Programme Committee

​Jacqueline Acquah is a registered pharmacist in Ghana and currently works with Johnson & Johnson as an associate director responsible for vaccines regulatory affairs in emerging markets in Europe, Middle East, and Africa (EMEA). She also currently serves as the Co-Chair for the Africa Regulatory Network (ARN) of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The association works in partnership with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonization of regulatory requirements on the African continent and strengthening of the regulatory ecosystem.

Sarah Adam leads regulatory policy and advocacy in Africa and beyond. This includes interactions with key global stakeholders and regional organizations involved in regulatory harmonization and system strengthening.

Previously, Sarah worked in regulatory and scientific affairs at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Working in academia, Sarah spent more than 10 years researching into pulmonary and pancreatic disease preclinical drug testing and vaccine development. Sarah was an appointed lecturer at the School of Pharmacy at the University of Geneva. She holds a PhD degree in Molecular Biology and an Engineering degree in Biotechnology.

Caroline Allheily has more than eight years experience working on projects in international public affairs. She joined Leem in 2023 as Head of International Affairs. Her portfolio includes international advocacy and global public health issues such as the African Medicines Agency and regulatory harmonization, the fight against falsified medicines, intellectual property, preparedness for future pandemics, antibiotic resistance, the international development of pharmaceutical companies, among others. 

Paula Barbosa is responsible for the IFPMA Influenza Vaccine Supply International Task Force, leading pathogen sharing policy and advocacy efforts for the pharmaceutical industry. Prior to joining IFPMA, Paula worked for GSK in different global marketing and commercial roles, including vaccines and rare diseases. Paula has a MSc in Global Health Policy from the London School of Hygiene and Tropical Medicine, a Master in Pharmaceutical Marketing from Universitat Pompeu Fabra, Barcelona, and a PharmD in Pharmaceutical Sciences from the University of Porto, Portugal.

Dr Samvel Azatyan is a Paediatrician and holds a PhD degree in clinical pharmacology and medical products regulation. Over his more than 20 years at the World Health Organization (WHO), he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team (RCN) and acting as Team Lead for Facilitated Product Introduction (FPI) Team at the WHO's Headquarters in Geneva, Switzerland.

Zainab Aziz is a pharmacist by qualification and holds a Masters in Pharmaceutical Affairs. She has been working in the pharmaceutical field for over 18 years, within hospital, retail, managed health care and industry settings. She has worked in the Regulatory Affairs environment for the past 12 years and has wide experience across various regulatory landscapes. Zainab is currently working at Novartis as an Associate Director for RA Policy and Strategic Operations for Sub-Saharan Africa. She is an active member of the IFPMA Africa Regulatory Network and is involved in several projects covering regulatory harmonisation, clinical trials, regulatory capability building, biosimilars and quality related matters.

Janis Bernat leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team to successfully deliver its policy objectives and advocate for improved regulatory system strengthening. Prior to joining IFPMA, Janis worked in quality assurance and regulatory compliance fora US-based multinational company that specializes in supplying custom value-added food products to a world leading food service and retail food brand. Janis holds a Master of Science in Communication-Public Relations and a Bachelor of Science in Agriculture-Food Science.

Sérgio Cavalheiro Filho works with different IFPMA regulatory workstreams in the development of technical policy documents and implementation of related advocacy activities for regulatory system strengthening, manufacturing quality, and regulatory reliance. He also spearheaded IFPMA’s contribution toward the establishment of the Fight the Fakes Alliance. Before joining IFPMA, Sérgio worked on late-stage drug formulation and development, and as a community pharmacist in Portugal. Sérgio holds a Diploma in Advanced Studies in Management of Clinical Trials from the University of Geneva and a Master in Pharmaceutical Sciences from the University of Coimbra, Portugal.

Isabelle Colmagne-Poulard is a Regulatory/QA executive with over 20 years of experience and accomplishments in the areas of drug and medical device development. Isabelle has joined Merck since 2008 where she held growing managerial roles in Reg. Affairs and Reg. CMC as Head of Department, based in Switzerland. She therefore has a solid practice of regulatory CMC requirements pre- and post-approval for small and large molecules and is used to represent Merck towards Health Authorities. She is actively involved in regulatory policy as member of EFPIA, Europabio, and IFPMA RSC since 2015. She represented IFPMA at various conferences in Asia, Europe, Middle East and Africa, has been a WHO ECSPP observer and is currently IFPMA representative at ICH Training Sub-Committee. In her current capacity as Head of International Global Regulatory Affairs & Scientific Policy, she leads the development of Merck International regulatory policy priorities, supporting the strategic development of Merck R&D portfolio. Prior to joining Merck, she worked for several companies in several areas including in Clinical Development for Servier and assumed various site managerial responsibilities within Sanofi QA/RA for 7 years.  Isabelle holds a Master degree in Biology & Sciences and a Pharm. D as Industrial Pharmacist, coupled with a Master in Quality Management from ESCP Paris.

Mrs. Delese Mimi Darko holds a Bachelor of Pharmacy from the Kwame Nkrumah University of Science and Technology (KNUST) and a Master’s in Business Administration from the University of Northampton. With her over 32-years of experience, she rose through the ranks at the Food and Drugs Authority (FDA) to become the first female Chief Executive Officer in 2017.

Mimi was instrumental in designating the FDA as a Regional Center of Regulatory Excellence, and the establishment and implementation of the food Safety Policy and Food emergency response plan in Ghana. Under her leadership, the FDA has introduced many innovations including the progressive licensing scheme, in collaboration with the Ghana Enterprise Agency (GEA). She currently chairs both WHO African Vaccines Regulatory Forum (AVAREF) and the West African Medicines Regulatory Harmonization Steering Committees and serves on several international and local advisory committees and bodies.

Her exemplary and commendable work has earned her several awards. Notable amongst them are: National Business Shero of the year for the government agency under the National Business Honours Awards 2022, the Public Sector Chief Executive Officer Award under the African Public Sector Awards in 2022, the 2019 GLiTZ Africa’s Award for Ghana Women of the Year Honours (Excellence in Health), and Ghana Business Standard Awards for the Female Business Leader of the Year in 2019.

Bunmi Femi-Oyekan is responsible for leading and providing strategic direction and oversight to the Country’s regulatory teams, thus ensuring the development and execution of regulatory strategies and plans to meet business objectives. Bunmi has over 30 years of experience in the pharmaceutical industry in Sales & mostly Regulatory Affairs (RA). She is a principled individual, passionate about integrity and business ethics, and a spirited team player. She is a member of the IFPMA African Regulatory Network. She sits on various committees for the development of Regulatory Policies and Guidelines to support regulatory systems strengthening in partnership with local trade associations and other stakeholders. Bunmi holds a bachelor’s degree in Pharmacy and an MBA from Obafemi Awolowo University, Ile-Ife, Nigeria.

Dr Djitafo Fah is a pharmacist, specialist in pharmaceutical regulatory affairs, responsible for health programs. Since 2014, he coordinates the Sub-regional Program for the Harmonization of Policies National Pharmaceutics in Central Africa, at OCEAC (Coordinating Organization for the fight against Endemics in Central Africa). OCEAC is CEMAC's implementing agency for public health issues.

Mümün Gencoglu works in regulatory affairs specializing in the field of biotherapeutics and advanced therapies. He is also involved in scientific policy development and co-founded a foodtech company looking to provide better management of gut health.Before joining IFPMA, Mümün was a Postdoctoral Research Fellow at University of Basel’s Biozentrum, working mainly on biological network dynamics and behavior. Mümün holds a PhD in Systems Biology and Genetics from the University of Basel. He has a Master in Biology from University of Zurich and a Bachelor’s in Chemical and Bioengineering from ETH Zurich.

Hussain Jafri is the Executive Director of World Patients’ Alliance. He is also the Secretary General of Alzheimer’s Pakistan, the national association of Alzheimer’s disease and related dementias that Hussain founded in 1999 as a result of his experiences as a care giver for his grandfather with Alzheimer’s Disease. He has been very active in the field of patient safety and has remined the Vice Chair of Advisory Group of WHO’s Patients for Patients Safety Program (PFPS). Hussain has also founded Pakistan Patient Safety Initiative and has been working towards several patient safety initiatives. He has remarkable experience of working as a volunteer in the social sector and has had an opportunity of working with government, national and international non-profit organizations. Hussain is also a member of the Person and Family Centred Advisory Council (PFCAC) of International Society for Quality in Health Care (ISQua). Moreover, he is also a taskforce member of Global Alliance of Partners for Pain Advocacy (GAPPA). Hussain is a PhD from University of Leeds, UK on prevention of genetic disorders.

Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities through EFPIA as well as the BIO and the PhRMA international Committees.

Neveen Kamel holds a degree of Bachelor of Pharmacy – Faculty of Pharmacy – Cairo University. She is currently Head of Regulatory Affairs North Africa, Egypt  & Africa Developing Markets at Merck, supporting regulatory policy advocacy efforts for the region. She has over 20 years of experience in industry and 16 years of them as Regulatory Affairs. Prior to Regulatory Affairs she worked in several multinational companies in different roles such as commercial, quality, pharmacovigilance, market access & pricing . Neveen is also an active member of several trade associations including IFPMA Africa Regulatory Network (ARN); PhRMA Egypt Regulatory working Group. She participated in writing the Position paper for Registration Sampling & QC testing (IFPMA ARN).

Lyne Le Palaire is Quality Advocacy Leader, member of Sanofi Global Quality External Liaison department. She is based in Lyon / France.

Lyne was graduated in 2003 with Master Sciences degree (MSc) in Strategy, Development & Production in Bio-industries obtained in a French University. She has almost two decades of experience in pharmaceutical industry within Quality, Supply Chain & Manufacturing Technology. As Quality Advocacy Leader, Lyne is in charge of developing Sanofi Quality Advocacy position, coordinating Quality Advocacy activities and connecting with external stakeholders. She is also involved in cross-functional activities such as a regulatory reliance pilot on Post Approval Changes.

Nevena Miletic is a Regulatory and Policy professional, passionate about bringing innovative therapeutic solutions to patients in need around the world. She is a pharmacist, with postgraduate studies in pharmacoeconomics, regulatory affairs and quality assurance, and a certified QP, with almost two decades of experience in pharmaceutical industry. Currently she works in the Global Regulatory Policy group in F. Hoffmann-La Roche, Switzerland, and for the last seven years, she is chairing IFPMA Africa Regulatory Network, as well as IFPMA CPP Network. She is also a member of research-based pharmaceutical companies associations and boards (IFPMA Regulatory Science Committee, IFPMA Africa Engagement Committee, DIA Middle East & Africa Advisory Board, EFPIA ERAO, IATF etc.), involved in numerous meetings, workshops and projects with regulators, cross-industry and public-private collaborative platforms (e.g. Pre-ICDRA, ICDRA, SCoMRA, IMI/IHI etc.). Nevena is a strong advocate for regulatory convergence and harmonization, as well as for modernization of regulatory frameworks to enable innovative approaches in drug development and review. She is strongly committed in bringing the voice of industry to key discussions related to the African Medicines Regulatory Harmonization (AMRH) initiative advancement and towards African Medicines Agency - AMA establishment. 

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports the development of harmonized, transparent, and predictable regulatory systems covering the lifecycle of medical products in Africa across the national, regional, and continental levels of the ecosystem. His work also involves support for regulatory emergency preparedness. In this role he works side by side with partners to facilitate development of new medical products, as well as patient access to quality essential medicines. He also serves as Chair of the AMRH Partners Platform, the partner collective that supports regulatory systems strengthening in Africa. Dr. Mukanga has a combined 25 years of experience spanning regulatory affairs, health systems development, clinical research, and product development. David received his professional training at Makerere University, the Johns Hopkins Bloomberg School of Public Health, and the Karolinska Institute.

John Mwangi currently works at Bayer as Head of Regulatory Affairs responsible for East & West Central Africa Region based in Kenya, responsible for Pharmaceuticals and Consumer Health divisions and doubling up as Regulatory Policy & Intelligence Lead for EEMEA Region.  He has previously held different roles in Pharmacovigilance and Quality Control within the Pharmaceutical Industry. He has been an active member of several industry associations including KAPI (Kenya Association of Pharmaceutical Industry) where he has served as member since 2013 including as past executive secretary and continues to serve in in various committees within KAPI and as Board Member.   

John is passionate about supporting the streamline of Pharmaceutical Regulatory Systems & Policy and is currently a member of the Africa Regulatory Network (ARN) within the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) where he is the immediate past co-chair. Additionally, John represents Bayer in the Africa Engagement Committee of the IFPMA and is currently a member of the Africa Strategy for the Global Self Care Federation (GSCF).

Until 30th June 2023, Margareth Ndomondo-Sigonda, has been working for AUDA-NEPAD as the Head of Health Programme. She was responsible for providing technical leadership and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency (AMA) as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa.  She also led the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework. She previously served as Chief Pharmacist Ministry of Health Tanzania (1998), responsible for providing oversight on implementation of the national medicines policy. She also served as a regulator in her capacity as the Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010).  She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.

Dr Winnie Nganga is a highly motivated notable thought leader in the healthcare industry, with 15+ years’ experience in Regulatory Science, Government Affairs, Global Health, Market Access, Advocacy and Policy and product and program development for Health Products and technologies. With vast experience in industry advocacy and policy shaping holding different leadership positions in the industry associations , she is currently the Chairperson of KAPI as well as Regulatory Affairs Director at GSK with Government Affairs role.  She has heightened private sector industry voice in Africa by building and strengthening partnerships and collaborations. Winnie is well versed with the Africa Regulatory environment having a wide array of achievements in portfolio optimization, innovations, clinical trials, access programs, stakeholder engagement, pricing strategy, government engagement, divestments, mergers and acquisitions, license maintenance, new product introductions, digital health  commercial geo-expansion and strategic planning to support patient care in Africa.

Niveen Osman joined Amgen in 2010, and was the lead in expanding the company’s footprint in the Middle East & African markets. She is based in Dubai and is currently Regulatory & Government Affairs Director, and a registered pharmacist and scientific office manager at UAE MoHAP. She works across 17 active countries, with 10 team members across 5 affiliates in MEA region. Prior to joining Amgen, Niveen worked for Sanofi, GSK and Valeant and has been responsible for pharmacovigilance, quality management and regulatory affairs. She has over 20 years solid experience in global pharmaceutical industry regulatory affairs and safety, and is a strong advocate for global convergence of regulatory requirements and pathways. After graduating from university of Alexandria Faculty of Pharmacy in Egypt 1999, she completed her pharmacy practice at Hospitals in Egypt. She also holds a Diploma in Business Administration from University of Leicester, UK.

Greg Perry is responsible for IFPMA’s Africa Engagement and Alliance Building strategies, focusing on innovation, access, and the regulatory environment. He has a long track record of leadership and advocacy in public healthcare and pharmaceuticals at international and European levels. Before he joined IFPMA, Greg was Executive Director of the Geneva based Medicines Patent Pool. He was previously Director General of the European Generic Medicines Association in Brussels, which he started, and co-founder of the International Generic & Biosimilars Medicines Association (IGBA). Greg also worked as the Managing Director and Partner in the Brussels office of a leading UK consultancy and as an advisor in the European Parliament. He has an MA in European Integration and Cooperation from the University of Hull, a BSoc.Sc in International Studies from the University of Birmingham, and a Diploma in Classical Studies from the Open University. Greg is a Member of the Advisory Council of the Organization for Professionals in Regulatory Affairs (TOPRA) and is a former member of the Standing Advisory Committee before the European Patent Office (SACEPO). He was awarded the Golden Cross of Merit of the Republic of Poland for his contribution to industry and European integration in 2004.

Lidija Samardzic is Associate Manager of Regulatory Affairs at IFPMA. She works on regulatory reliance, as well as matters related to the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. Prior to joining IFPMA, Lidija worked in the pharmaceutical company Krka in the marketing department. Having worked as Medical Representative to the Head of Field Force and Training for Southeast Europe, she brings with her experience on how to successfully manage all post-launch activities in the product lifecycle. She holds a Masters in Pharmaceutical Science from the University of Belgrade, Serbia. During her studies, she was involved in scientific work at the Department of Pharmacology.

Willemijn van der Spuij is the Executive Director Europe in the WorldWide Patient Safety Organisation in Bristol Myers Squibb. She is responsible for Patient Safety in the EU markets, Balkans, Baltics and CIS region and is based in Switzerland. Prior to her current role she held responsibilities for PV Intelligence & International Operations including the PSMF, the EU QPPV role and Training and Outsourcing activities.

Willemijn holds a Nursing Degree from the Netherlands, a BA (Hons) in Sociology from Goldsmiths college, University of London, UK and an MSc in Pharmacovigilance from the University of Hertfordshire, UK

She is a member of the EFPIA Pharmacovigilance Expert Working Group and Chair of the EFPIA International Pharmacovigilance Group.

Willemijn started her career in pharma in Quintiles with a focus on GCP activities and joined BMS in 2003 focusing on GVP activities.