Pharmacist Rana Musa Al-ali (Malkawi), MSc

Position: Head of Clinical Studies Department Regulatory Consultant at JFDA
Categories: Speakers 2022

She has a BSc in pharmacy from Jordan University of science & technology in 2003 and a MSc in pharmaceutical quality assurance/quality control from Jordan University of science & technology in 2006. Pharmacist Rana was the former registration officer in Jordan pharmaceutical manufacturing company (JPM) and former to that she was the section head of Biological drugs, sera & vaccines in the registration department at JFDA. Currently, she is working as Head of clinical studies department.

Her previous work experience involved the assessment & review of CTD files of originator drugs, vaccines & biological drugs, Receipt & assessment of post approval changes regarding registered biological, originator drugs & vaccines, Intellectual properties & public health issues related to pharmaceuticals. She collaborated in the team for the preparation & review of the “Guidance for Registration of Biosimilars in Jordan” that was published in May,2015 as the national guidance in the official gazette. In addition, she reviewed & approved of the Clinical studies protocols for studies submitted to be conducted in Jordan.

Currently, her work responsibilities consist of Reviewing the applications for accreditation of centers (CROs), hospitals, laboratories (both diagnostic & analytical) involved in the conduct of clinical trials/BE studies, as well as the Inspection of the sites (for accreditation & during study conduct), to ensure continuous adherence to standards & requirements and reviewing therapeutic & nontherapeutic protocols to ensure compliance to requirements.