Philadelphia, 15 - 17 April 2019

Schedule

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Apr 1608:50
Conference pass

Opening remarks

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Apr 1609:00
Conference pass

Collaboration: utilizing cross-company teams for PV initiatives - how Transcelerate prepares for four massive projects

Keynotes
Jose Vega, Chief Safety Officer, Merck
Apr 1609:20
Conference pass

Proactive strategy: bringing a lean biotech approach to big pharma using early value assessment - improving safety and lowering cost

Keynotes
Alexandre Kiazand, Chief Safety Officer, AstraZeneca
Apr 1611:00
Conference pass

Methods of signal collection and its influence on risk management: how your approach to signal detection affects data management and senior level decision making

PV METHODOLOGY
Avinash Kakade, Senior Director and Head of Pharmacovigilance, Cipla
Apr 1611:00
Conference pass

Growing companies and safety efficiencies: How to build safety programs of scale and implement them across company locations to maximize safety efficiency

GLOBAL PV
Stewart Geary, Senior Vice President, Chief Medical Officer, Director, Corporate Medical Affairs Headquarters, EISAI
Apr 1611:00
Conference pass

Understanding Toxicology: How understanding drug product attributes, toxicology study design, and measures of toxicity can help assess safety for moving into clinical trials

PREDICTIVE SAFETY
Jennifer Brown, Associate Director, MacroGenics, Inc.
Apr 1611:20
Conference pass

Mitigating patient risk through assessment of data: how to strategically combine human and artificial intelligence to improve your methodology in your approaches to risk

PV METHODOLOGY
Oscar Gonzalez, Director, Global Safety Officer, Sanofi Genzyme Corp
Qi Tang, Associate Director of Digital and Data Science, Sanofi
Apr 1611:20
Conference pass

Real world data and PV analytics in the rare disease landscape: How utilizing social media as a data collection source and incorporating innovative analytics can help your company assess rare disease

NEXT GEN TECH & DATA
Ale Maria Vazquez-Gragg, Vice President Of Global Patient Safety, Intarcia Therapeutics Inc
Apr 1611:20
Conference pass

Panel: Outsourcing vs. innovation

GLOBAL PV
How to lower costs, mitigate risk, and approach the differences in implementing safety procedures when globally outsourcing vs. implementing new technological innovation.
Richard Wolf, Senior Director, Global Clinical Operations & Pharmacovigilance, C.S.L. Behring Gmbh
Vicki Edwards, QPPV and VP for Pharmacovigilance Excellence, AbbVie
Maria D. Tello, Head of Safety, Rakuten Aspyrian
Apr 1611:20
Conference pass

Animal studies and their relation to toxicity in humans: how addressing hypersensitivity and evaluating statistical matches can help you predict later phase/post market results in humans

PREDICTIVE SAFETY
Elizabeth Baker, Pharmaceutical Policy Program Director, Physicians Committee for Responsible Medicine
Apr 1611:40
Conference pass

Risk management development: a case study in using desensitization for preventing adverse events in patients with allergies

PV METHODOLOGY
Adrian Dana, Aimmune Therapeutics
Apr 1611:40
Conference pass

Integration of continuum safety evidence for decision making

NEXT GEN TECH & DATA
How to assess the multi-source of real world safety data and consider design for RCT/PCT, observational trials, and post-marketing surveillance .
LiAn Lin, Senior Statistician in Clinical Safety Statistics, Merck & Co
Ed Whalen, Director in Clinical Statistics, Pfizer
Apr 1611:40
Conference pass

How to utilize toxicity data in team decision making: how linking preclinical data to predictive safety can be applied to making executive decisions

PREDICTIVE SAFETY
Tom Parry, Toxicologist & Pharmacologist, Ovid Therapeutics
Apr 1612:00
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

PV METHODOLOGY
April Davis, Global Pharmacovigilance Industry Director, Accenture
Apr 1612:00
Conference pass

Software for PV: how to incorporate software to store data, process cases, and centralize coding in your PV operations

NEXT GEN TECH & DATA
Vivek Ahuja, Vice President of Global Pharmacovigilance, ArisGlobal
Apr 1613:40
Conference pass

1) Small vs. large pharma: differences in approaches to methodology and risk

Keynotes
Bill Haddock, Head of Safety, Ovid Therapeutics
Nicole Baker, EEA QPPV, Head of Global Pharmacovigilance, Besins Healthcare
Apr 1613:40
Conference pass

2) Benefit Risk Discussion: comparing differences in approaches to benefit risk assessment and strategy

Keynotes
Quazi Ataher, Senior Director, Epidemiology. Worldwide Safety and Regulatory, Pfizer
Sophia Goodison, Director, Benefit Risk Evaluation, GSK
Amgad Shebl, Director of Global Clinical Safety and Pharmacovigilance, CSL Behring
Apr 1613:40
Conference pass

3) Brexit and PV: How the United Kingdom’s retreat from the European Union continues to affect pharmacovigilance and patient safety

Keynotes
Vicki Edwards, QPPV and VP for Pharmacovigilance Excellence, AbbVie
Apr 1613:40
Conference pass

4) Affiliate Pharmacovigilance Transformation

Keynotes
How to build a high-performing, sustainable and nimble Affiliate PV system that addresses the challenges of rising local volume of adverse event case processing, increasingly diverse local regulatory obligations and internal pressures to realize the value of safety in affiliate business strategies.
Kemi Yusuf, Senior Director, Office of the Product Safety Team and PV Portfolio Management, AbbVie
Gabrielle Sellick, Director, AbbVie
Apr 1613:40
Conference pass

5) Using automation to decrease errors: how computerized physician order entry, medication administration records, and discharge prescriptions and instructions can decrease errors and adverse events

Keynotes
Fatima Yousef Ali Ghethan, Head Of Quality and Medication Safety unit, King Abdullah Medical City
Apr 1614:10
Conference pass

10) 21st Century Reporting: How to properly, efficiently, and compliantly handle adverse event reports in today’s segmented digital age

Keynotes
Friderike Bruchmann, CEO, MEDIKURA Digital Health GmbH
Apr 1614:10
Conference pass

6) Social media signal detection: How it has or has not worked and potential ways to implement it in your company

Keynotes
Ale Maria Vazquez-Gragg, Vice President Of Global Patient Safety, Intarcia Therapeutics Inc
Shaun Comfort, Safety Science Principal Medical Director at Genentech, Genentech A Member of the Roche Group Inc
Apr 1614:10
Conference pass

7) Emerging Markets - Implementing Infrastructure: the benefits of improving safety, incorporating Corporate Social Responsibility, and lowering long term cost

Keynotes
Maria D. Tello, Head of Safety, Rakuten Aspyrian
Daniel Ciriano, Regional Medical Director, Roche SA
Raj Long, Deputy Director, Integrated Development, Global Health, The Bill & Melinda Gates Foundation
Andrea Maulwurf, Head of Pharmacovigilance, EU-QPPV, Allergy Therapeutics
Elias Kouchakji, VP of Clinical Development and Drug Safety, Fibro Gen Inc
Apr 1614:10
Conference pass

8) RWA Linking Pre-Clinical and Post Marketing Toxicology Data: applications of predictive safety and how to utilize them in your company

Keynotes
Jane Gunther, Director of Toxicology, Nektar Therapeutics
Mark Bluth, Senior Scientist, Bluth Bio Industries
Apr 1614:10
Conference pass

9) Regulatory requests for large post authorization studies from multiple companies

Keynotes
How to organize class-related post-authorization studies (Art. 31), obtain/analyze data across regions, communicate with different national authorities, and manage stakeholder expectations.
Michael Von Forstner, Chair, Pharmacovigilance Working Group, Medicines for Europe
Apr 1614:50
Conference pass

Aggregate safety assessment planning

PV METHODOLOGY
How leveraging multi-disciplinary management teams, conducting blinded safety monitoring procedures, and examining interviews with 20 thought leaders can help you mitigate risk and approach regulatory reviews.
Greg Ball, Senior Principal Statistician, Merck & Co
Barbara Hendrickson, Therapeutic Area Head, Abbvie S.A
Lothar Tremmel, Statistician, CSL Behring
Apr 1614:50
Conference pass

Statistical methods for signal management: how your approach to new regulatory requirements and confirming data with real world evidence can help you optimize the potential of your safety database

NEXT GEN TECH & DATA
Andres Gomez, Head of Epidemiology, Safety Science and Analytics, Bristol Myers Squibb
Apr 1614:50
Conference pass

PV regulatory intelligence: how the regulatory environment in emerging markets affects the safety structure for your acquisitions in foreign countries and the local safety officers’ roles

GLOBAL PV
Andrea Maulwurf, Head of Pharmacovigilance, EU-QPPV, Allergy Therapeutics
Apr 1615:10
Conference pass

AstraZeneca’s Benefit Risk Analysis Team (BRAT): how a cross functional team and a holistic approach to safety has helped AstraZeneca shift from reactive to proactive safety procedures

PV METHODOLOGY
Richard Hermann, Safety Science Physician, AstraZeneca
Apr 1615:10
Conference pass

The future of signal detection: harmonizing data standards, global databases, and open access/communication

NEXT GEN TECH & DATA
Mircea Ciuca, Head of Medical and Clinical Drug Safety, Vifor Pharma
Apr 1615:10
Conference pass

The changing regulatory landscape in China, Japan, and Australia: how joining the ICH is affecting transparency, increasing the number of inspections, and changing data acquisition

GLOBAL PV
Lana Gloukhova, Head of Regions, CSL Behring
Apr 1615:10
Conference pass

Predictive safety to prevent pain and suffering: how the clinical laboratory can utilize predictive safety to avoid adverse events in both trials and post market populations

PREDICTIVE SAFETY
Martin Bluth, Founder, Bluth Bio Industries
Apr 1615:30
Conference pass

Quantitative Benefit Risk Assessment: Pfizer’s approach to qBRA and its implications on PV

PV METHODOLOGY
Quazi Ataher, Senior Director, Epidemiology. Worldwide Safety and Regulatory, Pfizer
Apr 1615:30
Conference pass

Developing signal detection capabilities in real world data: how to leverage RWD more widely to increase effectiveness and approach models that lack a gold standard for comparison

NEXT GEN TECH & DATA
Qing (Kathy) Li, Director, Epidemiology, Worldwide Safety & Regulatory, Pfizer
Apr 1615:30
Conference pass

Implementation of PV following an acquisition: how to approach cultural barriers in safety management among local vendors and new training methods

GLOBAL PV
Mariette Boerstoel, SVP and Head of Global Drug Safety, Alexion Pharmaceuticals
Apr 1616:40
Conference pass

Think globally, report locally: how safety reporting technology and strategic utilization of local laws has enabled Roche to save $80M and overcome the complex processes of global harmonization

Keynotes
Steven Beales, Senior Vice President of Information Technology, WCG Clinical
Apr 1617:00
Conference pass

The digital revolution and implications for pharmacovigilance: using technology platforms to transform data analytics, risk management and the implementation of PV programs

Keynotes
Sundeep Sethi, Vice President, Safety Operations, AbbVie

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Apr 1708:55
Conference pass

Chairperson opening remarks:

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Apr 1709:00
Conference pass

Advances in predictive analytics

Keynotes
Using access to a wide range of information, including medical journals, regulatory filings, and relevant scientific data to help inform analytics and create more efficient PV operations.
Sherry Winter, Product Marketing Manager, Elsevier
Apr 1711:00
Conference pass

Methodologies with regards to filing for approval

PV METHODOLOGY
Overcoming relatively low regulatory approval rates for ATMPs through consistency in quality, a thorough dossier, and safety-inclusive clinical development models.
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics
Apr 1711:00
Conference pass

A case study in automation: using strategy to improve accuracy, increase efficiency, and generate hypotheories

NEXT GEN TECH & DATA
Arvind Bellur, Director, Head of Safety Data Management, Sanofi
Apr 1711:00
Conference pass

Patient Centricity: how to integrate new technology to monitor quality and compliance and improve patient outcomes

PATIENT SAFETY & MEDICAL DEVICES
Toyin Adewole, Drug Safety Assistant Director, Supernus Pharmaceuticals, Inc.
Apr 1711:00
Conference pass

Predictive toxicity and using models to assess safety: case study examples on targeting safety, identifying an issue, and using different models to assess whether that issue is on/off target

PREDICTIVE SAFETY
Andrew Olaharski, Senior Toxicology Director, K.S.Q. Therapeutics
Apr 1711:20
Conference pass

Panel: CAR-T, RNA, and viral vectors: differences in post market monitoring for cell therapies, utilizing data, and scaling studies for ATMPs

PV METHODOLOGY
Moderator: William O'Brien, Chairman of Medical Surveillance Team and Virology, Global Pharmacovigilance and Epidemiology, Bristol Myers Squibb
David Chonzi, Head of Patient Safety and Pharmacovigilance, Kite, A Gilead Company
Ashlyn Bassiri, Pharmacovigilance Lead - Hematology, Spark Therapeutics
Apr 1711:20
Conference pass

Apps as medical devices

PATIENT SAFETY & MEDICAL DEVICES
How apps have improved the patient experience, how companies are developing intuitive usage to improve safety, and how to approach the differences in regulations for medical devices.
Apr 1711:40
Conference pass

The hidden challenges in machine learning and how to overcome them: validating post market findings, navigating regulations, and acting as first mover

NEXT GEN TECH & DATA
Anupam Agarwal, Head, Global Drug Safety and Pharmacovigilance, Zogenix
Apr 1711:40
Conference pass

Combination products and safety monitoring devices

PATIENT SAFETY & MEDICAL DEVICES
How to employ safety surveillance methods in clinical trials, assess signals in data systems, and decide when to use early termination to protect patient safety.
Apr 1711:40
Conference pass

Enhanced evaluation of drug induced hepatotoxicity

PREDICTIVE SAFETY
How to use the interactive safety graphic tool to analyze drug induced liver injury data values across varying platforms to increase efficiency and reliability of your PV models.
Jim Buchanan, Clinician, Covilance, LLC
Xiao Ni, Lead Statistician for Ophthalmology in Early Development Biostatistics, Novartis
Apr 1712:00
Conference pass

The Future of PV Automation: how to examine PV across time to increase efficiencies by reducing the level of human intervention

NEXT GEN TECH & DATA
Dinesh Kasthuril, Client Director, Sciformix Corp
Apr 1713:40
Conference pass

1) PV processes in Africa and Asia: how to implement new processes and adapt to change in these regions

Keynotes
Nicole Baker, EEA QPPV, Head of Global Pharmacovigilance, Besins Healthcare
Apr 1713:40
Conference pass

2) Signal Detection: data sources, challenges, and innovative approaches

Keynotes
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin Health
Apr 1713:40
Conference pass

3) Reference safety information: RSI used in Clinical Trials based on the CTFG RSI Q&A Document and the EFPIA Draft Paper in response to such document

Keynotes
Maritess Esguerra, Principal Pharmacovigilance Process Leader, Genentech
Mariette Boerstoel, SVP and Head of Global Drug Safety, Alexion Pharmaceuticals
Apr 1713:40
Conference pass

4) Cell Therapies: Understanding the safety requirements and post marketing monitoring processes

Keynotes
David Chonzi, Head of Patient Safety and Pharmacovigilance, Kite, A Gilead Company
Apr 1713:40
Conference pass

5) Combination Product Regulations: differences in regulatory approaches for combination products and how to streamline your company’s strategy

Keynotes
Kirsten H. Paulson, Sr. Director Global CMC-Medical Devices, Pfizer
Apr 1714:10
Conference pass

10) Deep Dive into the Technology & Processes Behind the Roche Clinical Trial Safety Portal

Keynotes
A case study in eliminating over-distribution and improving patient safety, while significantly reducing costs.
Steven Beales, Senior Vice President of Information Technology, WCG Clinical
Apr 1714:10
Conference pass

6) Using AI to optimize workloads: How AI can facilitate organizational design, create a continued learning mindset, and standardize data to ease the workload on your team

Keynotes
Detlef Hold, Global Strategy Lead, Knowledge Cycling, Genentech
Apr 1714:10
Conference pass

7) PV regulatory changes in Russia and Eurasia: how to approach regulations in these areas and create a strategy for your company

Keynotes
Vladimir Andrianov, Head of Scientific Studies Department, Institute of Interdisciplinary Medicine
Apr 1714:10
Conference pass

8)Preventative safety and cross functional teams: How to communicate across teams and implement interdepartmental strategy

Keynotes
Tanja Fahlbusch, Senior Expert International Pharmacovigilance, Process Liaison, Roche
Apr 1714:10
Conference pass

9) Small bio startups: how to approach regulatory changes, implement PV programs, and provide training and support without wasting limited resources

Keynotes
Hedva Voliovitch, Vice President of Director of Pharmacovigilance, Teva Pharmaceutical lndustries Ltd
Apr 1714:50
Conference pass

Reimagining PV with the adoption and implementation of AI & machine learning: approaching signal management, causality assessment, aggregate analysis, and literature management

NEXT GEN TECH & DATA
Krishna Asvalayan, Senior Director, Head – Functional Services, Anclacorp
Apr 1714:50
Conference pass

Transforming Data Capture: How efficient data in-take and reporting can streamline PV operations

PATIENT SAFETY & MEDICAL DEVICES
Andrew Rut, CEO and Founder, MyMeds&Me
Apr 1715:10
Conference pass

Panel: Methodologies for implementation of PV programs: how to approach local regulations, use software to your advantage, and optimize leads to improve success rates

PV METHODOLOGY
William Wang, Executive Director, Clinical Safety Statistics, MSD
Daniel Ciriano, Regional Medical Director, Roche SA
Deepa Venkataraman, Senior Director, Section Head, Drug Safety and Pharmacovigilance Operations, Pharmacyclics
Apr 1715:10
Conference pass

PV Automation & Implementation: how adopting and properly implementing automation in your PV operations can save money and create efficiency

NEXT GEN TECH & DATA
Francois Audibert, VP of US Operations, Vitrana
Apr 1715:10
Conference pass

Patient studies: how to define synthetic cohorts to ensure accuracy in clinical trials

PATIENT SAFETY & MEDICAL DEVICES
Jie Li, Senior Director Global Patient Safety, Sanofi Aventis
Apr 1715:10
Conference pass

Dose-limiting toxicity: how to understand DLT in oncology clinical trials and approach challenges with modern agents and combination therapies

PREDICTIVE SAFETY
Yolanda Yang, Senior Director, Medical Safety Science, Acerta Pharma Bv
Apr 1715:30
Conference pass

Unstructured data analytics: how to utilize language processing technology, text mining, and increased data accessibility to scan literature databases and improve your analytics

NEXT GEN TECH & DATA
Veronica Urdaneta, Senior Principal Scientist/ Physician, Merck
Apr 1715:30
Conference pass

Patient reported adverse events: how to communicate safety or tolerability data, identify non-clinical data needed, and compile evidence for tolerability to build a patient profile

GLOBAL PV
Nneka Onwudiwe, Regulatory Reviewer, Food and Drug Administration
Apr 1715:30
Conference pass

Safety Evaluation in Early Phase Oncology

PREDICTIVE SAFETY
How to identify opportunities in Early Clinical Development for safety profile characterization and expedite development through FDA guidance on early oncology trials.
William Wang, Executive Director, Clinical Safety Statistics, MSD
Oswaldo Bracco, Associate VP, Clinical Safety and Risk Management, Merck & Co
Apr 1715:55
Conference pass

Chairperson Closing Remarks:

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
last published: 12/Nov/18 19:05 GMT

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