World Drug Safety Americas 2017 Follow Verify

World Drug Safety Americas 2017
Date	May 3-4, 2017
Place	Hilton, Philadelpia City Avenue

Drug safety is evolving to meet increasing regulatory and patient expectations and to exploit opportunities offered by big data and new technologies. Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

In order to succeed in this new environment, it is critical to be up to date on legislation globally and be transparent in all drug safety processes. We need to have effective systems in place to empower patients, physicians, drug manufacturers and consumers to make the best drug safety decisions. The 9th World Drug Safety Congress Americas on 3-4 May in Hilton Philadelphia will bring together key thought leaders and experts to explore these worldwide challenges. This is your opportunity to engage and sit alongside the pioneers who are driving forward innovation in pharmacovigilance. Explore benefit-risk management strategies and patient-centric approaches; discuss how you can tackle the challenges of social media and drug safety legislation globally. Make sure you are at the heart of the new drug safety era and participate in these critical discussions.

Conference Website

http://www.terrapinn.com/conference/world-drug-safety-us/index.stm

    Drug Safety remains a key topic as the regulatory landscape evolves to meet the demands of scientific innovation. In our ninth year, we will be covering the latest technological developments in drug safety including integration, data source, signal detection, safety analytics and regulation. Topics under discussion in 2017 include the use of social media to support risk management practices, applying fresh thinking to signal management challenges, outsourcing vs. in-house clinical data management and achieving collaboration between pharmacovigilance and technology. World Drug Safety Congress Americas is the meeting place of global pioneers who are shaping the pharmacovigilance industry
World Drug Safety Americas 2018 is the global leading drug safety strategy-led event for pharma and biotech organisations.

Since its launch in 2008, ourconference has stood out from the crowd. The event has always provided a unique forum for industry and partners to learn about the latest developments in drug safety and how they can tackle day-to-day critical challenges. We’ve kept this as our core concept ever since and tailored our program year after year to address exciting and emerging topics of highest relevance to the industry at that time. 2018 is set to be bigger and better than ever before. The meeting has a high proportion of pharma organisations year on year. We attract the biggest industry players from large, small and medium pharma and biotech organisations. We will have even more perspectives including regional specialists, technology partners, consultancies, CROs and global directors in attendance. This is the place to meet global pioneers who are shaping the pharmacovigilance industry.

Over 250 attendees were there in 2017: from the regulatory, biopharma, CRO, technology and consultancy community.

Drug Safety remains a key topic as the regulatory landscape evolves to meet the demands of scientific innovation. In our ninth year, we will be covering the latest technological developments in drug safety including integration, data source, signal detection, safety analytics and regulation.

Since its launch in 2008, this conference has stood out as a unique forum for the industry. Not only are we discussing the latest advances, practical sessions will provide you the tools to tackle day-to-day challenges. Topics under discussion in 2017 include the use of social media to support risk management practices, applying fresh thinking to signal management challenges, outsourcing vs. in-house clinical data management and achieving collaboration between pharmacovigilance and technology.

2017 is set to be the best year yet, with even more pharma representation than ever before. Companies already confirmed to attend include AbbVie, Alexion Pharmaceuticals, Amgen, AstraZeneca, Baxalta, Bristol Myers Squibb, Genentech, Genzyme, GlaxoSmithKline, Horizon Pharma, Merck, Novartis, Pfizer, Sanofi, and Takeda Pharmaceuticals . That's not all! The regulatory, CRO, technology and consultancy communities will also be in attendance. 

World Drug Safety Congress Americas is the meeting place of global pioneers who are shaping the pharmacovigilance industry.

We look forward to welcoming you to Philadelphia in May.

May 03-04, 2017

Philadelphia, PA Drug Safety remains a key topic as the regulatory landscape evolves to meet the demands of scientific innovation. In our ninth year, we will be covering the latest technological developments in drug safety including integration, data source, signal detection and safety analytics and regulation. Topics under discussion in 2017 include the use of social media to support risk management practices, applying fresh thinking to signal management challenges, outsourcing vs. in-house clinical data management and achieving collaboration between pharmacovigilance and technology. World Drug Safety Congress Americas is the meeting place of global pioneers who are placing the pharmacovigilance industry. Join us on Day 1 as David Balderson, Vice President of Safety Operations, Sciformix Corporation will be giving a presentation on “Pharmacovigilance Prioritization across the product lifecycle: An analysis of how PV can be managed differently for smaller companies with products in development versus larger companies with a diverse portfolio”.

Conference Agenda

Keynote Presentation: Evolving Pharmacovigilance (PV) Strategies

• Pragmatic approach to pharmacovigilance
• Key challenges and developments taking place in drug safety
• Achieving greater collaboration between PV and technology

Esther De La Cuesta, Global Safety Lead, Senior Medical Director Clinical Science R&D Marketed Products Group, Takeda

Collaborating for Transformation

• Explore unique features of PV that lend to various collaboration models
• Examples of how collaborations can lead to higher performance
• Discuss experiences, good and bad, with PV collaborations

Sundeep Sethi, Vice President, Safety Operations, Abbvie

Keynote Presentation Case Processing - Is there a better way?

• Artificial Intelligence approaches to allow human emphasis on important information
• Cross Industry machine learning approaches applied to pharmacovigilance
• Natural Language Processing for case intake

Bruce Palsulich, Vice President of Product Strategy, Oracle Health Sciences

Keynote Panel: PV and technology – how can we best leverage emerging tech?

• Social media platforms like facebook and twitter – how can these be utilized fully for PV?
• Smartphones and tablets – capitalizing on the interactive connection to patients
• ‘Appification’ – using apps to deliver software​

Robert Kane, Vice President & U.S Head, Life Science Industries, Tata Consultancy Services

Esther De La Cuesta, Global Safety Lead, Senior Medical Director Clinical Science R&D Marketed Products Group, Takeda

Walter Straus, Executive Director and Head, Scientific Affairs/ Vaccines, Merck And Company

William O'Brien, Chairman of Medical Surveillance Team and Virology, Global Pharmacovigilance and Epidemiology, Bristol Myers Squibb

BIG DATA AND RISK

INTERNATIONAL REGULATORY LANDSCAPE

PV – unfinished business

• How to position PV within the broader safety context
• Examining how entities can better work together to push the industry forward
• What still needs to happen?

Paul Beninger, Director, MD/MBA Program, Tufts University

BIG DATA & RISK

How Big Data is transforming risk management

• Latest developments taking place
• Overcoming key challenges through data
• What this means for the future of risk management

Leonardo Viana Nicacio, Senior Global Medical Affairs Leader, AstraZeneca

BIG DATA & RISK

Global Regulatory Landscape for Safety Monitoring: A Quantitative Perspective

FDA IND safety reporting final rule calls for:

• A multi-disciplinary approach
• Frameworks around aggregate review and level of evidence (not statistical decision rules)
• Assessments that are product specific and decisions that are driven by medical judgment
• Opportunity to partner with regulatory agencies to champion safety issues

Greg Ball, Principal Statistician, Merck & Co.

INTERNATIONAL REGULATORY LANDSCAPE

Case Study: Implementation of FDA Final Rule for IND Safety Reporting

• Sharing Merck’s best practices in successful implementation of the FDA’s Final IND Rule
• Compliance with this legislation still remains a challenge for many Biotechnology and Pharmaceutical companies, however, successful implementation results in gains of reduced ‘noise’ transmitted to FDA and decreases investigators burden

Cecilio Delgra, Associate Vice President Global Clinical Safety & Pharmacovigilance Head, Medical Safety Review and CT Safety Reporting, Merck

BIG DATA & RISK

Attaining Better Outcomes in Drug Safety through Enabling New Age Technology

Tata Consultancy Services

DATA MANAGEMENT STRATEGIES

PHARMACOVIGILANCE

Chairperson’s opening remarks

DATA MANAGEMENT STRATEGIES

Chairperson’s opening remarks

Ben locwin, President, Healthcare Science Advisors

PHARMACOVIGILANCE

Keynote Presentation: PV for combination products

• Device meets drug – what differences does industry need to consider?
• Reaching out to the patient – exploring non-traditional approaches
• Leveraging existing processes and structures to stay compliant

Dr Khaudeja Bano, Senior Medical Director, Abbott Diagnostics

DATA MANAGEMENT STRATEGIES

Cognitive Computing Changes the Game in Pharmacovigilance

• Artificial Intelligence – is it real?
• How is it permeating our lives?
• What does it mean to case processing?
• How will regulators react?

Nicole Drapeau Gillen, Senior Director, ArisGlobal

PHARMACOVIGILANCE

Optimizing patient outcomes requires a shift from the traditional transactional and risk-based safety approach

George Pushchinsky, Vice President, Product Management, Deloitte Consulting

DATA MANAGEMENT STRATEGIES

Global Oversight of Risk Management Plans: Adoption of Tools & Approaches Synopsis

• Global Oversight of RMPS: Key Requirements
• Selection of Tools to provide Global Oversight – One Size does not Fit All
• RMP Oversight & Tracking Tool:
• o Key Elements
• o Integrated Processes
• o Efficiency Improvements
• Future Opportunities

Sarah Frise, Director Risk Management, AstraZeneca

PHARMACOVIGILANCE

Safety Assessment for IND Safety Reporting

• FDA draft guidance Dec 2015
• Extra guidance to be aware of Reporting tools
• How pharmaceutical and medical device companies should respond to off label inquiries (including digital platforms)
• Addressing misinformation and fulfilling post marketing regulatory requirements for submission of “interactive promotional media” for FDA approved products

Dr Priya Jain, Medical Director, Alkermes

DATA MANAGEMENT STRATEGIES

Pharmacovigilance Outsourcing, can the Qualified Person for Pharmacovigilance be outsourced?

• What are the benefits and challenges of QPPV outsourcing?
• Rationale and drivers for Pharmaceutical /Biotech companies to outsource QPPV activities.
• Governance, capabilities, and strategies needed for a successful QPPV outsourcing relationship.

Nicole Baker, Director Drug Safety and EEA-QPPV, BioClinica

PHARMACOVIGILANCE

ProQuest Dialog: Intelligence on Demand

Research and workflow solutions designed for pharmaceutical and biomedical companies  ProQuest Dialog eliminates the risk of missing essential information. Using one simple interface, you can search hundreds of sources such as MEDLINE,® Embase,® BIOSIS Previews,® Derwent Drug File, IMS R&D Focus, and many more – including patents, news and trade, and dissertations and theses.

Bill Kivett, Director of Product Management for ProQuest Dialog and Pi2, ProQuest

PHARMACOVIGILANCE

PV Prioritization across the product lifecycle

An analysis of how PV can be managed differently for smaller companies solely with products in development versus larger companies with a diverse portfolio

Dr David Balderson, Global Vice President Safety Operations, Sciformix

PHARMACOVIGILANCE

Panel Discussion: signal management - establishing a proactive approach

• Quantitative vs qualitative techniques
• Identifying new Adverse Drug Reactions (ADRs) or changes in the frequency of ADRs
• Patient contribution to signal management

Daniel Reshef, Group Medical Director, Bristol Myers Squibb

Neal Grabowski, Signal Management Officer Global Patient Safety & Labeling, Amgen

Christina Budzynski, Director, Global Integration & Delivery in Global Pharmacovigilance, Otsuka America Pharmaceutical, Inc.

DATA MANAGEMENT STRATEGIES

Fireside Chat: Outsourcing clinical trial safety data management vs insourcing

• What can be outsourced?
• Work volume uncertainty – how much of a factor is this?
• Multiple reporting requirements and resource management – examining the pros and cons
• Which companies suit which strategy?

Esther De La Cuesta, Global Safety Lead, Senior Medical Director Clinical Science R&D Marketed Products Group, Takeda

Ben locwin, President, Healthcare Science Advisors

BIG DATA AND PV

TECHNOLOGICAL INNOVATION

Chairmans Opening Remarks

Wenda Brennen, Head of Pharmacovigilance Services, PharmaLex

BIG DATA & PV

Chairperson’s opening remarks

John Price, VP of Global Pharmacovigilance and Drug Safety, Alexion Pharmaceuticals

TECHNOLOGICAL INNOVATION

Innovative solutions to streamline case intake in PV

Jamie Portnoff, Vice President and Global Head of the Business Transformation Practice, Foresight Group International AG

BIG DATA & PV

Using Natural Language Processing (NLP) in Drug Safety - A Comparison of Coded EHR and NLP-Derived Acute Liver Disease in an IBD Population

• Can we use complete EHR data (both coded and NLP derived) to respond more rapidly and effectively to regulatory queries and safety study commitments?
• Does NLP-derived data meaningfully improve the information we receive from the coded electronic health record (EHR) data?
• This case study is aimed at evaluating the use of NLP-derived data for the evaluation of safety surveillance, as a supplement to electronic health record data.

Raj More, Chief Executive Officer, Rxlogix

TECHNOLOGICAL INNOVATION

Literature Management for Pharmacovigilance: Outsourcing or In-House solution?

• Literature plays an important role in pharmacovigilance
• Screening literature comes with a lot of challenges, and a lot of work.
• In-house solutions for literature management can increase oversight of the literature screening activities and are therefore a good alternative for outsourcing.

Neal Katz, Director of Solutions Marketing, Elsevier

BIG DATA & PV

Evolving Signal Management Approaches in Biosimilars Development to Support Demonstrating Biosimilarity Safety wise

• Current applicable regulations (e.g., FDA, EMA)
• Design a dynamic signal detection/management process from pre-market development to approval.
• What clinical trial data and additional exogenous data should feed into the process?
• The critical importance of appropriate documentation
• Data constraints and challenges?

Joash Krishna, Senior Safety Scientist, PRA Health Sciences

Top Authors

• Dr Snehal Vajani
• Rayeesa Mahboob
• RASHAD MAMMADOV
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