MEET OUR SPEAKERS
MEET OUR 2023 SPEAKERS
DR. KATYA NABEEL AILABOUNI
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. KATYA NABEEL AILABOUNI
Pharmacovigilance Officer at Ministry of Health - Prevention / Drug Department (MOH) - UAE
DR. MANAL YOUNUS
Dr Manal Younus is an ISoP Fellow and is currently the Director of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy.
She led the creation and the expansion of the Iraqi pharmacovigilance system. Currently, she is an Advisory Board member of the International Society of Pharmacovigilance (ISoP) and working with students to increase the awareness regarding pharmacovigilance. She is an Executive Committee member of the Council of International Organizations of Medical Sciences (CIOMS).
Manal is co-founder of the ISoP Patient Engagement SIG, the vice president of the ISoP Middle East chapter, and ISoP Pharmacovigilance Professional Qualification Framework SIG member. She had authored more than 30 articles in different drug safety related subjects.
She is a WHO benchmarking assessor. Finally, a member of the International Academy of Public Health (IAPH) Scientific Council and Antimicrobial Resistance Specialty committee member.
DR. MANAL YOUNUS
Director of Iraqi Pharmacovigilance Center based in MOH - Iraq
DR. REEM AL-ISSA
Acting Director of Drug, Inspection Administration, at Ministry of Health - Kuwait
MS. ALINA PANOURGIA
Alina holds a bachelor’s degree in Pharmacy from the University in Moscow and MBA degree from Nottingham University, UK.
Alina is an experienced Quality Assurance Auditor and Regulatory Affairs professional who worked across the EU, US and APAC regions.
Since moving to the Middle East from Asia, Alina has worked as a Regulatory, PV and Quality freelancer. Alina covers MENA, LATAM and CIS regions for regulatory submissions while working with UK and EU companies on PV projects.
Alina is due to complete her Thesis in Pharmacovigilance on “Post-authorisation safety studies in EU and MENA regions”.
MS. ALINA PANOURGIA
Pharmacovigilance Consultant in UAE
PHARMACIST, MSC. JOËLLE ISSA – BLOK
Joëlle Issa-Blok currently works at Acino MEA, UAE as Regulatory Affairs and Pharmacovigilance Director for the Middle East, Turkey, and Africa region. She is as well the QPPV for the UAE and Oman. She has 17 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 at Astellas where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations. She lived and worked 10 years in the Netherlands where she gained her experience in EU RA & PV regulations. Joëlle is a pharmacist graduated from the Saint Joseph University in Beirut, in addition she holds a Masters in Science degree in Drug Innovation Research & Development from the University of Utrecht in the Netherlands.
PHARMACIST, MSC. JOËLLE ISSA – BLOK
Regulatory Affairs & PV Director Middle East, Turkey & Africa, QPPV UAE & Oman at Acino
DR. EVA KOPECNA
Dr. Eva works for Acino International as a Head of Global Regulatory Affairs, Medical and Pharmacovigilance and is a member of management of the company. She has 20+ year experience at pharmaceutical industry in different positions, starting in R&D as a medical expert, than 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 organisation supporting R&D activities, new submissions, LCM activities for finished products and actives substances. In addition, Eva has wide experience with mergers & acquisitions & integration and divestment activities.
Dr. Eva is a medical doctor with 1st and 2nd degrees in Internal Medicine, in addition she holds MSc. degree in Regulatory Affairs from Cardiff University in the UK, 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 4 TOPRA modules since 2007. Eva is winner of TOPRA Award in Regulatory Excellence and served 4 years a member of Board of TOPRA Directors.
DR. EVA KOPECNA
Head of Global Regulatory Affairs, Medical & Pharmacovigilance at Acino
DR. NAHED YAISH
- 19 years experience in Pharmaceutical Field
- 14 years experience as QA Responsible Person, QPPV/LSR and Regulatory Affairs for Local & International Pharmaceutical Companies
- 4 years Experience as BD, QA, RA & PV consultant for Manufacturer and drugstores located in (Jordan)
- Established System for QA, PV & RA which passed successfully local inspections & European audits.
- Qualified International Trainer by International College in London (ICL)
- Owner & Founder of State Of Practices Consultancy Center (SOP Consultancy Center)
DR. NAHED YAISH
General Manager of State Of Practices Consultancy Center
DR. RASHA TAWFIK
Rasha Tawfik is a Pharmacovigilance manger and serves as LPPV for Middle East / Africa region for Bausch Health US, she also held position at global SDEA team.
Rasha is pharmacist by education, she held master’s degree in molecular biology and diploma in pharmacovigilance.
She previously served as regulatory affair specialist responsible for regulatory submission & regulatory intelligence.
She had previous experience at molecular biology field, she served as molecular biology and research lab associate. She served also as Clinical pharmacist.
In her PV role, Rasha manages daily operational activities, Oversee partner qualification. Support partner PV system creation and maintenance and ensure partner compliance as well as enforce SDEA execution.
Her ultimate goal is patient safety, improving PV awareness in MEA countries to assist medication safety decisions making and to ensure collected information is more relevant and applicable to domestic populations in the region.
DR. RASHA TAWFIK
PV Manager MEA and LPPV at Bausch Health
MR. MICHAEL FAUST
Since 2017 Michael supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.
Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than five years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.
MR. MICHAEL FAUST
RCC Business Consultant at EXTEDO
DR. ANDREA STRIEBEL
Dr. Andrea Striebel is Product Manager at EXTEDO GmbH, located near Munich (Germany). In her role she is responsible for the Safety Hub at EXTEDO and works closely together with the entire Product Management Team. Prior to taking over the PM role she started as Senior Business Consultant at EXTEDO in January 2016 and was working on customer projects. She is not only following the latest developments in pharmacovigilance, but also related to IDMP. Before joining EXTEDO she worked in the pharmaceutical industry for more than 11 years focusing on pharmacovigilance topics.
First as a scientist and later she took over the team leader position for global drug safety and in 2011, she became QPPV. In her role, she was responsible for establishing and maintaining the global pharmacovigilance system within the company. Being QPPV, Andrea was also involved in audits and inspections as well as XEVMPD topics. Additionally, she gave pharmacovigilance trainings and held presentations at national and international conferences.
DR. ANDREA STRIEBEL
Product Manager at EXTEDO
STAVROS KARDAHAKIS, PHD
Stavros joined EXTEDO’s Customer Care back in November 2020, where he has been acting as the Head of Business Consulting services for the last 1.5 years.
He is steering EXTEDO’s business consultants in delivering services in the fields of Agency support, Industry RIMS, Publishing, and Pharmacovigilance.
Before joining EXTEDO has was managing the core drug safety group of a major European drug manufacturer, overseeing pharmacovigilance and XEVMPD services for hundreds of clients. In parallel he was tasked with services portfolio expansion, domain business development and to act as point of contact with IT, Clinical Affairs, and QA teams. Notable achievements in his decade with the organization include a complete restructuring of the business operating procedures, establishing new service opportunities, contributing to the revenue and human capital growth, securing the reputation of the team, while successfully sustaining multiple EMA, NCA and client audits.
His previous assignment was a Deputy QPPV for a generic company, where he implemented the entire pharmacovigilance system from scratch.
Stavros is a Chemist by academia and holds a PhD in Molecular Quantum Mechanics.
STAVROS KARDAHAKIS, PHD
Head of Business Consulting at EXTEDO
DR. SHAHINAZ BADR
Shahinaz, pharmacist with more than 20 years’ experience in pharmacy and pharmaceutical business, currently working as Pharmacovigilance Consultant and auditor for PQE Group covering the EMEA region. Started her career as a clinical pharmacist in Cairo University Medical School Teaching Hospital integrating with top HCPs of different specialties in interdisciplinary healthcare systems, where safety monitoring was always an integral part of clinical practice.
Leveraging on her expertise, she joined the pharmaceutical industry working in Regulatory Affairs and later on regional positions before focusing on Pharmacovigilance. Actively working in pharmacovigilance regulatory Intelligence in a role enabling her to interact with industry colleagues and Competent Authority Pharmacovigilance departments.
Dr. Shahinaz has contributed to several international initiatives and partnerships to help support patient safety and improve the monitoring of drugs for safety. She is an active member the ISOP Special Interest Group collaborating in the initiation of the GPPC (Global Pharmacovigilance Certificate).
DR. SHAHINAZ BADR
Pharmacovigilance Consultant and PVQA Auditor - EMEA at Pharma Quality Europe
DR. ADO H. MUHAMMAD
Dr. Muhammad worked extensively in general medicine and orthopaedic surgery including a postgraduate degree at the Institute of Orthopaedics of the University College London before joining the pharmaceutical industry more 20 years ago. He worked in in early phase units and subsequently for PPD Inc, GW Pharmaceuticals, InMed Pharmaceuticals, Ipsen and AstraZeneca amongst others. He has also worked for the Nigerian regulatory agency, supporting the pharmacovigilance and post-marketing directorate.
Dr. Muhammad underwent pharmaceutical medicine specialty training at the UK’s Faculty of Pharmaceutical Medicine of the Royal College of Physicians as well as the postgraduate course at University of Wales in Cardiff between 2007 and 2011. Dr Muhammad also holds an MBA in pharmaceutical industry management. His expertise is in patients’ safety and pharmacovigilance and is a Board Member of the Faculty of Pharmaceutical Medicine.
Dr. Muhammad is a global health enthusiast and advocate, particularly in the areas of social justice, planetary, environmental, and social determinants of health. He is a fellow of the UK’s Faculty of Public Health of the Royal College of Physicians.
DR. ADO H. MUHAMMAD
CEO of Pharmedas Clinical Research & Consultancy (UAE, UK, USA)
DR. SHAIMAA ELMELIGY
Pharmacist with more than 20 years of experience in pharma industry, graduated from Alexandria university -Egypt, worked in many companies on national and international level in different roles.
She has a diversified experience as she managed registration and compliance of Pharmaceuticals, medical devices, cosmetics and FMCG products across the region.in her current tenure she is managing the regulatory affairs, Pharmacovigilance , quality, quality technical projects and medical promotional compliance across and Turkey region at Aspen MENAT.
She is a Certified auditor, holds a certificate in leadership, she has passion about patency laws, so she is certificated in pharmaceutical intellectual property law and recently she received a certificate in industrial biotechnology.
DR. SHAIMAA ELMELIGY
Pharmaceutical affairs Director Aspen healthcare- MENAT
MS. KAREN TAYLOR
Karen established Deloitte UK’s Centre for Health Solutions in November 2011. The Centre is the independent research arm of Deloitte’s Life Sciences and Health Care (LSHC) practices, providing a trusted source of relevant, timely and reliable insights on emerging trends, challenges, and solutions. The Centre combines creative thinking, robust research, and industry experience to develop evidence-based perspectives on some of the biggest and most challenging issues facing our life sciences and healthcare clients to help them to improve efficiency and cost-effectiveness and, importantly, benefit the patient.
Karen’ recent life sciences focus has been on a series of six reports on how AI is transforming the pharma value chain AI In Biopharma Collection | Deloitte Insights; with the most recent being AI in health care pharmacovigilance. Previous research relevant to compliance includes a series of ten predictions on the life sciences and healthcare in the regulatory impact is a cross cutting theme – The future unmasked (deloitte.com) deloitte-uk-life-sciences-healthcare-predictions.pdf and an earlier report A bold future for life sciences regulation | Deloitte UK.
Karen is a member of the Institute of Chartered Public Finance and Accountants and has extensive experience in leading research into healthcare and life-science issues in the UK and internationally. Between 1997 and 2010 Karen was the Director of Health Value for Money (VFM) Audit at the UK’s National Audit Office, and received an OBE for her work on Health VFM work. Karen was a Non-Executive Director (NED) at Dartford and Gravesham NHS Trust from 2011 to 2021, where she chaired the Quality and Safety Committee for six years and the Audit Committee for four years. Since 2022 Karen has been a NED at Kent Community NHS Foundation Trust and a member of the Workforce and Quality and Safety Committees.
MS. KAREN TAYLOR
Head of the Centre for Health Solutions at Deloitte - UK
DR. MICHELLE GEBARA
Dr. Michelle Gebara holds a Doctorate of Pharmacy degree from the Saint Joseph University of Beirut, Lebanon.
Throughout her journey in diverse regional and global pharmacovigilance roles within multinational pharmaceutical companies, she developed and enriched her passion for patient safety through multidisciplinary, innovative, and patient-centric approaches.
DR. MICHELLE GEBARA
Patient Safety Lead for UAE and Gulf countries at Roche Pharmaceuticals
DR. MARIAN ANWAR
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.
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.
DR. MARIAN ANWAR
Benefit Risk & Therapeutic Area Lead, Middle East & Africa, at AbbVie
DR. RAGHAV 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. RAGHAV PAI
Regional Director & Head of Pharmacovigilance MEA/Eurasia At Ipsen Pharma, Dubai
DR. FLORAH MATLALA
Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.
She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.
DR. FLORAH MATLALA
Head of Pharmacovigilance Unit of South African Health Products Regulatory Authority (SAHPRA)
DR. MIRHAN ISMAIL
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. MIRHAN ISMAIL
Safety Operation Lead for Middle East & Africa Region at AbbVie
DR. RAGHDA MOHAMED HASSAN
Raghda Has rich experience in Pharmacovigilance and Patient Safety since 2011 when she starts establishment new pharmacovigilance system in Middle East and North Africa at Eli-Lilly from scratch.
And she was working hand by hand with regulatory authority bodies within Middle East and North Africa region to implement and execute Arab Guidelines for Pharmacovigilance GVP first version.
She has several senior regional roles in multinational companies like Eli Lilly, Shire and now Takeda where she got diversified experience in Patient Safety in different geographical regions including not only Middle East and Africa but also some south European countries like Greece, Portugal, Israel, Spain and Italy by which has been exposed to different experience that she builds on her area of expertise in Middle East and Africa region.
Raghda has passionate to Promote for Patient Safety in general and to optimize patient Safety awareness in specific with full health community sectors.
She is active member in different regional PV associations, and she is active moderators for DIA forums and different Global Pharmacovigilance events.
DR. RAGHDA MOHAMED HASSAN
Pharmacovigilance Lead for Middle East & turkey Cluster at Takeda
DR. MAHA ALJMI
Dr. Maha is responsible for establishing pharmacovigilance system in the country with high quality and efficiency standards.
Dr. Maha has a bachelor’s degree in pharmacy from KSU, and she has 15 years of experience working within various sectors of the pharmaceutical industry having working across a range of key areas sales, medical affairs and pharmacovigilance functions. She has involved in audits and inspection visits.
Got several awards during her career from several departments due to her achievements.
Member in the Saudi Pharmaceutical Society – No. of membership is 4407 Since 2004 (1425 H) –Had been active Member in the Public Relations Committee – Saudi Pharmaceutical Society.
She has a good understanding of the challenges in maintaining regulatory compliance utilizing different methods of implementation. She is passionate about the importance of ensuring patient safety via building a better awareness and understanding of pharmacovigilance.
DR. MAHA ALJMI
Patient safety Lead for Saudi Arabia in Boehringer
DR. SYED ZAFERUDDIN
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.