2020 AGENDA

Boston, MA, 1 - 2 September 2020

Schedule

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Sep 108:30
Conference pass

Chairperson’s opening remarks

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Harborview Ballroom
Sep 108:40
Conference pass

Keynote address: Optimizing efforts: utilizing AI to shorten the time between input, detection, exploration, evaluation, and decision making

Keynotes
Alexandre Kiazand, Head Safety Science Center of Excellence, Patient Safety, AstraZeneca
Sep 109:00
Conference pass

Keynote address: Evolve or Revolutionize: Opportunities to transform the future of pharmacovigilance

Keynotes
Bruce Palsulich, Vice President of Safety Product Strategy, Oracle Health Sciences
Sep 109:20
Conference pass

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

Keynotes
If you are interested in speaking on this panel, contact Anna.Bagley@terrapinn.com
Moderator: Susan Welsh, Chief Safety Officer, CSL Behring
Michael Glaser, Innovation Technology Director, GSK
Deanna Montes De Oca, Director Global Pv Operations, Otsuka
Rahul Khajuria, Senior Director, Global Head Of Drug Safety Systems And Analytics, United Therapeutics
Harborview Ballroom
Sep 111:00
Conference pass

Large data volumes: How to manage high adverse event volumes from Patient Support Programs

SAFETY RISK MANAGEMENT (HARBORVIEW)
Victoria Bartasek, Senior Associate Director, Global Pharmacovigilanc, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 111:00
Conference pass

Beyond safety science: using AI to directly interact with patients and better manage drug benefits and risks

NEXT GEN TECH & DATA (WATERFRONT 2)
Meenal Patwardhan, Therapeutic Area Head, Infectious Diseases, Neurosciences, Men and Women's Health, General Medicine, AbbVie
Sep 111:00
Conference pass

Labeling in Japan: an update on PV planning and regulations due to the development of new database studies and PMDA guidance for e-labeling

GLOBAL PV (BEACON HILL)
Shinobu Uzu, Associate Executive Director, Pharmaceuticals and Medical Devices Agency
Sep 111:00
Conference pass

Improving predictive toxicology: collaborating with global regulators to change policies surrounding animal model alternatives and move toward the acceptance of human-based non-clinical approaches

PREDICTIVE SAFETY (WATERFRONT 3)
Elizabeth Baker, Pharmaceutical Policy Program Director, Physicians Committee for Responsible Medicine
Sep 111:00
Conference pass

EMA surveillance requirements: evaluating and modifying current device safety strategies to meet newly issued government safety standards

MEDICAL DEVICE SAFETY (WATERFRONT 1)
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Sep 111:20
Conference pass

A Question-Based Approach to Safety Data

SAFETY RISK MANAGEMENT (HARBORVIEW)
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 111:20
Conference pass

Artificial Intelligence and audit preparation: applying AI, rule-based systems, machine learning, and natural language processing to improve audit quality, efficiency, and effectiveness

NEXT GEN TECH & DATA (WATERFRONT 2)
Maha Saad, Americas Pharmacovigilance Head, Bioresearch Quality And Compliance, Quality Assurance, Johnson & Johnson
Sep 111:20
Conference pass

AI and preclinical testing: detecting a drug’s toxicity before clinical trials through the use of AI models ensuring patient safety during post market stages

PREDICTIVE SAFETY (WATERFRONT 3)
Coryandar Gilvary, Chief Data Scientist, OneThree Biotech
Sep 111:20
Conference pass

Post-Marketing Pharmacovigilance in China: tracing the evolution of PV and how the network continues to mature

PREDICTIVE SAFETY (WATERFRONT 3)
William Gregory, Senior Director, Worldwide Medical And Safety, Pfizer
Sep 111:20
Conference pass

A global paradigm shift: implementing in vitro diagnostic medical devices in clinical trials to support patient safety and meet changing regulations cross-regionally

MEDICAL DEVICE SAFETY (WATERFRONT 1)
Jennifer Dacpano-Komansky, Director, Medical Device Global Regulatory Affairs, Novartis
Sep 111:40
Conference pass

Measuring effectiveness: mitigating the lack of post marketing information and reported changes through the procurement and analysis of “spontaneous data”

SAFETY RISK MANAGEMENT (HARBORVIEW)
Amgad Shebl, Director Global Clinical Safety And Pharmacovigilance, CSL Behring
Sep 111:40
Conference pass

Moving the industry forward: making next gen, now gen

NEXT GEN TECH & DATA (WATERFRONT 2)
Sponsored by Arriello
John Price, Pharmacovigilance Consultant, Arriello
Sep 111:40
Conference pass

Brexit: discussions on the affects it will have on PV operations and regulations

GLOBAL PV (BEACON HILL)
Nino Gochitashvili, Head Of Uk Drug Safety Centre, Roche
Sep 111:40
Conference pass

Benchmark dose modeling (BMD): evaluating a drug’s toxicity through a more consistent, scientifically rigorous, and transparent framework

PREDICTIVE SAFETY (WATERFRONT 3)
Kan Shao, Assistant Professor Of Environmental And Occupational Health, Indiana University Bloomington
Sep 112:00
Conference pass

Managing the Aura of Artificial Intelligence: how to advance the needs of patients through realistic strategies and align the human workforce with artificial intelligence

SAFETY RISK MANAGEMENT (HARBORVIEW)
April Davis, Global Pharmacovigilance Industry Director, Accenture
Sep 112:00
Conference pass

Cell-specific testing: using a tissue stem cell-specific test for early detection of drug candidates with a higher success rate

PREDICTIVE SAFETY (WATERFRONT 3)
James Sherley, Director, ASYMMETREX
Sep 114:00
Conference pass

ROUNDTABLE 1: Software provider collaborations: discussing pharma’s need for open dialogue regarding their operational needs, including E2B(R3) readiness and working with combination products

Keynotes
Natalia Holman, Business Developer Americas, AB Cube
Yasmine Benlahrech, Sales & Strategic Alliances Manager EMEA, AB Cube
Sep 114:00
Conference pass

ROUNDTABLE 10: Aggregate safety assessment planning: creating a systematic approach to evaluating and processing data through the creation of diverse safety teams

Keynotes
Greg Ball, Senior Principal Statistician, Merck
Sep 114:00
Conference pass

ROUNDTABLE 11: Cross-team understandings: promoting open dialogues between other departments, affiliates, and vendors creating a more balanced and compliant PV team

Keynotes
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Colleen Walsh, Senior Director And Quality Operations, Alexion Pharmaceuticals
Sep 114:00
Conference pass

ROUNDTABLE 12: Multifaceted teams: mitigating pressure from regulators and payers to deliver products with higher benefit risk by forming balanced safety teams

Keynotes
Neha Sheth, Executive Director, Global Benefit, Risk Management, Astellas Pharma
Sep 114:00
Conference pass

ROUNDTABLE 13: Therapeutic use of cannabinoids

Keynotes
An in-depth look at the current landscape, regulatory challenges in clinical investigations, patient safety, and overcoming misconceptions associated with these therapies
Barbara Morollo, Head, Pharmacovigilance Operations, Corbus Pharmaceuticals
Sep 114:00
Conference pass

ROUNDTABLE 14: Collaborating with headquarters

Keynotes
Staying compliant with your company’s globally issued protocols in different regions through open discussions on your area’s issues and specific regulations
Natalia Hristov, Latin America Pharmacovigilance Manager, Merck Serono
Sep 114:00
Conference pass

ROUNDTABLE 15: Risk Evaluation and Mitigation Strategy (REMS): exploring the development, operational processes, challenges, and areas of improvement within a shared system REMS

Keynotes
Kal Elhoregy, Director, Risk Evaluation and Mitigation Strategy (REMS), Amneal Pharmaceuticals
Sep 114:00
Conference pass

ROUNDTABLE 2: Combination Products Complexities, Challenges and Opportunities: discussing the challenges and solutions organizations face due to updated regulations/guidances in the US and Europe

Keynotes
Lisa Moore, Executive Director Med Device, Administration, Covance
Sep 114:00
Conference pass

ROUNDTABLE 3: 21st Century Reporting

Keynotes
How to properly, efficiently, and compliantly handle adverse event reports in today’s segmented digital age prescriptions and instructions can decrease errors and adverse events
Friderike Bruchmann, Co-Founder And Chief Executive Officer, MEDIKURA Digital Health GmbH
Sep 114:00
Conference pass

ROUNDTABLE 4: AI for AE intake: breaking down what has been learned regarding AI’s implementation in adverse event detection

Keynotes
Rave Harpaz, Senior Director Research and Data Science, Oracle Health Sciences
Sep 114:00
Conference pass

ROUNDTABLE 5: Challenges and leading practices in selecting a PV business process outsourcer: a case study with Mitsubishi Tanabe

Keynotes
Vladimir Laguerre, Partner, Prudentia Group LLC
Minh Hoang, Senior Director, Drug Safety, Mitsubishi Tanabe
Sep 114:00
Conference pass

ROUNDTABLE 6: Standardizing practices: correcting the quality of data collected through formalizing methods of collection and analysis

Keynotes
Rama Vempati, Associate Director, AbbVie Oncology
Sep 114:00
Conference pass

ROUNDTABLE 7: Staying compliant: altering internal PV protocol within small pharma to stay up-to-date with FDA regulations

Keynotes
Oyinkansola Odebo, Senior Manager Drug Safety, Supernus Pharmaceutical
Sep 114:00
Conference pass

ROUNDTABLE 8: Supporting pharma: utilizing medical devices to explore safety questions and promote positive outcomes for patients

Keynotes
Lisa Beth Ferstenberg, Principal Patient Safety Physician, AstraZeneca
Sep 114:00
Conference pass

ROUNDTABLE 9: Applying for regulatory approval with a limited safety package: how to demonstrate the value of cancer and rare disease therapies with little clinical and competitive trials

Keynotes
Jawad Hasan, Exec. Medical Director, Global Drug Safety (GDS) Therapeutic Area Safety Head,, Alexion Pharmaceuticals
Sep 115:05
Conference pass

Pharmacovigilance and non-medical switching: understanding patients’ need for alternative therapies and collaborating with PV teams to ensure the safety of biosimilars before approval

SAFETY RISK MANAGEMENT (HARBORVIEW)
Philip Schneider, Advisory Board Chair, Alliance for Safe Biologic Medicines
Sep 115:05
Conference pass

Beyond case processing: how PV teams can fully utilize automation to improve the processes

NEXT GEN TECH & DATA (WATERFRONT 2)
Claudia Lehmann, Head Of Global Pharmacovigilance Operations, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 115:05
Conference pass

Pharmacovigilance operations in affiliates: challenges, strategies and solutions

GLOBAL PV (BEACON HILL)
Lana Gloukhova, Head Of Regions, CSL Behring
Sep 115:05
Conference pass

From animal models to RWD: discussing the challenges during the evaluation of drug safety data during pregnancy and lactation

PREDICTIVE SAFETY (WATERFRONT 3)
For speaking opportunities, contact Anna.Bagley@terrapinn.com
Mate Balazs, Country Head – Patient Safety – Hungary National QPPV – Hungary, Novartis Pharma AG
Sep 115:05
Conference pass

Combination products risk management

MEDICAL DEVICE SAFETY (WATERFRONT 1)
Reviewing essential performance requirements needed to support robust product development and life cycle management, ensuring processes are commensurate with a product’s complexity and assuring public health
Susan Neadle, Senior Director, Global Value Chain Quality Design Head, J&J Combination Products Cop, Johnson & Johnson
Sep 115:25
Conference pass

Building a high performing PV team: incorporating automation-based methods to support the evolution of a start-up to commercialization in a dynamic regulatory landscape

NEXT GEN TECH & DATA (WATERFRONT 2)
Deepa Venkataraman, Senior Director, Section Head, Drug Safety And Pharmacovigilance Operations, Pharmacyclics
Sep 115:25
Conference pass

Regional based approach

GLOBAL PV (BEACON HILL)
Ensuring oversight of local PV activities and the quality of the PV system through the assessment of local risks, tracking of deviations, and ensuring local inspection readiness
Bruno Mendez, MCCQ – PVQ, Sanofi Pasteur
Sep 115:25
Conference pass

Differentiating adverse event causes: understanding which events are caused by a device’s constituent drug to better interpret device caused events

MEDICAL DEVICE SAFETY (WATERFRONT 1)
Dennis Brooks, Global Safety Physician Infection And Vaccines, Astrazeneca
Sep 115:45
Conference pass

Acquiring REMS: successfully integrating inherited programs through reviewing documents, internal trainings, and collaborations across safety teams

SAFETY RISK MANAGEMENT (HARBORVIEW)
Jacqueline Gerena, Director, Rems Program And Drug Safety Compliance, Titan Pharmaceuticals Inc. 
Sep 115:45
Conference pass

Automation for adverse event assessment: applying natural language processing and model analysis to help triage safety data

NEXT GEN TECH & DATA (WATERFRONT 2)
Kevin Chiou, Senior Data Scientist Ii, Abbvie Pharmaceuticals Inc
Sep 115:45
Conference pass

ICH guidelines in Brazil: how new regulations impact pharmacovigilance daily practices

GLOBAL PV (BEACON HILL)
Raphael Pareschi, Pharmacovigilance Associate Director, Pv Country Lead Deputy, Merck
Sep 115:45
Conference pass

Optimizing the predictivity and translatability of preclinical safety data to the Clinic: utilizing human induced Pluripotent Stem Cells (hiPSCs) for better personalized cardio-oncology treatments

PREDICTIVE SAFETY (WATERFRONT 3)
Frederick Sannajust, Former Executive Director Of Safety and Exploratory Safety Pharmacology At Merck, Independent Consultant, Independent Consultant
Sep 116:05
Conference pass

Exploring AI’s journey in PV: is the transformation promised from Artificial Intelligence real, and can true business benefits be realized

NEXT GEN TECH & DATA (WATERFRONT 2)
Sponsored by Deloitte
Glenn Carroll, Principal, Life Sciences, Deloitte Consulting LLP
Amanda Bowles, Specialist Leader, Life Sciences, Deloitte Consulting LLP
Sep 116:05
Conference pass

Title to be decided

PREDICTIVE SAFETY (WATERFRONT 3)
Sponsored by FUJIFILM Cellular Dynamics
Sep 117:30
Conference pass

Keynote address: 20/20 vision: how automation is changing the PV landscape

Keynotes
Sponsored by RX Logix
Raj More, Chief Architect & CEO, Rxlogix
Sep 117:50
Conference pass

Keynote address: Combination products post market reports

MEDICAL DEVICE SAFETY (WATERFRONT 1)
Meeting FDA mandated safety reports for combination products to analyze adverse events and/or malfunctions associated with medical device reports
Khaudeja Bano, Senior Medical Director Abbott Diagnostics Division, Abbott Diagnostics Ltd

Create your personal agenda –check the favourite icon

Sep 208:30
Conference pass

Chairperson’s opening remarks

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Sep 208:40
Conference pass

Keynote address: Interdisciplinary efforts: Moving from Natural Intelligence and Intelligence Augmentation to Artificial Intelligence to advance aggregated safety planning and benefit risk evaluation

Keynotes
Jim Buchanan, Clinician, Covilance
William Wang, Executive Director, Clinical Safety Statistics, Merck
Sep 209:00
Conference pass

Keynote address: Validating AI Technologies in Pharmacovigilance: utilizing TransCelerate’s “validation framework” to affirm the functionality of automated systems and processes

Keynotes
Ellen (Lena) Mishalov, Director, Pv Technological Innovations, Astellas Pharma
Eileen Leonard, Vice President, Worldwide Patient Safety, Bristol Myers Squibb
Sep 209:20
Conference pass

Keynote address: Enhancing operations: enabling digital transformation with next-gen technology

Keynotes
Aman Wasan, Vice President Global Client Partner, ArisGlobal
Sep 209:30
Conference pass

