DR. RANA MALKAWI

Position: Drug Directorate Director | Regulatory Affairs Consultant - Jordan Food and Drug Administration (JFDA)
Categories: Speakers 2024

Dr. Rana holds a master’s degree in pharmaceutical quality assurance, with more than 16 years of experience in the field of Regulatory affairs, both the theoretical knowledge on legislations governing medical products & the understanding of the technicalities involved in regulatory submission.

Also serving as head of the clinical studies department for more than 5 years gave her experience in the field of clinical trials operations & GCP guidelines.

Also she was a member of the regulatory team who collaborated in the preparation & review of the “Guidance for Registration of Biosimilars in Jordan” that was published in May/2015, also she is a well-recognized speaker in the field of Biosimilar regulations & requirements, also she has fair knowledge in Intellectual property & public health issues related to pharmaceuticals.

 

She started her career in the private sector then moved to JFDA in 2008, since then she has held many positions including head of new drugs registration section, head of biological and vaccine registration section, head of Clinical Studies Department, administrative assistant to director general.

She chaired and was a member of many technical committees at JFDA and MOH.