Category Archives: What We Do

Module 6: Drug post-marketing follow up and pharmacovigilance

Introduction of drug post-marketing Usually, new drugs are approved based on the result of clinical research studies, also know as clinical trials, which involves relatively small number of patients selected for the purpose of assessing its safety and efficacy. Once these drugs are released on the market and prescribed to a higher number of people, a post-marketing follow up and […]

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Module 5: Health Technology Assessment (HTA) and drug pricing

Introduction to pharmacoeconomics Pharmacoeconomics refers to the branch of health economics which measures and compares the costs involved in pharmaceutical products (typically drugs) and services. It takes into account the research investment, production, distribution, storage, pricing and further use by patients. Pharmacoeconomics is useful when assessing the affordability and value of accessing a drug prescribed to a determined subgroup of […]

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Module 4: The European regulatory framework and drug approval process

The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the European Medicines Agency (EMA). This network is what makes the EU regulatory system unique. The network is supported by a […]

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Module 3: Statistics in clinical trials

Using statistics in research Statistical methods provide a way for formally accounting for sources of variability in patients’ responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information, and make sound decisions in the presence of uncertainty. Statistics are key to preventing errors and biases in medical research.  Hypothesis Testing A hypothesis […]

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