Keynote address: Implementation: considerations beyond technical aspects for an end to end digital platform project

Keynotes
Claudia Lehmann, Head Of Global Pharmacovigilance Operations, Boehringer Ingelheim Pharma GmbH & Co. KG
Sep 209:40
Conference pass

Keynote panel: Humanizing technology: integrating medical judgement in data analysis to improve outcomes in end-to-end safety operations

Keynotes
If you’re interested in becoming a panelist on this session, contact Anna.Bagley@terrapinn.com
Moderator: Brian Waterhouse, Director Safety Statistics, AbbVie
Arvind Bellur, Senior Director, Head Of Safety Data Management, Sanofi
Eileen Leonard, Vice President, Worldwide Patient Safety, Bristol Myers Squibb
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
Conference pass

Distributing risk strategies among various stakeholders

SAFETY RISK MANAGEMENT (HARBORVIEW)
Implementing structured information programs, mandatory training, and signed agreements with stakeholders to prevent patient adverse events and improve benefit risk
Sandra Raff, Executive Director, Intercept Pharmaceuticals Inc
Sep 211:00
Conference pass

Signal detection in early development

NEXT GEN TECH & DATA (WATERFRONT 2)
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 211:00
Conference pass

Emerging market inclusion: assisting new regions become stable enough for clinical trials through corporate responsibility

GLOBAL PV (BEACON HILL)
Maria Tello, Head Of Safety, Rakuten Medical
Sep 211:00
Conference pass

Moving away from animal models: incorporating new technology into liver toxicity measuring and prediction for more accurate results

PREDICTIVE SAFETY (WATERFRONT 3)
If you’re interested in speaking on this session, contact Anna.Bagley@terrapinn.com
Sep 211:00
Conference pass

Long term follow-ups for cell and gene therapies: challenges, expectations, and ways to improve processes for patients after receiving cell and gene therapies

ADVANCED THERAPIES (WATERFRONT 1)
David Chonzi, Vice President, Head Of Pharmacovigilance And Epidemiology ( Pve), Allogene Therapeutics
Sep 211:20
Conference pass

Risk Management and oral desensitization products: RMP and REMS strategies

SAFETY RISK MANAGEMENT (HARBORVIEW)
Adrian Dana, Vice President, Drug Safety, Aimmune Therapeutics
Sep 211:20
Conference pass

Quality tolerance limits: supporting signal detection processes through the use of AE and SAE reporting rate parameter

NEXT GEN TECH & DATA (WATERFRONT 2)
Ruma Bhagat, Senior G.C.P. Strategy Lead And Site Innovation Group Lead, Genentech, Inc. (A member of the Roche Group)
Shaun V Mohan, Md, Genentech, Inc. (A member of the Roche Group)
Sep 211:20
Conference pass

Growing regulations in the Middle East: how evolving regulations has led to an increase in reporting culture and collaborations with outside markets

GLOBAL PV (BEACON HILL)
Syed Zaferuddin, Deputy Qppv, Pharmacovigilance And Clinical Trial Manager, Julphar
Sep 211:20
Conference pass

Predicting drug induced Hepatotoxicity: using 3-dimensional cell culture systems and in vivo chimeric mouse models to identify back-up compounds with low-potential of causing liver toxicity

PREDICTIVE SAFETY (WATERFRONT 3)
Edward Chow, Toxicology Director, Allergan Inc
Sep 211:40
Conference pass

Risk based strategies: developing risk management strategies using a benefit risk framework

SAFETY RISK MANAGEMENT (HARBORVIEW)
Reema Mehta, Head Of Risk Management And Safety Surveillance Research, Pfizer
Sep 211:40
Conference pass

From pharma-focused AE reporting to patient-centred product feedback

NEXT GEN TECH & DATA (WATERFRONT 2)
How to capture and distribute experience data to familiar internal silos without drowning in data of little value.Sponsored by My Meds & Me
Jon Messer, Head Of Product Management, MyMedsandMe
Sep 211:40
Conference pass

Pharmacovigilance audit planning on a global scale: enhancing efficiency for new and existing markets via risk-based approach

GLOBAL PV (BEACON HILL)
Kishan Nandha, Manager, Pharmacovigilance Quality Assurance, Astellas Pharma
Sep 211:40
Conference pass

Bioethical challenges in Long Term Follow-up studies

ADVANCED THERAPIES (WATERFRONT 1)
Discussing the long- term potential risks patients enrolled in gene therapy and editing studies may encounter and the challenges they and sponsors may face during their follow-up process
Javier Waksman, Vice President, Head Of Drug Safety, Sangamo Therapeutics
Sep 212:00
Conference pass

Session Title to be Decided

SAFETY RISK MANAGEMENT (HARBORVIEW)
Sponsored by WCG.
Steven Beales, Senior Vice President Of Information Technology, WCG
Sep 212:00
Conference pass

Moving toward more accurate analysis: increasing data value through digital transformation

NEXT GEN TECH & DATA (WATERFRONT 2)
Sponsored by My Meds & Me.
Jon Messer, Head Of Product Management, MyMedsandMe
Sep 212:00
Conference pass

United global systems: discussing Japan’s current inclusion in international PV systems

GLOBAL PV (BEACON HILL)
Kc (Keisuke) Katsuyama, Vice President Of Drug Safety Japan Practice, Sophos IT Services
Sep 212:00
Conference pass

GOLD SPONSOR SLOT

PREDICTIVE SAFETY (WATERFRONT 3)
If you’re interested in sponsoring this session contact Joseph.Sica@terrapinn.com or +1 646-619-1839
Sep 212:00
Conference pass

Living drug therapies: discussing current challenges and solutions to limitations within CAR-T therapies

ADVANCED THERAPIES (WATERFRONT 1)
Wasim Khan, Medical Safety Assessment Physician (Msap), Bristol Myers Squibb
Sep 214:00
Conference pass

ROUNDTABLE 1: Overcoming adoption barriers: making the case for next gen automation and AI

Keynotes
Sponsored by Arriello.
Peter Kohut, Director Of Drug Safety, Arriello
Sep 214:00
Conference pass

ROUNDTABLE 10: 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

Keynotes
Maritess Esguerra, Principal Pharmacovigilance Process Leader, Genentech
Sep 214:00
Conference pass

ROUNDTABLE 11: Dissecting AI implementation: breaking down the results and expectations of integrating AI into PV practices

Keynotes
Omar Aimer, PV spécialiste, Brunel Canada
Sep 214:00
Conference pass

ROUNDTABLE 12: PV for rare diseases: navigating the challenging safety landscape for ultra-orphan drugs

Keynotes
If you’re interested in speaking on this session, contact Anna.Bagley@terrapinn.com
Peter Hawkins, Senior Director, Head Of Rare Genetic Disease Risk Management, Agios Pharmaceuticals
Sep 214:00
Conference pass

ROUNDTABLE 14: Supporting regulatory agency deliverables

Keynotes
Enhancing interactions between regulatory and PV teams to identify specific areas where the deliverable processes can be improved, ensuring better quality and quicker receiving times of safety documents.
Dawn Territo, Regulatory Affairs Associate Director And Manager, AbbVie
Sep 214:00
Conference pass

ROUNDTABLE 15: Antibodies pharmacovigilance: safety risk assessment for immunotherapies targeting oncology

Keynotes
Ying Cao, Associate Medical Director, Astellas Pharma
Sep 214:00
Conference pass

ROUNDTABLE 16: Global Planning: understanding basic aspects of the product lifecycle through a risk management context

Keynotes
Ale Maria Vazquez-Gragg, Vice President Of Global Patient Safety, Argenx
Sep 214:00
Conference pass

ROUNDTABLE 2: AVAILABLE FOR SPONSORSHIP

Keynotes
If you’re interested in sponsoring this roundtable, contact Joseph.Sica@terrapinn.com or+1 646-619-1839
Sep 214:00
Conference pass

ROUNDTABLE 3: Optimizing big pharma’s influence: adopting best safety practices used in big pharma within drug development to ensure positive outcomes

Keynotes
Toyin Adewole, Drug Safety Associate Director, Supernus Pharmaceuticals, Inc.
Sep 214:00
Conference pass

ROUNDTABLE 4: Outsourcing in small pharma: how to choose the correct safety solution technology for your specific needs

Keynotes
Bill Haddock, Head Of Safety, Ovid Therapeutics
Sep 214:00
Conference pass

ROUNDTABLE 5: Utilizing AI for safety analysis: How large and small pharma can leverage AI for better safety analysis

Keynotes
Coryandar Gilvary, Chief Data Scientist, OneThree Biotech
Sep 214:00
Conference pass

ROUNDTABLE 6: Patient safety and Latin America: promoting the patient voice within pharmacovigilance through education, leadership collaboration, and legislation

Keynotes
Patricia Zuluaga Arias, Board of Directors, Coordinator of Academic Committee, Colombian Pharmacovigilance Association
Sep 214:00
Conference pass

ROUNDTABLE 7: Improving safety profiling in labeling: using MedDRA Labeling Groupings to define adverse effects by pinpointing near synonyms

Keynotes
Ilona Grosse-Michaelis, Medical Dictionary Expert, Bayer AG
Sep 214:00
Conference pass

ROUNDTABLE 8: Meeting pharmas’ safety expectations: ensuring solution providers are reaching company regulatory standards through training, regular review courses, QPR’s and metrics

Keynotes
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Sep 214:00
Conference pass

ROUNDTABLE 9: Inspection management: Discussing inspection readiness, conduct in global organizations, and navigating through the challenges

Keynotes
Smruti Kothari, Associate Director, Pv Quality Operations, Alexion Pharmaceuticals
Sep 214:00
Conference pass

ROUNDTABLE: Current State of Play of Post-Approval Drug Safety in Japan: discussing the MAH pharmacovigilance requirements for marketed biopharmaceutical products

Keynotes
William Gregory, Senior Director, Worldwide Medical And Safety, Pfizer
Sep 214:00
Conference pass

ROUNDTABLE: Starting doses: merging clinical and pharmacovigilance outlooks to correctly determine starting doses for patients

Keynotes
Andrew Olaharski, Senior Director And Head Of Toxicology, K.S.Q. Therapeutics
Sep 215:05
Conference pass

Centralizing operations: managing your entire pharmacovigilance system in a unified solution

NEXT GEN TECH & DATA (WATERFRONT 2)
Kelly Traverso, Vice President, Vault Safety Strategy and Consulting, Veeva Systems
Sep 215:05
Conference pass

Technology: the impact of digitalization on adverse event intake

GLOBAL PV (BEACON HILL)
Sponsored by Nextrove
Anjani Jha, Founder and Chief Executive Officer, Nextrove
Sep 215:25
Conference pass

Cross-industry collaboration: bridging the gap between pharma and solution providers’ understanding of what is needed from technology through open dialogues and collaboration

NEXT GEN TECH & DATA (WATERFRONT 2)
Vipin Sethi, Head Of Global Pharmacovigilance And Medical Affairs, Cadila Pharmaceuticals
Sep 215:25
Conference pass

Outside partnerships: handling complexity and challenges in managing relationships with Business Partners through safety data exchange agreements

GLOBAL PV (BEACON HILL)
Marina Suvakov, Director, Compliance And Business Management, Otsuka Europe Development and Commercialisation Ltd
Sep 215:45
Conference pass

Adopting new technology: mitigating the natural apprehensiveness to changing methodologies for an improvement in success rates

NEXT GEN TECH & DATA (WATERFRONT 2)
Omar Aimer, PV spécialiste, Brunel Canada
Sep 215:45
Conference pass

Building safety programs: how to effectively grow safety teams across locations, maximize efficiency, and ensure compliance

GLOBAL PV (BEACON HILL)
Jaylaxmi Nalawade, Associate Director, Lupin Ltd
last published: 13/Mar/20 20:55 GMT

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t/ +1 646 619 1839

 

 

 

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joan.shutt@terrapinn.com
t/ +1 646 619 1775

 

 

 

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