DIA 2026 Global Annual Meeting: Full Schedule

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8:00am EDT

#700: Insights Regarding Implementation of the ASAP Process

Thursday June 18, 2026 8:00am - 9:00am EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00

We will focus on insights regarding implementation of the ASAP process, how it has been beneficial to implement, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).

Learning Objectives

Describe the steps to implement the ASAP process at a smaller company with limited resources; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts; Recognize how the ASAP process has been beneficial to implement for various projects.

Chair

Greg Ball, PHD

Speaker

Insights Regarding Implementation of the ASAP Process
Barbara Hendrickson, DrMed, MD

Advantages of Earlier Systematic and Strategic Safety Planning
Famina Hemani, PHARMD

Practical Implementation of ASAP Concepts
Shital Patel, PHARMD

Practical Implementation of ASAP Concepts
Cynthia McShea, MPH

Speakers

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Famina Hemani, PharmD, is a Pharmacovigilance leader with over 20 years of experience in pharmacy and biopharma, including more than a decade in strategic safety leadership. She has built and scaled PV functions from early clinical development through pre-commercialization across... Read More →

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Cynthia McShea

Head, Safety Statistics, UCB Biosciences, United States

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she... Read More →

Shital Patel

Associate Safety Lead, UCB, United States

Shital Patel

Associate Safety Lead, UCB Biosciences, United States

Thursday June 18, 2026 8:00am - 9:00am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
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8:00am EDT

#701: No Report Left Behind: Human-Centered Safety Reporting

Thursday June 18, 2026 8:00am - 9:00am EDT

103A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00

Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation, safety processes, and clinical operations partner to reduce missed reports, protect patients, and strengthen trial integrity.

Learning Objectives

Identify the key factors that contribute to patients underreporting adverse events and assess the resulting impact on safety, operations, and compliance; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.

Chair

Lani Hashimoto

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Jennifer Miller, PHD

Speakers

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Feature Topics Patient-Centered Design and Experience
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8:00am EDT

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You

Thursday June 18, 2026 8:00am - 9:00am EDT

117

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P; CME 1.00; RN 1.00

How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify, prioritise and effectively fix non-compliance in PV, exploring the role of psychological safety in this.

Learning Objectives

Describe how proactive approaches to investigating known issues, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.

Chair

Anna Adams, PHD

Speaker

Panelist
Manny Burga

Panelist
Andrew Cooper

Panelist
Helen Emery

Speakers

Anna Adams

Head, PV QA Europe, Daiichi Sankyo Co., Ltd., United Kingdom

As a senior leader in PVQA at Daiichi Sankyo, Anna is passionate about fostering a strong Quality Culture. Her group manages pharmacovigilance inspection readiness and PV compliance oversight, with transparency and proactive collaboration. She was previously Head of Performance and... Read More →

Manny Burga

Operations Executive, formerly J&J and Kenvue, Independent, United States

Andrew Cooper

Senior Director Business Partnering PV, Regulatory and Medical R&D, GSK, United Kingdom

Helen Emery

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Helen is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). Prior to joining the MHRA she spent several years in Industry, where she accumulated knowledge across the PV system. She held roles supporting the EU QPPV, which ultimately led... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Quality Assurance / Control & CMC
Tags Session