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Tuesday, June 28 • 10:30am - 11:45am
#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-600-L04-P; CME 1.25; IACET 1.25; RN 1.25

The requirement to properly plan, track, and manage signals from all sources has never been greater, and we are seeing an increasing focus of inspectors on companies' signaling strategies. This session describes cutting edge research from a local and a global perspective and will aid companies in designing a fit-for-purpose signal detection and management strategy for their product portfolios. This sesion will utilize real life examples in the presentation.

Learning Objectives

Describe signal management regulatory requirements in the EU, US, and other regions; Discuss how the basic principles of modern signal detection and management systems can be adapted to fit various-sized portfolios while ensuring quality is optimized; Recall developments in advanced signaling informatics.

Chair

Deirdre McCarthy, MS

Speaker

What Is the Utility of GIS Technology in the Postmarket Setting?
Henry "Skip" Francis

Practical Tools for Signal Management: How Do You Overcome Challenges and Meet the Regulatory Needs of Pharmacovigilance?
Shelley Gandhi, MS

Global Signal Detection with Regional Relevance: Development and Field Testing of Surveillance Strategies for the Emerging Indian Market
Ola Caster, PhD



Chair
avatar for Deirdre McCarthy

Deirdre McCarthy

Senior Benefit Risk Management Director, Quintiles Inc.
Over 15 years in PV, spanning CRO, regulatory authority and company. Areas of special interest are EU post-marketing safety systems & product benefit-risk management. Adjunct Lecturer in international PV at Tufts University School of Public Health and Community Medicine in Boston. Member of the ISoP Executive Committee for two terms and co-chair ISoP global training programme (ETP). Regular speaker and trainer at industry meetings and conferences... Read More →

Speakers
avatar for Ola Caster

Ola Caster

Senior Researcher, Uppsala Monitoring Centre
Ola Caster is Senior Researcher at the Uppsala Monitoring Centre and affiliated with the Department of Computer and Systems Sciences, Stockholm University. He has nearly ten years’ experience from research and development in global pharmacovigilance, with formal qualifications PhD in Computer and Systems Sciences and MSc in Pharmacy and Mathematical Statistics. His primary research interests are methods to support post-marketing signal... Read More →
HF

Henry Francis

Director for Data Mining and Informatics Evaluation and Research, OTS, CDER, FDA
Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety.
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley Gandhi brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years and 2 years with the NDA group working with industry. She has extensive knowledge of all European regulatory processes related to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public heath... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA