Next Gen Tech & Data

 

Innovation in technology, data, evidence, artificial intelligence and machine learning are the key areas explored by the industry in our program as they promote approaches in data collection methods, signal detection, automation, adoption and implementation.

 

Key Speakers

 

NEXT GEN TECH & DATA, Tuesday 16 April 2019

08:00

8:00 Registration and Breakfast

Jose Vega
09:00

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

Alexandre Kiazand
09:20

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

Bruce Palsulich
09:40

AI and Machine Learning: Using advanced technologies to help make PV operations more efficient

10:00

Speed Networking

10:20

Networking coffee break

NEXT GEN TECH & DATA
11:00

Using data to create risk management plans: how to strategize your approach to the both the FDA and the EMA requirements for risk management plans

Ale Maria Vazquez-Gragg
NEXT GEN TECH & DATA
11:20

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

Lian Lin
NEXT GEN TECH & DATA
11:40

Integration of continuum safety evidence for decision making

How to assess the multi-source of real world safety data and consider design for RCT/PCT, observational trials, and post-marketing surveillance .
Aman Wasan
NEXT GEN TECH & DATA
12:00

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

12:20

Networking lunch

Elena Davison

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

Elena Davison, Director of Global Pharmacovigilance Informatics, Sunovion Pharmaceuticals

1:40 ROUNDTABLES (1-hour roundtable sessions split between 2 rounds of 30 minutes – attendees can select two roundtables to attend)

Vicki Edwards

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

Gabrielle Sellick

4) Affiliate Pharmacovigilance Transformation

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.
Fatima Yousef Ali Ghethan

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

Michael Von Forstner

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

How to organize class-related post-authorization studies (Art. 31), obtain/analyze data across regions, communicate with different national authorities, and manage stakeholder expectations.
Andres Gomez
NEXT GEN TECH & DATA
14:50

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

Mircea Ciuca
NEXT GEN TECH & DATA
15:10

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

Qing (Kathy) Li
NEXT GEN TECH & DATA
15:30

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

16:10

Networking coffee break

Steven Beales
16:40

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

Sundeep Sethi
17:00

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

5:20 Closing remarks followed by networking drinks reception

last published: 06/Mar/19 17:05

NEXT GEN TECH & DATA, Wednesday 17 April 2019

Susan Welsh
08:55

Chairperson opening remarks:

Sherry Winter
09:00

A new approach to developing advanced drug safety solutions

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.
10:00

Networking coffee break

Arvind Bellur
NEXT GEN TECH & DATA
11:00

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

NEXT GEN TECH & DATA
11:20

AI and predictive outcomes: self learning machines and their influence on decision making

Anupam Agarwal
NEXT GEN TECH & DATA
11:40

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

Dinesh Kasthuril
NEXT GEN TECH & DATA
12:00

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

12:20

Networking lunch

Nicole Baker

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

Steven Beales

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

A case study in eliminating over-distribution and improving patient safety, while significantly reducing costs.
Leo Russo

12) The role of patient preference studies in supporting benefit-risk profiles: how to determine the impact on a specific product/disease area, identify key therapeutic decisions, and obtain alignment

1:40 ROUNDTABLES (1-hour roundtable sessions split between 2 rounds of 30 minutes – attendees can select two roundtables to attend)

Rudi Scheerlinck

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

David Chonzi

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

Tanja Fahlbusch

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

Hedva Voliovitch

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

Krishna Asvalayan
NEXT GEN TECH & DATA
14:50

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

Francois Audibert
NEXT GEN TECH & DATA
15:10

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

Veronica Urdaneta
NEXT GEN TECH & DATA
15:30

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

Susan Welsh
15:55

Chairperson Closing Remarks:

4:00 END OF CONFERENCE

last published: 06/Mar/19 17:05

 

 

 

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