Patient Safety

 

By shifting “patient centricity” from rhetoric into practical applications, the industry will examine patient management and patient safety profiles and analyze their effects on safety with a focus on improving the patient experience as a whole.

 

Key Speakers

 

PATIENT SAFETY & MEDICAL DEVICES, 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

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.
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

PATIENT SAFETY & MEDICAL DEVICES, 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

Toyin Adewole
PATIENT SAFETY & MEDICAL DEVICES
11:00

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

PATIENT SAFETY & MEDICAL DEVICES
11:20

Apps as 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.
PATIENT SAFETY & MEDICAL DEVICES
11:40

Combination products and safety monitoring 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.
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

Jie Li
PATIENT SAFETY & MEDICAL DEVICES
15:10

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

Susan Welsh
15:55

Chairperson Closing Remarks:

4:00 END OF CONFERENCE

last published: 06/Mar/19 17:05

 

 

 

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Get Involved At World Drug Safety Congress Americas

 

To Sponsor Or Exhibit


Joseph Sica
joseph.sica@terrapinn.com
t/ +1 646 619 1839

 

 

 

To Speak


Michaela Deitrick
michaela.deitrick@terrapinn.com
t/ +1 646 619 1799

 

 

 

To Register


Joe McManus
joseph.mcmanus@terrapinn.com
t/ +1 646 619 1774