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

Outsourcing pharmacovigilance post covid-19

Global PV
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 44:25 PM
Conference pass

Keynote address sponsored by ArisGlobal

Keynotes

Speaker TBA

Oct 44:45 PM
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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
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
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
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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