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Nov 5 2013 7:00AM - Nov 5 2013 5:15PM | Embassy Suites Old Town Alexandria
1900 Diagonal Road,
Alexandria, VA 22314
Travel Once, Learn Twice and Save up to 35%Register for both the DIA Meeting on Combination Products and the DIA Meeting on Personalized Medicines and Companion Diagnostics – and Save up to 35%.**You must register for both events at the same time. Price savings varies by registration fees
Advances in scientific knowledge and technology are driving growth and innovation for combination products and companion diagnostics, thereby enabling personalized therapies that:
This conference will provide a practical approach to development processes and regulations in these evolving landscapes. This one-day meeting will focus on combination products. DIA is hosting a related one-day meeting on personalized medicines and their companion diagnostics, November 6: DIA Meeting on Personalized Medicines and Companion Diagnostics
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they raise challenging policy, regulatory, and review management challenges. Differences in pathways ordinarily associated with each component can raise questions for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
This day will focus on:
Pharmaceutical, academic and government senior-level professionals and decision-makers involved in:
At the conclusion of this meeting, participants should be able to:
Travel Once, Learn Twice and Save up to 35%
The meeting will be held at the Embassy Suites Alexandria Old Town. A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 15, 2013, or until room block is filled). Please note: In order to receive the reduce room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners is as follows: Attendees can follow this link or call+1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #13021.
Standard Room Rate $189Rate includeds the following for all rooms booked using link or phone number noted above:
Hotel Address: 1900 Diagonal Road Alexandria, VA 22314
The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible.
Registration QuestionsToll Free 1.888.257.6457Phone +1.215.6100Fax +1.215.442.6199Monday-Friday 8:30AM - 8:00PM ETCustomerService@diahome.org
Agenda DetailsMelissa Buchanan, Content LeadPhone +1.215.442.6158Fax +1.215.442.6199Melissa.Buchanan@diahome.org
Event LogisticsBenjamin Zaitz, Event PlannerPhone +1.215.293.5803Fax +1.215.442.6199Benjamin.Zaitz@diahome.org
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; (703) 506-3275.As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .7 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.DIA’s Certificate Program This program is part of DIA’s Certificate Program and is awarded the following:• Clinical Research Certificate Program: 4 Elective Units • Regulatory Affairs Certificate Program: 4 Elective Units For more information go to www.diahome.org/certificateprograms
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
All participants must sign-in to record attendance at the program to receive a statement of credit. If attendance is not recorded, a participant will not be eligible to receive credit. No partial credit will be awarded. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Tuesday, November 19, 2013.To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE
Senior Manager, Human Factors EngineeringAmgen, United States
Senior Director, Regulatory AffairsProteus Digital Health, Inc., United States
Worldwide Vice President of Quality, Regulatory and ComplianceOrtho Clinical Diagnostic - Part of the Johnson & Johnson Family of Companies, United States
Director/Corporate Regulatory/Women's Health and CancerBecton Dickinson, United States
Vice President, Regulatory Affairs, OncologyGlaxosmithkline, United States
Senior Director, Regulatory AffairsGenentech, A Member of the Roche Group, United States
Director, Regulatory AffairsNovartis Pharmaceuticals Corporation, United States
PartnerEpstein, Becker and Green P.C., United States
Associate Director for Policy and Product Classification Officer, OCPFDA, United States
Combination Products State of the Union
Combination products increasingly incorporate both new technologies and novel marriages of drugs, biologicals, and medical devices. These products hold great promise, but bringing them to patients can challenge industry and regulators as they try to answer important questions about product safety and effectiveness. Nowhere is this more apparent than with combinations of drugs and biologicals with new delivery systems. This session will explore the challenges in developing combination products with a focus on drug/biological delivery systems, preclinical and clinical combination product data requirements, and human factor testing. FDA thought leaders will provide Agency perspectives, and industry experts will discuss their experiences in navigating these issues.
FDA issued the Current Good Manufacturing Practice (CGMP) Requirements for combination products to promote clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for organizations to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products. In this session, FDA will outline the final rule, discussing the requirement and expectations. Much of the session will be designed to provide an opportunity for audience participants to interact directly with CDER, CDRH, CBER and OCP.
As the market for global drug device combination products is expected to reach $30 billion by 2014, understanding international access challenges and regulatory changes is essential. In particular, changes to the Medical Device Directive in the EU will impact combination product oversight, and globally there are differences in how combination products are viewed by regulators. This session will provide overviews and insight into regulatory requirements and expectations of global markets.
FDA has predicted that it will come out with a final guidance on mobile medical apps by October 1. This session will explore that final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. To make the session more dynamic, we will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then we will ask the audience, using an electronic polling system, to vote to put the technology at issue into one of the following four categories: a.) Unregulated mobile app; b.) FDA regulated drug labeling; c.) FDA regulated medical device; or d.) FDA regulated medical device constituent part of a combination product. After seeing the audience poll, the panel will discuss whether they agree with the audience’s assessment.
Printable Registration Form
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.
Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.