Invited Speaker

New Drug Revolution Converting Fatal or Debilitating Diseases Into Manageable Therapeutic Options
Wafa Al-Katheeb
Jordan

New drug revolution changed the practice of medicine, converting many once fatal or debilitating diseases into manageable therapeutic options.

By law, the safety and efficacy of these drugs must be defined before marketing. Proper and intensive preclinical and toxicity testing should be done before being evaluated in humans taking into consideration that one third of drugs tested will be in the market. Testing in humans involves different clinical trial phases (I, II, III and IV)

Part of our ambitions as a leading Arab country in the region, Jordan has already taken many steps to be recognized as a site of excellence for clinical research. We have the appropriate infrastructure including the presence of the law of clinical studies No. 67 issued in the year 2001, the establishment of clinical trial unit (CTU) at the JFDA and the presence of clinical studies committee (CSC) formed according to the above mentioned law. CTU together with CSC work on licensing contract research organizations, hospitals and labs, conducting regular inspection to ensure adherence to ICH / GCP, conducting educational workshops & lectures to health care professionals, enhance public awareness about the importance and need to participate in medical research for the general welfare and maintaining ongoing communication with international regulatory authorities to keep up with best practices.

In order to participate with a meaningful portion of the technical progress, playing in harmony with the surrounding atmosphere is the means to reserve ourselves a footstep in this field.

It is the choice of the regulatory authorities whether or not to participate in the global studies within the scope of public interest taking into consideration that Helsinki Declaration is upheld.