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Monday, June 16
 

11:00am EDT

#105: Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-511-L04-P; CME 1.00; RN 1.00

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Chair

Tae Hyun Jung, PhD

Speaker

Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD

Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD


Speakers
avatar for Tae Hyun Jung

Tae Hyun Jung

Senior Statistical Reviewer, CDER, FDA, United States
Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases... Read More →
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Digital Biomarkers, Verily, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers at Verily, where she leads the research and evidence generation for digital measures and AI/ML capabilities. She oversees the development, validation, and implementation of the technology in internal and external clinical... Read More →
avatar for Tarik Yardibi

Tarik Yardibi

Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Tarik Yardibi is the Director of Sensing and Measurement at Takeda Pharmaceuticals, operating within the Digital Health Sciences department at Takeda R&D. As a digital health and data science technical leader, Tarik has contributed extensively across both medical device and pharmaceutical... Read More →
avatar for Vadim Zipunnikov

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Vadim Zipunnikov is an Associate Professor of Biostatistics at Johns Hopkins Bloomberg School of Public Health and co-leads the Wearable and Implantable Technology (WIT) group. His research focuses on developing statistical methods for analyzing digital health data from wearables... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

11:00am EDT

#109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Monday June 16, 2025 11:00am - 12:00pm EDT
152AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-515-L04-P; CME 1.00; RN 1.00

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


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

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 →
avatar for Kavita Dada

Kavita Dada

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 →
RH

Reina Hayashi

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).
avatar for Adil Nashed

Adil Nashed

Drug Specialist, Health Canada, Canada
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 →
avatar for Peter Twomey

Peter Twomey

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
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum |   02: ClinTrials-Ops, Forum

2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-521-L04-P; CME 1.00; RN 1.00

Master Protocols, including basket trials and umbrella trials, enable efficiencies in investigating multiple conditions or multiple treatments, respectively, under a single trial design. Applying Master Protocol trial designs to Cell & Gene therapies (CGTs) can streamline clinical and regulatory processes to speed the delivery of treatments to patients with rare diseases.

Learning Objectives

Identify barriers to and solutions for leveraging Master Protocol clinical trial designs to study Cell & Gene Therapies for rare diseases.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Thought Leader Perspective
Philip (P.J.) Brooks, PhD

Innovator Perspective
Kiran Musunuru, MD, PhD, MPH

Researcher Perspective
Jeff Allen, PhD


Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
avatar for Kiran Musunuru

Kiran Musunuru

Professor of Medicine, University of Pennsylvania, United States
An actively practicing cardiologist and committed teacher, Kiran Musunuru, MD, PhD, MPH, ML, MRA, is Professor of Cardiovascular Medicine, Genetics, and Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the development of novel... Read More →
avatar for Nancy Myers

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, United States
Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 20 years and has been active in the DC policy arena for three... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

2:15pm EDT

#123: A Masterclass: Patient Recruitment Campaign Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-520-L04-P; CME 1.00; RN 1.00

Go beyond platitudes and qualitative advice on planning, deploying, and measuring the success of your recruitment campaign. Enjoy this Master Class in Recruitment Campaign Management from some of the industry's best minds

Learning Objectives

Discuss how to build an evidence based forecast for centralized patient recruitment campaigns; Describe ways to optimize channel mixes, vendor management, performance models, technology selection; Identify methods to measure and optimize campaign performance and ROI.

Chair

Chris Venezia

Speaker

Case Study Presentation
Helen West

Case Study Presentation
Gretchen Goller, MA

Case Study Presentation
Adrienne Walstrum, MSc

Case Study Presentation
Tom Julian


Speakers
avatar for Gretchen Goller

Gretchen Goller

Head, Recruitment and Retention, Pfizer, United States
Gretchen leads the Patient Recruitment and Retention team at Pfizer working with a team of strategists and specialists to implement recruitment and retention programs on all Pfizer studies across therapeutic areas. Most recently Gretchen was the Head leading the Patient Recruitment... Read More →
avatar for Tom Julian

Tom Julian

Assoc. Director Design and Innovation, Gilead Sciences, United States
At Gilead Sciences, Tom leads efforts to improve clinical trial design and implements technologies to improve trial efficiency and reduce costs. He is focused in Virology and Inflammation. Previously, at Bristol Myers Squibb, he worked on testing and scaling digital solutions to improve... Read More →
CV

Chris Venezia

Chief Executive Officer, ProofPilot, United States
As the CEO., Chris Venezia brings more than 18 years of strong leadership experience to ProofPilot with a track record of success in product commercialization, patient recruitment, marketing, and sales. With his most recent role as the Chief Commercial Officer at Citeline Connect... Read More →
AW

Adrienne Walstrum

Senior Director, Global Trial Optimization, Merck, United States
Adrienne Walstrum is a Senior Director with Global Trial Optimization (GTO). She has over 15 years of clinical trial operations experience, with the last 9 years spent at Merck within GTO. In Adrienne’s current role, she oversees GTO’s Recruitment & Retention Center of Excellence... Read More →
avatar for Helen West

Helen West

Senior Director, Innovative Patient Recruitment, Evinova, United States
Helen West is a senior digital patient recruitment strategist with Evinova's Innovative Patient Recruitment group. Her background is in clinical operations, trial optimization and healthcare communications. She has lead patient recruitment strategies for more than 200 global studies... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session |   05: Patient-Impact-Product-Dev, Session

2:15pm EDT

#127: Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-524-L04-P; CME 1.00; RN 1.00

This session will delve into the historical and ethical context for distinguishing between clinical care and research and how the blurring poses a risk for engagement with patients. Experts in ethics and health literacy will discuss potential pitfall

Learning Objectives

Recognize the ethical and historical context for distinguishing between clinical care and research; Describe the regulatory and ethical challenges that are exposed when sponsors and investigators push patients to clinical research; Discuss how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Speaker

Bioethics Perspective
Lindsay McNair, MD, MPH, MS

Patient and Health Literacy Perspective
Catina O'Leary, PhD

IRB perspective
David Borasky, MPH


Speakers
avatar for David Borasky

David Borasky

Vice President, IRB Compliance, WCG Clinical, United States
David A. Borasky serves as Vice President of IRB Compliance for WCG IRB. Mr. Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities... Read More →
avatar for Karla Childers

Karla Childers

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 →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States
Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum |   04: MedAffairs-SciComm, Forum
  • Level Advanced
  • Keyword Bioethics
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

2:15pm EDT

#130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-527-L04-P; CME 1.00; RN 1.00

This forum will present: Health Authority (HA) expectations related to QbD, RBQM, and issue management. Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.

Learning Objectives

Discuss Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.

Chair

Michael Torok, PhD

Speaker

Industry Perspective
Michael Torok, PhD

FDA Perspective
Emily Gebbia, JD

Industry Perspective
Kevin Richards, MSc


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Kevin Richards

Kevin Richards

Senior Director, Clinical Quality, AstraZeneca, Canada
Lead the Global Clinical Quality organization at AstraZeneca leading quality compliance and GCP processes and teams. He established and also leads Study Quality Oversight, automated reporting, solutions and tools to help uplift study and organizational inspection readiness and compliance... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   03: Data-Tech, Session |   02: ClinTrials-Ops, Session

2:15pm EDT

#133: Health Canada Town Hall
Monday June 16, 2025 2:15pm - 3:15pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-530-L04-P; CME 1.00; RN 1.00

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
Kelly Robinson, MSc


Speakers
avatar for Alysha Croker

Alysha Croker

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 →
avatar for Kelly Robinson

Kelly Robinson

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 →
Monday June 16, 2025 2:15pm - 3:15pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

3:45pm EDT

#138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
Monday June 16, 2025 3:45pm - 4:45pm EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-536-L04-P; CME 1.00; RN 1.00

In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.

Learning Objectives

Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.

Chair

Mehdi Najafzadeh, PhD

Speaker

Challenges and lessons in Linkage of RWD to Trials: An Academic Perspective
Elisabetta Patorno, DrPH, MD

Pragmatic Approaches in Hybrid Designs: Industry Perspective
Mehmet Burcu, PhD, MS, FISPE

Linkage of trials to RWD: Evolving landscape and overview of US regulatory guidance
Marie C. Bradley, PhD, MPH, MPharm


Speakers
MB

Marie Bradley

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 →
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Senior Director, Medidata Solutions, United States
Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →
EP

Elisabetta Patorno

Associate Professor of Medicine, Brigham and Women's Hospital; Harvard Medical School, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

3:45pm EDT

#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-543-L04-P; CME 1.00; RN 1.00

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Chair

Emily Gebbia, JD

Speaker

Industry Perspective
Robert DiCicco, PharmD

MHRA Perspective
Jason Wakelin-Smith


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 Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session
 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
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  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
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  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming