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.
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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 […]
Self Help Groups / Patient Support Groups – Role in Clinical Research and Epidemiology
Posted onA patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing […]
Clinical Translational Research
Posted onA micro-segmentation of the research enterprise along with drying up drug pipelines and piling up of un-translated basic science discoveries has prompted all the stakeholders of innovation towards development of translational medicine tools for efficacious and expedited entry of products to the market. Clinical trials are important and have lately come under scrutiny for their […]
Consolidated Standards of Reporting Trials (CONSORT)
Posted onCONSORT (Consolidated Standards of Reporting Trials) includes various initiatives formulated by the CONSORT Group to identify and rectify the effects arising from inadequate reporting of randomized controlled trials. Deficient design and reporting of randomized controlled trials is widely acknowledged and the issues are addressed in the CONSORT statement. CONSORT Statement: The main document of the […]
Systems Biology – Virtual Patients
Posted onSystems biology can describe intricate responses to therapeutic interventions in pre-clinical studies and also provide predictive models for drug safety and efficacy before going for the clinical phases. Systems biology can potentially reduce the R&D expenditure and time by improving target identification and lead quality, better description of pharmacokinetic and toxicity profiles, as well as […]
Translational Research – Public Private Partnerships
Posted onAs stated in the NIH Road map for medical research, translational research has proven to be a powerful process that drives the clinical research engine. This requires fuel (finance) to burn and a strong research infrastructure which can strengthen and accelerate this critical part of the clinical research enterprise. The Regional Development Agency, Advantage West […]