DIA 2026 Global Annual Meeting: Full Schedule

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11:00am EDT

Monday June 15, 2026 11:00am - 12:15pm EDT

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

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 →

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

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Regulatory
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

Monday June 15, 2026 11:00am - 12:15pm EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.

Learning Objectives

Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.

Chair

Jeffrey Francer, JD, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD

Speakers

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States

Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States

Barrett Tenbarge

Partner, Faegre Drinker, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Project Management & Strategic Planning
Feature Topics Student and Early Career Pathway
Tags Forum

4:00pm EDT

#450: Medical Writing Ted Experience

Monday June 15, 2026 4:00pm - 5:00pm EDT

105AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P; CME 1.00; RN 1.00

Medical writing myths persist, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity, accuracy, and scientific integrity continue to rise. In this TED-talk–style session, three presenters will explore why medical writing expertise matters, how writers can evolve into influential cross-functional leaders, and the value and limitations of AI currently in use. Attendees will leave with practical insights to elevate the role of medical writers and adopt emerging tools responsibly to improve quality, efficiency, and credibility in drug development communication.

Learning Objectives

Examine the specialized value professional medical writers bring, including how writing expertise reduces risk, improves efficiency, and strengthens scientific credibility—beyond what generalist writing can achieve; Identify the skills and mindsets needed for “future-ready” medical writers; Describe practical ways to grow from document execution roles into strategic leadership and cross-functional influence; Assess current AI uses in medical writing, distinguishing opportunities from hype.

Chair

Monica Chiaramonte, PHD

Speaker

Panelist
Anna Whitling, PHARMD

Everyone Thinks They Can Write: Why Medical Writers Make the Difference
Monica Chiaramonte, PHD

Amid the Ballyhoo Over AI, What Are We Losing?
Steve Sibley, MS

Speakers

Monica Chiaramonte

Director, Clinical Regulatory Writing, AstraZeneca, United States

Monica Chiaramonte is a Director of Clinical Regulatory Writing at AstraZeneca, with over 35 years in the scientific field and 19 years in Medical Writing across CRO and pharmaceutical settings. She brings deep expertise in authoring and leading high quality regulatory submissions... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States

With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States

Anna Whitling

Senior Manager of Medical Writing, Alcon Laboratories, Inc, United States

Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Artificial Intelligence, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence,Student and Early Career Pathway
Tags Forum

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions

Monday June 15, 2026 4:00pm - 5:00pm EDT

202AB

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive, flexible, and sustainable mentoring practices.

Learning Objectives

Assess mentorship myths using interactive cases; Differentiate mentorship from management; Apply the REAL framework to build inclusive, flexible, lasting mentoring relationships.

Chair

Carol Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH

Speakers

Tywnia Brewton

Executive Director, Human Resources, United States

Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States

Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States

Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Basic
Area Student and Early Career Pathway
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Student and Early Career Pathway
Tags 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

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

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biotechnology & Investors
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags 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

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 →

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan

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

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Clinical Development & Operations
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

DIA 2026 Global Annual Meeting

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DIA 2026 Global Annual Meeting

11:00am EDT

Alysha Croker

Sophie Sommerer

11:00am EDT

Jeffrey Francer

Clare Paoletta

Barrett Tenbarge

4:00pm EDT

Monica Chiaramonte

Steve Sibley

Steve Sibley

Anna Whitling

4:00pm EDT

Tywnia Brewton

Sabhorak Horn

Carol Morales

Leslie Sam

4:00pm EDT

Amira Younes

4:00pm EDT

Daisuke Koga

Seiko Usami

Yoshiaki Uyama

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