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Friday, August 7, 2015

Patent Analyst : Research and Development - Novozymes

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Patent Analyst, Intellectual Property, Research & Development
Location: Bengaluru, India
Last Date: 18- August 2015
Company Profile:


At Novozymes, we work in close partnership with our customers to make an impact and help create a better world. We use science to advance industries, and as part of R&D, you will create and develop the biological answers that will pave the way for a brighter future.
You’ll be part of a dynamic international team of patent analysts and attorneys based in Bengaluru and other locations across the world, and will assist in delivery of quality results in search and analysis domain within intellectual property. 
You thrive in a fast-paced learning environment and are as comfortable with working in a team by coordinating with other analysts and attorneys on a day-to-day basis as you are with working independently with attention to detail - interpreting data, performing analysis and presenting results. For the right individual, this is a fantastic career opportunity with potential for personal and professional development.

Requirements:
  1. Have a Master’s degree with relevant experience within biotechnology, biochemistry, or molecular biology, possibly supplemented with a PhD
  2. You should have 2-4 years of experience working as a Patent analyst or in a similar role – especially in making excellent searches and informative reports
  3. Have expertise in working with Freedom to Operate Analysis (FOA) and clearance searches (added advantage)
  4. Be a team player with strong analytical, documentation and communication skills
  5. Be able to work independently and take ownership
  6. Be creative, take initiative, learn fast, display result orientation and work with challenging deadlines
How to apply: Click here

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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Thursday, August 6, 2015

Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

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Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

Role : Clinical Research Associate / Scientist
Number of Openings : 03
Experience required : 1-4 years 

Location : Bangalore


Ecron Acunova provides end-to-end services for Phase I-IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. Ecron Acunova has research facilities in Asia as well as an established presence in various parts of Europe and the United States. We offer clinical development services to the pharmaceutical, biotechnology, nutritional, device and medical diagnostics industries. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform.


Job profile: 
The responsibility is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH-GCP guidelines.

  1. Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM.
  2. Preparation, conduct and reporting of site selection visits.
  3. Negotiation & obtaining Investigator agreement on site budget, payment to the sites.
  4. Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents.
  5. Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner.
  6. Maintenance of TMF and Site specific file.
  7. Scanning & uploading documents into shared drive.
  8. Transmission of documentation into project files.
  9. Preparation of regulatory dossier, regulatory submission and follow-up.
  10. Preparation of EC dossier, EC submissions and follow-up.
  11. Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting.
  12. Development of meeting materials along with required presentations for investigators meeting.
  13. Site initiation visit planning, preparation, conduct, report and follow-up of pending issues.
  14. Co-ordinating the IP request between sites and pharmacist/ vendor/ sponsor. 
Desired Candidate Profile :

UG : B.Pharma - Pharmacy, PG : M.Pharma - Pharmacy, Doctorate : Any Doctorate - Any Specialization, Doctorate Not Required


Worked in Ophthalmology or Oncology studies Clinical Studies I-IV
  1. Ability to interact professionally with clients/vendors.
  2. Excellent interpersonal, verbal and written communication skills and ability to work in a team.
  3. Effective time management skills and prioritize tasks to manage study timelines.
  4. Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills.
  5. A minimum of 65% on average.

Recruiter Name : M. Chaarumathi

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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Drug Safety Associate - Clinical Development : Dr.Reddy's

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Drug Safety Associate, Clinical Development - Dr. Reddy's



Role : Drug Safety Associate, Clinical Development
Number of Openings : 01
Experience required : 1-3 years in Pharmacovigilance operation
Location : Hyderabad


Dr. Reddy's Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. 

For more information, log on to: www.drreddys.com

Job Profile: 

1. Assimilate information on adverse events, perform initial checks, update safety data tracking tool, do case validation, preliminary assessment of case reportability and create case report file.

2. Ensure complete and consistent data entry of adverse event reports from source documents with acceptable timeline and quality.

3. Manage handling of non-expeditable AE reports, legacy AE reports including review for completeness and accuracy.
4. Use medical dictionaries and business guidance to check correct coding of medical history, drugs and adverse event terms.
5. Identify clinically relevant information missing from case report and facilitate its collection (from medical team) to generate appropriate follow-up request as needed.
6. Alert manager about important safety concerns based on preliminary case reports.
7. Work with drug safety team to ensure high compliance for end to end ICSR management.
8. Work with drug safety team in various safety data related administrative and procedural activities as required or requested.

Educational Qualification :  Masters Degree in life sciences or related fields; or equivalent.

Professional requirement :
  1. Good understanding and experience of adverse event cases processing (ISCRs) from various sources such as Spontaneous, Post marketing surveillance Studies, Published Medical Literature, Health Authority/ Legal notification & Clinical Trials etc.
  2. This includes primarily, case processing, coding of events, medical history and drugs, narrative writing etc.
  3. Familiarity and general understanding of medical terminology, experience in working with medical dictionaries (MedDRA & WHO DDE).
  4. Good understanding of pharmacovigilance, Global and local regulatory reporting requirements, etc.
  5. Experience with working on Global standard safety data bases such as ARISg and/or Argus safety.
  6. Basic understanding of clinical trials procedure.
  7. Good ability to ability to write good English or communicate.
  8. High commitment for compliance.
  9. Sense of urgency and commitment for timely completion of activities.

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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Manager - Medical Monitoring : Dr. Reddy's

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If you see an opportunity you would like to explore further, do write in to us with your CV on careers@drreddys.com.

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Happy Blogging...!!!
Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Walk in for Clinical and Project Management - Quintiles


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Walk in Event for Clinical and Project Management - Aug 8 2015 in Quintiles - Bengaluru 

Role: Clinical Research Associate / Scientist

Number of Openings : 50

Experience required : 1-6 years

LocationQuintiles, Etamin Block, Wing A, Prestige Tech Park II, Outer Ring Road, Sarjapur, Bangalore - 560103
Date : 8 - August 2015, 08:00 am
Documents to carry : CV, last 3 months pay slip, id proof
Interview processAssessment process - CV screening- Aptitude tests- HR Interview- Technical interview- Final interview.
Salary 2,50,000 - 7,50,000 P.A

Company profile: Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

More details: 

1. Clinical Research Professionals Candidates with 1-8 years of experience in clinical research field.
2. Records Management Professionals Candidates with 2-6 years of working in the field of clinical research or in a parallel lead role. Strong ability to identify clinical research documents. Knowledge of systems, databases and software programs. 
3. Project Management professionals Candidates with 5+ years of experience in project management preferably in clinical / healthcare domain. 

Desired Candidate Profile :

Education:

UG : Any Graduate - Any Specialization, B.Pharma - Pharmacy, BDS : Dentistry

PG : Any Postgraduate - Any Specialization, Post Graduation Not Required

Doctorate : Any Doctorate - Any Specialization, Doctorate Not Required

Contact number91-80-41384900

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Happy Blogging...!!!
Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Message to Indian Pharmacists: Opportunities in the Global Market

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I'm very much thankful to His excellency Lt. Colonel PRASAD R TIRUNAGARU M. Pharm., MSC, R.PH for sharing this valuable information with us.

Lt. Colonel Prasad received his B.Pharm and M.Pharm degrees from Andhra University and Medical Service Core training as a combat pharmacist at the Academy of Health Sciences of US Army Medical department centre, Texas, USA. He was the first South Indian to be commissioned as an officer in the US Army. He was the first foreigner to pass the prestigious California State Board Exams in the world.

He has thirty five years of experience as a registered pharmacist in USA, as Assistant Chief and Chief of Pharmacy in various army medical centres. Specialties include clinical research in developing human genetic insulin, nutritional studies, in-patient and outpatient pharmacies, oncology, chemotherapy and nuclear pharmacies. Developed hospital formulary, clinical training modules for healthcare professionals.


Message to Indian Pharmacists: 


US Job Market: There is always great demand for registered pharmacists in USA, the pharmacists are highly respected, most trusted and well paid professionals. The average salary is $120,000 to $200,000 per year. 

Retail and Community Pharmacist: It provides majority of the pharmacist jobs in USA. The major function of the pharmacists is filling and dispensing medications by reviewing and interpreting physician orders, detecting therapeutic incompatibilities. They counsel the patients regarding drug usage, side effects and precautions, they also administer vaccines and drug information. They help physicians and healthcare professionals regarding proper usage, selection of medications and therapeutic guidelines. 

Hospital Pharmacist: Pharmacists play a very important role as a healthcare team member in the hospital providing high quality comprehensive pharmaceutical care. Specialties include outpatient pharmacy, inpatient pharmacy, oncology/IV Admixture. They dispense all required medication to the wards for patient administration. They provide clinical drug data, therapeutic information to all medical team members, monitor drug reactions and patient profiles. They help patients with drug counselling to optimize therapy. 

Clinical Pharmacist: Clinical pharmacists play a vital role in the applied therapeutics; they require 1-2 years of specialized programmes and training in various specialties, i.e., ambulatory care, internal medicine, pediatrics, psychiatry, geriatrics. They are well paid. They are part of every medical and therapeutic team in the hospital. Recently, State Provider Statues Bill became law in many US states. The Legislation provides that “A pharmacist may perform any patient care service delegated to the pharmacist by a physician”.


Industrial Pharmacist:This is a very promising field, specialties include drug discovery, drug development, manufacturing, clinical trials and marketing. Now, there is an exciting new world bioinformatics, genome therapy, stem cell research and promising nano-technology. 

Regulatory Authorities: US Food and Drug Administration and State Boards of Pharmacies have special and important jobs. FDA has several mission-critical medical and science positions at biological evaluations, drug evaluation and research, food safety, applied nutrition, toxicological research and drug inspectors, drug regulatory authorities at various state boards.

Immigration to USA: The important step is getting an immigrant visa to enter into USA. The choices are go for higher education or PhD in various universities. The other one is getting a dependent visa.

State Board Exams: All foreign graduates must obtain certification by the Foreign Pharmacy Graduate Equivalency Committee (FPGEC) before they can get an intern pharmacist licence. They must pass Foreign Pharmacy Graduate Equivalency Exam. In order to practice as a registered pharmacist, you have to pass the North American Pharmacists Licensure Examination (NAPLEX). Rules vary from state to state, please check individual state websites.

Tips for Passing Board Exams

Pharmacy Law: It is a very important part of the State Board Exam. Laws are very strict and precise; each state has its own state board of pharmacy laws. 

Pharmacy Mathematics: Our students can easily get 100% , mostly drug dosing conversions, drug percentage calculations and drug formulations etc. 

Drug Identifications: They must be able to identify important medications by color, shape, markings on tablets. PDR has all the information. 

Trade and Generic Names: They need to learn generic and trade names for the top 200 drugs and more. 

Drug Interactions: It is very important to know pharmacological actions of various important drugs, their medicinal chemistry, actions on target organs, drug metabolism, excretion and side effects. 

Drug and Food Interactions: They have to know food and drug interactions of all critical drugs. 

Clinical Pharmacy: It is a very critical part of patient case studies, patient profiles and interpretation of clinical laboratory tests and adverse drug reactions.


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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Tuesday, July 21, 2015

Oral Contraceptive failure due to Antibiotics : A Bogus Interaction


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Over past 3 decades, published literature described hundreds of women on oral contraceptives have become pregnant after a course of oral antibiotic therapy. Accordingly, many pharmacists warned their patients who were on oral contraceptives to take additional precautions to avoid pregnancy when using antibiotics concomitantly. Yet, there exists many misconceptions about this purported interaction. First of which is that adequate data are available to prove or disprove the existence of the interaction.

A Bogus Interaction? 
This interaction has not been disproved, despite frequent proclamations that it is a “myth.” Some people have erroneously concluded that—because there are substantial flaws in the data supporting the existence of the interaction—the interaction has been shown not to exist. In making this claim, however, they have failed to understand the saying

“Absence of proof is not Proof of absence.”



Inadequacies in the Positive Studies and Reports:

The reports of oral contraceptive failure during antibiotic therapy are numerous, but they are with amusing results. Specific details of the cases are rarely reported, and it is not possible to determine whether the unintended pregnancy resulted from the antibiotic or simply represents the “background” failure rate normally seen with oral contraceptives. Although some of the pregnancies occurred in women who had been taking oral contraceptives correctly and successfully for years, there is still no certainty that the antibiotic caused the contraceptive failure in any given case.

Inadequacies in the Negative Studies and Reports:

There are also serious flaws in the studies that failed to find an increase in oral contraceptive failure rate with concurrent antibiotics. All of the studies had 1 or more of the following flaws: retrospective design, dependence on patients’ memory of events, long-term antibiotic use, or combining data for antibiotics that might reduce estrogen levels (amoxicillin) with those for antibiotics that may increase estrogen levels (erythromycin, clarithromycin). 

Some of the antibiotics (clarithromycin, ciprofloxacin, metronidazole) would not be expected to reduce estrogen levels. Moreover, if only a small fraction of women (< 5%) develop this interaction, a statistically significant change in estrogen pharmacokinetics would not be expected. Women taking an antibiotic for an acute infection might be less likely to have sexual intercourse because they are not feeling well, either due to the infection or because of side effects of the antibiotic (nausea, vomiting, diarrhea). This could result in an underestimation of the ability of antibiotics to reduce the efficacy of oral contraceptives. Another flaw in most negative studies is the failure to consider how many of the patients received information on how to avoid the interaction.

Proposed Mechanism of the Interaction:

The mechanism, if any, is not clear. Theoretically, antibiotics such as penicillin and tetracycline can reduce bacteria in the intestine that are involved in the enterohepatic circulation of estrogens, leading to a reduction in estrogen serum concentrations. Other mechanisms include enzyme induction following rifampin, griseofulvin, nafcillin, and dicloxicillin, or malabsorption of contraceptive hormones due to antibiotic-induced diarrhea and vomiting.

Pharmacists’ Role:

Women on oral contraceptives still should be warned about the possibility of contraceptive failure if they receive a prescription for an oral antibiotic. To comply with oral contraceptive product information, the patient should be advised to add alternative non-hormonal contraception during the time and for 7 days after the antibiotic is taken. No one knows, however, whether 7 days is enough. The pharmacist should recommend backup contraception for 2 weeks after discontinuation of the antibiotic or through the end of the current cycle—whichever is longer. Advising the patient to report any menstrual irregularities may be efficient, but there is no evidence that their absence ensures adequate contraception.

Conclusion:

In any given patient, antibiotics are unlikely to impair the efficacy of oral contraceptives. The data emphatically, however, do not establish that any antibiotic can be used in any woman on any oral contraceptive without increasing the risk of unintended pregnancy. Thus, only 2 possibilities are left:
  1. Antibiotics cause contraceptive failure in a very small percentage of patients.
  2. Antibiotics have no effect on oral contraceptive efficacy.
With the available data, it is simply not possible to choose which of these 2 possibilities is correct, so pharmacists must continue to warn patients accordingly.

References: 
  1. Drug Interactions by Hasten and Horn : Current topics in Drug Interactions.
  2. Lexicomp - clinical information solutions and drug interaction checker.
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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Tuesday, June 9, 2015

How to prevent Diabetes : Action Speaks

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There is nothing much to do for an individual to prevent diabetes as the entire process have been done by the International Diabetes Federation on our behalf, all that leftover is to know the facts and figures and the Global economic burden of diabetes. Getting and making people aware is much important simply download the guide to know more details and if you are from any of the G7 countries don't forget to tweet until it reaches your political leaders.

You are just one click away to Know how to prevent it:

To download a guide book on Economical Burden:
Click Here to Download Guide

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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Every 7 seconds one person dies from Diabetes : How to prevent it

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World Diabetes Day (WDD) is celebrated annually on November 14. Led by the International Diabetes Federation (IDF), World Diabetes Day was created in 1991 by IDF and the World Health Organization in response to growing concerns about the escalating health threat posed by diabetes.


Global Burden : Interesting facts
  1. The human and economic burden of diabetes is enormous: it affects almost 400 million people, results in over 5 million deaths annually and consumes almost US$ 550 billion in health related expenditures.
  2. The majority of the costs related to diabetes are spent on treating complications, which can affect the heart, eyes, kidneys and feet; these complications can be prevented through early diagnosis and proper management of diabetes.
  3. Delayed diagnosis means that many people already have at least one complication by the time they are diagnosed with diabetes.
  4. Over 70% of type 2 diabetes cases can be prevented or delayed by adopting healthier lifestyles, equivalent to up to 150 million cases by 2035.
  5. Eating a healthy breakfast decreases the risk of developing type 2 diabetes.
  6. A healthy diet containing leafy vegetables, fresh fruit, whole grains, lean meat, fish and nuts can help reduce a person’s risk of type 2 diabetes and avoid complications in people with diabetes.
  7. Skipping breakfast is associated with weight gain, one of the main risk factors for type 2 diabetes. Overweight and obesity account for up to 80% of new cases of type 2 diabetes.
  8. Reducing the prevalence of type 2 diabetes will result in an increased participation and productivity in the workforce, given that the greatest number of people with diabetes are between 40 and 59 years of age.
  9. Diabetes accounts for 10-15% of the total healthcare budgets in high income countries. 1 in 9 healthcare US$ is spent on diabetes.
  10. Up to 11% of total healthcare expenditure in every country across the globe could be saved by tackling the preventable risk factors for type 2 diabetes.
Know how to prevent it: 


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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia

Wednesday, June 3, 2015

Public Health : 100 Global Health issues

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Today, I would like to list out 100 important global health issues that are covered under Public health.
I have come across many students making fun of Public health, when asked what is public health they say.. "it is health of public and why you are asking it when it is so simple". Let me add few points for their innocence.

What is Public health?

Public health refers to all organized measures to prevent disease, promote health, and prolong life among the population as a whole. Its activities aim to provide conditions in which people can be healthy and focus on entire populations, not on individual patients or diseases. Thus, public health is concerned with the total system and not only the eradication of a particular disease. 

The three main public health functions are:
  • The assessment and monitoring of the health of communities and populations at risk to identify health problems and priorities.
  • The formulation of public policies designed to solve identified local and national health problems and priorities.
  • To assure that all populations have access to appropriate and cost-effective care, including health promotion and disease prevention services.
Public health is all around us: the water we drink, the immunizations we receive and the environment in which we live in..  


List of various Global health issues covered under Public Health:
  1. Adolescent health
  2. Ageing
  3. Bacterial diseases
  4. Biological issues
  5. Biosafety
  6. Blood transfusion safety and blood products
  7. Cancer
  8. Cardiovascular diseases
  9. Chemical Safety
  10. Child and Maternal health
  11. Communicable diseases
  12. Diabetes
  13. Diarrhoeal diseases and Cholera
  14. Disabilities and Rehabilitation
  15. eHealth
  16. Emergency and Humanitarian action
  17. ePortuguese programme 
  18. Environmental and Humanitarian action / hazards
  19. Ethics
  20. Event based surveillance 
  21. Evidence informed policy making
  22. Filarial infections
  23. Finance
  24. Food safety
  25. Gender, Women and Health
  26. General management
  27. Genetics and hereditary diseases
  28. Global health observatory
  29. Global Learning and performance management
  30. Global mass gathering
  31. Health economics and financing
  32. Health information, statistics, measurement and trend assessment 
  33. Health legislation and human rights
  34. Health promotion and education
  35. Health security
  36. Health systems research and development
  37. Health technology (laboratory services)
  38. Healthy cities
  39. Hepatitis
  40. HIV/AIDS
  41. Human Resources management
  42. Human resources for health (excluding Nursing)
  43. Immunology
  44. Influenza
  45. Informatics and telemedicine
  46. Information technology and telecommunications
  47. Injuries, violence and accident prevention
  48. International health regulations
  49. Laboratory biorisk management
  50. Laboratory biosecurity
  51. Legal
  52. Leishmaniasis
  53. Leprosy
  54. Library services and publishing
  55. Malaria
  56. Mental health and Neurosciences
  57. Monitoring and Evaluation
  58. Non-communicable diseases
  59. Nursing
  60. Nutrition
  61. Occupational health
  62. Oral health
  63. Organ transplantation
  64. Outbreak alert and response
  65. Parasitic diseases
  66. Patient safety
  67. Pharmaceuticals (Essential drugs and Medicines)
  68. Planning, Resource coordination and Performance monitoring 
  69. Poliomyelitis
  70. Prevention of Blindness
  71. Prevention of Deafness
  72. Public Health Emergency
  73. Rabies
  74. Radiation
  75. Reproductive health
  76. Research policy and development
  77. Respiratory infections
  78. Rheumatic diseases
  79. Risk assessment
  80. Risk communication
  81. Safety measures in Microbiology
  82. Schistosomiasis
  83. Security management
  84. Sexual Transmitted Diseases
  85. Small pox
  86. Social determinants of health
  87. Suicide prevention
  88. Substance abuse (alcohol and drugs)
  89. Surgical care
  90. Tobacco
  91. Tourist health and travel medicine
  92. Traditional medicine
  93. Trypanosomiasis
  94. Tuberculosis
  95. Vaccines
  96. Vector biology and control
  97. Viral diseases
  98. Viral hemorrhagic fevers
  99. Water and sanitation
  100. Zoonoses.
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Happy Blogging...!!!
Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia