MEET OUR SPEAKERS

Dr Manal Younus is currently the head of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy. Key achievements include the establishment and the expansion of the Iraqi pharmacovigilance system. Represent Iraq in the WHO international drug monitoring program (PIDM).

She is an International Society of Pharmacovigilance (ISoP) Advisory Board member and represent ISoP in the Council of International Organizations of Medical Sciences (CIOMS). Manal is the vice president of the ISoP Middle East chapter, ISoP Pharmacovigilance Professional Qualification Framework SIG member and she had authored more than 30 articles in different drug safety related subjects. Finally, a member of the specialized committee for Antimicrobial Resistance of the International Academy of Public Health (IAPH).

Jaber M. Jaber, head of the rational drug use and pharmacovigilance department at Jordan food and drug administration (JFDA).

Pharmacist Jaber is a senior pharmacovigilance specialist with more than 18 years of experience in both public and private sector. Pharmacist by education, obtained master’s degree in pharmacology from the university of Jordan.

He had participated in several committees like the validation of the method of analysis, re-registration for originator & generic medicines and currently the head of health hazard evaluation committee.

Jaber is a member in the international society of pharmacovigilance (ISoP) and a member in the Brighton collaboration.

Dr. Katya is the Pharmacovigilance officer Working at Ministry of Health – Prevention / Drug Department (MOH) in UAE

She’s also the Pharmacovigilance office reporter of the UAE National Pharmacovigilance Committee from 2008 till this day.

Dr. Katya was also the registration Officer for new drug application, renewal of registration, minor variation, manufacturing facilities registration and local manufacturer registration as well at the Ministry of Health and Prevention (MOH) in UAE.

As for Dr. Katya’s educational background, she has a B.SC Pharmacy from Philadelphia University in Amman Jordan

Dr. Emad Eldin Munsour is a supervisor pharmacist at the Pharmacy and Drug Control Department, Ministry of Public Health (MoPH), Qatar. He has completed his PhD in pharmacy practice from Universiti Sains Malaysia, Penang, Malaysia. His professional experience started as a drug information and clinical pharmacist at Sri Ramakrishna hospital; Lecturer of Pharmacy Practice Department at University of Medical Sciences and Technology and Regulatory Affairs Manager (East Africa) at Hikma Pharmaceuticals Ltd.

He led the development of Qatar National Formulary (QNF) as a website and mobile application, Dr. Emad also served in the capacity of QNF editor and committee member from January 2013 till now. He participated in the comprehensive restructuring of Qatar’s drug regulatory teams and cross-functional processes. Dr. Emad is the focal point, Qatar Pharmacovigilance Center (Associate Member of Uppsala Monitoring Center, WHO). He served as the coordinator for Qatar National Drug Coding Project, Qatar Pharmaceutical Track and Trace System and Qatar National Medicines Security Strategy.

Dr. Emad served as an external member, the Graduate Supervisory Committee, College of Pharmacy, Qatar University and as a representative of the Pharmacy and Drug Control Department for Qatar’s National Health strategy (2018-2022).

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Senior Leadership team.

He has been manager of the Vigilance Intelligence and Research Group for 10 years and in 2019 become Head of Pharmacovigilance Strategy.

Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation and WHO.

Mick continues to have oversight of the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems.

He is currently leading the MHRA’s transformation of vigilance systems with a remit to develop common IT and methodologies for medicines and devices.

Mick is Chair of the MedDRA Management Committee, and a member of the Uppsala Monitoring Centre Board.

He graduated from Clinical Pharmacy at the Addis Ababa University and he’s currently finalizing my Master’s degree in Medicine Regulatory Affairs. Mr. Nathan is  an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy. In addition he is the Co founder and Vice President of East Africa Regulatory Affairs Professionals Association. He works closely with the Ethiopian Food and Drug Authority (EFDA) in the medicine registration, inspection and PR departments. He also works as an external regulatory consultant for medicine registration.

Dr. Reem Al-Essa has a PhD in Pharmaceutical Regulations and an EU2P MSc in Pharmacovigilance and Pharmacoepidemiology, with a long and diversified experience in both government and private sectors in Kuwait.

She started her career in Kuwait Ministry of Health in September 1999, Drug and Food Control, Pharmaceutical and Herbal Medicines Registration and Control Administration as a Regulatory Reviewer of Pharmaceutical Registration Dossier. She was promoted to become the Head of Drug Registration Department, and then Drug Registration and Release Superintendent. She then moved from the Government career to join the community pharmacy field and worked on the raising the community’s awareness in ADR reporting, Pharmacovigilance and Medication Management Services in the private sector since 2013. With her continuous passion in Pharmacovigilance, Dr. Reem became an active Pharmacovigilance Advocate in the social media since 2016 with her social media presence under the title “Report Me Kuwait”. She then reached an opportunity to continue making positive changes in her field at the Ministry of Health, so she made her mind to end her community practice in the private sector and moved back to MOH in 2017 to work in the Drug Inspection Administration carrying out the role of pharmacy licensing and inspection in addition to her role as a PV focal point and PV Advocate in the social media.

Dr. Al-Essa became The Coordination and Development Superintendent at the Pharmaceutical Services Administration, Ministry of Health in 2019. She is responsible for ensuring the best quality pharmaceutical care practice at government hospitals and primary healthcare clinics, which include the availability of safe and effective treatments as well as coordinating any safety issues related to the use of medications with the phamacovigilance team at the Drug and Food Control sector.

Dr. Reem Al-Essa was the main role player in obtaining Kuwait’s Full member in the WHO International Programme in Drug Monitoring in 2021.

Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AIMajma’ah, but soon moved to the Saudi Food & Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert inP harmacovigilance.

In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation-SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.

Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.

Dr. Marian is a strategic and accomplished leader with more than 15 years of resounding success in Pharmacovigilance, Clinical Research, Medical affairs and Business Development within the Pharmaceutical industry across the Middle East and Africa region. Distinguished career reflects scientific expertise in promoting the safe use of pharmaceutical products through PV system development, product vigilance, and risk assessment/mitigation strategies.

Dr. Marian started her career as a medical representative in Cairo, Egypt and then relocated to Dubai, UAE , where she held several regional senior roles in different top multinational pharmaceutical companies,” Novartis , GSK, Allergan and Abbvie”

Dr. Marian accomplished Extensive knowledge of Pharmacovigilance regulations and practices in the assigned territories with profound experience in quality control and management of PV procedures with high level of collaboration with relevant stakeholders. Recognized as a Subject Matter Expert with track record of success in providing PV insights through safety assessments, regulatory compliance, PV partnership and drug safety audits.

Merihan has multi-functional and diversified working experience in (Pharmacovigilance, drug safety and clinical research) since 2010.

Possessing 12 years’ experience in multinational pharmaceutical companies with getting involved in all pharmacovigilance activities locally & globally, starting from Novartis pharma in Cairo then joined Abbvie biopharmaceuticals in 2015 as pharmacovigilance specialist Gulf, relocated in Dubai in 2015, then promoted to be PV manager/ASR Gulf in 2018.

After AbbVie’s acquisition of Allergan in May 2020, merihan supported the global and local PV integration’s network in building the Middle East & Africa PV hub strategy and was appointed as Middle East & Africa safety operations & compliance lead.

Merihan also got the Master of Business Administration degree in 2013 as well as the Dubai health authority license in 2015.

She also has a great experience in delivering trainings to different stalk holders as pharmaceutical companies, third parties, distributors, and clinical research organizations, as well as being part of GCC PV training in 2019 in, her session was well recognized by the audience.

Merihan also is working to elevate the PV brand and overcoming the PV challenges and obstacles by being part of trade associations like Middle East and Africa EFPIA IPVG Work stream as well as the Pharma group in Egypt.

Merihan believes that Pharmacovigilance is crucial function as it is related to the patients’ safety and that should be everyone’s responsibility.

Dr. Eva Kopečná works at Acino International, Switzerland as Head of Global Regulatory Affairs, Medical and Pharmacovigilance. She has spent more than 23 years in the pharmaceutical industry in different positions, starting in R&D as a medical expert, then as Head of clinical trials, and finally she moved to Regulatory Affairs where she has been building and leading different Regulatory Affairs, Pharmacovigilance and Medical Affairs teams and organizations supporting R&D, Regulatory and Pharmacovigilance activities. Eva is a Medical Doctor with 1^st and 2^nd degrees in Internal Medicine, in addition she holds a MSc. degree in Regulatory Affairs from Cardiff University in the UK and Ph.D. in Pharmacy from Charles University in Prague. Eva is the author of several scientific publications, including one book on GCP. Eva has been TOPRA MSc module leader or co-leader for four TOPRA modules since 2007 and is teaching in other universities on Regulatory and GCP topics. Eva is a winner of TOPRA Award in Regulatory Excellence and is currently a member of Board of TOPRA Directors.

Ahmed has more than 12 years of experience in Pharmacovigilance (PV) and Quality Compliance. He started his career in Egyptian Health Authority in Drug Factories inspections, then moved to Pharmacovigilance center before joining the Pharma companies as Qualified Person for Pharmacovigilance since 2015.

Ahmed managed to establish and maintain efficient and complaint PV system in more than 14 countries throughout his years of experience in close partnership with Health Authorities and Local License Partners including Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Pakistan, Qatar, Sudan, UAE, and Yemen. In his role as regional Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey and Africa (IMETA) at Boehringer Ingelheim; Ahmed is supporting and leading IMETA OPUs to act as Patient ambassadors within the organization so that we can lead the internal and external environment to achieve the safest use of our products.

Joëlle Issa-Blok works at Acino MEA, UAE as Regulatory Affairs, Quality and Pharmacovigilance Director for the Middle East, Turkey and Africa region. She has 16 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations. Joëlle is a Pharmacist, in addition she holds a MSc degree in Drug Innovation R&D from the University of Utrecht in the Netherlands.

Samar El Gendy is a Country Safety Head & QPPV for the Gulf affiliate at Biogen. She has a very diverse cross-functional experiences working in several roles in Quality, Commercial Excellence, Learning & Development, Medical Operations & Excellence, Governance, Compliance, Regulatory and Pharmacovigilance.

Samar is a key strategic partner for the local business and provides valued consult and collaboration to all affiliate stakeholders and functions to support local objectives. Her passion for pharmacovigilance started since she was a student, and she sees Pharmacovigilance instrumental in ensuring that patients come first

Furthermore, she is a strong believer of the value of “great workplace” and she had stretched herself above and beyond her call of duty where she has been appointed as Women’s Leadership Initiative lead and a Chief Wellness Officer during her time in GSK and currently she is a council member of the Diversity, Equity and Inclusion at Biogen BIR region.

Samar is a pharmacist by qualification, a Global Health nerd, a volunteering advocate, a pianist by passion and a believes that every day is an opportunity to learn something new.

Ahmed is a pharmaceutical industry professional with over 10 years of experience in regulatory health authority engagement, pharmaceutical product licensing and lifecycle maintenance, market access/reimbursement, good pharmaceutical manufacturing, distribution and quality management.

He started his career with GSK in 2011 and moved to Roche in 2020. He has been a standing representative on the Regulatory Affairs Working Group (PHRMAG) since 2015, and has been leading UAE policy advocacy efforts on behalf of the group since 2021.

He is a licensed pharmacist and a published academic. He holds a Bachelor of Science in Pharmaceutical Sciences and Biotechnology from the German University in Cairo.

Ms. Rehab is the Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare FZ LLC. She has 14 years experienced pharmacist with a diversified expertise and a high exposure to the medical registration and regulatory issues as well as deep understanding of the registration requirements and procedures of the MENA Ministries of Health. Previously she worked as a Regulatory Affairs & Pharmacovigilance Manager at Aspen HealthCare FZ LLC. Prior to that she was also the Senior Regulatory Affairs & Labelling Associate MENAT at Aspen HealthCare FZ LLC and she began with Pfizer Consumer Healthcare as a Regulatory Affairs Officer in 2017

Dr. Ahmed Hegazy is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine

(First Class Honor), Mini MBA, Medical Quality Management Diploma and Hospital Management Diploma.

• He holds certificates on programs or courses from:
• • The George Washington University, USA
  • Columbia University, USA
  • Royal College of Physicians, UK
  • Hibernia College, Ireland
  • Uppsala Monitoring Center, WHO
• He attended many trainings in leadership, strategic thinking, decision-making, brand planning, building efficient teams, high performance, accountability, communication skills, and persuasion and selling skills.
• Moreover, He attended courses in Outcome Research and Health Economics, Drug discovery and development, Medical Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
• Ahmed had been trained on ISO 9001-2015 Quality Lead Auditor Certification and Lean and Six Sigma Greenbelt Holder.

Dr. Ahmed received various awards and recognitions in innovation (Upjohn Award), achievements and others.

• He has scientific publications in international journals.
• Advisory Board, Committee member or member to International Scientific Journals, Associations and Conferences.
• He is a member of Emirates Medical Association
• He is a member of Emirates Health Economics Society
• He is a member of the ISoP society and was a committee member of the ISoP Middle East Chapter.
• He was invited as a speaker for hundreds of local, regional, international events and on TV as well as various online programs.
• He attended numerous (~100s) conferences and events.

He owns more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and

functions (sales, training, medical, marketing and PV).

• He is an Expert in the Medical Affairs as he worked for 11 years in various positions in the Medical Affairs (Sr. Manager, Regional Manager and Head) in which he got experience in all MA roles, clinical research, governance, compliance, quality. He possesses strong medical knowledge in various therapeutic areas and many products’ portfolios. Currently, he conducts medical development programs.
• He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.

Currently he is a:

• Consultant for Medical Affairs, and Pharmacovigilance for Global, Regional and Local companies.
• Senior Auditor for an international EU-based firm.
• Speaker, Lecturer and Trainer for some colleges, companies, and health authorities.

Alina holds a bachelor’s degree in Pharmacy from the University in Moscow and MBA degree from Nottingham University, UK.

Alina is an auditor and has experience in Quality Assurance and Regulatory Affairs across EU, US and APAC regions.

Since moving to the Middle East from Malaysia Alina has been working as a freelancer in Quality, Regulatory and PV in GCC and Russia, while working on her Master`s degree in Pharmacovigilance with the Drug Safety Research Unit (DSRU, UK).

She also currently supports research on Drug Safety and Risk/Benefit Assessment with the University of Hertfordshire, UK.

Syed Zaferuddin is a Pharmacovigilance & Medical Device vigilance professional working as Global Vigilance Manager & QPPV at Julphar UAE. In past worked for companies like Jamjoom Pharma, TCS, Cognizant and Clinnovo. He is a speaker for World Drug Safety Congress in Europe and America. Skilled in Good Clinical Practice (GCP), Pharmacovigilance, Medical Device vigilance, Drafting Agreements, management of ICSR, aggregate reports, Pharmacovigilance intelligence, PV QMS, PV safety database and PV LMS. A strong legal professional with a Master’s Degree focused on Pharmacology. Also heading an NGO aims to increase the ICSR reporting culture in the Middle East.

Eman has a wealth of experience in PV since 2012; with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.

She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.

She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.

After Abbvie’s acquisition of Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed on May 2021 as the Lead of the Middle East & Africa PV hub , the largest PV hub in Abbvie.

She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.

Lastly, Eman has participated in GCC PV trainings that took place in Dubai, UAE, in years 2019 and 2020, 2021 and her sessions were widely recognized and got excellent feedback from the audience and regulators as well.

She also has multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College since 2020.

Eman is now the Middle East & Africa MEA Hub Lead in Abbvie and also is a member of International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.