Dr. Doaa Mohamed Soliman

BSc. Pharm. Cairo University, Egyptian Board of Healthcare Management. Ministry of health, Master of health care quality management Candidate-Arab Academy for science, technology and Maritime transport (AASTMT).

 

Manager of accreditation and development administration- General administration for pharmaceutical vigilance- Egyptian Drug Authority (EDA).

 

Previously work as Senior PV specialist in PSMF assessment unit then PV specialist in ICSR assessment unit.

Has work experience as inpatient hospital pharmacist, inspection team on community pharmacies, supply chain subunit in a governmental primary care, community pharmacy and pharmaceutical production area pharmacist supervisor.

 

Doaa Soliman is an Administrative Manager with 10 years of experience working within health care sector. Doaa specializes in pharmacovigilance and is responsible of Supervising and management of 3 units which are the PV training, PV inspection and PSMF assessment units.

  • Participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
  • Conducted PV inspection on pharmaceutical companies in Egypt.
  • PSMF related Pitfalls specialized training sessions for pharmaceutical companies’ PV focal points in Egypt.

Dr. Diakalia Traore

 

Dr. Rania Aly

Summary:

Dr Rania is the Patient Safety Lead at Roche Egypt affiliate for 4.5 years, with previous experience in the pharmaceutical industry since 2008 ranging between sales experience for five

years and Pharmacovigilance experience for more than nine years.

Additionally, she was appointed as a Risk Management Product Lead on rotation for one and a half years in the Roche Affiliate Global Interface team.

Dr Rania is also a member of the ISOP (International Society of Pharmacovigilance), Egypt Chapter.

 

 

Professional Experience:

Current Position:

Patient Safety Lead, Roche Egypt

 

Previous positions:

  • RM Product Lead on rotation, Jan 2022- July 2023, Roche AGI team
  • Global Safety Senior Associate, Amgen, Egypt Cluster (Egypt/ Iran/ Sudan) and Levant cluster (Lebanon/Jordan/ Iraq), April 2017-May 2019.
  • Affiliate Safety Representative, AbbVie Egypt, May 2015-October 2016.
  • Pharmacovigilance Specialist, Pharma-Tech, September 2014- May 2015.
  • Senior Oncology Product Specialist, AstraZeneca Egypt for Pharmaceutical Industries, January 2013-November 2013.
  • Oncology Product Specialist, AstraZeneca Egypt for Pharmaceutical Industries, September 2008-January 2013.

 

 

Associations:

Member of the ISOP Egypt Chapter, 2020- Present

 

Education

Bachelor of Pharmaceutical science – 2008, Alexandria University, Egypt

 

Certifications:

  • Competency Accelerator Experience, Powered by the Live with Intent Pathway, Roche, September 2023
  • Safety Risk Management Bootcamp, Roche, December 2021
  • Pharmacovigilance Audit Training, Egyptian Pharmaceutical Vigilance Center, 16-17 February 2020
  • Practical Guide to Writing Risk Management Plans, Management Forum, London, 28 Jan 2019
  • Hands on Practice Pharmacovigilance training, Egypt Pharma Regulatory Conference, 17-18 October 2018
  • Amgen Distributors’ day, Dubai, 2-4 October 2018.
  • Pharmacovigilance training, GCC Pharma Regulatory Summit, Dubai, 12-13 March 2018.
  • Affiliate Research workshop, Abbvie Germany, 1-2 June 2016.
  • Principles of Good Clinical Practice Workshop, by ClinArt, Dubai, 16-18 May 2016.
  • The Arab Africa Pharma Conference and workshops on Pharmacovigilance, 5-8 May 2016
  • Onboarding Medical Training, AbbVie Paris, October 2015.
  • Common Arab Pharmacovigilance Guidelines (Pharmacovigilance system and their quality systems, Pharmacovigilance System Master File, Pharmacovigilance audits and inspections), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, August 2015.
  • Common Arab Pharmacovigilance Guidelines (Risk Management Plans and Risk Minimization Measures), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, April 2015.
  • Common Arab Pharmacovigilance Guidelines (Periodic Safety Update Report), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, March 2015.
  • Common Arab Pharmacovigilance Guidelines (Pharmacoepidemiology), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, January 2015.
  • Common Arab Pharmacovigilance Guidelines (Post authorization safety studies, Signal management, Additional monitoring, Safety communication), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, December 2014.
  • Dale Carnegie Training in Team Building, April 2013.
  • Social Styles Training Course, 2012.
  • TTM associates Training in Key Account Management, 2010.
  • The Dale Carnegie Seminar in Effective Communications and Human Relations, June 2009.

 

 

 

Dr. Raghavendra Pai

Pharmacovigilance Leader with Passion For Patient Safety with expertise In APAC, MEA, And Eurasian Region PV:

 

  • 20+ years in pharmaceutical industry specializing in pv and clinical research.
  • 15+ years of international pv leadership experience, coaching and empowering next-gen pv leaders.
  • Proficiency in pre and post marketing pv regulatory requirements in apac, middle east, and Eurasian region.
  • Proven expertise in building, developing, and executing pv qms, regional and affiliate pv governance model.
  • Savvy in pv audits/ inspections and capa implementation.
  • Track record of strong personal performance combined with demonstrated ability to build and lead a high performing team.

Dr. Nesrine Fraoui

Dr. Nesrine is a highly accomplished professional in the field of pharmacy, serving as the PharmD (Doctor of Pharmacy) in Charge of Vigilance at the Department of Technical Monitoring, Inspections, and Vigilance within the prestigious National Agency for Pharmaceutical Products of Algeria (ANPP).

