DIA 2016 Annual Meeting

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

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Did you know that Japan has a relief system for adverse reactions which makes payments to patients who have suffered adverse reactions during use of drugs for their approved indications? Are you aware of the many actions taken recently in Japan for under-reporting or missed reporting of adverse reactions by domestic and foreign-headquartered pharmaceutical companies? Do you struggle to understand the requests of your Japanese partners and colleagues related to managing pharmacovigilance and adverse reaction report exchange in that country? Have you ever been overwhelmed by solicited cases from Japanese observational studies or had trouble interpreting the results of all-case surveillance studies from that country? This session aims to give a full background on the postmarketing surveillance system in Japan including the re-examination and re-evaluation systems, the role of observational studies and the current practices in risk management. The session will also examine recent cases of non- or under-reporting of ICSRs and the possible connection between complexity of PV regulation, the multitude of ways in which safety information can reach pharmaceutical companies and unintentional noncompliance with reporting regulations. Finally, since 1980 Japan has had a Fund for Relief Services for Adverse Drug Reactions. The details of the system and how it serves as a safety net will be described.

Learning Objectives

Discuss how the complexity of pharmacovigilance regulation can be a factor in non- or under-reporting of ICSRs; Describe the regulatory and legal context for pharmaovigilance in Japan; Recognize the different varieties of Japanese postmarketing observational studies and how they are performed; Interpret Japanese pharmacovigilance regulations and expectations; Explain the Relief System for Adverse Reactions in Japan, how it operates and is funded, and its practical effects on patients.

Chair

Stewart Geary, MD

Speaker

Observational Studies in Japan and Asia
Stewart Geary, MD

Relief Services in Occurrence of Serious Adverse Drug Reactions
Naohiro Otaki

Root Cause Analysis of and Solutions for Under Reporting Safety Information of ICSRs in Clinical Research and Sales Activities
Teiki Iwaoka, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss the concept that there is no agreed upon or standardized approach to outsourcing pharmacovigilance. Other industries use the safety case model so vendors present a common model for sponsors to examine and the latest thinking will be applied to pharmacovigilance outsourcing.

Learning Objectives

Discuss a more standardized approach to outsourcing pharmacovigilance; Identify a common model for pharmacovigilance outsourcing.

Chair

Brian David Edwards

Speaker

Pharmacovigilance Sourcing, Emerging Business Models
Kelly Traverso

Pragmatic Approach to Pharmacovigilance Outsourcing
Lillian M. Kirk, DrSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-582-L05-P; CME 1.50; IACET 1.50; RN 1.50

Some health authority regulations require the assessment of all adverse events from solicited programs. This session will present multi-company data and discuss various viewpoints from both industry and health authority representatives.

Learning Objectives

Evaluate the quality of adverse event information from solicited programs for potential safety signals; Assess various program types to develop a pragmatic, risk-based approach for appropriate safety oversight; Recognize how to standardize handling of solicited programs for market authorization holders and health authorities to generate insight into real-life use of marketed drugs and patient perception.

Chair

Bruce A. Donzanti, PhD

Speaker

Industry Survey on Pharmacovigilance Oversight of Solicited Programs
Jamie Portnoff

A Regulatory View of ICSR Reporting Requirements for PSPs
Mick Foy

Pragmatic Compliance: A QPPV View of PSPs
Sue Rees, MS

Organized Data Collection Systems: A Pure Compliance Challenge or More?
Heike Schoepper, MD, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-581-L05-P; CME 1.00; IACET 1.00; RN 1.00

PatientsLikeMe and FDA have a research collaboration agreement to explore how patient-reported data can give new insights into drug safety. In this session, we will discuss the objectives, agenda, progress, and findings from our early research.

Learning Objectives

Discuss the evolving research goals and findings from the collaboration between FDA and PatientsLikeMe; Outline identified applications of patient-generated data in a regulatory context to inform pharmacovigilance, pharmaco-epidemiology, medication error, and risk management efforts.

Chair

Ben Heywood, MBA

Speaker

Patient-Generated Data in Drug Safety
Ben Heywood, MBA

Systematic Exploration of Patient-Generated Health Data for Use in Postmarketing Safety Monitoring
Carol A Pamer

FDA Perspective
Sonja Brajovic, MD