MONDAY, 15 SEPTEMBER
Navigating Japanese and the Chinese Regulations With a Combination Drug-Device Product
Professional Levels: lll, IV
11:00 am - 12:00 pm | Room 309
Regulations for combination products in Japan and China are complex and evolving. It is essential to have a clear understanding of regulations and requirements in those countries for a successful combination product application.
Experts from the region will introduce you to the current regulatory processes and basic requirements for combination product registration in Japan and China. You will learn about challenges, strategies to deal with these requirements and clinical data management, thereby allowing you and your organization to shorten the approval timeline. Also, hear first-hand one company’s experience and lessons learned with successfully commercializing a combination product in Japan and China.
Session Leader:
Karen Juo-Lai Chu, PharmD, executive director, international clinical operations, Parexel Apex International Co.
Speakers: Karen Juo-Lai Chu, PharmD, executive director, international clinical operations, Parexel Apex International Co.
Chie Iwaishi, director, regulatory affairs, Cordis Corporation
Advertising and Promotion Requirements for Combination Products
Professional Levels: ll, lll, IV
1:30 - 3:00 pm | Room 309
The US regulation of combination products involves the convergence of sometimes widely-varying Food and Drug Administration requirements. Understanding the application and interplay of these requirements can be challenging in the absence of formal agency rules or guidance.
In this session, you will learn how to apply drug, device and biological product advertising and promotional requirements to combination products, including direct-to-consumer and television advertising. Speakers will discuss current trends, describe recent enforcement activities and discuss the implications in the regulatory environment.
Session Leader:
Bradley Merrill Thompson, JD, RAC, attorney, Epstein Becker & Green PC
Speakers:
Anna Longwell, JD, principal, food and drug law, Longwell and Associates
Bradley Merrill Thompson, JD, RAC, attorney, Epstein Becker & Green PC
TUESDAY, 16 SEPTEMBER
Drug-Device Combination Products: A Regulatory Perspective
Professional Levels: lll, IV
11:00 am - 12:00 pm | Room 302
In this session, you will be immersed in discussions about recent regulatory trends regarding product jurisdiction, marketing pathways, nonclinical studies, technical testing requirements and clinical trial design for certain combination products. You will gain the knowledge necessary to more effectively get your product to market and position it for sustained success.
Session Leader:
Alina Caraballo, regulatory manager, Cordis Corporation
Speakers:
Alina Caraballo, regulatory manager, Cordis Corporation
Jennifer Paine, director, regulatory affairs, Ethicon Inc.
Joyce Frey-Vasconcells, executive director, cells tissues and gene therapy, Pharmanet Development Group Inc.
Combination Products: Regulatory Challenges and Latest FDA Initiatives
Professional Levels: lll, IV
1:30 - 3:00 pm | Room 309
Combination products, such as drug-device, drug-biologic or device-biologic products, present unique challenges for even experienced regulatory professionals.
In this session, you will explore the legal, regulatory and practical challenges for premarket review, postmarket regulation and cross-labeling of combination products. You will hear directly from FDA representatives and take away strategies for successfully navigating this innovative area of medical product regulation.
Session Leader:
Mark D. Kramer, RAC, vice president, regulatory affairs, GE Healthcare
Speakers:
Mark D. Kramer, RAC, vice president, regulatory affairs, GE Healthcare
Thinh X. Nguyen, director, Office of Combination Products, US Food and Drug Administration
Suzanne M. O’Shea, LLM, JD, counsel, Baker & Daniels LLP
Mark J. Raza, associate chief counsel, Office of Chief Counsel, Office of the Commissioner, US Food and Drug Administration
Combination Product Review in EU: Latest Initiatives
Professional Levels: III, IV
3:30 - 5:00 pm | Room 309
EU combination product regulations differ significantly from those in the US and Asia.
Find out what is new from regulatory leaders regarding EU combination product regulations and guidance documents and what to expect in the immediate future. You will take away valuable tips and strategies to help you navigate the diverse and evolving combination product environment.
Session Leader:
Paul C. Brooks, vice president, country manager, BSI PS Healthcare
Speakers:
Paul C. Brooks, vice president, country manager, BSI PS Healthcare
Matthias M. Buerger, director, quality management systems, regulatory affairs, GE Healthcare
WEDNESDAY, 17 SEPTEMBER
Drug-Biologic Combination Products: A Regulatory Perspective
Professional Levels: I, ll, lll,
8:30 - 10:00 am | Room 311
Most combination products have traditionally involved a medical device combined with either a drug (e.g., drug delivery systems, drug-eluting stents, etc.) or a biologic (e.g., morphogenic proteins or growth factors). In recent years, the development of drug-biologic combination products has been on the rise.
In this session, you will hear about the evaluation, testing and regulatory challenges presented by these types of combination products in which both components are biologically active. This valuable insight will better prepare you to address the many challenges facing you and your organization.
Session Leader:
Mason W. Diamond, DDS, vice president, regulatory affairs, Isolagen Inc.
Speakers:
Peter F. Bross, MD, oncology team leader, Division of Clinical Evaluation, Center for Biologics Evaluation and Research, US Food and Drug Administration
Mason W. Diamond, DDS, vice president, regulatory affairs, Isolagen Inc.
GMP and Adverse Event Reporting
Professional Levels: I, ll, lll,
10:30 am - 12:00 pm | Room 309
It is widely acknowledged that combination products have special Good Manufacturing Practice and adverse event reporting requirements. Notices for Proposed Rulemaking on each of these topics are expected to provide clarity to the industry on how to deal with these requirements.
In this roundtable discussion, you will hear insights from industry leaders about the proposed rules and their expected impact on the regulatory profession. You will take away practical tips and strategies for how to effectively approach these issues.
Session Leader:
Mason W. Diamond, DDS, vice president, regulatory affairs, Isolagen Inc.
Speakers:
Linda S. Alexander, CEO/founder, Alquest Inc.
Mason W. Diamond, DDS, vice president, regulatory affairs, Isolagen Inc.
Thomas R. Hutchinson, vice president, quality assurance, Davol Inc.