GCC REGULATORY AFFAIRS
PHARMA SUMMIT 2024

Over the last 16 years of my career, I have developed strong working relationships with the various Ministries’ of Health (MOH) in the Middle East and thus consolidated my presence as a seasoned pharmaceutical regulatory affairs professional in the region.

I have completed my B. Pharm in 2002 from Dubai Pharmacy college and Master of Science in EU Regulatory affairs from KREMS , Vienna University and MBA from Preston University.

.In 2013, I co-founded Professional Regulatory Affairs (PRA), a leading healthcare regulatory consultancy in the Middle East. To further uphold the ethics and compliance standards within the industry, I also persevered with Dubai Pharmacy College, industry experts and authorities to set up the GCC Regulatory Affairs (RA) Course, a first-of-its-kind certification, which educates graduates and professionals on the new career advancements and opportunities in this sector to become industry experts.

My true passion lies in helping authorities to find solutions and apply policies and regulations, which will lead to better health and safety within the regional communities. I have been instrumental in launching the GCC Regulatory Affairs Pharma Summit in 2015 and running it successfully for the last five years in Dubai. I also launched PHARMA REG AFRI summit , MEVAS and ACRAS summits in the region .

I am advisory board member with Dubai Pharmacy College and a member with the Women’s’ Business Council at the Dubai Chamber of Commerce

I have been recently elected as a board member at Emirates Medical Association – Pharmacy chapter

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.

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.

Current positions:

Appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. Member of supreme Council of Health, Member of the National Task Force for competing Covid19.

Qualifications:

• Arab Board certificate in Family & Community Medicine in 1990
• Higher studies diploma in medical education from Dundee University in Scotland in 1994
• Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000

Previous positions:

• Assistant Undersecretary for Primary Care and Public Health 2009- 2015
• Member of the Executive Board of The Health Ministers’ Council for GCC States 2009- 2016,
• Advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs). 2009-2015
• Member of Academic accreditation Committee of the supreme council for Higher education in 2016-2018.
• A member of the Sura Council in 2000, and a member of the National Institute for Human rights.

Honorees & medals

• The Nelson Mandela Award by the world health organization 2023
• Prince Salman bin Hamad Medal for Medical Merit for frontline professionals2021
• International Data Corporation IDC Award CEO catalysts of the year 2021.
• Global award for health pioneers from UAE 2019.
• Award was presented to women leaders in the legislative field. 2019 by Her Highness Sheikha Sabeeka bint Ibrahim Al Khalifa, Princess of Bahrain, and President of the Supreme Council for Women, in the celebration of the National Women’s Day.
• GCC leaders Award 2019 awarded by GCC ministers of Civil Service Bures.
• Medal of efficiency by his majesty the king of Bahrain In December 2011
• Awarded among women leaders in health by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council on the National Woman Day Celebration; in 2009
• Awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region in June 2011Awarded by the prime minister among the leaders of Moharraq Governorate in 1990.

H.E. started his career at the Ministry of Health in 1985 while still pursuing his education. He graduated from Aberdeen University in Scotland with a Ph.D. in blood transfusion medicine in 2003. He revolutionized the blood transfusion practices in the UAE with the establishment of 3 world-class centres for blood donation and the development of all relevant policies.

He was appointed as assistant undersecretary since 2006 and he successfully handled various responsibilities with the Ministry of Health.

Currently, as the Ass. undersecretary for Health Policies, H.E. is responsible for the Drug management, Control, Audit and Inspection, Licensing and Accreditation, Standards and Guidelines along with the Organ Donation and Transplantation Office.

His excellency has written numerous books and scientific publications in the field of blood medicine and received many awards from local and international organizations for his contribution to science and his commitment to humanitarian causes.