 

With a solid educational background and extensive experience, Dr. Nesrine has become a trusted figure in the pharmaceutical industry. She holds a Doctor of Pharmacy degree, which reflects her deep understanding of the field and her dedication to improving the quality and safety of pharmaceutical products.

 

In her role at the ANPP, Dr. Nesrine is responsible for ensuring the safety and efficacy of pharmaceutical products within Algeria. She oversees the vigilant monitoring of technical processes, conducts thorough inspections, and enforces strict quality standards to guarantee the well-being of the Algerian population. Her work is instrumental in upholding the highest pharmaceutical standards and protecting the health of the nation.

 

Dr. Nesrine is known for her unwavering commitment to her profession and her strong sense of responsibility. Her dedication to her work is driven by a genuine desire to make a positive impact on healthcare in Algeria. Her expertise, attention to detail, and her leadership within the ANPP have earned her a reputation as a top professional in the field, inspiring trust and respect from colleagues and peers alike.

 

Outside of her professional life, Dr. Nesrine enjoys staying up-to-date with the latest developments in the pharmaceutical industry and is a passionate advocate for public health and safety. Her career continues to be marked by her relentless pursuit of excellence and her unwavering dedication to ensuring that the people of Algeria have access to the highest quality pharmaceutical products. Dr. Nesrine’s work serves as a testament to her commitment to the betterment of healthcare in Algeria and her enduring impact on the pharmaceutical industry.

Dr. Andrea Julsing Keyter

Dr. Andrea Julsing Keyter Has Over 15 Years Of Experience Within The Field Of Regulatory Affairs For Pharmaceuticals And Medical Devices, Regulatory System Strengthening, Quality Management And Production.

She Is A Pharmacist By Profession And Has Completed Her Phd In Regulatory Affairs At The University Of Hertfordshire In The UK In 2020.

She Worked For The South African Health Products Regulatory Authority As A GMP Inspector Followed By Her Role As The Head Of The Medical Device Unit. Prior To That She Worked In The Pharmaceutical Industry Both In Production And Quality Assurance. Dr Keyter Has Expert Knowledge And Experience In Regulatory System Strengthening And The Application Of Reliance Pathways For Enhanced Regulatory Performance.

She Has Participated As A Member And Chair Of A Number Of Committees Including PIC/S, The African Medicines Regulatory Harmonization And The African Medical Device Forum; And WHO-Led Working Groups Relating To Quality Management Systems For National Regulatory Authorities, HIV Self-Testing, Artificial Intelligence For Health, GBT For Medical Devices And Post-Market Surveillance.

In Her Current Capacity As A Technical Officer, Appointed In The WHO Regulatory System Strengthening Team, Dr Keyter Is Responsible For WHO-Led Benchmarking Activities, Providing Technical Assistance And Training To Member States And Is The Focal Point For The WHO Coalition Of Interest Parties (CIP) Network And The WHO Global Competency Framework.

 

Dr. Laura B. Martin

Laura Martin, PhD is the Vaccines Program Director, Global Health Technical Programs at the United States Pharmacopeial Convention (USP). Dr. Martin brings more than 20 years of increasing scientific and leadership responsibilities for the end-to-end development of vaccines of poverty-related disease in industry, government and academia, and a passion for global health.

 

In her role at USP, Dr. Martin leads the development and implementation of USP’s Global Health vaccine strategy to ensure access to quality-assured essential medical products.  Previously, Dr. Martin was responsible for portfolios of candidate vaccine projects including those combatting antimicrobial resistant bacteria and malaria.

MS. HELA BEN SOLTANA

She is a pharmacist, that graduated from University of Pharmacy in Tunisia and also holds a master’s degree in marketing Intelligence and Strategic Monitoring.

Prior to joining Bausch and Lomb, she worked for several companies in pharmacovigilance and regulatory affairs sectors (AbbVie, Novo Nordisk, and Sanofi Pasteur).

Ms. Hela also has regulatory experience with Novo Nordisk and Sanofi Pasteur for Tunisia and Libya.

Dr. Mukesh Dheda

Dr. Mukesh Dheda is the Director of the Pharmacovigilance Centre for Public Health Programmes based at the National Department of Health, South Africa. He obtained a B Pharm from the University of Durban Westville, an M Pharm from the University of Potchefstroom and a PhD from the University of KwaZulu Natal.

He has been instrumental in understanding pharmacovigilance (PV) in South Africa. He is involved in a number of policy, research and training initiatives which have grappled with the challenge of improving PV in South Africa. He has worked in the area of PV, both regulatory and public health PV, since the early 2000s. In his ongoing tenure as a registered pharmacist for almost forty years, Dr. Dheda has trained many pharmacists and interns, some directly under his supervision.

Mr. Libert Chirinda

Libert Chirinda is a Chief Regulatory Officer in the Pharmacovigilance and Clinical Trials (PVCT) Division at the Medicines Control Authority of Zimbabwe (MCAZ), where he is involved in managing vigilance activities as well as clinical trials oversight activities.

He has ten (10) years’ experience in pharmacovigilance activities, clinical trial oversight, and medicines regulatory affairs, and has been part of the PVCT Division, which is also the National Pharmacovigilance Centre for Zimbabwe, since 2013. He has been involved in several pharmacovigilance initiatives locally, regionally, and internationally, and seeks to improve pharmacovigilance systems in Zimbabwe and beyond.

He is also a member of the Medical Research Council of Zimbabwe (MRCZ) National Health Research and Development Committee (NHRDC), which is involved in reviewing protocols submitted to the MRCZ for ethics approval.

He holds a Bachelor of Pharmacy Degree from the University of Zimbabwe (UZ), as well as a Master of Health Sciences Degree in Pharmacovigilance from the University of KwaZulu-Natal (UKZN).