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 →
Monday June 16, 2025 11:00am - 12:00pm EDT TBDWalter 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
Assess 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
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Associate Center Director - Strategic Initiatives, 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 →
Monday June 16, 2025 2:15pm - 3:15pm EDT TBDWalter 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 →
Monday June 16, 2025 2:15pm - 3:15pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.
Learning Objectives
Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.
Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
Associate Center Director - Strategic Initiatives, 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 →
Monday June 16, 2025 2:15pm - 3:15pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
