DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#108: Risk Management in Advanced Device Technology Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

Learning Objectives

Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

Chair

James Wabby, MHS

Speaker

Panelist
Kimberly Trautman, MS

Panelist
Donna Rycroft, BSN

Panelist
Olivia Wong, MBA

Speakers

Kimberly Trautman

Managing Director, Trautman International Services, United States

Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4... Read More →

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Donna Rycroft

Director, Study Risk Management, AbbVie, United States

Strategic Leader in Clinical Development with 11 years expertise in Risk-based Quality Management (RBQM) leading the development, implementation and change management of RBQM models and supporting systems at AbbVie and Allergan. Currently leading a team of Study Risk Leads supporting... Read More →

Olivia Wong

Director, Quality, Combination Products, Gilead, United States

Olivia Wong is the Director of Quality, Combination Products at Gilead Sciences in Foster City, CA. She has 22 years of industry experience in medical devices and combination products, where she has provided quality engineering expertise throughout the product lifecycle, including... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum | 06: TranslationalDelivery Tech-PrecMedicine, Forum

Format Forum
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, RN
Tags Forum

2:15pm PDT

#130: Interactive Safety Graphics in the Regulatory Decision-Making Process

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:

Broader use of interactive displays in submissions

Sponsor provides interactive package(s)

Regulators/sponsors use their own interactive package(s)

Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

Learning Objectives

Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

Chair

Greg Ball, PhD

Speaker

Panelist
Scott Proestel, DrMed, MD

Panelist
Y. Veronica Pei, MD, MEd, MPH

Panelist
Glen Wright Colopy, PhD, MSc

Panelist
David Nahamya

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Glen Colopy

Head of Data Science and Statistics, Wildfell Software, United States

Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →

David Nahamya

Secretary to the Authority, Uganda National Drug Authority, Uganda

David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Scott Proestel

Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States

Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Forum | 01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#202: Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE)

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-557-L04-P; CME 1.00; RN 1.00

Counterfeit drugs are important public health concern that impact both developed and LMICs. The session is to understand the current landscape and global impact of these and hear from industry, regulators and others on best approaches to address this

Learning Objectives

Discuss the significance and current landscape of counterfeit (falsified) medicines; Describe the economic, socio-economic and pervasive health threats to the global population from counterfeit products; Identify the current interventions implemented by regulators, industry, policy makers to combat this; Recognize new approaches to develop more focused programs that address the root cause.

Chair

Lubna Merchant, PharmD, MS

Speaker

Academic Update
Saifuddin Ahmed, MD, PhD

WHO Update
Rutendo Kuwana, RPh

FDA Update
Sangeeta Chatterjee

Patient Perspective
Regina Mariam Kamoga, MPA

Speakers

Lubna Merchant

Director, Risk Management Center of Excellence, Pfizer Inc , United States

Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →

Saifuddin Ahmed

Professor, Department of Population, Family, and Reproductive Health, Johns Hopkins University, United States

Sangeeta Chatterjee

Deputy Office Director, Office of Drug Security, Integrity, Response, OC, CDER, FDA, United States

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda

She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

Learning Objectives

Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

Chair

Steven M. Weisman, PhD

Speaker

Panelist
Claudia A Salinas, PhD

Panelist
Naomi Boxall, PhD

Panelist
Vera Ehrenstein, DrSc, MPH

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Steven Weisman

Global President, Clinical and Regulatory, Lumanity Inc, United States

Over the years, Dr. Weisman has built a stellar reputation as a regulatory and medical affairs consultant helping clients achieve productive relationships with regulatory authorities in the United States and around the world. Dr. Weisman has played a pivotal role working on important... Read More →

Naomi Boxall

General Manager, PHARMO Institute, Netherlands

Naomi is General Manager at PHARMO and INSZO and is accountable for a portfolio of RWE projects using health data from various sources to support drug development and commercialization for global life science sector. With over 20yrs experience from a breadth of epidemiology topics... Read More →

Vera Ehrenstein

Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark

Vera Ehrenstein is professor of pharmacovigilance at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has more than 20 years' experience as an epidemiologist, including more than 15 years' experience leading multinational postauthorisation safety studies of... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Claudia Salinas

Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States

Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

Learning Objectives

Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

Chair

Alison Cave, PhD

Speaker

From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
Sarah Vaughan

Patient Perspective
Christine Von Raesfeld

Industry Perspective
Gregory Powell, PharmD, MBA

Academic Perspective
Kathleen M. Giacomini, PhD

Speakers

Alison Cave

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 →

Kathleen Giacomini

Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States

Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →

Christine Von Raesfeld

Founder/SME, Patient Experience, The Light Collective, United States

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Risk Management, Regulator Perspectives
Level Intermediate
Feature Topics Risk Management,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

Learning Objectives

Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

Chair

Gregory Powell, PharmD, MBA

Speaker

MHRA Update
Phil Tregunno

Patient Update
Dave deBronkart

Physician/EHR update
Auren Weinberg, MD, MBA

Speakers

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States

"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Auren Weinberg

Chief Medical Officer, Veradigm, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#359: A Safety Surveillance Plan for Serious Anticipated Events

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

Learning Objectives

Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

Chair

Greg Ball, PhD

Speaker

Panelist
Susan Talbot

Panelist
Ranjeeta Sinvhal, MD

Panelist
Susan Kindig, JD, MD

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Susan Kindig

Prior Executive Director, Medical and Drug Safety, United States

Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience... Read More →

Ranjeeta Sinvhal

Executive Medical Director, Medical Safety, AbbVie, United States

Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety... Read More →

Susan Talbot

Director Biostatistics, Amgen, United States

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum