2020 AGENDA

Live, 1 - 2 September 2020

Schedule

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Sep 109:00
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Keynote panel: Technology for PV efficiency: integrating new technologies into PV practices to improve operational processes, reporting, and risk assessment

Keynotes
Deepa Venkataraman, Senior Director, Head of Global Case Management and Medical Safety Operations, AbbVie
Deanna Montes De Oca, Global Head of Case Processing, Director PV Operations, Otsuka
Rahul Khajuria, Senior Director, Global Head Of Drug Safety Systems And Analytics, United Therapeutics
Michael Glaser, Innovation Technology Director, GSK
Sep 110:00
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Evolve or Revolutionize: opportunities to transform the future of pharmacovigilance

Keynotes
Bruce Palsulich, Vice President of Safety Product Strategy, Oracle Health Sciences
Sep 110:40
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Moving the industry forward: making next gen, now gen

NEXT GEN TECH & DATA
John Price, Pharmacovigilance Consultant, Arriello Sro
Sep 110:40
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Brexit: discussions on the affects it will have on PV operations and regulations

GLOBAL PV
Nino Gochitashvili, Head Of Uk Drug Safety Centre, Roche
Sep 111:00
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Moving From a fragmented to a unified pharmacovigilance solution

NEXT GEN TECH & DATA
Kelly Traverso, Vice President, Vault Safety Strategy and Consulting, Veeva Systems
Sep 111:00
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Patient safety and Latin America: promoting the patient voice within pharmacovigilance through education, leadership collaboration, and legislation

GLOBAL PV
Patricia Zuluaga Arias, Vice President, Coordinator of Academic Committee, Colombian Pharmacovigilance Association
Sep 111:20
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Pharmacovigilance operations in affiliates: challenges, strategies and solutions

GLOBAL PV
Lana Gloukhova, Head Of Regions, CSL Behring
Sep 111:30
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Essential for pharma today: Value above data with insights for patients and products

NEXT GEN TECH & DATA
Join us as we explore the maturity curve of insight led patient and safety product evaluations.Navigating at the crosshairs of data, modern data management technologies, data driven skillsets, and innovation, we share how market leaders are driving towards solutions that illuminate safety factors as products are incubated through launch and use with patient experiences and events.Lest not we forget the latest and greatest regulatory requirements to measure data with 1-Many external data sources, such as ARIA.
April Davis, Global Pharmacovigilance Industry Director, Accenture
Sep 112:20
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Global Pharmacovigilance Network – work with safety teams across locations, maximize efficiency, and ensure compliance

Keynotes
Jaylaxmi Nalawade, Associate Director, Lupin Ltd
Sep 112:40
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How to implement Quality oversight on local PV activities?

Keynotes
Bruno Mendez, MCCQ – PVQ, Sanofi Pasteur
Sep 113:10
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ROUNDTABLE SESSION

Keynotes
TABLE 1: Software Provider & Pharma Collaboration: From Combination Products to E2B(R3) readiness, open dialogue regarding the industry's operational needs & requirements
Natalia Holman, Business Developer Americas, AB Cube
Yasmine Benlahrech, Sales & Strategic Alliances Manager EMEA, AB Cube
TABLE 2: COVID-19 Vaccine Safety Reporting and Assessment: Challenges and Strategies
TABLE 3: 21st Century Reporting – how to properly, efficiently, and compliantly handle adverse event reports in today’s segmented digital age prescriptions and instructions to decrease errors and adverse events
TABLE 4: AI for AE intake: breaking down what has been learned regarding AI’s implementation in adverse event detection
Rave Harpaz, Senior Director Research and Data Science, Oracle Health Sciences
TABLE 5: Aggregate safety assessment planning: creating a systematic approach to evaluating and processing data through the creation of diverse safety teams
Greg Ball, Senior Principal Statistician, Merck
TABLE 6: Staying compliant: altering internal PV protocol within small pharma to stay up to date with FDA regulations
Oyinkansola Odebo, Assistant Director Drug Safety, Supernus Pharmaceutical
Sep 114:20
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Signal detection in early development

NEXT GEN TECH & DATA
Integrating signal detection in all phases of drug development, safety governance models, streamlining processes across teams, risk strategy creation, and data analysis.
Mircea Ciuca, Global Therapeutic Area Head Of Global Clinical Safety And Pharmacovigilance, CSL Behring
Sep 114:20
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Emerging market inclusion

GLOBAL PV
Assisting new regions become stable enough for clinical trials through corporate responsibility.
Maria Tello, Head Of Safety, Rakuten Medical
Sep 114:40
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Exploring AI’s journey in PV

NEXT GEN TECH & DATA
Is the transformation promised from Artificial Intelligence real, and can true business benefits be realized?
Glenn Carroll, Principal, Life Sciences, Deloitte Consulting LLP
Amanda Bowles, Specialist Leader, Life Sciences, Deloitte Consulting LLP
Sep 114:40
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Growing regulations in the Middle East

GLOBAL PV
How evolving regulations has led to an increase in reporting culture and collaborations with outside markets.
Syed Zaferuddin, Deputy Qppv, Pharmacovigilance And Clinical Trial Manager, Julphar
Sep 115:00
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Cross-industry collaboration

NEXT GEN TECH & DATA
Bridging the gap between pharma and solution providers’ understanding of what is needed from technology through open dialogues and collaboration.
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Sep 115:00
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Outside partnerships

GLOBAL PV
Handling complexity and challenges in managing relationships with Business Partners through safety data exchange agreements.
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Sep 115:20
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A Perfect Storm: managing the demands of safety reporting for the COVID-19 response

NEXT GEN TECH & DATA
COVID-19 brings new challenges to pharmacovigilance teams as outdated and often disjointed processes are stressed by the incoming wave safety reports resulting from the accelerated approval of new treatments and the implementation of mass vaccination campaigns. Drawing on his experience leading the H1N1 pandemic preparedness at GSK,Dr Andrew Rut will discuss the challenges of managing AE intake and processing in a fast-paced and high impact development cycle and outline how digital transformation of pharmacovigilance means we are better placed to manage post approval safety monitoring during the COVID-19 response.
Andrew Rut, Chief Executive Officer And Founder, MyMeds&Me
Sep 115:20
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Technology: the impact of digitalization on adverse event intake

GLOBAL PV
Anjani Jha, Founder and Chief Executive Officer, Nextrove
Sep 115:40
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Adopting new technology

NEXT GEN TECH & DATA
Mitigating the natural apprehensiveness to changing methodologies for an improvement in success rates.
Omar Aimer, PV spécialiste, Brunel Canada
Sep 115:40
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Pharmacovigilance audit planning on a global scale

GLOBAL PV
Enhancing efficiency for new and existing markets via risk-based approach.
Kishan Nandha, Manager, Pharmacovigilance Quality Assurance, Astellas Pharma
Sep 116:10
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Combination products: Integrated development and risk management

Keynotes
Susan Neadle, Senior Director, Global Value Chain Quality Design and Head, Combination Products CoP, Johnson & Johnson
Sep 116:30
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Combination products post market reports

Keynotes
Meeting FDA mandated safety reports for combination products to analyze adverse events and/or malfunctions associated with medical device reports
Sep 116:50
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Combination products Q&A

Keynotes
Susan Neadle, Senior Director, Global Value Chain Quality Design and Head, Combination Products CoP, Johnson & Johnson

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Sep 209:00
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Interdisciplinary efforts

Keynotes
Moving from Natural Intelligence and Intelligence Augmentation to Artificial Intelligence to advance aggregated safety planning and benefit risk evaluation.
Jim Buchanan, Clinician, Covilance
William Wang, Executive Director, Clinical Safety Statistics, Merck
Sep 209:20
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Enhancing operations

Keynotes
Enabling digital transformation with next-gen technology.
Aman Wasan, Senior Vice President, Business Development & Client Partners, ROW, ArisGlobal
Sep 209:40
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Validating AI Technologies in Pharmacovigilance

Keynotes
Utilizing TransCelerate’s “validation framework” to affirm the functionality of automated systems and processes.
Ellen (Lena) Mishalov, Director, Pv Technological Innovations, Astellas Pharma
Sep 210:00
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Keynote panel: Automation in PV – What? Why? When? And How

Keynotes
Advancing process technology & validation in PV.
Moderator: Maha Saad, Americas Pharmacovigilance Head, Bioresearch Quality And Compliance, Quality Assurance, Johnson & Johnson
Arvind Bellur, Senior Director, Head Of Safety Data Management, Sanofi
Ellen (Lena) Mishalov, Director, Pv Technological Innovations, Astellas Pharma
Mariette Boerstoel-Streefland, Senior Vice President Of Pharmacovigilance And Drug Safety, Alexion Pharmaceuticals
Sep 211:00
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Risk based strategies

SAFETY RISK MANAGEMENT
Developing risk management strategies using a benefit risk framework.
Reema Mehta, Head Of Risk Management And Safety Surveillance Research, Pfizer
Sep 211:00
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From animal models to RWD

PREDICTIVE SAFETY
Discussing the challenges during the evaluation of drug safety data during pregnancy and lactation.
Mate Balazs, Country Head – Patient Safety – Hungary National QPPV – Hungary, Novartis Pharma AG
Sep 211:20
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Large data volumes

SAFETY RISK MANAGEMENT
How to manage high adverse event volumes from Patient Support Programs.
Victoria Bartasek, Senior Associate Director, Global Pharmacovigilanc, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 211:20
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Optimizing the predictivity and translatability of preclinical safety data to the Clinic

PREDICTIVE SAFETY
Utilizing human induced Pluripotent Stem Cells (hiPSCs) for better personalized cardio-oncology treatments.
Frederick Sannajust, Former Executive Director Of Safety and Exploratory Safety Pharmacology At Merck, Independent Consultant, Independent Consultant
Sep 211:40
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A question-based approach to safety data

SAFETY RISK MANAGEMENT
Utilizing a question-based approach to safety data analysis assisting in the creation of a drug’s safety profile using focused, comprehensive, and well thought out systematic analyses.
Melvin Munsaka, Senior Director, Head Safety Statistics, AbbVie
Sep 211:40
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Title TBC

PREDICTIVE SAFETY
Ravi Vaidyanathan, Cardiac Product Manager, Fujifilm Cellular Dynamics
Sep 212:10
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Biosimilars in insulin

SAFETY RISK MANAGEMENT
Discussing Biocon’s work in the development and approval of the first biologic version of insulin.
Sundar Ramanan, Vice President, Head, Global Regulatory Affairs, Biocon Pharmaceuticals
Sep 212:10
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Panel discussion: Liver Toxicity

PREDICTIVE SAFETY
Sep 212:30
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Fireside Chat: Biosimilars risk assessment and pharmacovigilance

SAFETY RISK MANAGEMENT
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Raffaella Balocco-Mattavelli, INN Program Manger, World Health Organisation
Yvonne Nanciu, Senior Manager - Pharmacovigilance And Medical Information, AbbVie
Sep 213:20
Conference pass

ROUNDTABLE SESSION

Keynotes
TABLE 1: Overcoming adoption barriers: making the case for next gen automation and AI
Peter Kohut, Director Of Drug Safety, Arriello Sro
TABLE 2: Optimizing big pharma’s influence: adopting best safety practices used in big pharma within drug development to ensure positive outcomes
Toyin Adewole, Drug Safety Associate Director, Supernus Pharmaceuticals, Inc.
TABLE 3: Cross-team understandings: promoting open dialogues between other departments, affiliates and vendors, creating a more balanced and compliant PV team
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Colleen Walsh, Senior Director And Quality Operations, Alexion Pharmaceuticals
TABLE 4: Combination product complexities: mitigating safety regulation challenges caused by new the post market reporting guidance in the US and the changes in medical device regulations in EU
Maritess Esguerra, Principal Pharmacovigilance Process Leader, Genentech
TABLE 5: Multifaceted teams: mitigating pressure from regulators and payers to deliver products with higher benefit risk by forming balanced safety teams
Neha Sheth, Vice President, Risk Management and Epidemiology, Pharmacovigilance, Astellas Pharma
TABLE 6: Can RWD/EHR improve the safety profile by providing predictive insights for benefit-risk management
Reena Gollapudy, Senior Director, Indegene
Vladimir Penkrat, Associate Vice President, Indegene
Sep 214:30
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Combination products risk management

MEDICAL DEVICE SAFETY
Reviewing essential performance requirements needed to support robust product development and lifecycle management, ensuring processes are commensurate with a product’s complexity and assuring public health.
Susan Neadle, Senior Director, Global Value Chain Quality Design and Head, Combination Products CoP, Johnson & Johnson
Sep 214:30
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Panel discussion: Safety in advanced therapies

ADVANCED THERAPIES
Moderator: Wasim Khan, Medical Safety Assessment Physician (Msap), Bristol Myers Squibb
Maria Tello, Head Of Safety, Rakuten Medical
Donna Valencia, Senior Director Of Drug Safety, Axovant Sciences
David Chonzi, Vice President, Head Of Pharmacovigilance And Epidemiology ( Pve), Allogene Therapeutics
Sep 214:50
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EMA surveillance requirements

MEDICAL DEVICE SAFETY
Evaluating and modifying current device safety strategies to meet newly issued government safety standards.
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 215:10
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Differentiating adverse event causes

MEDICAL DEVICE SAFETY
Understanding which events are caused by a device’s constituent drug to better interpret device caused events.
Dennis Brooks, Global Safety Physician Infection And Vaccines, Astrazeneca
Sep 215:40
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Acquiring a REMS program

SAFETY RISK MANAGEMENT
Successfully integrating inherited programs into your organization.
Sep 215:40
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Improving predictive toxicology

PREDICTIVE SAFETY
Collaborating with stakeholders to change policies surrounding animal model alternatives and move toward the acceptance of human-based non-clinical approaches.
Elizabeth Baker, Pharmaceutical Policy Program Director, Physicians Committee for Responsible Medicine
Sep 216:00
Conference pass

Preventing safety compliance issues

SAFETY RISK MANAGEMENT
Combining technology, organizational structure, and regulatory approaches.
Steven Beales, Senior Vice President Of Information Technology, WCG
Sep 216:00
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Bridging the gap: Animal models for mental diseases to de-risk drug safety in humans

PREDICTIVE SAFETY
Sep 216:20
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Immunoaffinity chromatography Isoagglutinin reduction in IVIG (IgPro10/Privagen) reduced hemolytic adverse reactions

SAFETY RISK MANAGEMENT
Amgad Shebl, Director, Global Clinical Safety And Pharmacovigilance, CSL Behring
Sep 216:20
Conference pass

Benchmark dose modeling (BMD)

PREDICTIVE SAFETY
Evaluating a drug’s toxicity through a more consistent, scientifically rigorous, and transparent framework.
Kan Shao, Associate Professor Of Environmental And Occupational Health, Indiana University
Sep 216:40
Conference pass

Risk Management and oral desensitization products

SAFETY RISK MANAGEMENT
RMP and REMS strategies.
Adrian Dana, Vice President, Drug Safety, Aimmune Therapeutics
Sep 216:40
Conference pass

AI and preclinical testing

PREDICTIVE SAFETY
Detectingdrug’s toxicity before clinical trials through the use of AI models ensuring patient safety during post market stages.
Coryandar Gilvary, Chief Data Scientist, OneThree Biotech
last published: 31/Aug/20 20:05 GMT

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