World Drug Safety USA 2017 - Day One

 
08:00

Registration and breakfast

 
 

THE DRUG SAFETY INDUSTRY – VIEW FROM THE TOP

 
09:00

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
 
09:20

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
 
09:40

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
 
Panel discussion
 
10:40

SPEED NETWORKING

 
 
11:00

MORNING REFRESHMENTS

 
 

INTERNATIONAL REGULATORY LANDSCAPE

 

BIG DATA AND RISK

 
 
INTERNATIONAL REGULATORY LANDSCAPE
11:30

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?
 
BIG DATA & RISK
11:30

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
 
 
BIG DATA & RISK
11:50

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
 
 
INTERNATIONAL REGULATORY LANDSCAPE
12:10

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
 
BIG DATA & RISK
12:10

Attaining Better Outcomes in Drug Safety through Enabling New Age Technology

Tata Consultancy Services
 
12:30

LUNCH

 
 

PHARMACOVIGILANCE

 

DATA MANAGEMENT STRATEGIES

 
 
PHARMACOVIGILANCE
14:00

Chairperson’s opening remarks

 
 
PHARMACOVIGILANCE
14:05

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
 
DATA MANAGEMENT STRATEGIES
14:05

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?
 
 
DATA MANAGEMENT STRATEGIES
14:25

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
 
 
PHARMACOVIGILANCE
14:45

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
 
DATA MANAGEMENT STRATEGIES
14:45

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.
 
 
PHARMACOVIGILANCE
15:05

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.

 
PHARMACOVIGILANCE
15:05

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
 
 
DATA MANAGEMENT STRATEGIES
15:25

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?
 
 
 
16:00

Afternoon refreshments and exhibition viewing

 
 

TECHNOLOGICAL INNOVATION

 

BIG DATA AND PV

 
 
 
BIG DATA & PV
16:35

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
16:55

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.
 
BIG DATA & PV
16:55

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?
 
 

NETWORKING DRINKS RECEPTION