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Trk 14: Clin Safety-PV [clear filter]
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
 

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