GLOBAL PV

 

The Clinical development and regulatory landscape for small molecule drug development becomes ever more complex. Companies, patient groups and regulators will key issues areas including patient centric clinical development, regulatory considerations in trial design, and clinical evidence and patient data.

 

Key Speakers

 

GLOBAL PV, 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

Stewart Geary
GLOBAL PV
11:00

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

Richard Wolf
GLOBAL PV
11:20

Panel: Outsourcing vs. innovation

How to lower costs, mitigate risk, and approach the differences in implementing safety procedures when globally outsourcing vs. implementing new technological innovation.
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.
Andrea Maulwurf
GLOBAL PV
14:50

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

Lana Gloukhova
GLOBAL PV
15:10

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

Mariette Boerstoel
GLOBAL PV
15:30

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

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

GLOBAL PV, 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

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

Nneka Onwudiwe
GLOBAL PV
15:30

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

Susan Welsh
15:55

Chairperson Closing Remarks:

4:00 END OF CONFERENCE

last published: 06/Mar/19 17:05

 

 

 

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

 

 

 

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

 

 

 

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