2023 Agenda
Boston, MA, 18 - 19 October 2023
Schedule
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Oct 188:55
Conference pass
Chair's Remarks
Keynotes
Oct 189:00
Conference pass
Becoming Strategic Partners: Moving drug safety departments from cost centers to strategic partners
Keynotes
Fatima Bhayat, Vice President, Head of Global Patient Safety and Chief Safety Officer, Amgen Inc
Oct 189:20
Conference pass
Digital Patient 2025 Vision
Keynotes
The Transformative Safety platform that puts the patient at the center for an integrated patient experience
Oct 189:40
Conference pass
Technologies in Pharmacovigilance: Emerging Use Cases and Best Practices
Keynotes
Moderator: Alejandra Guerchicoff, Industry Leader, TCS ADD™ Safety, Tata Consultancy Services
Michael Murphy, Executive Director, Head of Pharmacovigilance Operations, Amgen
Barbara Dawson, VP, Head of PV Operations, GSK
Oct 1810:20
Conference pass
Networking break
Keynotes
Join us in the exhibition hall for refreshments
Oct 1811:15
Conference pass
Chair's Remarks
AI & Machine Learning
Vikram Anand, President, Compliance Service Line, EVERSANA
Oct 1811:15
Conference pass
Chair's Remarks
Global PV
Steve Dingman, Vice President, Head of Pharmacovigilance, ImmunoGen Inc
Oct 1811:15
Conference pass
Chair's Remarks
Next Gen Tech & Data
Priya Jain, VP, Head of Pharmacovigilance, Deciphera
Oct 1811:15
Conference pass
Chair's Remarks
Safety Risk Management
Maria Tello, Senior Medical Director, Patient Safety & PV Lead, Strategy and Innovation, Horizon
Oct 1811:15
Conference pass
Chair's Remarks
Vaccine Safety
Oct 1811:20
Conference pass
FDA computer system validation guidance: What does it mean for QM systems
Next Gen Tech & Data
Oct 1811:20
Conference pass
Moving from pandemic to endemic: Lessons learned to advance safety processes
Vaccine Safety
Jamie Wilkins, Senior Director, Head- Risk Management Center of Excellence, Pfizer
Kourtney Davis, Vice President, Global Epidemiology, Janssen R&D
Oct 1811:20
Conference pass
Regulations and requirements for global pharmacovigilance in Asia
Global PV
Mamiko Kasho, Executive Director, Eisai
Oct 1811:20
Conference pass
Risk management and cross functional collaborations: streamlining the process
Safety Risk Management
Abimbola Cole, Scientific Director, Safety Evaluation & Risk Management (SERM), GSK
Sophia Goodison, Senior Director,Safety Evaluation, GSK
Oct 1811:20
Conference pass
The reality and true use of automation: source through interfaces
AI & Machine Learning
Tarak Thakker, Head of Safety Systems, BeiGene
Oct 1811:40
Conference pass
Challenges of safety review meetings: Best practices for effective decision making
Safety Risk Management
Maria Tello, Senior Medical Director, Patient Safety & PV Lead, Strategy and Innovation, Horizon
Oct 1811:40
Conference pass
Knitting the Smartest Safety Data Fabric: How to Make Good Data Great
Next Gen Tech & Data
Siva Thiagarajan, Associate Principal, ZS
Vartika Pandya, Strategy Insights & Planning Consultant, ZS Associates
Oct 1811:40
Conference pass
Qinecsa Solutions
Global PV
Humaira Qureshi, President, Qinecsa Solutions
Oct 1811:40
Conference pass
Safety case processing: Getting it right first time
AI & Machine Learning
Graeme Ladds, Director of Pharmacovigilance & Chief Executive Officer, PharSafer
Oct 1812:00
Conference pass
AI’s impact on the transformation of Pharmacovigilance
AI & Machine Learning
Moderator: Heather Adinolfi, Integrated Business Analysis Practice Lead, Astrix Technology Group
Siva Kumar Buddha, Global Pharmacovigilance Physician, Senior Manager, Teva Pharmaceuticals
Oct 1812:00
Conference pass
PV application moving into the cloud and building database
Next Gen Tech & Data
Vikalp Khare, Director, Global Safety Data Management, GPV, Otsuka Pharmaceutical
Oct 1812:00
Conference pass
PV intelligence and regulations in the Middle East
Global PV
Oct 1812:20
Conference pass
Global collaboration initiatives to achieve medical safety
Global PV
Angela Caro Rojas, President, International Society of Pharmacovigilance
Oct 1812:20
Conference pass
Pandemic vaccines: a formidable challenge for pharmacovigilance
Vaccine Safety
Alexandre Kiazand, Head Safety Science Center of Excellence, Patient Safety, AstraZeneca
Oct 1812:40
Conference pass
Networking lunch
Keynotes
Enjoy an hour lunch break
Oct 1813:40
Conference pass
Analysis of data generated after Audit and Inspections
Roundtables
Oct 1813:40
Conference pass
Best Practices: Case Management in Pharmacovigilance
Roundtables
Oct 1813:40
Conference pass
Ecopharmacovigilance
Roundtables
Melissa Bernal, Vice President, Asociación Colombiana de Farmacovigilancia
Oct 1813:40
Conference pass
From Data to Action: Leveraging Regulatory Intelligence for Data-Driven Decision Making in Pharmacovigilance
Roundtables
Oct 1813:40
Conference pass
Harmonizing pharmacovigilance practices
Roundtables
Lana Gloukhova, Vice President Global Patient Safety & Pharmacovigilance, Athira Pharma
Oct 1814:20
Conference pass
Break
Keynotes
Short break
Oct 1814:25
Conference pass
Chair's Remarks
AI & Machine Learning
Oct 1814:25
Conference pass
Chair's Remarks
Global PV
Oct 1814:25
Conference pass
Oct 1814:30
Conference pass
AE reporting with social media
Next Gen Tech & Data
Jaylaxmi Nalawade, Associate Director, Pharmacovigilance and REMS, Lupin
Oct 1814:30
Conference pass
AI in PV: Opportunities and challenges
AI & Machine Learning
Oct 1814:30
Conference pass
Building a global PV organization
Global PV
Nilay Gami, Acting Global Head of Pharmacovigilance, Kyowa Kirin, Inc.
Oct 1814:30
Conference pass
Pharmacovigilance: A practical approach to training the next generation of safety scientists
Safety Risk Management
Omar Aimer, Executive Committee member and Medical Device Safety SIG lead, ISoP; Founder, Innovigilance
Walter Jones, Professor of Molecular Pharmacology & Neuroscience; Director of Pharmacovigilance Programs, Loyola University Chicago
Fabio Lievano, Vice President Safety Science, Abbvie Pharmaceuticals Inc
John Price, Vice President of Continuing Medical Education, American Society of Pharmacovigilance Physicians
Oct 1814:30
Conference pass
Vaccine technology: Managing correlates to increase safety
Vaccine Safety
Oct 1814:50
Conference pass
Multidisciplinary collaboration: a critical element in safety management throughout a product lifecycle
Global PV
Oct 1814:50
Conference pass
The adoption of AI to automate the end-to-end lifecycle of Pharmacovigilance documentation and auto-synthesize powerful patient safety intelligence as part of active post-market surveillance
AI & Machine Learning
Satya Sagi, Founder & Chief Executive Officer, Techsol Life Sciences
Oct 1814:50
Conference pass
The art of simplifying pharmacovigilance
Next Gen Tech & Data
Vivek Ahuja, SVP -Global Delivery Excellence, Strategy & Growth, PV, Quality & Regulatory Service Lines, EVERSANA
Oct 1815:10
Conference pass
Best practices in safety analytics: Managing today and preparing for tomorrow
AI & Machine Learning
Milind Sardesai, Senior Director & Head, Pharmacovigilance, Covis Pharma
Oct 1815:10
Conference pass
Models for an International Pharmacovigilance function
Global PV
Tina Veizovic, Senior Director, GPS International and PV Partnerships, BeiGene
Oct 1815:10
Conference pass
Plant-based vaccines: advantages and considerations for safety
Vaccine Safety
Asif Mahmood, Chief Safety Officer, Global Clinical Safety & Pharmacovigilance, Medicago
Oct 1815:10
Conference pass
Use of tech to support better data collection
Next Gen Tech & Data
Phil Tregunno, Deputy Director, Patient Safety Monitoring, Medicines & Healthcare products Regulatory Agency
Oct 1815:30
Conference pass
Culture and innovation: How a new culture can help embrace innovative solutions in the drug safety space
Next Gen Tech & Data
Michael Glaser, Safety Innovation Technology Director, GSK
Richard Wolf, Executive Director, PV Operations, CSL Behring
Oct 1815:30
Conference pass
Evaluation of Drug-Induced Liver Injury risk in pre-marketing clinical drug trials
Safety Risk Management
Oct 1815:30
Conference pass
Session title to be announced
Global PV
Maria Anitan, Global Head of Pharmacovigilance and Drug Safety, Med Communications Inc
Oct 1815:50
Conference pass
Break
Keynotes
Short break followed by closing keynote presentations
Oct 1816:15
Conference pass
Panel: How industry and regulators achieve alignment to improve patient safety
Keynotes
Moderator: Nancy Dubois, Head of Global Patient Safety, US Region, EMD Serono
Lana Gloukhova, Vice President Global Patient Safety & Pharmacovigilance, Athira Pharma
Juan Camilo Gonzalez, Executive Director Head of Pharmacovigilance - Rest of the World, Moderna
Michelle Motta Dardeno, Vice President and Head - Global Patient Safety, Aurinia
Oct 1816:55
Conference pass
Chair's Closing Remarks
Keynotes
Oct 1817:00
Conference pass
Cocktail reception and networking
Keynotes
Join us in the exhibition hall for cocktails and freshments
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Oct 198:00
Conference pass
Expo hall and registration opens
Keynotes
Expo hall and registration opens
Oct 198:55
Conference pass
Chair's Remarks
Keynotes
Felix Arellano, Global Head of Safety and Risk Management, F.Hoffmann-La Roche
Oct 199:00
Conference pass
Update from the FDA
Keynotes
Helen Edelberg, MD, MPH, Deputy Director of Safety, Office of New Drugs, FDA
Oct 199:40
Conference pass
Panel: Real-World Evidence (RWE) Framework: What does it mean for drug safety?
Keynotes
Moderator: Fatima Bhayat, Vice President, Head of Global Patient Safety and Chief Safety Officer, Amgen Inc
Juhaeri Juhaeri, VP & Head, Epidemiology and Benefit-Risk, Sanofi
Ryan Kilpatrick, Vice President & Head, Global Epidemiology, AbbVie
Oct 1910:20
Conference pass
Session title to be announced
Keynotes
Oct 1910:40
Conference pass
Networking break
Keynotes
Join us in the exhibiton hall for refreshments
Oct 1911:15
Conference pass
Chair's Remarks
Patient Engagement
Oct 1911:15
Conference pass
Chair's Remarks
Next Gen Tech & Data
Sophia Goodison, Senior Director,Safety Evaluation, GSK
Oct 1911:15
Conference pass
Oct 1911:15
Conference pass
Chair's Remarks
Safety in Medical Devices
Omar Aimer, Executive Committee member and Medical Device Safety SIG lead, ISoP; Founder, Innovigilance
Oct 1911:20
Conference pass
Consumer healthcare and safety evaluations
Patient Engagement
Amrit Gill, Therapeutic Area Head, Sanofi
Tracy Crooks, Director Risk Management and Vigilance, Reckitt Benckiser
Christina Dickson, Head of Pharmacovigilance Operations, Haleon
Oct 1911:20
Conference pass
EU MDR vigilance impact assessment strategy
Safety in Medical Devices
Oct 1911:20
Conference pass
Tools for aggregate safety and benefit risk assessment planning and execution from the DIA-ASA Biopharma Interdisciplinary Safety Evaluation (DAISE) working groups
Safety Risk Management
Susan Colilla, Benefit Risk Assessment Planning (BRAP) Task Force; Senior Director and Head of Epidemiology, Teva Pharmaceuticals U.S.A.
Oct 1911:20
Conference pass
Transforming safety case processing with AI/ML for quality, compliance, and operational excellence
AI & Machine Learning
Oct 1912:00
Conference pass
Automation, AI, and machine learning PV: concept and case study
AI & Machine Learning
Oct 1912:00
Conference pass
Practical learnings from implementing a structured benefit risk assessment process in a biopharmaceutical company
Safety Risk Management
Chris Bone, Pharmacovigilance Scientist, Biogen
Oct 1912:00
Conference pass
Sanofi case study: While closing affiliates, how to ensure patient safety first and PV business continuity?
Patient Engagement
Oct 1912:00
Conference pass
Session title to be announced
Safety in Medical Devices
Joan D’souza, Independent PV Expert, Institute of Pharmacovigilance
Oct 1912:00
Conference pass
Session to be announced
Next Gen Tech & Data
Arpita Bhowmick, Director, Global Omni Channel Contact Center Technology, Digital, Moderna
Oct 1912:20
Conference pass
Different safety approach between pharma, devices, and combination products
Safety in Medical Devices
Melissa Bernal, Vice President, Asociación Colombiana de Farmacovigilancia
Omar Aimer, Executive Committee member and Medical Device Safety SIG lead, ISoP; Founder, Innovigilance
Oct 1912:20
Conference pass
Patient engagement and quality: How to ensure quality oversight and patient safety
Patient Engagement
Moderator: Deepa Venkataraman, Vice President, Drug Safety and Pharmacovigilance, Corcept Therapeutics
Nadiya Neyezzhalova, Consumer Safety Regional Director, Americas, Haleon
Oct 1912:20
Conference pass
PV and risk management compliance within stakeholder discipline
Safety Risk Management
Oct 1912:40
Conference pass
Need to explore ChatGPT in pharmacovigilance
Next Gen Tech & Data
Siva Kumar Buddha, Global Pharmacovigilance Physician, Senior Manager, Teva Pharmaceuticals
Oct 1913:00
Conference pass
Networking lunch
Keynotes
Networking lunch
Oct 1914:00
Conference pass
Automation - Practical Applications in Production
Roundtables
Discuss pharmacovigilance automation uses cases - benefits and risks, best practices, approach to validation and conforming to existing regulators guidance on AI/ML and automation.
Oct 1914:00
Conference pass
DE&I in clinical trials
Roundtables
Philisha Mack, Director Drug Safety, Azurity Pharmaceuticals
Oct 1914:00
Conference pass
Drug-device combination products
Roundtables
Joan D’souza, Independent PV Expert, Institute of Pharmacovigilance
Oct 1914:00
Conference pass
Mainstream pharma and psychedelics
Roundtables
Oct 1914:00
Conference pass
Pregnancy registry
Roundtables
Anthony Adamkovic, Senior Director of Pharmacovigilance, Harmony Biosciences, LLC
Oct 1914:00
Conference pass
PV professionals: Developing the next generation
Roundtables
John Price, Vice President of Continuing Medical Education, American Society of Pharmacovigilance Physicians
Oct 1914:00
Conference pass
Session title to be announced
Roundtables
Lorina Ouimette, Associate Director, US Safety Compliance, EMD Serono
Oct 1914:40
Conference pass
Break
Keynotes
Short break
Oct 1914:45
Conference pass
Chair's Remarks
Safety in Advanced Therapies
Ale (Maria) Vazquez, Senior Vice President & Head Medical Safety Science, Astellas Pharma
Oct 1914:45
Conference pass
Oct 1914:45
Conference pass
Chair's Remarks
Safety Risk Management
Han Ma, SVP, Chief Safety Officer, BeiGene
Oct 1914:45
Conference pass
Chair's Remarks
Safety in Advanced Therapies
Ale (Maria) Vazquez, Senior Vice President & Head Medical Safety Science, Astellas Pharma
Oct 1914:45
Conference pass
Chair's Remarks
Data & Signal Management
Priyavadhana Moka, Patient Safety Specialist, EMD Serono Inc
Oct 1914:50
Conference pass
How can PV influence high quality adverse event data from suppliers
Safety Risk Management
Oct 1914:50
Conference pass
Leveraging Advocacy to Enhance Drug Profiles and Patient Outcomes
Patient Engagement
Jacqueline Gerena, Director, Risk Management Strategy, Janssen
Taj Nero, CMC & NC Project Manager, GSK
Oct 1914:50
Conference pass
Preventability and severity assessment in reporting adverse drug reactions: balancing effectiveness, safety and the responsible use of limited healthcare resources
Data & Signal Management
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Oct 1914:50
Conference pass
Safety/PV regulatory requirements for ATMPS: An overview
Safety in Advanced Therapies
Oct 1915:10
Conference pass
Implication for PV machine learning at light: Understanding possibilities and actual accuracy
AI & Machine Learning
Oct 1915:10
Conference pass
Patient centric tools in innovative approval pathways
Patient Engagement
Oct 1915:10
Conference pass
Safety review and challenge of adoptive cell therapy in cancer
Safety in Advanced Therapies
Tarik Messaoud, Drug Safety Physician, Access Clinical Research
Oct 1915:10
Conference pass
Session to be announced
Data & Signal Management
Oct 1915:10
Conference pass
What’s next? New horizons for patient safety and personalized medicine
Safety Risk Management
Sara Rogers,PharmD, BCPS, President, American Society of Pharmacovigilance
Oct 1915:30
Conference pass
AE groupings in safety (AEGiS): Operationalizing the FDA medical queries (FMQs)
Safety Risk Management
Peg Fletcher, President, MedAssessment, Inc.
Oct 1915:30
Conference pass
Anticipating safety issues gene & cell therapies
Safety in Advanced Therapies
Mitra Tavakkoli, Vice President; Clinical Development, 4DMT
Adel Abou-Ali, Head of Benefit Risk Center of Excellence (CoE), GPSE, Takeda Pharmaceutical Company Ltd.
Oct 1915:30
Conference pass
Drug induced liver injury: Tips on assessment, monitoring, and management in drug development
Data & Signal Management
Oct 1915:30
Conference pass
New technologies in PV: hype or reality?
AI & Machine Learning
Oct 1915:30
Conference pass
Patient-centric approach to dose optimization
Patient Engagement
Mark Stewart, Vice President, Science Policy, Friends of Cancer Research
Oct 1915:50
Conference pass
Natural language processing in pharmacovigilance and aggregate reports
AI & Machine Learning
Oct 1916:10
Conference pass
CONCLUSION OF WORLD DRUG SAFTEY CONGRESS
Keynotes
Thank you for attending and we look forward to seeing you at our 2024 edition.
Want to learn how to get involved?Email Gina McHugh at gina.mchugh@terrapinn.com
last published: 05/Jun/23 18:45 GMT
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