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

10:45am EDT

#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, United States
Robert Paarlberg is 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 worked at Pharmacia (Upjohn) and UCB... 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 EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Forum
 
Tuesday, June 28
 

2:00pm EDT

#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 Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... 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 EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Forum
 
Wednesday, June 29
 

10:30am EDT

#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Limited Capacity seats available
Component Type: Session
Level: Advanced
CE: CME 1.00; IACET 1.00; RN 1.00

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough


Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance and Integrity, HCA Healthcare, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →

Wednesday June 29, 2016 10:30am - 11:30am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session |   Trk 01: Clinical Operations, Session

4:00pm EDT

#366: Infectious Disease Containment and Lessons Learned
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-565-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will bring together industry, health scientists, and regulators to discuss scientific, regulatory, and other issues related to advancing preparedness for Ebola vaccine development based on the previous year’s experience.

Learning Objectives

Identify important scientific lessons learned from the Ebola outbreak of 2014 and the vaccine development process; Identify scientific and regulatory issues to address future Ebola vaccine development.

Chair

Jinjie Hu, PhD

Speaker

How Can We Develop Medicinal Products for Emerging Disease?
Junko Sato

Regulatory Response and Pathways for Licensure of Ebola Virus Vaccines: FDA Perspective
Sara Gagneten, PhD

Ethical Perspective
Walter Straus


Chair
JH

Jinjie Hu

co-chair of FDAAA International Network committee; Senior Consultant, Biologics Consulting Group
Dr. Hu received her Ph.D. in Comparative Pathology from UC, Davis, followed by postdoctoral fellowship at the NIAID, NIH. She worked at FDA for almost 12 years where she is recognized as the IVD expert on FDA regulation and QSR requirement. She chaired many review committees for 510... Read More →

Speakers
avatar for Sara Gagneten

Sara Gagneten

Associate Div Director, Policy, Office of Vaccines Research and Review, CBER, FDA
Dr. Gagneten completed her graduate studies at the Uniformed Services University for the Health Sciences (USUHS) in Maryland and conducted research in virology and genetic recombination before joining the Office of Vaccines Research and Review (OVRR) at CBER, FDA. Currently she is... Read More →
avatar for Junko Sato

Junko Sato

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session