2023 Agenda

 

Boston, MA, 18 - 19 October 2023

Schedule

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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 1811:20
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
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
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
Oct 1814:25
Conference pass
Oct 1814:25
Conference pass

Chair's Remarks

Safety Risk Management
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
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
Oct 1910:40
Conference pass

Networking break

Keynotes

Join us in the exhibiton hall for refreshments

Oct 1911:15
Conference pass
Oct 1911:15
Conference pass

Chair's Remarks

Next Gen Tech & Data
Sophia Goodison, Senior Director,Safety Evaluation, GSK
Oct 1911:15
Conference pass

Chair's Remarks

Safety Risk Management
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

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
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 1912:40
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

Chair's Remarks

Patient Engagement
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
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
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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