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Trk 09: Med Devices/InVitro/CombProd [clear filter]
Monday, June 27
 

10:45am

#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-561-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this session, basic information on regulations of software as a medical device will be provided. Also, the expectation of mobile health devices in terms of quality of life and medical economy and challenges to develop such devices will be discussed.

Learning Objectives

Explain the regulations on software as a medical device including topics discussed in the International Medical Device Regulators Forum Standalone Medical Device Software Harmonization Working Group for the utilization of mobile health for enhancement of quality of life; Discuss the potential of mobile health in terms of reducing medical costs.

Chair

Madoka Murakami, PhD

Speaker

Academic Perspective
Hiroshi Hosoi

Industry Perspective
Nersi Nazari, PhD

FDA Perspective
Bakul Patel



Chair
MM

Madoka Murakami

Unit Chief, Division of Regulatory Cooperation, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)

Speakers
avatar for Hiroshi Hosoi

Hiroshi Hosoi

President, Nara Medical University
Hiroshi Hosoi, M.D., Ph.D. is a president of Nara Medical University in Japan. He is a doctor who specializes in Otorhinolaryngology. In 2004, he found a new sound conduction pathway “cartilage conduction,” which is different from the two previously known sound conduction pathways... Read More →
avatar for Nersi Nazari

Nersi Nazari

Chairman and Chief Executive Officer, Vital Connect, Inc.
Nersi is Chairman & CEO of VitalConnect, a medical device and healthcare solutions company applying advanced biosensor technology and surrounding data management systems to deliver an innovative platform that enables clinical-grade continuous monitoring of vital signs. He is a veteran... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Division, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →


Monday June 27, 2016 10:45am - 12:00pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

2:00pm

#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-556-L04-P; CME 1.25; IACET 1.25; RN 1.25

Digital technology is being integrated with drugs, biologics, and devices in an effort to improve treatment monitoring and management. This session will examine regulatory challenges of these combinations from the perspective of industry and FDA.

Learning Objectives

Recognize FDA requirements for approval of combination products involving digital technology; Identify challenges faced by industry in developing these products and by FDA during their review; Describe how industry and FDA are addressing these challenges.

Chair

Todd Paporello

Speaker

Determining the Regulatory Classification of Software Used in Tandem with Pharmaceuticals
Bradley Merrill Thompson

Tool to Product: An Interactive Case Study in the Evolution of a Pharma App from Clinic to Commercial
Anthony D. Watson, MBA, MS

CDRH Perspective
Bakul Patel

Office of Combination Products Perspective
John Barlow Weiner, JD

CDER Perspective
Ashley Boam



Chair
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →

Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Division, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
avatar for Bradley Thompson

Bradley Thompson

General Counsel, Combination Products Coalition, Epstein, Becker and Green P.C.
BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Mr. Thompson also advises such companies on the... Read More →
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA