BSc in Pharmacy from Jordan University, 1991

MSc in drug analysis from Monastir University, Tunisia, 1998

PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.

 

I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.

 

Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 14 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.

 

Other Activities in the Educational Field:

Jordan University of Science and Technology-Deanship of Scientific Research:

• Member in the “Scientific Research Committee” during the scholar year 2019-2020.

Yarmouk University:

• Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.

Jordan University of Science and Technology (JUST) & Yarmouk University:

• Deliver lectures to 5^th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).

Jordanian Association for Pharmacists:

Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).

 

Topic of Submission

Deficiency letters trending leading to shaping the guidelines on Analytical Validation registration requirements

Project-Safa

Ms. Karen Sultan has joined Genpharm Services since 2017 and she is currently holding the title of Regulatory Affairs and Quality Assurance Manager.

She is responsible for handling all the regulatory procedures for the MENA region including new product applications, renewals, and lifecycle maintenance activities.

Ms. Karen Has an active involvement to ensure timely submissions and approvals as per the planned strategy to meet the launch timelines.

She focuses on establishing and maintaining professional relationship with business partners and competent authorities. In addition, she is a cross functional support including Logistics and supply chain, distribution Management and Sales and Marketing departments depending on the needs of the business. Also, she liaises with the competent authorities and local distributors regarding all regulatory affairs related issues.

In addition, Ms. Karen does a close follow up and monitoring of the regulatory activities within the local distributors in the MENA region and principal partners by exchanging monthly reporting, TCs and face to face meetings. She also Maintain a full up to date database for tracking the regulatory activities in the MENA region.

Ms. Karen is a holder of RAPS Global Regulatory Affairs Certificate for Pharmaceuticals and Medical devices (Dual), and a bachelor’s degree in chemistry and Pharmacology, University of Western Ontario, Canada – July 2015.

Topic of Submission

Bringing Cures to Rare Disease Patients in the MENA Region

Brining-Cures-to-MENA-Patients-RA-GCC-Award-Karen-Sultan