This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.
Learning Objectives
Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT 207AWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies
Learning Objectives
Describe the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.
Chair
Mandy Kaur Budwal-Jagait, MSc
Speaker
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized Adil Nashed
Panelist Peter Twomey, MA, MPharm
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized Kavita C. Dada, PharmD, RAC
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized Reina Hayashi
Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
Captain Kavita Dada, Pharm.D., RAC, is the Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at FDA's Center for Drug Evaluation and Research. With over 20 years of regulatory experience, she leads initiatives to modernize... Read More →
Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reina Hayashi currently serves as an inspector of the Office of Non-clinical and Clinical Compliance in the Pharmaceuticals and Medical Devices Agency (PMDA).
Adil Nashed graduated as a Veterinarian from University of Khartoum, Sudan.He successfully completed his Veterinary Internship in Vienna, Austria under the supervision of the University of Vienna. Adil also holds a post graduate diploma in Homeopathic Medicine and Science from the... Read More →
Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT 152ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.
Learning Objectives
Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative and explain how sponsors can benefit from participating in Project Orbis.
Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation, Therapeutics Goods Administration, Australia
Dr. Sarah Golding is dual qualified; both as a medical doctor and a biomedical scientist with honours in biochemistry and molecular biology. Her 12 years' experience at Australia's Therapeutic Goods Administration (TGA) include 9 years in the clinical review and approval of oncology... Read More →
Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
Head of the Pharmaceuticals Registration Department, Medical Technology, Health, Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department at the Medical Technologies, Health Innovation, Information, and Research Directorate, Israel Ministry of Health. In charge of several units evaluating non-clinical and clinical data as part of MA applications and post-approval variations... Read More →
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Regulatory Consultant/Clinical Lead, Health Products Regulation Grou, Singapore HSA, Singapore
Regulatory Consultant and clinical Lead at Health Sciences Authority (HSA), Singapore, with over 15 years of experience in regulation and clinical evaluation of medicinal products specialising in vaccines and oncology products. Medical training from Osmania Medical College, India... Read More →
Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
Dianne Spillman is the Associate Director for Global and Regulatory Outreach in the FDA's Oncology Center of Excellence (OCE). She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government service spans over 30 years, with the majority in FDA... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT 147ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The International Council for Harmonisation (ICH) was established in 1990 by regulatory authorities and industries in the United States, Japan, and Europe with a mission to harmonize requirements for the development of medicines. Since, the Association was reformed in 2015 to establish ICH as a true global entity, increase participation from regulatory authorities and industry around the world and increase the implementation of ICH guidelines globally thereby speeding access to medicines for patients and supporting the global supply of medicines. It has been nearly 10 years since the ICH reforms were completed. In this session, Regulatory and Industry experts will reflect on how far we’ve come and the progress achieved in harmonizing scientific and technical requirements for the development of medicines since 1990. Speakers will share perspectives on the evolution of medicines development as a result of ICH guideline development. Further, speakers will exchange perspective on future opportunities for international regulatory harmonization with consideration of the increasing globalized nature of medicines development and navigating the evolving landscape and use of innovative approaches before turning it over to the audience to hear their ideas around how to promote international harmonization and continued global drug development and patient access to medicines.
Learning Objectives
Discuss progress in international harmonization of regulatory requirements for the development of medicines since ICH was established in 1990 and its increased global footprint following the reforms in 2015; Evaluate impact of ICH guidelines in global drug development; Identify future opportunities and how ICH can evolve to keep pace with innovation and further promote international regulatory harmonization and increased patient access to medicines.
Chair
Amanda Roache, MS
Speaker
US Regulatory Perspective on the Future of International Harmonization Theresa Mullin, PhD
Industry Priorities for the Future of International Regulatory Harmonization Wassim Nashabeh, PhD
ANVISA Perspective on International Global Harmonization and Future Opportunities Marcelo Moreira, MS
EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities Peter Twomey, MA, MPharm
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Associate Center Director - CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States
Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific... Read More →
Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT 150ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.
Learning Objectives
Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.
Director of the Centre for Policy, Pediatrics and International Collaboration, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →
Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT 145ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Crossing 1.5 billion population in 2024, Africa's demographic boom is urging new models of development and innovation. In this fireside chat, four pioneers (from leading U.S. medical centers to Top 10 pharma to big-name philanthropies) will share their ground-breaking journey in advancing Africa healthcare and R&D capabilities, and ambitious plans ahead. The panelists will be joined by DIA's incoming and past Board Chairs to help unlock our community's collective energy and creativity on this worthy front and explore win-win collaborations.
Learning Objectives
Discuss the significant social progress and momentum in the world's fastest growing continent, as well as implications for healthcare development, patient needs and opportunities, and life science innovations. Recognize the vision, achievements, lessons learned, and future goals shared by this cross-section of global and on-the-ground change makers.
Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
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... Read More →
Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT 206Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.
Learning Objectives
Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.
Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot works in Regulatory Policy & Science at Bayer. Prior to joining Bayer, he worked as consultant in regulatory affairs at PharmaLex. He is a pharmacist (PharmD) by training and has a master's degree in international drug development and registration. He is based in Basel... Read More →
Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of... Read More →
Ben Moscovitch leads Amazon Web Services public policy efforts in the Americas for healthcare, life sciences, education, and other sectors. Ben focuses on legislative and regulatory policy reforms to facilitate responsible AI adoption, enable data interoperability, support innovation... Read More →
Associate Director, Regulatory Affairs CMC, Novartis, United States
David Yao is an experienced regulatory CMC project lead at Novartis. He is a pharmacist by training with expertise on global regulatory submissions and registrations in the oncology area. In recent years, David has also been leading digital innovation in regulatory affairs, overseeing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT 146BCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.
Learning Objectives
Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.
Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
Division Director, Division of Planning and Management, Office of International, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2024-present Division Director, Division of Planning and Management, Office of International Strategy and Planning, PMDA 2019-2024 Deputy Review Director, Office of Cellular and Tissue-based Products, PMDA 2015-2019 Senior Reviewer, Office of pharmacovigilance II, PMDA 2013-2015 Section... Read More →
Executive Vice President Data Business, CMIC Co., Ltd, Japan
Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes CDM, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing, Quality Management and Dx Strategy. Eri Sekine has over 30 years' experience in various functions in clinical... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT 147ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.
Learning Objectives
Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.
Chair
Stephanie Choi, PhD
Speaker
An Overview of Emerging Regulatory Guidance & Frameworks for Developing Fit-for-Purpose Real-World Evidence: Proposed Areas for Harmonization Rachele Hendricks-Sturrup, DrSc, MA, MSc
ICH M14: Establishment of an ICH guideline on “General principles on the plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” David Moeny, MPH, RPh
Collaborative international efforts on RWD/RWE: What is coming next? Patrice Verpillat, DrMed, MD, PhD, MPH
Opportunities for regulatory alignment? Data quality assessment and reporting Nicole Mahoney, PhD
Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States
Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →
Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
Executive Director US Regulatory Policy & Intelligence, Novartis, United States
Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →
Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States
David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT 144ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.
Learning Objectives
Describe MHRA’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with MHRA regulators.
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
Group Manager - British Pharmacopoeia & Laboratory Services, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility... Read More →
This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.
Learning Objectives
Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.
Chair
Jamie Wilkins, PharmD
Speaker
Recent EMA Risk Management Initiatives- GVP XVI r3 Priya Bahri, PhD, RPh
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
Head, Risk Management Center of Excellence, Pfizer Inc, United States
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT 207AWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.
Learning Objectives
Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Bachelor's degree in Pharmaceutical Sciences with Clinical and Industrial qualification. Master's degree in Health Science. Professional experience as a pharmacist at the Ministry of Health in Brazil. Since 2014, working as a CMC reviewer at the National Health Surveillance Agency... Read More →
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT 145ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.
Learning Objectives
Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.
Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
Director, Global Bioethics and Technology Ethics Lead, Takeda, United States
I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →
Director, Office of Clinical Policy, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 204ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.
Learning Objectives
Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.
Chair
Elena Popa, MPharm
Speaker
Panelist Patrice Verpillat, DrMed, MD, PhD, MPH
Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update Kelly Robinson, MSc
A Comparative Analysis of Data Quality Frameworks Simon Bennett, MSc
Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
Chief of Staff, Global Regulatory Affairs, Bayer, Switzerland
Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 147ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.
Learning Objectives
Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.
Director, Office of Pediatric Therapeutics, FDA, United States
Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →
Chief Medical Adviser, Australia Health Products Regulation Group, Australia
Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.
Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands
Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 209ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.
Learning Objectives
Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.
Chair
Ling Su, PhD
Speaker
Brief Introduction from the NMPA Feng Zhu
The Progress of China's Drug Review and Approval Reform Jianwu Zhang, PhD
Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective Wei Zhang
The Past Decade of China's Biopharma Innovation Xiaoyuan Chen, PhD
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?
Learning Objectives
Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance
Chair
Melissa Herman, MSc
Speaker
Industry Perspective Maria Apostolaros, JD, PharmD, MS, RPh
Industry Perspective Lesley Maloney, PharmD
Industry Perspective Elizabeth Rosenkrands-Lange, MPH, MS
Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →
Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.
Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →
Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 146BCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Washington, D.C. Office in November, 2024 for one of the purposes of strengthening regulatory cooperation between U.S. and Japan. After the establishment of the Office, direct communication and practical cooperation at D.C. time make possible, and it is also possible to make the foundation of regulatory cooperation. This session will explore the purpose behind the establishment of PMDA’s Washington, D.C. Office and its role in strengthening U.S.-Japan regulatory cooperation. Representatives from PMDA and FDA will share their perspectives on collaborative opportunities, followed by a panel discussion on how this initiative can enhance global regulatory alignment and communication.
Learning Objectives
Analyze the strategic purpose behind the establishment of PMDA’s Washington, DC Office and evaluate its role in enhancing regulatory cooperation between the US and Japan; Engage in a panel discussion to identify and propose opportunities for collaborative initiatives between PMDA and FDA that support global regulatory alignment and improved international communication.
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
Director, Oncology Center of Excellence, CDER, FDA, United States
Richard Pazdur, MD, is founding director of the FDA Oncology Center of Excellence since 2017. He joined FDA in 1999 as director of the Division of Oncology Drug Products and led consolidation of cancer drug review divisions in 2005. He earned a BS from Northwestern University (1973... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT Salon CWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
ICMRA played a key role during the COVID-19 pandemic, ensuring sharing of vital information, providing common responses and aligning regulatory practices. A critical lesson learnt was that during a global crisis regulators need to become the main source of trusted information, both for each other and for the general public.
Learning Objectives
Evaluate ICMRA’s role in promoting global regulatory alignment and information sharing during the COVID-19 pandemic; Analyze strategies used by regulators to counter misinformation and disinformation during health emergencies.; Formulate evidence-based communication approaches to build public trust in regulatory authorities.
Chair
Tony Lawler, MD, MBA
Speaker
Panelist Daniel Pereira
Regulators as Communicators in High-Income Settings Emer Cooke, MBA, MSc
Findings from the 2025 Edelman Trust Barometer Special Report: Trust and Health Camille DeSantis
Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
Managing Director, US Lead Health Brand Development, Edelman, United States
Camille DeSantis is Managing Director and U.S. Lead of Health Brand Development at Edelman. She returned to Edelman after founding Guard Dog Brand Development and SIGNAVA. A pioneer in archetypal brand strategy and inventor of research methods, she builds successful health brands... Read More →
Deputy Secretary, Health Products Regulation Group, Australian Department of Health and Aged Care, Australia
Professor Lawler is the Deputy Secretary, Health Products Regulation Group with the Australian Department of Health and Aged Care. Prior to this he was the Chief Medical Officer and Deputy Secretary Clinical Quality, Regulation and Accreditation with the Tasmanian Department of H... Read More →
National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.
Learning Objectives
Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.
Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt
Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating... Read More →
Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA... Read More →
Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates
Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT 145ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.
Learning Objectives
Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.
Chair
Kwaku Marfo, PharmD, MBA, MPH
Speaker
Harnessing Partnerships and Collaboration to Sustain the Ecosystem Chimwemwe Chamdimba
Clinical Trial Conduct In Africa: Current Regulatory Systems and Regulations Yvonne Adu-Boahen
Unlocking Clinical Research to Drive Access to Innovation Beno Nyam Yakubu, DVM
African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa
Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →
Africa Market Development Specialist, IQVIA, Ghana
Kwaku Marfo currently holds a role of Market Development Specialist for sub-Sahara Africa with IQVIA. Kwaku is a dynamic Life Sciences leader with 18 years of experience in Pharma and Global Health across US, Europe and Africa markets in diverse therapeutic areas such as Hematology... Read More →
Head of Clinical Trial Department, National Agency for Food and Drug Administration, Nigeria
Dr Yakubu background training is Veterinary Medicine, have undergone related trainings on vaccines, epidemiology, Bioethics, and other regulatory activities for over 20 years. has attended many WHO trainings on Vaccines regulatory activities. Dr Yakubu has been involved in the review... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT 209ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia
Learning Objectives
Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.
Chair
Toshiharu Sano, RPh
Speaker
Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks Kenichi Nakamura, MD, PhD, MBA
Changes in Japan's Pharmaceutical Regulations and Clinical Environment Akihiro Ishiguro, PhD
What is Drug Lag and Loss: Challenges for Globalization in Japan Nobutaka Kobayashi, MPharm
Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
Deputy Director, Mitsubishi Tanabe Pharma Corporation, Japan
Kobayashi was engaged in medicinal chemistry as a research scientist in the pharmaceutical company for 13 years. After that, he was engaged in medical policy, drug price application, and management planning for 13 years.
Chief, Department of International Clinical Development, National Cancer Center Hospital, Japan
Dr. Nakamura is Chief of International Clinical Development at the National Cancer Center Hospital. After earning his MD from Kyoto University in 1999 and completing surgical training, he joined NCC to manage JCOG, Japan’s largest cancer clinical trial group. Since 2015, he has... Read More →
Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT 151BWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.
Learning Objectives
Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.
Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT 146BCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.
Learning Objectives
Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.
Chair
Judy Shin, PhD
Speaker
Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP Min-Jung Lim, MPharm, RPh
Case study using Real-World Data on Post-Marketing Safety in Korea Bonggi Kim, PhD
An Overview of RWD Utilization for Drug Safety Assessment in PMDA Shinya Watanabe
Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance Jeff Lange, PhD
Director of Observational Research in Asia, Amgen, Hong Kong
Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the... Read More →
CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of
Min-Jung Lim is the CEO and Senior Pharmacovigilance Consultant at MediSafe, with over 25 years of experience in clinical research and pharmacovigilance. She previously led drug safety functions as Head of Pharmacovigilance & Post Marketing Studies at GSK Korea. She also serves as... Read More →
Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Reviewer (Epidemiology), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinya Watanabe is an epidemiologist at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. He conducts pharmacoepidemiological studies using medical information databases, such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT 201Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.
Learning Objectives
Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.
Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis 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... Read More →
African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa
Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →
Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
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... Read More →
Bunmi Femi-Oyekan is a pharmacist with over 32 years of experience in the pharmaceutical industry, primarily in regulatory, sales, and safety, currently serving as the Regulatory Lead, Accord and Access for Pfizer. She is responsible for development and execution of regulatory strategies... Read More →
In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.
Learning Objectives
Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.
Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →
Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT 146BCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The Indonesian regulation for clinical research has shown a significant transformation during the past year, after practically being at a very low level for the past decade. The Ministry of Health, together with the Indonesian Drug and Food Regulatory Body are prepared to welcome global pharmaceutical companies to conduct researches in various hospitals in the country.
Learning Objectives
Discuss the recent transformations in Indonesian clinical research regulations and their impact on the country's research environment; Recognize the opportunities and challenges for global pharmaceutical companies conducting clinical research in Indonesia under the new regulatory framework.
Chair
Endang Wahjuningtyas Hoyaranda
Speaker
Indonesia’s Health Research Revolution: Fast-Tracking Innovation & Global Collaboration in Clinical Trials Budi Gunadi Sadikin
Head of Clinical Research Unit, Research Manager, National Brain Center, Mahar Mardjono Hospital, Indonesia
Dr Yuli is a neurologist specializing in neuro-oncology and currently serves as Head of the Clinical Research Unit at the National Brain Center Hospital Mahar Mardjono in Jakarta, Indonesia. She is pursuing a doctoral research program at Universitas Airlangga. She earned her medical... Read More →
President, Indonesian Association For the Study of Medicinals (IASMED), Indonesia
Endang is currently the President of the Indonesian Association for the Study of Medicinals, aside from holding her responsibilities as President of Prodia Utama which is the holding company of Prodia Group, a Group of 8 healthcare companies including the largest health laboratory... Read More →
Chairperson, Indonesia Food and Drug Authority, Indonesia
Prof. dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. Since August 2024, Prof. Ikrar brings exceptional expertise in pharmacology, cardiovascular science, and neuroscience to DIA's Annual Meeting. His remarkable journey spans education at Hasanuddin University, University of Indonesia, and... Read More →
Mr. Sadikin was the Vice Minister I of State-owned Enterprises and tasked to establish market leading and globally competitive state-owned enterprises. From July 2020 until December, 22nd 2020, he lead the National Economic Recovery and Transformation Task Force amidst the COVID-19... Read More →
Director, Center for Biomedical and Health Genomics and INA-CRC, Indonesia Ministry of Health, Indonesia
Indri Rooslamiati Supriadi is Director of Indonesia’s National Center for Biomedical and Health Genomics and the Indonesia Clinical Research Center (INA-CRC) under the Ministry of Health. She leads national efforts in precision medicine and clinical research, streamlining regulations... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT 150ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.
Learning Objectives
List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.
Chair
Ralf Herold, DrMed, MD
Speaker
How Industry Is Shaping Public-private Partnerships To Facilitate New Development Pathways For Products Ginny Beakes-Read, BSN, JD
The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges Louis Stancato, PhD
Accelerating Translation of Regulatory Science Research – EFPIA’s perspective Solange Corriol-Rohou, DrMed, MD, PhD
Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →
VP Enabling Technologies, Indiana Biosciences Research Institute, United States
Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT 150ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.
Executive Director, Regulatory Policy and Science, Bayer, United States
Amy Bertha is currently Executive Director, Regulatory Policy and Science at Bayer. Her prior experience includes, regulatory program and project management at FDA Center for Drug Evaluation and Research, regulatory affairs at Pfizer, and research scientist at Hoffman-La Roche. She... Read More →
Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →
Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
Health Science Policy Analyst, OMP, CDER, FDA, United States
Dr. Gabriel Innes is a Health Science Policy Analyst on the Real-World Evidence (RWE) Analytics Team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), FDA. Responsibilities on the RWE Analytics Team include internal consults related to RWD and... Read More →
Thursday June 19, 2025 10:30am - 12:00pm EDT 146ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
