2022 Agenda
Boston, MA, 4 - 5 October 2022
Schedule
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Oct 48:00 AM
Conference pass
Expo hall and registration opens
Keynotes
Expo hall and registration opens
Oct 48:50 AM
Conference pass
Opening remarks from Terrapinn
Keynotes
Opening remarks from Terrapinn
Oct 48:55 AM
Conference pass
Chair opening remarks
Keynotes
Susan Welsh MD, Senior Vice President, PV & Chief Safety Officer, Mirati Therapeutics
Oct 49:00 AM
Conference pass
Connecting FDA commitments past & present
Keynotes
Helen Edelberg, MD, MPH, Deputy Director of Safety, Office of New Drugs, FDA
Oct 49:40 AM
Conference pass
Panel Discussion: The future of pharmacovigilance: how do we serve patients’ safety best?
Keynotes
Moderator: Claudia Lehmann, Head Global Patient Safety & Pharmacovigilance Operations, Boehringer Ingelheim International
Sridevi Ponduru, Senior Medical Director, Global Patient Safety Evaluation, Takeda Pharmaceuticals USA Inc
Vivek Ahuja, Vice President, MACR & Global Head, Pharmacovigilance, Sun Pharmaceutical Industries Limited
Christina Dickson, Head of Pharmacovigilance Operations, GSK
Oct 411:20 AM
Conference pass
Gene therapy within ophthalmology
Safety in Advanced Therapies
Edward Chow, Executive Director, Toxicology, AbbVie
Oct 411:20 AM
Conference pass
GSK’s PV intelligent automation journey
Next Generation Tech & Data
Oct 411:20 AM
Conference pass
How pharmacogenomics affects pharmacovigilance
Safety Risk Management
Andrew A. Monte, MD, PhD,, Professor of Emergency Medicine & Medical Toxicology, University of Colorado Hospital, Medical Director, Rocky Mountain Poison & Drug Safety Center (RMPDS)
Oct 411:20 AM
Conference pass
Navigating through the challenges of PV in Asia Pacific. The role of Chinese GVP and latest developments.
Global PV
Oct 411:20 AM
Conference pass
Reserved for biologit
AI & Machine Learning
Speaker TBA
Oct 411:20 AM
Conference pass
Session to be announced
Global PV
Speaker TBA
Oct 411:40 AM
Conference pass
Case processing – the most important part of pharmacovigilance?
AI & Machine Learning
Oct 411:40 AM
Conference pass
Oct 412:00 PM
Conference pass
Benefit risk assessments for gene therapies
Safety in Advanced Therapies
Moderator: David Chonzi, Global Head of PVE, Instil Bio
Ram Vempati, Head of Pharmacovigilance, Arcellx Inc
Adel Abou-Ali, Director, Risk Management & Benefit Risk, Global Pharmacovigilance, Astellas Pharma
Oct 412:00 PM
Conference pass
Effective risk minimization measures – sharing experiences
Safety Risk Management
Moderator: Amgad Shebl, Senior Director, Global Safety Lead, Immunology, CSL Behring
Maha Saad, Senior Director Drug Safety and Pharmacovigilance, Atara Biotherapeutics
Patricia Zuluaga Arias, President, Asociación Colombiana de Farmacovigilancia
Oct 412:00 PM
Conference pass
Navigating the changing landscape of PV safety databases
AI & Machine Learning
Abhay Dhingra, Associate Director of Pharmacovigilance Digital Innovation, Moderna, Inc.
Ellen (Lena) Mishalov, Director, Pv Technological Innovations, Astellas Pharma
Oct 412:00 PM
Conference pass
PANEL: Session title to be announced
Global PV
Milind Sardesai, Senior Director & Head, Pharmacovigilance, Covis Pharma
Deepa Venkataraman, Head of Global Patient Safety/PV and QA, Summit Therapeutics Inc
Oct 412:00 PM
Conference pass
When AI meets Pharmacovigilance
Next Generation Tech & Data
Sponsored by Tata Consultancy Services
Oct 41:40 PM
Conference pass
Can PV Operations manage and measure the automation roadmap to intelligence without risk?
Roundtable
Oct 41:40 PM
Conference pass
Innovations in PV operation: discussion on best practices
Roundtable
Oct 41:40 PM
Conference pass
Managing the challenges of preparing partner PV agreements
Roundtable
Oct 41:40 PM
Conference pass
Pharmacovigilance digital transformation
Roundtable
Oct 41:40 PM
Conference pass
Removing the roadblocks for pharmacists
Roundtable
Oct 41:40 PM
Conference pass
Risks through drug development: easy to get into but hard to get out of
Roundtable
Oct 41:40 PM
Conference pass
Session to be announced
Roundtable
Oct 41:40 PM
Conference pass
Think globally while acting locally to lower costs and streamline local pharmacovigilance and medical information tasks
Roundtable
Oct 41:40 PM
Conference pass
Think globally while acting locally to lower costs and streamline local pharmacovigilance and medical information tasks
Roundtable
Oct 41:40 PM
Conference pass
Where do we begin with AI?
Roundtable
Oct 42:20 PM
Conference pass
ADR / How to implement PV in the MI region
Global PV
Muhammad Ashar Naeem, Global Director, Head of Pharmacovigilance and Medical Affairs Department, Jamjoom Pharma
Oct 42:20 PM
Conference pass
Advance therapeutics in rare dieses: signaling and risk management challenges
Safety in Advanced Therapies
Oct 42:20 PM
Conference pass
Machine learning decision support tools for assessing causality
AI & Machine Learning
Shaun Comfort, Principal Science Enablement Director, Genentech
Oct 42:20 PM
Conference pass
Safety risk assessment for first-time clinical trials: Diving deeper into the nonclinical target organ toxicities
Safety Risk Management
Oct 42:20 PM
Conference pass
Using data for personalized safety
Next Generation Tech & Data
Antonio Del Santo, Principal Medical Director Personalized Safety Interface Product Development Safety, Hoffmann La-Roche AG
Oct 42:40 PM
Conference pass
Bringing diverse data to improve productivity and decision making in safety
Next Generation Tech & Data
Padma Vellanki, Director of Worldwide Patient Safety and Global Regulatory Data Analytics, Bristol-Myers Squibb
Oct 42:40 PM
Conference pass
Transformation of pharmacovigilance operations to enable oversight and proactive management of compliance, quality through automation, digital processes, metrics & risk indicators
AI & Machine Learning
Satya Sagi, Founder & Chief Executive Officer, Techsol Life Sciences
Oct 43:00 PM
Conference pass
China’s GVP Practices: what it means for safety systems suite
Next Generation Tech & Data
Tarak Thakker, Director, Safety Systems, BeiGene USA, Inc.
Oct 43:00 PM
Conference pass
Important safety signals to consider for advanced therapies
Safety in Advanced Therapies
Bill Haddock, Head Of Safety, Ovid Therapeutics
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Oct 43:00 PM
Conference pass
Prepping for New Drug Applications (NDAs)
Safety Risk Management
David Lilienfeld, MD, Vice President, Drug Safety and Pharmacovigilance, Elevar Therapeutics
Oct 43:00 PM
Conference pass
PV regulations across the Middle East
Global PV
Syed Zaferuddin, Global Pharmacovigilance Manager and QPPV, Julphar
Oct 43:00 PM
Conference pass
Use cases of automation
AI & Machine Learning
Abhay Dhingra, Associate Director of Pharmacovigilance Digital Innovation, Moderna, Inc.
Oct 43:20 PM
Conference pass
Pharmacovigilance in clinical trials
Safety Risk Management
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Oct 43:20 PM
Conference pass
Reshaping pharmacovigilance process agility and scalability with modern technologies
Next Generation Tech & Data
Oct 43:40 PM
Conference pass
Break
Keynotes
Break
Oct 43:45 PM
Conference pass
How has COVID-19 changed Pharmacovigilance?
Keynotes
Oct 44:25 PM
Conference pass
Keynote address sponsored by ArisGlobal
Keynotes
Speaker TBA
Oct 44:45 PM
Conference pass
Chair closing remarks
Keynotes
Susan Welsh MD, Senior Vice President, PV & Chief Safety Officer, Mirati Therapeutics
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Oct 58:55 AM
Conference pass
Chair opening remarks
Keynotes
Mariette Boerstoel Streefland, Senior Vice President Patient Safety, Chief Safety Officer, AstraZeneca
Oct 59:20 AM
Conference pass
Integrating real-world data in your pharmacovigilance workflow
Keynotes
Bruce Palsulich, Vice President of Safety Product Strategy, Oracle Health Sciences
Oct 511:00 AM
Conference pass
Benefit risk assessment for medical devices
Safety in Medical Devices
Oct 511:00 AM
Conference pass
Global safety reporting model: direct vs matrix reporting
Global PV
Rawad Antoun, Director, Gcsp Regions Lead, Americas, CSL Behring
Oct 511:00 AM
Conference pass
REMS compliance and enhancing internal stakeholder education
REMS
Sherice Mills, Executive Director, Head of Risk Management – US & Canada, Jazz Pharmaceuticals
Oct 511:00 AM
Conference pass
The future of pharmacovigilance at the MHRA
Data & Signal Detection
Phil Tregunno, Head of Vigilance Operations, Medicines & Healthcare Products Regulatory Agency
Oct 511:00 AM
Conference pass
Use of natural langue process in pre-approval setting
AI & Machine Learning
Oct 511:20 AM
Conference pass
AI Driven Safety Case Processing - Learnings and Experiences
AI & Machine Learning
Speaker TBA
Oct 511:20 AM
Conference pass
Medical Device Vigilance: EU MDR perspective
Safety in Medical Devices
Aarekh Shrestha, Head of Pharmacovigilance, Veranex
Oct 511:40 AM
Conference pass
Digitalizing SDEA operations for effective management of partners & affiliates while aligning to Glo
AI & Machine Learning
Paridhi Anand, Associate Director, PV Operations, ICSR Quality and Analytics, Moderna Therapeutics
Ram Vempati, Head of Pharmacovigilance, Arcellx Inc
Oct 511:40 AM
Conference pass
Fostering strong vendor relations and new technology integration to manage shared REMS strategies
REMS
Moderator: Marc DeLuca, M.ENG HSE, US Risk Management Lead, Sanofi
Andrew Yazwa, Risk Management Lead, Janssen
Kishore Gopu, Senior Director, REMS Operations, Teva Pharmaceuticals
Jason Ancell, Director, Global Patient Safety, Gilead Sciences
Oct 511:40 AM
Conference pass
Hepatic safety & DILI
Data & Signal Detection
Moderator: Dennis Vargo, Vice President, Head Of Drug Safety And Pharmacovigilance, Akebia Therapeutics , Inc.
Paul Hayashi, DILI Team Lead, Division of Hepatology & Nutrition, FDA
Raúl J. Andrade, Professor of Medicine and Director, Department of Medicine, University of Malaga
Oct 511:40 AM
Conference pass
Pharmacogenomics approaches for drug safety and personalized /precision medicine as a pre-emptive PV model
Global PV
Oct 511:40 AM
Conference pass
Software as a medical device
Safety in Medical Devices
Oct 512:00 PM
Conference pass
Building a worldwide PV organization from the ground up: strategies and opportunities in a complex landscape
Global PV
Tina Veizovic, Senior Director, Global Patient Safety Business Strategy, Planning and Execution, BeiGene
Oct 51:20 PM
Conference pass
Audit and inspection: transitioning back to in-office visits
Roundtable
Oct 51:20 PM
Conference pass
Emerging use cases and challenges for AI/ML, NLP and data science in drug safety
Roundtable
Oct 51:20 PM
Conference pass
Interconnection of safety, quality, and compliance in advanced cell therapy: experiences from small biotech
Roundtable
Dany Ward, Senior Director, Clinical Safety and Risk Management, AlloVir
Badrish Patel, M.D., Vice President, Head of Safety, AlloVir
Oct 51:20 PM
Conference pass
Is Automation leaving companies behind?
Roundtable
Oct 51:20 PM
Conference pass
New medical device regulations
Roundtable
Omar Aimer, Executive Committee member of ISoP; CEO and Founder, InnoVigilance
Oct 51:20 PM
Conference pass
New ways to innovate: real world data beyond clinical safety
Roundtable
Bianca Vora, Clinical Pharmacology Scientist, Genentech
Oct 51:20 PM
Conference pass
Recent trends, challenges, and future prospects in literature surveillance of Pharmacovigilance
Roundtable
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Oct 51:20 PM
Conference pass
Session title to be announced
Roundtable
Oyinkansola Odebo, Assistant Director Drug Safety, Supernus Pharmaceutical
Oct 51:20 PM
Conference pass
Starting the automation journey
Roundtable
Richard Wolf, Executive Director, C.S.L. Behring Gmbh
Joe Elicone, Global Head, Business Process, CSL Behring
Oct 52:00 PM
Conference pass
Data science, AI, and machine learning: the path to improved safety
AI & Machine Learning
Oct 52:00 PM
Conference pass
Integrated risk management and mitigation strategy
Safety Risk Management
Israel Gutierrez, VP, Drug Safety & Pharmacovigilance, Compugen Ltd
Oct 52:00 PM
Conference pass
Predictive pharmacovigilance focusing on AI/ML techniques
Predictive Safety
Michael von Forstner, Head of Clinical Safety and Pharmacovigilance, Biosimilars, Biogen
Oct 52:00 PM
Conference pass
Safety of medical communication technique in imaging and radiology devices
Safety in Medical Devices
Oct 52:00 PM
Conference pass
Session title to be announced
Data & Signal Detection
Farida Abane, Senior Medical Director, Pharmacovigilance, Deciphera Pharmaceuticals Llc
Oct 52:20 PM
Conference pass
Aggregate safety assessment planning (ASAP) to support IND safety reporting
Safety Risk Management
Jacqueline Corrigan-Curay, Director, Office of Medical Policy, Center for Drug Evaluation and Research, FDA
Mengchun Li, Pharmacovigilance Director, T.B. Alliance
Barbara Hendrickson, Vice President, AbbVie
Oct 52:40 PM
Conference pass
Combination products
Safety in Medical Devices
Moderator: Khaudeja Bano, Vice President, Combination Product Quality, Amgen
Paridhi Anand, Associate Director, PV Operations, ICSR Quality and Analytics, Moderna Therapeutics
Steve Dingman, VP, Drug Safety and Pharmacovigilance, Alkermes
Oct 52:40 PM
Conference pass
Quantitative drug safety, signal detection and benefit risk
Data & Signal Detection
Oct 52:40 PM
Conference pass
Session title to be announced
AI & Machine Learning
Oct 52:40 PM
Conference pass
Translating genomics into improved patient outcomes
Predictive Safety
Moderator: Sara Rogers,PharmD, BCPS, President, American Society of Pharmacovigilance
Moderator: Benjamin Brown, Executive Director, American Society of Pharmacovigilance
Oct 53:00 PM
Conference pass
Building a cross-functional Safety Management Team to ensure proactive safety data review and risk management
Safety Risk Management
Yuli Wu, Executive Director and Head of Drug Safety and Pharmacovigilance, Zai Lab
Nancy Dubois, Head of Global Patient Safety, EMD Serono
Oct 53:00 PM
Conference pass
Leveraging cloud AI to optimize omnichannel customer experiences
AI & Machine Learning
Arpita Bhowmick, Director, Global Omni Channel Contact Center Technology, Digital, Moderna
Oct 53:25 PM
Conference pass
Afternoon keynote address
Keynotes
Speaker TBA
last published: 12/Aug/22 14:25 GMT
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