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Trk 10: Pub Pol/HealthCare Compl/Law [clear filter]
Monday, June 27
 

10:45am

#136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates
Limited Capacity seats available

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

This forum will involve a panel and analyze the ClinicalTrials.gov Final Rule, discuss how companies are navigating the US and EU disclosure/transparency mandates, and discuss data sharing expectations.

Learning Objectives

Identify the requirements of the Final Rule expanding the ClinicalTrials.gov database; Describe how industry is navigating US and EU disclosure mandates; Discuss how companies are approaching data sharing expectations

Chair

Robert Paarlberg, MS

Speaker

Panelist
Rebecca J. Williams

Panelist
Marla Jo Brickman, PhD



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →

Speakers
avatar for Marla Jo Brickman

Marla Jo Brickman

Senior Director/Team Leader, Clinical Trial Disclosure Group, Pfizer Inc
Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of... Read More →
avatar for Rebecca Williams

Rebecca Williams

Acting Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory... Read More →


Monday June 27, 2016 10:45am - 12:00pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

2:00pm

#243: Patient Involvement Today and Tomorrow: What’s in It for Patients?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-563-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patient engagement (PE) is the latest catch phrase in health care. But how can stakeholders apply it in a meaningful way? This forum will draw a picture of the PE landscape and trends and articulate a path forward to high value patient outcomes.

Learning Objectives

Identify the current patient engagement landscape by providing an overview of initiatives underway that are focused on meaningful patient involvement; Discuss general trends in patient engagement with respect to patient involvement through the research to care continuum, highlighting predictions for how this may impact future efforts; Examine the current and future impact of patient engagement efforts on patients’ life goals, quality of life, and desired clinical outcomes.

Chair

Marc M. Boutin, JD

Speaker

Panelist
Lode Dewulf

Panelist
Anton Hoos

Panelist
Graeme Johnston, CPA

Panelist
Isabelle Moulon, MD

Panelist
Theresa M. Mullin, PhD

Panelist
Bettina Ryll



Chair
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →

Speakers
avatar for Lode Dewulf

Lode Dewulf

Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments... Read More →
avatar for Anton Hoos

Anton Hoos

Vice President and Medical Director, Europe, Amgen GmbH
Tony Hoos currently serves as the Chief of Medical for Amgen in Europe, which includes all therapeutic areas as well as all medical departments in Europe. Tony has been passionate about patient involvement in the development and life cycle of medicines for many years. He has worked... Read More →
avatar for Graeme Johnston

Graeme Johnston

Patient and Member of the Advisory Board of PFMD
Graeme (63) is a retired partner of PWC in London, UK. He had cancer in 2001 and was diagnosed with Rheumatoid Arthritis in 2006. He retired in 2009. Since then he has been active in health and patient advocacy initiatives at a local and national level in the UK. When the PFMD initiative... Read More →
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA