2024 Conference Agenda
Boston, MA, 29 - 30 October 2024
Schedule
Create your personal agenda –check the favourite icon
Oct 298:00
Conference pass
Expo hall and registration opens
Networking Break
Pick up your badge and join us in the expo hall
Hall C
Oct 298:45
Conference pass
Chair's Remarks
Keynotes
Han Ma, SVP, Chief Safety Officer, BeiGene
Oct 298:50
Conference pass
Disruption in safety systems: Cutting through GenAI hype to generate true ROI
Keynotes
Effective applications of Automation and GenAI are driving upwards of 60% efficiency gains in Safety workflows. Boards and Executive Teams areturning up the pressure for their organizations to cut through the noise and deploy Advanced Automation and GenAI to cut costs and reduce timeto market.
In this session, Aman Wasan, CEO of ArisGlobal, will discuss specific LifeSphere technology automation and GenAI use cases to optimize dataflowand declutter Safety systems to deliver ROI today.
Hall C
Oct 299:30
Conference pass
What is next for safety in the boardroom: Thoughts from the industry’s leading Chief Safety Officers
Keynotes
Moderator: Serban Ghiorghiu, Chief Safety Officer, AstraZeneca
Han Ma, SVP, Chief Safety Officer, BeiGene
Hall C
Oct 2910:10
Conference pass
Session title to be announced
Keynotes
Sponsored by IQVIA
Oct 2910:30
Conference pass
Networking, posters, expo hall
Networking Break
Join us in the expo hall for networking and poster viewing
Hall C
Oct 2911:09
Conference pass
Chair's Remarks
AI & Machine Learning
Elena Persiantsev, Director, Life Sciences Sales, Welocalize
Oct 2911:09
Conference pass
Chair's Remarks
Safety Risk Management
Sophia Goodison, Senior Director, Oncology, Cell and Gene Therapy, SERM, GSK
Oct 2911:09
Conference pass
Chair's Remarks
Patient Safety
Katie Ellis Tupe, Senior Manager, US Patient Safety Operations, EMD Serono
Oct 2911:10
Conference pass
Acceptable validation of automation use cases in PV
Next Gen Tech & Data
Tarak Thakker, Director, Head of Safety Systems and Analytics, BeiGene
Oct 2911:10
Conference pass
Integration of AI & machine learning for PV
AI & Machine Learning
Ranjeeta Sinvhal, Executive Medical Director, Abbvie
Oct 2911:10
Conference pass
PV system masterfile in Asia
Global PV & Regulatory
Mamiko Kasho, Executive Director, Eisai
Oct 2911:10
Conference pass
The strategic role of affiliate patient safety in patient centricity - our journey
Patient Safety
Oct 2911:10
Conference pass
Transformative partnerships: Advancing patient safety goals with PV business and tech collaboration
Digital Transformation and Partnerships
Saba Darvesh, Director - Global Safety Systems Owner, Vertex Pharmaceuticals
Thuy Truong, Director, PV Systems, Vertex Pharmaceuticals Inc.
Oct 2911:30
Conference pass
Embracing change: The journey from manual to automated case workflows
AI & Machine Learning
Oct 2911:30
Conference pass
Future-proofing pharmacovigilance: Governance, data collection and analyses for global success
Global PV & Regulatory
Oct 2911:30
Conference pass
Navigating the future: GenAI in pharmacovigilance
Digital Transformation and Partnerships
In this session, we explore the transformative potential of generative AI in pharmacovigilance, addressing regulatory landscape, implementation challenges, scientific testing protocols and its role in shaping the future of drug safety.
Brian Kaulback, Vice President, Technology Solutions -Safety & Logistics, Parexel
Laurie McRae, Vice President Solutions Consulting and Account Management, Parexel
Oct 2911:30
Conference pass
Session title to be announced
Next Gen Tech & Data
Sponsored by RxLogix
Oct 2911:30
Conference pass
Signal detection in early-phase clinical drug trials
Safety Risk Management
Sumit Verma, President, Clinical Safety and PV, Soterius, Inc.
Oct 2911:50
Conference pass
Global data security and compliance
Global PV & Regulatory
Moderator: Maria Anitan, Global Head of Pharmacovigilance and Drug Safety, Med Communications Inc
Tina Veizovic, Senior Director, GPS International and PV Partnerships, BeiGene
Oct 2911:50
Conference pass
Perspectives in safety management for cell and gene therapies
Patient Safety
Vineet Kacker, Managing Director & Global Technical Head, APCER life sciences
Oct 2911:50
Conference pass
Session title to be announced
Safety Risk Management
Moderator: Kevin Fetterman, Exec Director, Client Engagement, Orbit By Feith Systems
Oct 2911:50
Conference pass
Session title to be announced
Digital Transformation and Partnerships
Anna Monaco, Associate Director, Pharmacovigilance Partner Strategy & Management, Merck
Oct 2911:50
Conference pass
Unifying pharmacovigilance to navigate dynamic regulatory landscape with speed and efficiency
Next Gen Tech & Data
Michael Kruczek, Senior Director, Vault Safety, Veeva Systems
Oct 2912:10
Conference pass
Session title to be announced
AI & Machine Learning
Sponsored by IQVIA
Oct 2912:30
Conference pass
Emerging digital health challenges and opportunities for drug safety regulators and industry
Digital Transformation and Partnerships
Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech
Oct 2912:30
Conference pass
Harnessing LLMs for advanced applications in pharmacovigilance
AI & Machine Learning
Sponsored by TriNetX
Oct 2912:30
Conference pass
Session title to be announced
Next Gen Tech & Data
Sponsored by Oracle
Oct 2912:30
Conference pass
Strategic alliance management
Patient Safety
Jaylaxmi Nalawade, Director, Pharmacovigilance and REMS, Lupin
Oct 2912:30
Conference pass
Using predictive modeling to support early assessments of targets and toxicology concerns
Safety Risk Management
Oct 2912:50
Conference pass
Auditing a global safety database to meet country level regulatory compliance
Global PV & Regulatory
Oct 2912:50
Conference pass
Drug safety implementation in hospitals: The process & challenges and the role of drug supply chain in risk mitigation
Safety Risk Management
Soha Eladly, Drug Supply & Safety Specialist, Central Administration of Pharmaceutical Affairs
Oct 2912:50
Conference pass
Emerging safety requirements in Cosmetovigilance
Patient Safety
Karthik Babu Parasumanna Sudarsan, CHC Global PV Operations Head, Opella
Namita Joshi, Regional PV Head North America, Opella
Amrit Gill, VP - Global Head of Consumer Safety (PV) - Global Medical & Pharmacovigilance, Opella
Oct 2912:50
Conference pass
Not all innovation is technological
Next Gen Tech & Data
Oct 2912:50
Conference pass
Session title to be announced
AI & Machine Learning
Sponsored by TCS
Oct 2913:10
Conference pass
Networking, posters, expo hall
Networking Break
Food for purchase in the expo hall
Hall C
Oct 2913:40
Conference pass
Roundtable 01: Complying with global regulations: Safety reporting in clinical trials
Roundtables
Hall C
Oct 2913:40
Conference pass
Roundtable 02: Determining ROI for GenAI use cases within PV to gain funding: Complexities and solutions
Roundtables
This session will delve into the intricacies of evaluating the return on investment (RoI) for Generative AI applications in Pharmacovigilance (PV), focusing on the challenges and solutions for securing funding. Attendees will gain insights into effective methods for quantifying benefits, overcoming financial and operational hurdles, and presenting compelling business cases to stakeholders. Let us explore practical strategies and innovative approaches for demonstrating the value of Generative AI in enhancing PV processes and driving organizational success.
Nikesh Shah, Vice President and Global Head, Drug Safety and Pharmacovigilance, Indegene
Hall C
Oct 2913:40
Conference pass
Roundtable 03: Supercharging digital evolution
Roundtables
Sponsored by HCL
Hall C
Oct 2913:40
Conference pass
Roundtable 04: Accelerating safety implementations: Approaches, best practices, and business considerations
Roundtables
Christina Kim, Senior Director, Vault Safety, Veeva Systems
Hall C
Oct 2913:40
Conference pass
Roundtable 05: Selecting or reevaluating your drug safety strategic partner
Roundtables
Suneet Walia, Chief Executive Officer, Soterius, Inc.
Hall C
Oct 2913:40
Conference pass
Roundtable 06: Achieve more than cost savings, how to work with your PV partner to add value to your PV program
Roundtables
Sponsored by ProductLife Group
Beth Shaleesh, Head of North America Account Management, Safety and Vigilance, ProductLife Group
Hall C
Oct 2913:40
Conference pass
Roundtable 07: Role of generative AI in PV literature monitoring
Roundtables
Abdul Rahim, Co-founder, ALWIS Solutions Limited
Hall C
Oct 2913:40
Conference pass
Roundtable 08: Session title to be announced
Roundtables
Hall C
Oct 2913:40
Conference pass
Roundtable 09: Can AI replace humans within PV?
Roundtables
Angie Robertson, Director, Systems and Submissions, ProPharma
Hall C
Oct 2913:40
Conference pass
Roundtable 10: Session title to be announced
Roundtables
Sponsored by Deloitte
Hall C
Oct 2913:40
Conference pass
Roundtable 11: Session title to be announced
Roundtables
Sponsored by BioPoint Inc.
Hall C
Oct 2913:40
Conference pass
Roundtable 13: Demystifying impact of digital health on drug safety
Roundtables
Anna Monaco, Associate Director, Pharmacovigilance Partner Strategy & Management, Merck
Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech
Hall C
Oct 2913:40
Conference pass
Roundtable 14: Combination devices
Roundtables
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Hall C
Oct 2913:40
Conference pass
Roundtable 15: Safety reporting in patient support programs
Roundtables
Anthony Adamkovic, Executive Director, Pharmacovigilance, Harmony Biosciences, LLC
Hall C
Oct 2913:40
Conference pass
Roundtable 16: Leveraging Real-World Evidence (RWE) for rare diseases: Strategies for enhancing drug development, regulatory approval, and post-market surveillance
Roundtables
Michelle Kasprzak, Director of Global Pharmacovigilance and Patient Safety, Sobi (Swedish Orphan Biovitrum)
Hall C
Oct 2913:40
Conference pass
Session title to be announced
Roundtables
Sponsored by Whatfix
Oct 2914:25
Conference pass
Short break
Networking Break
Short break before afternoon breakout sessions continue
Hall C
Oct 2914:29
Conference pass
Chair's Remarks
AI & Machine Learning
Elena Persiantsev, Director, Life Sciences Sales, Welocalize
Oct 2914:29
Conference pass
Chair's Remarks
Patient Safety
Katie Ellis Tupe, Senior Manager, US Patient Safety Operations, EMD Serono
Oct 2914:30
Conference pass
Crafting innovative solutions with advanced technology for unrivaled safety and efficiency
Next Gen Tech & Data
Oct 2914:30
Conference pass
Diversity and inclusion in clinical trials: Increasing inclusiveness of patient centric care
Patient Safety
Philisha Mack, Director of Drug Safety, Azurity Pharmaceuticals
Oct 2914:30
Conference pass
Good pharmacovigilance practices (GPV) systems operations
AI & Machine Learning
Shivangi Kishore Kachalia, Associate Director, Global Safety Data Managmeent, Otsuka Pharmaceuticals
Vikalp Khare, US Head of Global Safety Data Management, GPV, Otsuka Pharmaceutical
Oct 2914:30
Conference pass
Risk management in early-stage clinical development for cell & gene therapy
Safety Risk Management
Kamlesh Prabhu, Sr.Director Pharmacovigilance, Omega therapeutics
Oct 2914:30
Conference pass
Safety practices in small pharmaceutical company settings
Digital Transformation and Partnerships
Bill Haddock, Head Of Safety, Ovid Therapeutics
Oct 2914:50
Conference pass
A blueprint for optimizing pharmacovigilance for country affiliates
Global PV & Regulatory
Barry Mulchrone, Head of Safety Science & Strategy Lifecycle Safety, IQVIA
Oct 2914:50
Conference pass
Bridging compliance gap in risk minimization measures: Plan to performance evaluation
Safety Risk Management
Oct 2914:50
Conference pass
Enhancing FAERS data quality and usability thorugh standardiziation
Next Gen Tech & Data
Oct 2914:50
Conference pass
How to leverage advanced AI in your PV operation and realize time savings and increased quality in the first year
AI & Machine Learning
Tim Howard, Chief Executive Officer, Arietta.ai
Oct 2914:50
Conference pass
The role of medical doctors: Harnessing medical expertise in risk management
Patient Safety
Juan Daccach, Vice President, Global Product Safety, Merz Aesthetics
Oct 2915:10
Conference pass
Addressing the challenges of monitoring unstructured safety data - a focus on next gen solutions for optimizing audio source data workflows with results
Next Gen Tech & Data
Deepanshu Saini, Director of Program Management, IQVIA
Oct 2915:10
Conference pass
Has patient medication safety plateaued?
Patient Safety
Moderator: Benjamin Brown, Executive Director, American Society of Pharmacovigilance
Gerson Peltz, Senior Vice President of Patient Safety & Pharmacovigilance, Arcus Biosciences Inc
Oct 2915:10
Conference pass
Influencing from within: A drug safety perspective
Digital Transformation and Partnerships
Geneviève Larouche, Global Director, Pharmacovigilance and Medical Information, Knight Therapeutics
Oct 2915:10
Conference pass
Migrations made easy
AI & Machine Learning
Antara Gaur, Vice President, Pinnaxis
Vedaant Shourie, Safety Systems SME, Pinnaxis
Oct 2915:10
Conference pass
Optimizing detection, monitoring, and assessment of drug induced liver injury during clinical drug development
Safety Risk Management
Javier Waksman, Vice President, Head Of Global Drug Safety, Cerevel therapeutics
Paul Hayashi, DILI Team Lead, Division of Hepatology & Nutrition, FDA
Eric Cohen, Senior Medical Director, AbbVie
Oct 2915:30
Conference pass
Communication: The unspoken key to your PV system
Global PV & Regulatory
Katrina Goddard, Director of Global Drug Safety in Pharmacovigilance, Arriello
Oct 2915:30
Conference pass
Implications of digital health on PV
Digital Transformation and Partnerships
Oct 2915:30
Conference pass
Real-time benefits and operations oversight using digitalization & automation of global pharmacovigilance operations to enhance operational efficiency, quality and compliance
AI & Machine Learning
Sriram Varma, Senior Vice President (Technology & Data Services), Techsol Life sciences
Oct 2915:30
Conference pass
Session title to be announced
Next Gen Tech & Data
Sponsored by Ultragenic
Oct 2915:50
Conference pass
Approaches for patient- centered risk management communication
Safety Risk Management
Elizabeth Kurian, Director, SERM, GSK
Abimbola Cole, Scientific Director, Safety Evaluation & Risk Management (SERM), Gsk
Oct 2915:50
Conference pass
Maximizing efficiency today: Leveraging AI automation for process improvement – Concept and case study
AI & Machine Learning
Anand Ananthakrishnan, Senior Director, Drug Safety and Pharmacovigilance, Blueprint Medicines
Oct 2916:10
Conference pass
Short break before keynotes
Networking Break
Short break before keynotes
Hall C
Oct 2916:35
Conference pass
Pharma perspectives on AI-driven innovations for operational efficiency: Evaluating technology and solution providers
Keynotes
Michael Murphy, Associate Vice President, Head of Pharmacovigilance Operations, Amgen
Badrish Patel, M.D., Vice President, Global Drug Safety and Pharmacovigilance, Jazz Pharmaceuticals
Hall C
Oct 2917:15
Conference pass
Chair's Remarks
Keynotes
Han Ma, SVP, Chief Safety Officer, BeiGene
Oct 2917:20
Conference pass
Cocktail reception and networking
Networking Break
Join us for cocktail hour in the expo hall
Hall C
Create your personal agenda –check the favourite icon
Oct 308:00
Conference pass
Expo hall and registration opens
Networking Break
Pick up your badge and join us in the expo hall
Hall C
Oct 308:40
Conference pass
Chair's Remarks
Keynotes
Felix Arellano, Global Head of Pharmacovigilance and Drug Safety, Roche
Hall C
Oct 308:45
Conference pass
Session title to be announced
Keynotes
Reserved for Johnson & Johnson
Hall C
Oct 309:05
Conference pass
Session title to be announced
Keynotes
Sponsored by Oracle
Hall C
Oct 309:25
Conference pass
Safeguard your safety technology investment
Keynotes
Sponsored by ArisGlobalJoin this panel conversation to learn how global pharma IT leaders are establishing goals and metrics from the outset. The panel will offer practical advice on effectively reporting and managing stakeholders, as well as share strategies for advocating internally to secure continuedinvestment in new technologies. Attendees will gain insights into how these innovations can ultimately save R&D time and costs, with real-world examples and actionable takeaways to apply within their own organizations.
Hall C
Oct 3010:05
Conference pass
Forecasting and prediction of Adverse Event trends and volumes using AI methods
Keynotes
Satya Sagi, Chief Executive Officer, Techsol Life sciences
Hall C
Oct 3010:35
Conference pass
One world, one standard: The future of pharmacovigilance
Keynotes
Oct 3011:05
Conference pass
Networking, posters, expo hall
Networking Break
Join us in the expo hall for networking and poster viewing
Hall C
Oct 3011:44
Conference pass
Chair's Remarks
PV Education & Training
Oct 3011:44
Conference pass
Oct 3011:45
Conference pass
Evolving REMS landscape: Regulatory updates and compliance challenges
Safety Risk Management
Reema Mehta, Vice President, Head of Risk Assessment and Management, Pfizer
Oct 3011:45
Conference pass
Pharmacovigilance 2.0: Navigating the future through innovative skillsets
PV Education & Training
Oct 3011:45
Conference pass
Post Approval Safety Studies (PASS): Challenges and risks for PV
Quality Assurance & Compliance
Oct 3011:45
Conference pass
Safety review and challenge of adoptive cell therapy in cancer
Next Gen Tech & Data
Tarik Messaoud, Drug Safety Physician, Access Clinical Research
Oct 3011:45
Conference pass
Validating safety signals and monitoring post-market safety with daily-updated EHR data
AI & Machine Learning
- Conduct real-time post-market safety studies with data from 100M+ US patients
- Assess drug and vaccine safety during pregnancy with data from 1M+ mother-child pairs
- Understand drug interactions, adverse events, and comparative product safety with data on all drugs, diseases, and devices
Oct 3012:05
Conference pass
Benefit-risk assessment and reverse vaccinology in vaccine (product) development
Vaccine Safety
Ajinkya Inamdar, Senior Director (Global Medical Safety Strategy), BioNTech SE
Oct 3012:05
Conference pass
PV oversight of AI in AE detection to ensure quality and compliance
Quality Assurance & Compliance
Joann Evangelista, Head of US Patient Safety Operations & Innovations, Genentech, A Member of the Roche Group
Oct 3012:05
Conference pass
Session title to be announced
PV Education & Training
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Oct 3012:25
Conference pass
Non traditional backgrounds for safety roles
PV Education & Training
Oleg Zvenigorodsky, Director, Medical Safety / Innovation Lead, Jazz Pharmaceuticals
Oct 3012:25
Conference pass
Pharmacovigilance 2.0: To AI or not to AI?
AI & Machine Learning
Oct 3012:25
Conference pass
RWE and innovation in vaccine studies
Vaccine Safety
Emily Bratton, MSPH; Category Lead, Safety Evidence for Regulators Real World Solutions, IQVIA
Oct 3012:25
Conference pass
Striking the balance: Effective strategies for vendor case processing quality oversight without taking over
Quality Assurance & Compliance
Oct 3012:45
Conference pass
Ethical AI in drug safety: Navigating bias, transparency, and accountability
AI & Machine Learning
Nicole Richie, Vice President Health Equity and Population Science, Genentech
Oct 3012:45
Conference pass
Mobile health applications: Opportunities and challenges in safety monitoring
Next Gen Tech & Data
Elena Davison, Executive Director, Pharmacovigilance Informatics, SMPA
Oct 3012:45
Conference pass
Pharmacovigilance partnerships: A guide to effective strategies for PV vendor oversight
Quality Assurance & Compliance
Jennifer Kane, Sr. Director, Head of Pharmacovigilance, Entasis Therapeutics
Oct 3012:45
Conference pass
Regulatory requirements for advanced therapies: A focus on gene and cell therapies
Safety Risk Management
Moderator: David T Chonzi, Independent Pharma Physician, Independent PV Expert
Oct 3012:45
Conference pass
REMS industry consortium: Enhancing PV through education and collaboration
PV Education & Training
Kishore Gopu, Senior Director, REMS Operations, Teva Pharmaceuticals
Oct 3012:45
Conference pass
Session title to be announced
Vaccine Safety
Narayan Nair, Division Director for Division of Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Oct 3013:05
Conference pass
Drug supply chain security act: Are you ready to meet the November 2024 deadline?
Quality Assurance & Compliance
Oct 3013:05
Conference pass
Leveraging AI and RWE for enhanced drug safety: Innovations in detection, data access, and operational efficiency
Next Gen Tech & Data
Moderator: Joshua Gagne, Vice President and Global Head of Epidemiology, Johnson & Johnson
William Blumentals, Head of Pharmacoepidemiology, Specialty Care, Sanofi
Mariette M Boerstoel, Senior Vice President, Worldwide Patient Safety Officer, Bristol Myers Squibb
Scott Kelly, Senior Director, Global Medical Epidemiology, Pfizer
Oct 3013:05
Conference pass
Session title to be announced
AI & Machine Learning
Sponsored by IQVIA
Oct 3013:25
Conference pass
Novel methods for signal assessment
Safety Risk Management
Chris Bone, Director, Safety and Benefit Risk, Biogen
Oct 3013:25
Conference pass
Training of safety teams
PV Education & Training
Lois Ahn, Associate Director, PV Science, Alnylam Pharmaceuticals
Elena Yureneva, Executive Director, Head of Medical Safety and Risk Management, Alnylam Pharmaceuticals
Oct 3013:45
Conference pass
Networking, posters, expo hall
Networking Break
Food for purchase in the expo hall
Oct 3014:14
Conference pass
Chair's Remarks
Medical Devices Safety
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Oct 3014:14
Conference pass
Chair's Remarks
PV Education & Training
Oct 3014:14
Conference pass
Oct 3014:14
Conference pass
Oct 3014:15
Conference pass
Elevating global patient safety: Quality assurance in PV and risk management
Quality Assurance & Compliance
Maha Saad, Associate Vice President, Pharmacovigilance & REMS, Braeburn Pharmaceuticals
Rena Pandit, Exec Director, Global Patient Safety Head of Compliance & Training, Amgen
Oct 3014:35
Conference pass
Addressing target organ safety issues in drug discovery
Next Gen Tech & Data
Oct 3014:35
Conference pass
Session title to be announced
PV Education & Training
Vasu Miduturu, Director, Pharmacovigilance operations, Tango Therapeutics
Oct 3014:35
Conference pass
Software as a medical device: SaMD
Medical Devices Safety
Ben Kitchens, Associate Director, Medical Devices, Digital and Diagnostics Lead, Otsuka Pharmaceuticals
Oct 3014:55
Conference pass
Automation of risk management
AI & Machine Learning
Israel Gutierrez, Chief Medical Officer, TLR Therapeutics
Oct 3014:55
Conference pass
Differences in patient safety approaches between pharma, combination products and medical devices
Medical Devices Safety
Moderator: Juan Daccach, Vice President, Global Product Safety, Merz Aesthetics
Khaudeja Bano, Vice President, Combination Product Quality, Amgen
Omar Aimer, Executive Member of ISoP and NASoP President, International Society of Pharmacovigilance (ISoP)
Oct 3014:55
Conference pass
Introduction to pharmacovigilance auditing
PV Education & Training
Ujjval Trivedi, Global System Auditor, Bayer
last published: 25/Jul/24 13:06 GMT
Get Involved At Drug Safety Congress Americas
Created by
Terrapinn is proud to be a member of isla.
Working together to build sustainable events