Stafford refers to as ‘mental blind spots’.
So while it may seem unecessary to think that testing yourself when not properly prepared might be a good thing.



what is SAS

SAS is software where in they can use it in their domain and it is comparitively easy to learn as SAS® is neither a menu-driven nor a command driven application. Rather it relies on user-written scripts or “programs” that are processed when requested to know what to do. Because it is a script-based application, the key to being successful using SAS is learning the rule and tricks of writing scripts.

• Can process large data set(s)

• Easy to cope with multiple variables

• Can track all the operations on the data set(s)

• Can generate systematic output

• Summary statistics

• Graphs

• Regression results


WHY SAS IS THE ANSWER:

Clinical data is sensitive information that should be treated as a valuable asset as well as a regulated commodity. Not only can improper management of clinical data cause the invalidation of an entire clinical trial, but it may also result in strict remedies, including serious financial penalties, from the FDA.

At the time of this writing, the FDA has not issued revised CFR 21 Part 11 guidance. This indicates that the FDA is still struggling with the difficult issue of Part 11 requirements compliance for a clinical database. However, it is known that the FDA does request that all clinical DBMS prevent unauthorized access to data. This requires that data be password protected and allow updates only by authorized users of the clinical DBMS.

The FDA also requires maintenance of complete audit trails for clinical data. Both the entry and revision of clinical data is to be logged to indicate the user performing the action, the date and time of the action, as well as the reason for change of data.

These requirements and many others are all easy goals when working with the SAS System. In addition to being easy to use, SAS is also the choice of the FDA for receiving and reviewing clinical data. The FDA is still requesting SAS transport data sets as the standard for receiving electronically submitted data. At a minimum, each FDA reviewer is equipped with the SAS System Viewer.

Since the use of SAS is essential to clinical information management, keeping clinical data in SAS makes sense. SAS is the government and the industry standard for performing clinical analysis. Reporting is also effectively accomplished using SAS.


 Who can pursue SAS

Graduates & PGs from any discipline (MBAs, Commerce, Engineering Life sciences, Arts, Medicine, MCAs Statistics etc) can learn SAS.

 Applications

SAS applications are used in
• Financial Services
• Banking
• Insurance
• Retail
• Manufacturing
• Media
• Education
• Communications
• Government
• Hospitality & Entertainment
• SAS Solutions for Small to Medium Businesses
• Aerospace
• Health Insurance
• Automotive
• Energy & Utilities
• Life Sciences
• Government
• Federal Government
• State Government

In the given industries SAS can be used in the following areas

• Customer Relationship Mgmt
• Financial Intelligence
• Human Capital Mgmt
• Profitability Management
• Performance Management
• Risk Management
• Business Intelligence
• Reporting
• Query & Analysis
• Microsoft Office Integration
• Forecasting & Econometrics
• IT Management
• Activity-Based Management
• Compliance (Basel II, Sarbanese Oxly Act etc.)
• Service Intelligence • Supplier Intelligence
• Supply Chain Intelligence
• Web Analytics
•On Demand Solutions
• Data Integration & ETL
• Connectivity & Metadata
• Data Cleansing & Enrichment
• ETL
• Migration & Synchronization
• Data Federation• OLAP
• Integrated Analytics
• Visualization
• Analytics
• Statistics
• Data & Text Mining
• Optimization
• Model Mgmt. and Deployment
• Quality Improvement
• Enterprise Intelligence Platform
• Data Integration & ETL
• Business Intelligence
• Analytics
• Intelligence Storage

HOW TO PREPARE FOR COMPETITIVE EXAMS ?

HOW TO PREPARE FOR COMPETITIVE EXAMS ?
Fortunately or unfortunately, competitive exams have become a strict norm for selection to various professional courses in our country. Notwithstanding the demerits of such a system, competitive exams are a reality for the lakhs of students who appear in them every year. 

In such a scenario, everyone wants to success. Success in these exams brings immense glory and confidence to the individuals, besides giving them a clear cut break into the career line of their choice. However, seats are limited and not everyone who appears can be selected. This does not mean that those who are not selected do not deserve a training in these courses. It only means that there aren't sufficient seats to accommodate all the deserving candidates.

Keeping this background in mind, let us explore what it takes to succeed in these competitive exams particularly at the undergraduate level.

To my mind, the first prerequisite for success in these examinations is determination. The candidate must be quite sure of his level of motivation. Without a high level of motivation, no one can go through the rigorous preparation process. Thus, you must be absolutely determined to give your best efforts in your endeavor.

Once one is sufficiently motivated, one needs to be ready to give sufficient number of hours of his or her time in studies. This is real hard work and involves significant sacrifices on the part of the individual. "All work and no play, makes Jack a dull boy". Therefore it is also important that the candidate does take out some time for relaxation either through sports, music or other art forms. Regular exercise ( about 15 - 20 minutes ) every day will help maintain a healthy body which in turn will house a healthy mind.

The third requirement, is selection of the right study material. One should not go for shortcuts. Instead, try to understand the chapters / concepts in detail and practice sufficient number number of questions. Therefore go for standard textbooks, study materials provided, as various correspondence courses and other coaching institutions serve as supplementary and complementary material to the textbook material.

The fourth consideration is an appropriate 'Study Strategy'. A very common question which students ask is, How to balance the school studies with competitive exam study. Think that school studies can be incorporated within the broad framework of one's competitive exams' preparation strategy. One strategy is to look at each chapter as a chapter to be learnt, a material to be mastered; rather than dichotomizing it as school & competitive exam-related study material. Ultimately, if one's clear about the concepts of say, "Current & Electricity", and has practiced sufficient number of questions / numericals ; one can face any examination whether of school or competition. One can use periodical tests in school as an opportunity to master the material that one has collected rather than restricting yourself to the limited knowledge & practice that is needed for doing well in the periodical test itself. Of course, you may not be able to complete all the practice material for one test but clear the concepts. You can use the rest of the practice material for revision and self evaluation at a later time.

 As the examinations come closer, practicing previous years papers is also key to doing well in these examinations. 

Also revise the important concepts, facts, problems that you would have marked during during your 1.5 - 2 years of preparation before the examination.

On the day of examination, keep your cool and attempt the questions. Remember, if you have given your best during the last 1.5 - 2 years, you need not fear anything. Ultimately, only effort and not the result is in your hand. Which you should do to your maximum capability as outlined above. Rest is your destiny or luck. So go ahead, give your best and leave the rest!

Wednesday, 29 June 2016

Allergenics Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.
Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Currently, there are two types of licensed allergen extracts:
  • Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Among the injectable allergen extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For the other injectable allergen extracts there is no measure of potency, and these are called "non-standardized."
  • Sublingual allergen extract tablets are used for treatment only and are also derived from natural substances known to elicit allergic reactions in susceptible individuals, and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis.
Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause of contact dermatitis, and are manufactured from natural substances or chemicals (such as nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.
Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.
 

Allergen extracts

Allergen patch tests

Antigen skin tests

Vaccines for Use During Pregnancy to Protect Young Infants from Disease – FDA Update

Did you know that vaccinating pregnant women may protect the mother and/or her infant from infectious diseases?
Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure their safety and effectiveness.  Currently, there are no vaccines approved by FDA specifically for use during pregnancy to protect the infant.
On Thursday, June 30th, FDA will host a webinar on the use of vaccines during pregnancy to benefit both the mother and the infant.  Marion Gruber, PhD, Director, Office of Vaccines Research and Review with FDA’s Center for Biologics Evaluation and Research, will discuss how vaccinating mothers during pregnancy may protect young infants against infectious diseases, the global interest in this topic, and the role of FDA in assuring these vaccines are safe and effective.
After the presentation, there will be an opportunity to ask questions.