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Trk 11: Quality in CT-GCP [clear filter]
Tuesday, June 28
 

10:30am EDT

#222: Valuing the Clinical Trial Patient
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-566-L01-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly, during clinical research development, decisions are made on how to make trials more patient centric, increase patient engagement, and how/when patients will receive their individual research results. In this session, a patient advocate will share perspectives on each of these elements of research design and execution and a bioethicist will share the bioethical considerations for providing individual clinical trial test results to patients. Finally, participants will also hear about a pharmaceutical company's challenges and lessons learned when they decided to thank their clinical trial patients in a national television advertisement.

Learning Objectives

Recognize an increased awareness of clinical trial patients desired benefits from participating in a research study; Describe bioethical considerations when determining whether to provide clinical trial patients with their individual trial test results; Discuss a sponsor company’s experience with thanking clinical trial patients in a television advertisement.

Chair

Jane Perlmutter

Speaker

Bioethical Considerations with the Return of Individual Research Results and Incidental Findings to Clinical Trial Research Participants
Sandra Prucka, MS

Panelist
Deborah Howe


Chair
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Patient Advocate
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of... Read More →

Speakers
avatar for Deborah Howe

Deborah Howe

Associate Director, Vendor Alliance Lead, Bristol-Myers Squibb
Deborah Howe is an Associate Director in Vendor Alliance Management in Global Clinical Operations at Bristol-Myers Squibb. Deborah joined Bristol-Myers Squibb in 2005 and has held positions of increasing responsibility in the area of clinical trial enrollment and engagement. Deborah... Read More →
avatar for Sandra Prucka

Sandra Prucka

Innovation Lead, Eli Lilly and Company
Before coming to Eli Lilly and Company in 2009 I was a clinical genetic counselor and Director of Genetic Counseling Services at the University of Alabama at Birmingham. I have been in the Tailored Therapeutics group at Lilly for 7 years. During this time I completed an internship... Read More →

Tuesday June 28, 2016 10:30am - 11:30am EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Forum

4:00pm EDT

#269: Making Quality Stick: Building a Complete Quality Culture
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Interactive panel discussions and audience data gathering provides examples of cultural elements to further implementation and sustainment. The audience will leave with ideas to change the mindset from tone at the top to DNA of the broad enterprise. We will discuss the role of culture in quality management systems, how to build a quality culture, and a local non-pharma executive provides perspective on building a quality culture.

Learning Objectives

Discuss examples of successes and challenges in implementing quality management systems including how culture plays a role; Describe methods, tips, and approaches to managing detractors so that you can drive a culture of quality.

Chair

Coleen Glessner, MBA

Speaker

Panelist
Elizabeth Luczak, MBA

Panelist
William Andrew Erhardt, DrMed


Chair
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable... Read More →

Speakers
WE

William Erhardt

Vice President, Global Product Development, Pfizer Inc
Bill is a board certified physician in Pediatrics and Pediatric Infectious Diseases and has completed a Staff Fellowship in Regulatory Sciences at the U.S. FDA. Bill joined Pfizer in 1999. Since joining the company Bill has served as a leader in both Clinical Development and Medical... Read More →
avatar for Elizabeth Luczak

Elizabeth Luczak

Vice President, Regulatory Compliance Quality Assurance, Covance Inc.
Elizabeth is Vice President of Regulatory Compliance/Quality Assurance at Covance (division of LabCorp) where she heads a global group of quality assurance professionals providing quality management strategies across clinical development services. Elizabeth has more than 25 years... Read More →

Tuesday June 28, 2016 4:00pm - 5:00pm EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Forum