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Monday, June 15
 

11:00am EDT

#416.1: International Regulatory Cooperation with the African Medicines Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
110A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-608-L04-P; CME 1.25; RN 1.25

A 60-minute session with AMA, FDA, and partners will review successes in collaboration, explore future opportunities to enhance oversight and access, and conclude with interactive Q&A on advancing harmonized regulatory systems in Africa.

Learning Objectives

Discuss the FDA priorities in regulatory alignment, supply chain resilience, and collaboration in Africa; Recognize how regulators work across regions to improve access, using approaches such as reliance, convergence, and joint inspections to reduce duplication, strengthen resilience, and advance public health.

Chair

Meisha Sampson, MS

Speaker

International Regulatory Cooperation with the African Medicines Agency
Emile Bienvenu

Panelist
Aissatou SOUGOU

International Regulatory Cooperation with the African Medicines Agency
Delese Mimi Darko, MBA, RAC

International Regulatory Cooperation with the African Medicines Agency
Ahmed Mohamed

International Regulatory Cooperation with the African Medicines Agency
Heran Gerba, PHD


Speakers
EB

Emile Bienvenu

Director General, Rwanda Food and Drug Authority, Rwanda
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
HG

Heran Gerba

Director General, Ethiopian Food and Drug Authority (EFDA), Ethiopia
AM

Ahmed Mohamed

Chief Executive Officer, Pharmacy and Poisons Board, Kenya
avatar for Meisha Sampson

Meisha Sampson

Director, FDA, United States
Meisha Sampson is the inaugural Director of the FDA African Medicines Agency Liaison Office within FDA’s Office of Global Policy and Strategy, based at the U.S. Embassy in Kigali, Rwanda, home to the African Medicines Agency. In this role, she advances a collaborative FDA–AMA... Read More →
AS

Aissatou SOUGOU

Director General, Department of Pharmacy and Laboratories (DPL) , Senegal
Monday June 15, 2026 11:00am - 12:15pm EDT
110A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#413: Health Canada Town Hall
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25

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.

Chair

Alysha Croker, PHD

Speaker

Panelist
Sophie Sommerer


Speakers
avatar for Alysha Croker

Alysha Croker

Director, Strategic and Horizontal Policy, 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 →
avatar for Sophie Sommerer

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada
Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives
Monday June 15, 2026 2:30pm - 3:30pm EDT
108B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P; CME 1.00; RN 1.00

No one can solve today’s R&D challenges alone. But are industry consortia fit for 2030? We examine the "head, heart, and gut" to re-imagine collaboration and explore what’s needed to accelerate co-creation and innovation.

Learning Objectives

Recognize the value of industry collaborations, analyze emerging trends and future innovation opportunities; Explain how to shift from patient-centric to patient-driven design thinking.

Chair

Sarah Tremethick

Speaker

Industry Collaboration 2030: Head Perspective
Adrian Hernandez, MD, MHS

Industry Collaboration 2030: Head, Heart and Gut Perspectives
Rebecca Vermeulen, RPH

Industry Collaboration 2030: Gut Perspective
Jeff Smith


Speakers
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
JS

Jeff Smith

The Curator, Smith and Jones Innovation, United States
avatar for Sarah Tremethick

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom
A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

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 15, 2026 2:30pm - 3:30pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-529-L04-P; CME 1.00; RN 1.00

Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.

Learning Objectives

Describe how ICH M11 and digital protocol standards enable seamless, patient-centric clinical trial design and regulatory submissions; Evaluate the impact of AI, cloud, and interoperable data platforms on accelerating regulatory review and improving patient access to innovation; Apply strategies for integrating patient experience data and digital tools to enhance trial inclusivity, data quality, and regulatory confidence.

Chair

Vada Perkins, MS

Speaker

Panelist
Mumtaz Sultani

Panelist
Jimita Parekh

Panelist
Robert DiCicco, PHARMD


Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
avatar for Jimita Parekh

Jimita Parekh

Managing Director, Independent, United States
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
MS

Mumtaz Sultani

European Medicines Agency, Netherlands
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00

Global interest in early intervention for chronic diseases is driving regulatory innovation, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized, patient-focused approaches.

Learning Objectives

Analyze global regulatory and reimbursement challenges associated with decision-making for early treatment of chronic diseases; Assess existing gaps and opportunities within US and EU regulatory and reimbursement frameworks to advance in this area.

Chair

Simon Bennett, MS

Speaker

Regulatory challenges facing the development of treatments for chronic neurological disorders
Steffen Thirstrup, MD, PHD

Panelist
Julian Beach, MBA

Patient Perspective
Mindy Cameron


Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
avatar for Simon Bennett

Simon Bennett

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 →
MC

Mindy Cameron

Patient Advocate, Advocacyworks, United States
Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P; CME 1.00; RN 1.00

Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities.

Learning Objectives

Discuss Industry experience with reliance initiatives; Explain ICMRA and ICH efforts to facilitate a pharmaceutical quality knowledge management capability; Identify benefits and challenges for expanding global regulatory reliance and collaboration; Outline how cloud-based platforms and harmonized regional requirements can strengthen reliance.

Chair

Amanda Roache, MS

Speaker

Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration
Sarah Pope Miksinski, PHD

Panelist
Evdokia Korakianiti, PHD, MSC

FDA Reflection on Experiences with International Regulatory Collaboration and Opportunities
Ashley Boam, MS

Industry Experiences with Regulatory Reliance and Collaboration Initiatives
Joann M Parker, MS, RPH


Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s... Read More →
JP

Joann Parker

Vice President of Regulatory CMC, Pfizer, United States
avatar for Amanda Roache

Amanda Roache

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 15, 2026 2:30pm - 3:30pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00

This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.

Learning Objectives

Analyze how regulatory harmonization and collaboration accelerate global study start-up; Differentiate key principles of ICH E17, E5, and regional oncology MRCT guidelines; Summarize strategies to navigate regional regulatory differences and enable global studies.

Chair

Angelika Joos, MPHARM

Speaker

ethical aspects of conducting MRCTs from a global perspective
Sarah A. White, MPH

Experience from global conduct of MRCTs
Aloka Chakravarty, PHD

Panelist
Paz Vellanki

PMDA perspective
Yoko Aoi, PHD


Speakers
avatar for Yoko Aoi

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →
avatar for Angelika Joos

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →
PV

Paz Vellanki

Associate Director, OND, CDER, FDA, United States
avatar for Sarah White

Sarah White

Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Area Global Alignment in Practice
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Regulatory
  • Feature Topics Global Alignment in Practice
  • Tags Forum

4:00pm EDT

#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-544-L04-P; CME 1.00; RN 1.00

Discover Coalition For Epidemic Preparedness Innovations (CEPI) Pandemic Preparedness Engine (PPE) regulatory node—a forward-looking digital platform using AI and cloud technology to accelerate vaccine approvals through structured data, automated workflows, and global collaborative review.

Learning Objectives

Discuss the conceptual framework of CEPI’s Pandemic Preparedness Engine (PPE) regulatory node and its role in accelerating emergency vaccine approvals; Recognize how AI-enabled workflows and cloud-based platforms can support concurrent, global regulatory review through PDDF and DSVI integration; Identify opportunities for regulatory collaboration and input to shape the future of digital dossier.

Chair

Ashley Jones-Mitchell, MPH

Speaker

Panelist
Melody Chessia

Panelist
Kevin Bugin, MS, RAC

Panelist
Teginder Singh, MPHARM


Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
avatar for Ashley Jones-Mitchell

Ashley Jones-Mitchell

Head of Global Regulatory Policy, Accumulus Synergy, United States
Ashley is Head of Global Regulatory Policy for Accumulus Synergy. With over 19 years of experience in the federal government and industry, Ashley advocates for policies that will advance digital transformation. Prior to her time at Accumulus Synergy, Ashley was with the U.S. Food... Read More →
TS

Teginder Singh

Global Head Regulatory Quality Safety, Google, United States
Teginder Singh is a senior executive and pharmacist with over 25 years of leadership in health & life sciences. His early career focused on drug discovery, and he has since led complex transformation programs across R&D, Regulatory, Quality and Safety at Fortune50 companies like Google... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:00pm EDT

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00

Explore regulatory and manufacturing challenges in cell and gene therapy, including starting material variability, potency testing, comparability, specification, and stability strategies. Gain insights into FDA expectations, ICH initiatives, and collaborative approaches to harmonize definitions and accelerate development while ensuring quality and regulatory clarity across individualized therapies.

Learning Objectives

Identify key regulatory and manufacturing challenges in CGT development, including starting material variability, comparability, stability, setting specifications, and post-approval changes; Discuss FDA and global expectations, harmonization needs, and strategies for individualized therapies to ensure quality and compliance across development phases.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Defining and Controlling Raw and Starting Materials for CGT Manufacturing
Kevin Carrick, PHD

Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
Andrew Chang, PHD

Setting specifications for ATMPs: insights from the ICHQ6 revision
Cecilia Tami, PHD

Stability Considerations for Cell and Gene Products
Akanksha Kaushal, MS


Speakers
avatar for Kevin Carrick

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States
Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →
avatar for Andrew Chang

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

4:00pm EDT

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P; CME 1.00; RN 1.00

The Middle East is a fast-emerging innovation hub. Aligning with global standards, the region is opening new opportunities and incentives. Join us to discover Middle Eastern innovations and why companies should view it as a top investment destination.

Learning Objectives

Discuss how the Middle East has rapidly evolved over the past decade, benchmarking regulatory systems, achieving higher maturity levels, and accelerating cross-stakeholder collaboration.

Chair

Amira Deia Younes

Speakers
avatar for Amira Younes

Amira Younes

Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:00pm EDT

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00

This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis.

Learning Objectives

Identify innovative regulatory strategies for pediatric drug development, including the ICH E11A guideline; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.

Chair

Christina Bucci-Rechtweg, MD

Speaker

Panelist
Laura Jawidzik, MD

Panelist
Lauren Krupp, MD

Panelist
Lynne Yao, MD


Speakers
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →
LJ

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States
Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →
LK

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum

4:00pm EDT

#455: Japan Town Hall
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00

This session explores the benefits of drug development and approval in Japan, highlighting market size, development predictability, and regulatory support, with insights from administrative bodies and the international pharmaceutical industry.

Learning Objectives

Recognize misconceptions about Japan's drug development environment and learn the latest updates; Discuss the benefits of drug development in Japan from regulatory and industry perspectives.

Chair

Daisuke Koga, MS, MSC

Speaker

Panelist
Seiko Usami, PHD

Panelist
Yoshiaki Uyama, PHD, MS, RPH


Speakers
avatar for Daisuke Koga

Daisuke Koga

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 →
SU

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session
 
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    Spark Stage
    TBD
    Zone A
    Zone B
  • Filter By Type
    00: Plenary
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    01: ClinSafety-PV-RM
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    02: ClinicalTrialOps-Innovation
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    03: Data-Tech-AI
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    04: MedAffairs-SciComm
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    05: PersonalizedMed-ComboProd-Diagnostics
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    06: ProfDevelop-Program-PortfolioMgmt
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    07: RegCMC-Product Quality
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    Tutorial
    Workshop
    08: RegPolicy-Strategy-GlobalCollaboration
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    09: RD-Quality-Compliance
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    10: Stats-EvidenceGeneration-RWE
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    Tutorial
    11: Spark Stage
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    12: Content-Hubs
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    Workshop
    13: Community-Rounds
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    14: Posters
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    15: Networking-Opportunities
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    16: InnovationTheaters
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    17: Short-Courses
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    Tutorial
    18: Lift-Series
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  • Audience
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  • Area
    Artificial Intelligence
    Biotech-ClinTech-Pathway
    Cross-Functional Collaboration
    Digital Enablement and Modernization
    Ethics
    Evidence Innovation
    Global Alignment in Practice
    Patient-Centered Design and Experience
    Student and Early Career Pathway
    Therapeutic Pathways
    Trust and Responsible Innovation
  • Timezone
DIA 2026 Global Annual Meeting
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118C
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203AB
204AB
Ballroom AB
Content Hub
Exchange
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
Spark Stage
TBD
Zone A
Zone B
  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
  • 13: Community-Rounds
  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation