Mohamed Fazil M

regulatory affairs master of pharmacy drugdevice combination product risk management risk journal club cdsco biologicals regulations & legislation the principles of ich gcp institutional review board independent ethics commitee investigator's brochure investigator sponsor ib iec irb ich e6 ich gcp e6 guidelines good clinical practice clinical research guidelines clinical research regulations saudi food & drug authority saudi arabia mra201t semester 2 matster of pharmacy auditing strategies audits unit 3 mra 102t document & regulatory writing 1st semester out of specifications (oos) quality management systems good regulatory practices