Seminar M2 – Risk analysis of the drug development process – focus on the patient

 

Ensuring the safety, effectiveness and quality of human drugs is an increasingly complicated task. Vigilance of adverse events and definition of the benefit-risk profile during the development process of a new molecule is a shared responsibility of investigators, clinicians, pharmaceutical industry and regulators. However, due to the faster drug development process and to the need of an accelerated track for approval of several medicines, some may argue that this process is under harm. The overall effort should be placed in seeking meaningful clinical criteria for efficacy, making the risk – benefit ratio more favourable toward the benefit. Hospital pharmacists became familiar with clinical trials methodology since it became a tool for their daily practice, e.g., for drug information, evaluation of new technologies, clinical research.

 

There is now the need to be kept updated on the evolution of the methodology and on how this can affect the overall drug development chain.

 

The seminar will address the process of risk analysis before marketing and its evolution based on the changes in conducting clinical research.

 

 

• To describe the process of risk assessment for drugs in the premarketing phase;

• To describe the evolution in medicine research in the last few years.

 

 

After the presentation the participants should be able:

 

• to recognise new methodologies in clinical research;

• to critically evaluate potential benefits and risk of new medicines;

• to apply the concepts in their daily practice.