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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