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
Barriers and enablers in international RWE harmonization Nicole Mahoney, PhD
Comparison of RWE guidelines across regions Rachele Hendricks-Sturrup, DrSc, MA, MSc
ICH Efforts in International RWE Harmonization David Moeny, MPH, RPh
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 Pharmaceuticals Corporation, 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 →
Acting 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 TBDWalter 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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT TBDWalter 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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
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.
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 TBDWalter 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 TBDWalter 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, Office of Clinical Policy and Programs, OC, 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 TBDWalter 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
Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update Kelly Robinson, MSc
A Comparative Analysis of Data Quality Frameworks Simon Bennett, MSc
Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly... 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, Marketed Health Products Directorate, Health Canada, Canada
Kelly is the Director General of Health Canada’s Marketed Health Products Directorate. She leads a diverse team on a range of health product regulatory activities including surveillance, assessment, and risk management; risk communications; health product advertising; use of real-world... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT TBDWalter 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, OC, 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 →
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 →
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.
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 →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT TBDWalter 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) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.
Learning Objectives
Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.
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 →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
With several regulatory and ethics authority initiatives to encourage patient input to trial design, how can authorities provide aligned review, guidance and expectations towards these activities and how should sponsors communicate patient engagement?
Learning Objectives
Discuss US (FDA) and EU (EUCTR and country ethics committees) initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from sponsor survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance; Describe emerging markets.
Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and engagement across neurology and neuro-rare development programs.
Tuesday June 17, 2025 4:00pm - 5:00pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
