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Trk 14: Clin Safety/PV [clear filter]
Tuesday, June 28
 

10:30am

#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
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... 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... Read More →
avatar for Henry Francis

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... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →


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

2:00pm

#249: Current Topics for Pharmacovigilance in Japan
Limited Capacity seats available

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



Chair
avatar for Stewart Geary

Stewart Geary

Senior Vice President, Chief Medical Officer, Eisai Co., Ltd.
Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He was a member of the CIOMS VII, VIII and IX Working Groups, and currently serves on the Executive Committee of JAPhMed and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical... Read More →

Speakers
avatar for Teiki Iwaoka

Teiki Iwaoka

Executive Consultant, Director of Drug Safety Outsourcing Planning, CAC Croit Corporation
Drug Safety & Pharmacovigilance expert. EWG for ICH E2B, and Rapporter for ICH E2D. Lecturer of many educational seminars worldwide more than 20 years. Executive Consultant, and Auditors for Global Pharmacovigilance Compliance.
avatar for Naohiro Otaki

Naohiro Otaki

Technical Officer, Application Review Division I, Office of Relief Funds, Pharmaceuticals and Medical Devices Agency (PMDA)
Technical officer of PMDA since Feb.2010 and technical officer of Office of Relief Funds of PMDA since Jan. 2014.


Tuesday June 28, 2016 2:00pm - 3:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?
Limited Capacity seats available

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



Chair
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →

Speakers
avatar for Lillian Kirk

Lillian Kirk

Director, Global Pharmacovigilance Case Management, Alexion
Lillian is a Doctor of Chiropractic with over 19 years’ healthcare experience, including clinical practice, teaching, drug safety/pharmacovigilance & medical affairs. The last 3 years, she provided safety expertise companywide & for external partners. She has worked to develop valuable... Read More →
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

2:00pm

#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?
Limited Capacity seats available

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



Chair
avatar for Bruce Donzanti

Bruce Donzanti

Senior Group Director, Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in... Read More →

Speakers
avatar for Mick Foy

Mick Foy

Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 9 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible for two large European projects to improve drug safety... Read More →
avatar for Jamie Portnoff

Jamie Portnoff

Vice President, Foresight Group International
Jamie Portnoff is a Vice President and Global Practice Leader with 15 years of experience in Life Sciences. In the past 10 years Ms. Portnoff has delivered a broad scope of business solutions including multiple PV operational and organizational integrations. Prior to Foresight, Ms... Read More →
avatar for Sue Rees

Sue Rees

EU QPPV, Executive Director, Global Patient Safety, Amgen Ltd
Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV, based in Cambridge, UK. Sue is an honorary Fellow of PIPA and sits on the Efpia PV Expert Group. Prior to joining Amgen Sue spent 3 years at Eisai Europe as Head of International PV... Read More →
avatar for Heike Schoepper

Heike Schoepper

Head of Global Drug Safety, Merck KGaA
Heike is a registered physician, practiced in internal medicine at university hospital in Berlin and Erlangen, Germany. She holds specialist registration in internal medicine and diplomas in public health, epidemiology from the University in Heidelberg, Germany and a diploma in tropical... Read More →


Wednesday June 29, 2016 2:00pm - 3:30pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
Limited Capacity seats available

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



Chair
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →

Speakers
avatar for Sonja Brajovic

Sonja Brajovic

Medical Officer, OSE, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →
CP

Carol Pamer

Program Lead for Pharmacovigilance, OSE, CDER, FDA
Carol Pamer is Program Lead for Pharmacovigilance in the FDA CDER Office of Surveillance and Epidemiology (OSE) Regulatory Science Staff. She is a Principal Investigator for the FDA-PatientsLikeMe Research Collaboration Agreement. She earned her B.S. degree in Pharmacy from Ohio State... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA