GCC REGULATORY AFFAIRS
PHARMA SUMMIT 2024

She is a prime pharmacist, and the head of 1st registration committee in registration department/directorate technical affairs/ Iraqi MOH. She recently became the manager of pharmacy department in the same directorate-MOH.

A collaborative, strategic professional with a highly result oriented and problem-solving mind.  Almost 17 years of regulatory affairs practice and efficient training courses gave him a solid and enriched knowledge in different regulatory aspects in terms of registration of medicinal products; GSL products and medical devices, Marketing authorization functions, post approval changes and renewal process. His core strengths and competencies are building new Regulatory departments and leading cross functional team as well as developing creative regulatory solutions that reflect on achieving the company organizational commercial targets and business objectives successfully.

She has a Masters in Pharmaceutical Technology from Ajman University of Science & Technology, bachelor’s in pharmacy from Dubai Pharmacy Collage, 15 years’ experience in the retail pharmacy, 10 years’ experience in Ministry of Health and prevention in the drug department import and export section. Team leader responsible for the implementation of ISO Continuity of business and ISO Risk Assignment & representative in the E-Transformation project in the drug department.

She has participated in Dubai international Pharmaceuticals & technologies Conference & Exhibition- DUPHAT 2016 and awarded the 11th best pharmacy student oral presentation award in 2016

Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.

Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.

In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.

She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.

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.

Aisha has 5 years’ experience with NHRA in the Pharmacy and Pharmaceutical Product regulation Department as a Regulatory affairs specialist, responsible for re-registration of applications and review of the submitted Registration, variations, and renewal applications.

She also participated in the conferences held by NHRA, and she was part of the Grievances committee filed by Pharmacy Practitioners and Pharmacy centers.

She has graduated from the University of Jordan faculty of pharmacy in 2017, following that in 2018 she joined NHRA as a team leader of the Medicine variation as a primary responsibility.

Through her journey at NHRA, she gained extensive experience and knowledge in e CTD submission, evaluation of the medicine new registration files and safety notification.

Additionally, she is responsible for identifying any safety concerns related to medicine and ensuring that those concerns are addressed to the health care professionals where appropriate.

In June 2023, Shima participated in the 3^rd NHRA regulatory conference as a speaker in the main conference hall.

Samar Abdalhalim graduated with a bachelor’s degree in Pharmaceutical Sciences in 2007.

With over 15 years of dedicated experience in the pharmaceutical and personal healthcare industry, Dr. Samar Abdalhalim has had the privilege of making significant contributions to the regulatory field. She has been at the forefront of shaping the regulatory landscape and ensuring compliance within the P&G Health organization.

Dr. Samar Abdalhalim has held various positions at leading companies such as Hospira-Pfizer and Johnson & Johnson, where she honed her expertise in regulatory affairs, regulatory intelligence, and strategic planning.

Currently, he is the Regulatory Affairs Lead in Acino, based in Cairo Egypt, managing Gulf

Dr. Khaled has more than 18 years’ experience in Regulatory Affairs in different region; GCC, Middle East, & Africa.

He started his career in 2002 in Manufacturing Quality Assurance & Validation.

Then he has shifted to Regulatory Affairs since 2006 & he has been working among many local & multinational companies such as Novartis & Pfizer until joining Acino in 2019.