European Medicines Agency (EMA) updated GCP draft published for comments
Posted onAn update as an addendum to the ICH GCP E6 has been released by European Medicines Agency (EMA) for comments from the public.
Careers in Pharmacovigilance – A Stable Evergreen Industry
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Tags: Careers in Pharmacovigilance, Pharmacovigilance Training, Online Pharmacovigilance Courses Pharmaceuticals is regarded as an evergreen industry. Drug safety or Pharmacovigilance is at the center stage of new drug development as well as postmarketing evaluation of approved drugs and devices. This creates a very vital niche for the pharmacovigilance industry inside the much larger and expanding pharmaceutical business. It would […]
Tropical Medicine in the Era of International Connectivity
Posted onTags: Tropical Medicine, Tropical Medicine Courses, Tropical Medicine Diploma In the modern era in which air travel has shrunken international boundaries, the study of tropical medicine has gained a more serious relevance for all nations. As a major example the Ebola virus disease (EVD) epidemic that surfaced in early 2014 has brought to limelight the […]
Importance of Tropical Medicine in Africa
Posted onMany health issues are specific to certain parts of the world based on their geography, socioeconomic and other factors. A branch of international medicine also known has tropical medicine is involved in addressing issues related to health which mainly include communicable diseases common in the tropical and subtropical regions.
Active drug safety surveillance improves public health (Drug Safety Surveillance)
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‘All drugs need to be safe and efficacious’ is an ideal goal and the objective of the pharmaceutical industry, researchers and the regulatory agencies is to come closer to this goal as much as possible. In the public health scenario the concepts of drug safety takes a higher priority due to a wider application of […]
Vulnerable subjects in clinical research
Posted onAccording to the dictionary definition, the word vulnerable means someone who is “exposed to the possibility of being attacked or harmed, either physically or emotionally”. So who constitutes the vulnerable population in Clinical Research and why do we need to protect them? To answer this question first, let’s take a brief look at the history […]
Informed Consent Procedure in Clinical Trials
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Informed Consent in clinical trial is often the most important part of clinical trial and sometimes neglected too, resulting in serious consequences, for the patient, the doctor involved in the trial and the pharmaceutical company sponsoring the trial. Which brings us to the question of what exactly is an Informed Consent Procedure? It is process […]
Clinical Pharmacology and Pharmacoepidemiology
Posted onClinical Pharmacology is defined as the study of the effects of drugs in human beings and Pharmacoepidemiology falls under the category of Clinical Pharmacology.
Development of Malaria Vaccine in Africa
Posted onMalaria continues to be widespread disease in killing more than 2 million people annually in Africa. The sub Saharan desert registers the most number of cases of malaria with a whopping 90%. The World Health Organization, estimates that in the year 2010, malaria killed an estimated 660000 people, mostly children. It is estimated by the […]
The Microdosing Concept in Clinical Trials
Posted onEvery professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed. Statistics have confirmed reports that the number of molecules which enter the market to become […]