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Trk 14: Clin Safety-PV [clear filter]
Monday, June 27
 

8:30am

#117: IDMP: A Compliance Project or a New Way of Conducting Business?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA



Chair
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →

Speakers
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry... Read More →


Monday June 27, 2016 8:30am - 9:30am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?
Limited Capacity seats available

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

The session will review the implementation status of the 2010 EU Pharmacovigilance Legislation and its associated Good Pharmacovigilance Practices Guidelines, focusing on the key challenges and uncertainties arising from implementation, as well as some future proposals to measure impact on facilitating the performance of pharmacovigilance in the European Union. Did it do what it originally set out to achieve? Key to the success of implementing a robust pharmacovigilance system is the ability to strengthen the monitoring of benefit risk throughout a products life cycle. The results of the PROTECT work stream that arose as a quantum leap forward in benefit risk evaluation from the Innovative Medicines Initiative in the EU will be explored and how the results have changed industry and regulatory authority standards.

Learning Objectives

Discuss the current status, challenges, and uncertainties arising from the implementation of the EU Good Pharmacovigilance Practices Guidelines associated with the 2010 EU Pharmacovigilance Legislation; Describe future strategies to measure the impact that the legislation and guidelines have had since implementation; Explore how the results of PROTECT have changed industry and regulatory standards.

Chair

Valerie E. Simmons, MD, FFPM

Speaker

Introduction, General Overview of Implementation of the EU GVP Guidelines: Did They Actually Deliver?
Valerie E. Simmons, MD, FFPM

IMI PROTECT: Challenges, Successes, and the Effect on PhV in Europe
Stella C.F. Blackburn

Important Risks Resulting from EU PV Legislation and Guidance: Best Practice to Allow Optimized Patient Safety?
Leonardo Ebeling



Chair
avatar for Valerie Simmons

Valerie Simmons

EU QPPV, Global Patient Safety, Eli Lilly and Company Ltd
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val... Read More →

Speakers
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →


Monday June 27, 2016 8:30am - 9:45am
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-576-L05-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to understand, develop, and implement the review/reporting process for events considered anticipated based upon the disease under study which is an important new procedure within clinical development. Attendees will also learn through the examination of case studies clarifying issues leading to uninformative safety reporting.

Learning Objectives

Describe barriers to implementation of the FDA Rule; Clarify the FDA Rule and guidance in order to reduce the number of uninformative safety reports; Recognize the end to end process of the aggregate review and reporting of Anticipated Events; Convert the knowledge of the process into a tangible approach for adoption; Identify how to guide an organization to develop and implement a process; Identify opportunities for improving the quality and efficiency of IND safety reporting processes.

Chair

Robert (Mac) Gordon, MS

Speaker

Using Case Studies to Facilitate Implementation of the FDA Rule for IND Safety Reporting
Marsha Millikan

FDA Perspective
Jonathan P. Jarow, PhD

One Company's Approach to Developing and Implementing an Anticipated Events Review Process
Robert (Mac) Gordon, MS



Chair
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Associate Director, Biostatistics, Janssen Research & Development, LLC
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →

Speakers
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... Read More →
avatar for Marsha Millikan

Marsha Millikan

Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company
18 years of pharmaceutical drug safety experience. Currently oversees global PV expedited reporting business processes. She supported multiple projects including the FDA IND rule changes, database updates, creation of an investigator line listing report, & EU GVP process updates... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

A multiperspective, practical look at incorporating social listening into pharmacovigilance practices—including challenges, knowledge and guidance gaps, regulatory guidance, and recent research as well as experiential findings from both pharma and academia. Come hear some very up-to-date and practical learnings from social media in pharmacovigilance and be challenged to rethink some preconceptions about it.

Learning Objectives

Discuss current challenges and gaps in use of social media for pharmacovigilance including patient privacy, regulatory guidance, legal and reporter identification as global issues; Explain how some pharmaceutical companies have overcome some of those challenges to collect and analyze social media data to augment current postmarketing pharmacovigilance measures and where value has been found; Describe some findings from recent research efforts and data collection methods.

Chair

Laurie S. Anderson, PharmD

Speaker

Current Gaps and Challenges in Pharmacovigilance with Respect to Social Media
Lalitha P. Aiyer, MD, MBA, MS

A Real-World Look at Mining Social Media for Adverse Events: Impact of Regulatory Definitions and Methods
Michael A. Ibara, PharmD

Real-World Use of Social Listening for Pharmacovigilance Currently in the Pharmaceutical Industry
Lorrie Schifano, PharmD



Chair
avatar for Laurie Anderson

Laurie Anderson

Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
Manager-Safety Evaluation and Risk Management Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned her... Read More →

Speakers
avatar for Lalitha Aiyer

Lalitha Aiyer

President and Senior Medical Advisor, Medical and Pharma Advisors Group
Lalitha is a board certified physician with subspecialty training in Internal Medicine with 14 +years in clinical practice & over 15 years in the Pharmaceutical Industry. She runs an independent consultancy practice. Previously she worked in Ardea BioSciences as Head of Pharmacovigilance... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

Measuring effectiveness of risk minimization activities is an essential part of risk management, but doing it can be challenging. Experts will discuss requirements in different regions, CIOMS IX, possible methodologies, and the challenges.

Learning Objectives

Describe the importance of measuring the effectiveness of risk minimization activities and the requirements in different regions; Discuss the different methodologies for measuring effectiveness; Discuss opinions from regulatory, industry, and contract research on the challenges of measuring effectiveness.

Chair

Stella C.F. Blackburn

Speaker

Risk Management Plans and Risk Minimization: What Have We Learned and Where Is It All Going?
Shelley Gandhi, MS

CIOMS IX and the Theory of Assessing Effectiveness
Stella C.F. Blackburn

Additional Risk Minimization Measures for EU Centrally Authorized Products, 2006-2014: A Qualitative and Quantitative Review
Annalisa Rubino, PhD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
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 →
AR

Annalisa Rubino

Director of Risk Management Epidemiology, Oxon Epidemiology
Annalisa Rubino is Director of Risk Management Epidemiology with OXON Epidemiology. She is a Pharmacoepidemiologist with extensive research experience in drug development in academia and industry. She has worked in consultancy for the pharmaceutical industry in therapeutic risk management... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs
Limited Capacity seats available

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

On September 29, 2010, FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information in order to reduce the number of uninformative reports distributed by sponsors. An audit of randomly selected expedited safety reports submitted to FDA’s Office of Hematology and Oncology Products (OHOP) in 2015 revealed that the majority of submitted safety reports were uninformative. Submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Representatives from OHOP will present the current state of safety report submissions and efforts to modernize safety reporting.

Learning Objectives

Recognize the current state of safety report submissions to FDA’s Office of Hematology and Oncology Products (OHOP) based on a 2015 audit of safety reports as well as actions that OHOP has taken to guide sponsors to submit informative safety reports; Describe processes and procedures that the pharmaceutical industry has implemented to improve expedited safety reporting practices for hematology and oncology products; Describe OHOP-led initiatives to modernize safety reporting submission.

Chair

Tamy Kim, PharmD

Speaker

FDA Perspective
Suranjan De, MBA, MS

A Large Pharma’s Experience with Implementing the FDA Final Rule on Expedited IND Safety Reporting
Nina Stuccio, DO



Chair
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →

Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Nina Stuccio

Nina Stuccio

Therapeutic Area Lead, Clinical Safety and Risk Management, Oncology, and Bone, Merck Research Laboratories
Nina Stuccio, D.O. is the Therapeutic Area Lead, Oncology and Bone, Global Safety and an Industry member of the Clinical Trial Transformation Initiative (CTTI) IND Safety Advancement Project, focused on oncology trials to determine barriers and identify solutions for compliance with... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide an overview of ongoing initiatives at government, industry, and academic sites on leveraging Big Data for adverse drug reactions detection.


Learning Objectives

Discuss how Big Data can improve the detection of adverse drug reactions; Identify the data sources that will likely to be part of the Big Data paradigm envisioned for pharmacovigilance; Define the strengths, limitations, and challenges associated with the use of each of the identified data sources for improving the detection of adverse drug reactions.

Chair

Rave Harpaz, PhD

Speaker

Harnessing Scientific Literature Reports for Pharmacovigilance: FDA Perspective
Alfred Sorbello, DO, MPH

Maximizing Data Sources for Signal Detection: Pharmaceutical Company Perspective
Amy Purrington, MD

Social Media Mining for Public Health Monitoring and Surveillance
Graciela Gonzalez Hernandez, PhD



Chair
avatar for Rave Harpaz

Rave Harpaz

Senior Research Scientist, Oracle Health Sciences
Rave Harpaz is a Senior Research Scientist at Oracle Health Sciences. Previously, Rave was a Research Scientist at Stanford University, a post-doctoral fellow at Columbia University, and a quantitative risk modeling analyst at Merrill Lynch. Rave holds a PhD in Computer Science from... Read More →

Speakers
GG

Graciela Gonzalez Hernandez

Associate Professor, Department of Biomedical Informatics, Arizona State University
avatar for Amy Purrington

Amy Purrington

Head, Signal Management Group, Janssen Pharmaceuticals, Inc.
Amy is an experienced pharmacovigilance physician, focusing on proactive surveillance. She has been in industry for 15 years and at JNJ for the last 12. She is currently the lead of the Signal Management Group, which is dedicated to the development and implementation of new signal... Read More →
avatar for Alfred Sorbello

Alfred Sorbello

Medical Officer, Office of Translational Sciences, CDER, FDA
Dr. Alfred Sorbello is a Medical Officer at FDA in the Office of Translational Sciences of the Center for Drug Evaluation and Research (CDER). Previously, he worked in CDER’s Office of Surveillance and Epidemiology /Division of Pharmacovigilance II and in CDER’s Office of New... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA