Speakers

Christelna Reynecke is the COO of South African Health Products Regulatory Authority (SAHPRA). She holds a Master of Business Administration (MBA) from the Edinburgh Business School (Heriot Watt University). She also has a BPharm Degree from the University of the North West. Before joining SAHPRA in Jan 2021, Christelna spent 13 years in the Pharma Logistics sector in both Quality Assurance/Regulatory Compliance and Logistics Operations roles and developed an appreciation for Lean Six Sigma approaches, tools and process improvement. The first 8 years of her career in the Retail and Courier Pharmacy sector cemented her passion for prioritizing patient well-being and out-of-the box thinking – to find different, new and innovative approaches to problems that frontline healthcare workers are confronted with.

Isabelle is a Regulatory/QA executive with over 20 years of progressively responsible 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. In this respect, 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.

Teresa Eastwood-Kiefer is an established regulatory leader, with over 18 years of experience in Pharmaceutical Development Regulatory, currently leading global data and content submission and automation teams within Roche. Teresa is an active member of the EFPIA eCTD Subgroup (Subgroup of European Regulatory Affairs Operations), actively contributing to EFPIA positions with regards to global adoption of digital solutions, electronic common technical document (eCTD) and common data standards, and cloud-based submissions. Teresa is a member of the newly established Industry Focus Group on EMA’s Raw Data Pilot. A passionate advocate for innovation and digitalization, Teresa leads various automation and AI programs and she regularly assesses trends in industry and technology to proactively translate them into opportunities to increase efficiency and advance Roche’s and industry’s global submission strategies.

Uchenna Adesugba is a trained pharmacist with 17 years of experience in the pharmaceutical and consumer goods sectors. She is currently the Head, RA Policy & Strategic Operations, SSA, Novartis based in Lagos, Nigeria. Before joining Novartis in December 2016, she has held Regulatory Affairs, Quality Assurance as well as Corporate Affairs & Communication roles in different organizations. In her current role, she is responsible for identifying policy issues and actions to shape the regulatory environment in SSA, developing regulatory strategy and acceleration plans for key products across the Region, clinical trials and compliance oversight. She is very passionate about improving access to safe, quality, and efficacious medicines for patients in Africa

Dr. Jayesh M. Pandit is the Pharmacovigilance Country Head (PVCH) and the Qualified Person for Pharmacovigilance (QPPV) for Bayer Pharmaceuticals and Consumer Health in East Africa, based in Kenya and coordinates pharmacovigilance activities across North-West Africa (NWA) country cluster. Before joining Bayer, Jayesh was the Head of the Medicines Information and Pharmacovigilance Division at the Pharmacy and Poisons Board- Kenya’s National Medicines Regulatory Authority, where he served for 10 years. Jayesh initiated and developed the National Pharmacovigilance System to ensure the quality, safety, and efficacy of medicines used in Kenya. Jayesh has also served as the Secretary to the Expert Committee on Clinical Trials, has been a member of the Africa Vaccines Regulatory Forum (AVAREF), a member of various public health program- technical working groups (TWGs) as well as WHO’s team of consultants on Pharmacovigilance in Africa (Pharmacovigilante-Sans-Frontier). Currently Jayesh is an active member of the Pharmaceutical Society of Kenya (PSK), International Society of Pharmacovigilance (ISoP) and its Africa chapter and ISoP’s Special Interest Group on Eco Pharmacovigilance (EcoPV), among other professional groups. At the Kenya Association of Pharmaceutical Industries (KAPI), Jayesh, until recently, also Chaired the Pharmacovigilance and Medical Affairs Committee.

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.

Sean Burke has 20 years working in pharmacovigilance, of which 11 have been as a director of pharmacovigilance for the affiliates at MSD. 

In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions.

Sean supports in the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. He is responsible for Pharmacovigilance activities such as PV Intelligence and Operational activities within the International PV organization. Sean is a chairperson of two EFPIA PV working groups (Africa and the Middle East).

Dr. Vasee Moorthy is Senior Advisor, Research for Health Department, WHO Science Division, Geneva, Switzerland. Since 2008, he has held progressively senior roles at WHO in malaria vaccine policy development, Ebola vaccine phase 1-2 trials, global norms in sharing research data and results during public health emergencies, WHO R&D Blueprint for action to prevent epidemics, global consensus on clinical trials policy norms, WHO COVID-19 Research & Innovation Roadmap and the WHO Solidarity Trial of therapeutics supporting clinical trials networks in over 40 Member States in all WHO regions, and most recently, the adoption of resolution (WHA75.8) on clinical trials. Prior to joining WHO, Dr. Moorthy worked as a medical researcher at the University of Oxford, UK (2005-2008); with an NGO, PATH, in USA (2003-2005); running a clinical trials programme at MRC Laboratories in The Gambia (1999-2003), and as a government medical officer in Kwazulu/Natal, South Africa (1996-1997). He received a B.A. and M.A. from the University of Cambridge in Natural Sciences, a B.M.B.Ch medical degree and a Ph.D in malaria immunology and clinical trials both from the University of Oxford.

Nankanja Ruth Mukiibi is a 49 year old female Ugandan citizen living with sickle cell disease. A teacher by profession and hold a B.A (Education) degree from Makerere University.

She is the Founder/ Executive Director Sickle Cell Association of Uganda. Among others, she has been board member at The Academy for Health Innovation, Infectious Disease Institute representing community perspective; board member of the School of Biomedical Sciences Research and Ethics Committee, Makerere University Kampala; member technical working committee for Non-communicable diseases Ministry of Health Uganda (MOH), and Member National Steering committee for Sickle Cell Disease, MoH.

Over the years she has participated on the core national planning teams of Ministry of Health namely, technical working committee for non- communicable diseases. She has also been on the national sickle cell steering committee where we worked on the National Health policy, Health sector strategic implementation plan, National Anemia policy and strategy plus reviewing the training manuals and clinical guidelines to consider Sickle cell issues. 

Jacqueline is a pharmacist and a pharmaceutical biotechnologist with over 15 years’  cumulative experience in regulation of medicines, biopharmaceuticals, vaccines, blood and blood products, and tobacco products.

Her current role at WHO, supports regulatory capacity in review of clinical trial applications via the African Vaccines Regulatory Forum (AVAREF) multi-country joint review procedure, regulatory and ethics training, development of  guidelines and training courses aimed at regulatory systems strengthening mainly in Africa.

Nankanja Ruth Mukiibi is a 49 year old female Ugandan citizen living with sickle cell disease. A teacher by profession and hold a B.A (Education) degree from Makerere University.

She is the Founder/ Executive Director Sickle Cell Association of Uganda. Among others, she has been board member at The Academy for Health Innovation, Infectious Disease Institute representing community perspective; board member of the School of Biomedical Sciences Research and Ethics Committee, Makerere University Kampala; member technical working committee for Non-communicable diseases Ministry of Health Uganda (MOH), and Member National Steering committee for Sickle Cell Disease, MoH.

Over the years she has participated on the core national planning teams of Ministry of Health namely, technical working committee for non- communicable diseases. She has also been on the national sickle cell steering committee where we worked on the National Health policy, Health sector strategic implementation plan, National Anemia policy and strategy plus reviewing the training manuals and clinical guidelines to consider Sickle cell issues. 

Nankanja Ruth Mukiibi is a 49 year old female Ugandan citizen living with sickle cell disease. A teacher by profession and hold a B.A (Education) degree from Makerere University.

She is the Founder/ Executive Director Sickle Cell Association of Uganda. Among others, she has been board member at The Academy for Health Innovation, Infectious Disease Institute representing community perspective; board member of the School of Biomedical Sciences Research and Ethics Committee, Makerere University Kampala; member technical working committee for Non-communicable diseases Ministry of Health Uganda (MOH), and Member National Steering committee for Sickle Cell Disease, MoH.

Over the years she has participated on the core national planning teams of Ministry of Health namely, technical working committee for non- communicable diseases. She has also been on the national sickle cell steering committee where we worked on the National Health policy, Health sector strategic implementation plan, National Anemia policy and strategy plus reviewing the training manuals and clinical guidelines to consider Sickle cell issues. 

Kelly Chibale is a Professor of Organic Chemistry at the University of Cape Town (UCT) where he holds the Neville Isdell Chair in African-centric Drug Discovery & Development. He is also the founding Director of the South African Medical Research Council Drug Discovery & Development Research unit at UCT, the Founder and Director of the UCT Holistic Drug Discovery and Development Centre H3D, a Johnson and Johnson (J&J) Centre for Global Health Discovery. Kelly obtained his PhD in Synthetic Organic Chemistry from the University of Cambridge in the UK. This was followed by postdoctoral stints at the University of Liverpool in the UK and at The Scripps Research Institute in the USA. He was a Sandler Sabbatical Fellow at the University of California San Francisco, a US Fulbright Senior Research Scholar at the University of Pennsylvania School of Medicine, and a Visiting Professor at Pfizer in the UK.

Karim Kacimi is a PharmD from Algiers University with a PhD in Pharmacology on clinical trial applied to the establishment of biosimilarity. He has 10 years of experience in the field of regulatory affairs,  covering Algeria and French speaking Africa. He is chair of Algeria industry association regulatory workstream group.

Jacqueline 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.

Gabriela Zenhäusern, a pharmacist with a PhD in biomedical research, joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. In her current position, she is responsible for the coordination of international collaboration, acts as Vice-Chair of the Assembly of the International Council of Harmonisation (ICH) and represents Swissmedic at the Management Committee of the International Pharmaceutical Regulators Programme (IPRP) and the Access Consortium (Australia-Canada-Singapore-Switzerland-United Kingdom). In addition, she is leading the patient organisation working party at Swissmedic. Gabriela Zenhäusern used to work in the sector authorization at Swissmedic from 2010 to 2015 before joining the Regulatory System Strengthening Team in Regulation and Safety at the World Health Organisation (WHO) from 2015 to 2019.

Nankanja Ruth Mukiibi is a 49 year old female Ugandan citizen living with sickle cell disease. A teacher by profession and hold a B.A (Education) degree from Makerere University.

She is the Founder/ Executive Director Sickle Cell Association of Uganda. Among others, she has been board member at The Academy for Health Innovation, Infectious Disease Institute representing community perspective; board member of the School of Biomedical Sciences Research and Ethics Committee, Makerere University Kampala; member technical working committee for Non-communicable diseases Ministry of Health Uganda (MOH), and Member National Steering committee for Sickle Cell Disease, MoH.

Over the years she has participated on the core national planning teams of Ministry of Health namely, technical working committee for non- communicable diseases. She has also been on the national sickle cell steering committee where we worked on the National Health policy, Health sector strategic implementation plan, National Anemia policy and strategy plus reviewing the training manuals and clinical guidelines to consider Sickle cell issues. 

Benita Morar is MEA PV Partnership Lead for AbbVie. She is a highly skilled professional with 16 years of pharmaceutical industry experience. Before devoting her time to Pharmacovigilance, Benita worked in Quality Assurance for Reckitt Benckiser and Ranbaxy. 

Dirk has a background of 35 years in drug development with strong expertise in clinical operations, and quality management. Before taking up his current role in 2017 as Head Capacity Development – Global Public Health R&D, he has taken senior positions in Janssen and Tibotec as Head Clinical Operations Central and Eastern Europe, Global Head Clinical Operations and Quality Management at Tibotec, Global Head Quality Management & Training at GCO and Global Head Quality Assurance BRQC.

During his career he applied strong data driven risk-based approaches that resulted in significant increase in efficiencies and compliance for the applicable organizations. In his current function, Dirk is responsible to mitigate the increased risk and challenges linked to the execution of clinical trials and other clinical data generation activities in low- and middle-income countries. He drives different projects that will result in the execution of cost-effective and compliant clinical trials in resource limited settings. These initiatives include both Janssen-internal and consortium projects such as CTCAN, involving other pharma companies through the cross-pharma capacity development initiatives that aim to bring more clinical trials to Africa and ensure earlier access to medical innovations for African patients.

His team also drives the Ebola vaccine projects and supports the Dengue, TB and Leprosy development programs.

Paloma Tejada joined IFPMA in July 2020. She is the focal point for patient, health professional, and civil society engagement.

Before joining IFPMA, Paloma launched Rare Diseases International, a global advocacy platform for rare disease patient organizations.

Prior to this, Paloma was responsible for communications at the non-profit EURORDIS-Rare Diseases Europe. She started the first Rare Disease Day and grew it from a European patient awareness day to a global communications campaign.

Paloma began her career in global health as a Programme Coordinator for Médecins du Monde’s international HIV/AIDS network. She has extensive experience working for non-governmental organizations in Europe, America, and Asia.

She has a Masters in Development Management from the London School of Economics and Political Science (LSE) and holds a Bachelor in Communications and Print Journalism from The American University.

Alex Adusei is Executive Director of Women’s Hope Foundation an NGO advancing patient safety, women and girls human rights and gender equality in Ghana. He is a World Health Organization Patient for Patients Safety Advisory Group Member and Patient Safety Champion in Ghana. He is a member of the Global Patient for Patients Safety Network, as well as a member of the WHO Guidelines Developing Group (GDG) for the new WHO guidelines on the prevention of bloodstream infections (BSI) and other infections associated with intravascular catheters (IVCs). I’m a Council member of the World Patient Alliance. He is a Human Right Advocate and Community ealth Health Promoter and works as a researcher, facilitator, trainer and consultant on Patient Safety issues in Ghana.

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.

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.