When new drugs are tested on humans what are the potential benefits and harms for patients associated with such testing?
Clinical trials are the studies conducted on new drugs in order to verify if these drugs are safe and effective on humans.
There are a number of benefits in participating in clinical trials including having early access to new treatments. These new treatments are not available to the public so your ability to access them is much higher. Another benefit is that the new treatment may cure or control the illness. It is important to note that throughout the clinical trials participants have access to expert medical advice.
There are also harms associated with participating in clinical trials. The main harm in clinical trials …show more content…
Side effects can be extremely harmful to the health of a participant in a drug trial. If an unforeseen side effect arises in the health of a participant (i.e kidney problems) the participant needs to be removed from the trial. Government plays a role in keeping track of negative side effects and intervening when necessary. Government conducts site visits where clinical trials are being held to ensure patients are being monitored by doctors.
What is the role of a Regulatory Affairs Specialist? Where in industry do they work?
A Regulatory Affairs Specialist acts as a link between their employer, its products and regulatory agencies. Regulatory Affairs Specialist ensures the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to have their products approved for sale and distribution.
A regulatory affairs specialist (RAS) has a number of duties. An RAS is involved in all aspects of the drug application required to take the product to market. This includes developing and writing clear arguments and explanations for new product licenses. RAS’s job also requires responding to inquiries from regulatory agencies such as Health Canada. Communication with regulatory agencies is crucial as there are times when an RAS will be required to participate in regulatory agency
Clinical trials are the studies conducted on new drugs in order to verify if these drugs are safe and effective on humans.
There are a number of benefits in participating in clinical trials including having early access to new treatments. These new treatments are not available to the public so your ability to access them is much higher. Another benefit is that the new treatment may cure or control the illness. It is important to note that throughout the clinical trials participants have access to expert medical advice.
There are also harms associated with participating in clinical trials. The main harm in clinical trials …show more content…
Side effects can be extremely harmful to the health of a participant in a drug trial. If an unforeseen side effect arises in the health of a participant (i.e kidney problems) the participant needs to be removed from the trial. Government plays a role in keeping track of negative side effects and intervening when necessary. Government conducts site visits where clinical trials are being held to ensure patients are being monitored by doctors.
What is the role of a Regulatory Affairs Specialist? Where in industry do they work?
A Regulatory Affairs Specialist acts as a link between their employer, its products and regulatory agencies. Regulatory Affairs Specialist ensures the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to have their products approved for sale and distribution.
A regulatory affairs specialist (RAS) has a number of duties. An RAS is involved in all aspects of the drug application required to take the product to market. This includes developing and writing clear arguments and explanations for new product licenses. RAS’s job also requires responding to inquiries from regulatory agencies such as Health Canada. Communication with regulatory agencies is crucial as there are times when an RAS will be required to participate in regulatory agency