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Trk 14: Clin Safety-PV [clear filter]
Sunday, June 26
 

8:30am

#25: Signal Detection: Identifying and Managing Safety Signals
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Signal detection is an essential element of the overall risk management process. This intermediate to advanced tutorial provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The tutorial also provides participants with the context to evaluate new research in the field.

Who should attend?

This tutorial is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The tutorial will also benefit participants who make risk management decisions based on signal detection results.

Learning Objectives

• Identify strengths and limitations of methods for signal detection;
• Interpret outputs from automated quantitative signal detection methods (data mining results);
• Discuss how to integrate signal detection methods into the larger signal and risk management process;
• Describe emerging methods for signal detection.


Speakers
avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#43: Risk Management and Safety Communication Strategies
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-505-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Risk communication is increasingly important to everyone involved in our health care system, especially the patients whose lives we strive to improve. This tutorial will look at current initiatives and new strategies to advance the safe use of drugs. The current status and future of Risk Evaluation and Mitigation Strategies (REMS) in the US will be discussed, and compared with Risk Management Plans in Europe and Japan.

What You Will Learn:
• Current state of risk communication in the United States
• Health literacy, risk perception, and other safety communication issues
• New strategies to improve understanding of drug safety concerns among health care providers and to promote better communication to patients
• The development of risk evaluation and mitigation strategies (REMS) in the US
• How US REMS with risk management plans compare with those of Europe and Japan
• The importance of good communication during a crisis situation.

Who should attend?

This tutorial is designed for professionals who work in clinical safety and pharmacovigilance, regulatory affairs, medical writing, and marketing and communications.

Learning Objectives

• Describe current risk communication strategies;
• Discuss the development of REMS in the US;
• Explain new methods to improve the proper use of medicines to maximize patient benefit and minimize risk;
• Discuss the future of drug safety and risk communication especially during a crisis situation.


Speakers
avatar for Nancy Smith

Nancy Smith

Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#44: The Good Pharmacovigilance Practices in the EU: Global Applications
Limited Capacity seats available

Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The objective of this tutorial is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

    • Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems
    • Management and reporting of adverse reactions and signal management
    • Updates of GVP Module VI
    • The new EU E2B(R3) ICSR implementation guide
    • New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA
    • Updates to the EudraVigilance Access Policy.


Who should attend?

This tutorial is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

Learning Objectives

• Describe recent developments on EU Good Pharmacovigilance Practices guidance;
• Examine principles for new literature monitoring and the revised EudraVigilance Access Policy;
• Discuss FAQs in signal management;
• Identify important aspects in preparing risk management plans and conducting postauthorization safety studies;
• Describe key principles for pharmacovigilance audits and inspections.


Speakers
avatar for Steve Jolley

Steve Jolley

Chief Executive Officer, SJ Pharma Consulting, LLC
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events. Steve has 30 years’ experience in drug safety and pharmacovigilance and has worked with over 100 clients in North America... Read More →
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit
Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this workshop, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role playing as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

Who should attend?

This tutorial is designed for professionals involved in clinical safety and pharmacovigilance.

Learning Objectives

• Describe the key milestones needed to create a REMS assessment report;
• Identify who and how to engage in the multidisciplinary team required to create the report;
• Discuss the type of sections included in various types of REMS assessment reports.


Speakers
avatar for Mark Ammann

Mark Ammann

President, Catalyst Regulatory Services, LLC
Mark A. Ammann is the owner and President of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided... Read More →
avatar for Catherine Sigler

Catherine Sigler

Executive Director, Safety, Epidemiology, Registries, and Risk Management (SERRM, UBC, An Express Scripts Company
Dr. Catherine Sigler is a Senior Epidemiologist and Executive Director in United BioSource Corporation (subsidiary of Express Scripts Inc.) department: Surveillance, Epidemiology, Registries and Risk Management (SERRM). She provides technical expertise in pharmaceutical safety issues... Read More →
avatar for Annette Stemhagen

Annette Stemhagen

SVP & Chief Scientific Officer, UBC
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management within... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
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
 
Tuesday, June 28
 

10:30am

#226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Limited Capacity seats available

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

As pharmaceutical companies seek ways to centralize and better coordinate with affiliates, some pharmacovigilance activities, such as interfacing with health care professional and patients, must be managed locally. Dealing with these activities across multiple countries can be extremely complicated, and companies must find ways to simplify and improve their processes. In this forum, we will explore the Pharmacovigilance (PV) Affiliate Network from both corporate and local perspectives and review case studies of issues faced by companies of all sizes, from start-up to multi-national. In addition, we will present an approach to clarifying the current affiliate situation using an affiliate’s survey tool as well as available in-house data sources. We will also demonstrate a risk-assessment approach that can be applied to generate a clear view of systemic risk (exposure across all or many affiliates) and unique risks (exposure specific to one particular or a few local affiliates). Finally we will highlight methods to streamline PV affiliate processes and the benefits this approach provides to the enterprise. A panel discussion following the presentations offers attendees the opportunity to ask questions and to discuss ideas about global PV affiliate management with the speakers.

Learning Objectives

Assess similarities and differences between regions including recognizing peculiarities in present day international pharmacovigilance scenarios; Describe a methodology for identifying and assessing systemic and unique risks across the affiliate network; Identify the potential benefits from implementation of an affiliate risk-reduction and simplification exercise on portfolio management; Evaluate the company needs and formulate high-impact solutions to minimize risk and improve processes.

Chair

Hershell William Thompson

Speaker

Managing a PV Affiliates Network: The Challenges and Considerations in Maintaining Oversight and In-Country Connections
Lesia Tontisakis, BSN

A Global Conundrum: Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Marco Anelli



Chair
avatar for Hershell Thompson

Hershell Thompson

Managing Consultant, Navitas Life Sciences, Inc.
Hershell is a Managing Consultant with Navitas Life Sciences and has with over 25 years of medicines development and change management experience. He has extensive operational experience in phase I-IV clinical trials, health outcomes, pharmacovigilance and medical devices. He was... Read More →

Speakers
avatar for Marco Anelli

Marco Anelli

Head of Pharmacovigilance and Medical Affairs Advisory Services, Productlife Group
Marco Anelli is Head of Pharmacovigilance and Medical Affairs Advisory Services at ProductLife Group . In the past 25 years he has worked in Phase I-IV and PV. In addition, Marco is also QPPV and has prepared and signed over 200 non-clinical and clinical overviews and summaries... Read More →
avatar for Lesia Tontisakis

Lesia Tontisakis

Director, Pharmacovigilance, Global Patient Safety and Epidemiology, Allergan
Lesia Tontisakis joined Allergan in 2011 leading key Safety Operations functions ensuring global quality & compliance targets are met. Key responsibilities include QMS oversight, compliance, Inspection Readiness, PVA Management, Training and Vendor Oversight (ICSR management and Affiliate... Read More →


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

2:00pm

#248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

Effective benefit-risk communication is central to ensuring safe and appropriate use of medicinal drug products. Additionally, regulatory authorities across the globe are now demanding evidence of the effectiveness of risk communication measures included as part of formal risk management programs. Currently, however, the design, dissemination and application of best practices in benefit-risk communication have been limited. This forum seeks to highlight the main gaps in the design, implementation, and evaluation of benefit-risk communication for medicinal products, to identify best practices in those areas, and to explore ways to reduce those gaps moving forward.

Learning Objectives

Identify the main facilitators and barriers in the design of current benefit-risk communications; Describe the key gaps in the translation and implementation of benefit-risk communication best practices into real-world practices (e.g., at the community level, and across cultures, health care systems and regulatory authority jurisdictions); Discuss the major gaps in the evaluation of risk communication, and how these gaps can be effectively addressed.

Chair

Meredith Y. Smith

Speaker

Communicating Risk Information to Patients: Gaps in Current Approaches and How Health Literacy and Information Orientation Measures Can Improve Effectiveness
Kristina Birnbrauer, PhD

Gaps and Best Practices in Designing Risk Minimization Communication Campaigns
Elaine H Morrato, DrPH, MPH

Evaluating Effectiveness of Benefit-Risk Communication
Gerald J. Dal Pan, MD



Chair
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

Speakers
avatar for Kristina Birnbrauer

Kristina Birnbrauer

Sr. Research Consultant, MSP Analytics
Kristina Birnbrauer is a health communication and research professional with expertise in patient and healthcare provider education and health behavior interventions. Kristina found her niche after a life-threatening mosquito borne virus in 2010. She is experienced in study and survey... Read More →
avatar for Elaine Morrato

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health
Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
113C 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

#372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes
Limited Capacity seats available

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

On July 1, 2015, the European Medicines Agency initiated the monitoring of medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances and entering the relevant information into the EudraVigilance database. One of the key objectives of this initiative is to prevent duplication of cases reported by multiple marketing authorization holders (MAHs) for the same active substance through worldwide literature searches. Other intended benefits are to enhance the efficiency of adverse reactions reporting, improve data quality, contribute to resource savings, simplify processes, and support signal detection activities. This session will discuss the need for MAHs to assess the impact of this initiative on their existing process of literature safety report identification, case processing, and expedited reporting.

Learning Objectives

Identify the salient features of the European Medicine Agency's (EMA) medical literature monitoring (MLM) service; Assess the impact on existing global literature search, case processing, and expedited reporting; Identify measures required to align existing pharmacovigilance processes consequent to the implementation of EMA’s MLM service.

Chair

Vineet Kacker, PhD

Speaker

EMA Medical Literature Monitoring Service: Impact on EU Pharmacovigilance
Vineet Kacker, PhD

Authority-Based Medical Literature Monitoring in the EU: Impact on US and Global Pharmacovigilance
Leonardo Ebeling



Chair
avatar for Vineet Kacker

Vineet Kacker

Managing Director and Co-founder, APCER Life Sciences
Dr. Vineet Kacker is a Pharmacologist having completed his PH.D in 1997 from All India Institute of Medical Sciences in India. After more than 15 years in Academia, he switched his interests to Pharmaceutical Industry in 2000 and since then he has worked in Regulatory and Pharmacovigilance... Read More →

Speakers
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 →


Wednesday June 29, 2016 4:00pm - 5:00pm
113C 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