Business Insight presented by Arlington Dermatology Safety and Compliance in Pharmaceutical Products Do you know anybody who never took any medication? An average person takes at least one medication to prevent or treat a disease. Some, take multiple pills every day and often have their medicine adjusted or added by a doctor every month. So how do we know that the medicine we receive is safe and helping? We hear a lot of advertising of new drugs, with a list of side effects truly scaring us more than giving hope. And a pharmacy provides us often with a long list of possible medical problems that medicine can cause. All new drugs must be approved by the Federal Drug Administration (FDA) based on multiple levels of clinical research conducted by pharmaceutical companies. There are very strict and clear rules describing how to perform the clinical studies and all of them must be followed by everyone participating in the process. Those rules are called Good Clinical Practice (GCP) and pharmaceutical sponsors, managing organizations, and physicians who are clinical investigators of new drugs are all subjects of those rules and regulations. GCP has been established to help protect individuals who participate in the clinical studies as well as future patients who will use the approved drug. Safety is number one priority during the process of research and every medical event reported during studies, whether related or not to the study drug, must be listed as, so called, adverse event. What you can hear during the advertising is a list of all possible adverse events that were experienced by anyone participating in the research process for any particular drug. Your doctor can explain in more details if you should worry about those events or not, based on your medical history. Medical science always goes forward in attempt to find more and better cures for many problems. We all are responsible for making sure those new studies follow GCP guidelines and provide us with new and safe medical treatment. Pharmaceutical companies and their partners, Clinical Research Organizations (CROS) manage the clinical trials processes, but the true science and data are a part of work of laboratory scientists and doctors and their patients. Meetings at round tables never produced a good trials are the key to improve what we need drug. Experiments in the labs and human for treatment and prevention of diseases. Your participation in research studies may help develop new drugs and you should always consider talking to your doctor about the safety of medications you take. would like to participate in studies for To find out more about GCP or if you psoriasis, acne, rosacea, or any other skin condition, please call our research team at Arlington Dermatology at 847 392 5440. We always welcome new patients who would like to become a part of our studies. Participation offers free of charge medical treatment and medication. You may be compensated for your time to come to our office. And you discoveries in medical science. always can learn more about the newest Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight presented by Arlington Dermatology Safety and Compliance in Pharmaceutical Products Do you know anybody who never took any medication ? An average person takes at least one medication to prevent or treat a disease . Some , take multiple pills every day and often have their medicine adjusted or added by a doctor every month . So how do we know that the medicine we receive is safe and helping ? We hear a lot of advertising of new drugs , with a list of side effects truly scaring us more than giving hope . And a pharmacy provides us often with a long list of possible medical problems that medicine can cause . All new drugs must be approved by the Federal Drug Administration ( FDA ) based on multiple levels of clinical research conducted by pharmaceutical companies . There are very strict and clear rules describing how to perform the clinical studies and all of them must be followed by everyone participating in the process . Those rules are called Good Clinical Practice ( GCP ) and pharmaceutical sponsors , managing organizations , and physicians who are clinical investigators of new drugs are all subjects of those rules and regulations . GCP has been established to help protect individuals who participate in the clinical studies as well as future patients who will use the approved drug . Safety is number one priority during the process of research and every medical event reported during studies , whether related or not to the study drug , must be listed as , so called , adverse event . What you can hear during the advertising is a list of all possible adverse events that were experienced by anyone participating in the research process for any particular drug . Your doctor can explain in more details if you should worry about those events or not , based on your medical history . Medical science always goes forward in attempt to find more and better cures for many problems . We all are responsible for making sure those new studies follow GCP guidelines and provide us with new and safe medical treatment . Pharmaceutical companies and their partners , Clinical Research Organizations ( CROS ) manage the clinical trials processes , but the true science and data are a part of work of laboratory scientists and doctors and their patients . Meetings at round tables never produced a good trials are the key to improve what we need drug . Experiments in the labs and human for treatment and prevention of diseases . Your participation in research studies may help develop new drugs and you should always consider talking to your doctor about the safety of medications you take . would like to participate in studies for To find out more about GCP or if you psoriasis , acne , rosacea , or any other skin condition , please call our research team at Arlington Dermatology at 847 392 5440. We always welcome new patients who would like to become a part of our studies . Participation offers free of charge medical treatment and medication . You may be compensated for your time to come to our office . And you discoveries in medical science . always can learn more about the newest Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net