MINISTRY OF FOREIGN AFFAIRS OF DENMARK THE EMBASSY OF DENMARK, WASHINGTON, DC FDA Seminar on Combination Products The Embassy of Denmark in Washington, DC is proud to present again in Copenhagen its unique two-day seminar in collaboration with the (FDA) and its Office of Combination Products (OCP) and the Center for Devices and Radiological Health (CDRH). The seminar provides the latest updates and forward-thinking from FDA speakers. Program topics The program has been developed to provide a review/update on such topics as: Role of OCP Classification and assignment Premarket review issues Human factors cgmp for combination products Postmarket adverse events Case studies on regulatory considerations Hot topics Why Attend An opportunity for one-on-one meetings with FDA officials Understand the critical changes to create successful strategies in the US Benchmark your regulatory strategy against agency requirements Network with peers during lunch and refreshment breaks Registration fee 7.500 DKK per person which includes two-day seminar participation, materials, lunches/refreshments, and individual consultations with FDA officials. A certificate of participation will be issued after the seminar. Location Ministry of Foreign Affairs, Eigtveds Pakhus, Asiatisk Plads 2G, Copenhagen, Denmark Information & Registration See enclosed program, speaker biographies, and registration form. Questions? Contact Justin Origen at jusori@um.dk Registration deadline April 12, 2016 Seating is limited, early registration is advised 1
Day 1 Program* Wednesday, April 27, 2016 08:30 09:00 Registration & Light Refreshments 09:00 09:15 Welcome & Introduction 09:15 10:30 Organizational structure of FDA A brief introduction to the way FDA is organized and how the various components relate to one another, focusing on the components (Centers) responsible for human medical products and the Office of the Commissioner. Introduction to OCP The Office of Combination Products plays an important but unusual role. This discussion will provide an overview of the history and functions of the Office of Combination Products, including how OCP came into existence and its chief duties and activities: ensuring the timely, effective pre-market review and consistent, appropriate post market regulation of combination products, and classification of medical products and assignment of them to Centers. It will address how OCP interacts with the Centers and other agency components on product-specific matters and on policy development and implementation. It will provide some general background on combination products, including the different types of combination products, and what is and is not a combination product in the US system. It will also introduce some of the key challenges faced by FDA and industry with respect combination products and the combined use of medical products more broadly. 10:30 11:00 Break & Networking 11:00 12:00 Classification and assignment The boundary lines among product types and standards for determining where in the agency the product will be reviewed can be challenging to understand, and missteps can lead not only to delays but to a lack of a viable pathway to market. This session will focus on the standards for classifying products as drugs, devices, biological products, or combination products, and the procedures available for obtaining a determination. The presentation will address some of the challenging issues that arise and how to avoid surprises and delays 2
Day 1 12:00 13:00 Lunch & Networking 13:00 14:00 Premarket review issues including inter-center consult process Combination products present particular challenges for premarket review because they combine products ordinarily reviewed under different regulatory pathways and within different regulatory programs. This session will address how FDA approaches premarket review for combination products. It will address substantive review issues raised by different types of combination products, and the review process within FDA with a focus on inter-center collaboration and the workings of the inter-center consultation process. It will also speak to ways to engage with the agency for feedback on concepts and to ensure the review process runs smoothly. 14:00 14:30 Break & Networking 14:30 15:30 Human Factors Human factors is the study of interactions between users and technology, it is an engineering discipline with wide-ranging application, and it is a central consideration when assessing medical devices and combination products that include devices. This session will address what human factors are and how they are studied. It will present the recently published final guidance on human factors for devices and draft guidance on human factors for combination products. The session will offer insights regarding issues including design of human factors studies and the timing for them to support clinical study of combination products 15:30 15:45 Adjourn 15:45 17:00 One-on-one sessions with FDA officials (15 min. each) * Program can be subject to changes 3
Day 2 Thursday, April 28, 2016 08:00 08:30 Light Refreshments 08:30 08:45 Recap & Introduction Program* 08:45 9:45 Initiatives relating to innovative products FDA has a variety of pathways and programs designed to enable timely review of innovative products and prompt introduction of safe and effective products to market. This session will address these various pathways and dos and don ts for combination products to take best advantage of them. 09:45 10:00 Break & Networking 10:00 11:15 Current good manufacturing practices for combination products Manufacturing of combination products presents special challenges because combination products incorporate products that raise distinct manufacturing considerations. In response to industry calls for clarity, FDA published a final rule addressing how to reconcile regulatory expectations for the different constituent parts and how they relate to the manufacture of the combination product as a whole. This session will discuss the CGMP requirements for combination products in the US, as codified at 21 CFR, part 4. It will also address the agency s draft companion guidance, feedback FDA has received, and efforts underway with stakeholders to identify creative solutions for challenges combination products present. 11:15 12:00 Postmarket Adverse Events for combo products Ensuring the post-market safety for combination products, as for other medical products, depends importantly on the timely identification and response to adverse events and other issues that can affect product safety. Combination products add the challenge of addressing distinct types of issues particular to devices, drugs, and biological products. This session will discuss FDA s proposed rule on post-market safety reporting for combination products, comments received and best practices while the agency completes its work on the final rule. 4
Day 2 12:00 13:00 Lunch & Networking 13:00 14:15 Case Studies on regulatory considerations for combination products Speakers will lead participants in analysis of case studies regarding classification, development, premarket review, and post-market considerations for combination products. The case studies will be designed to capture and elucidate the conference learnings. The session will afford attendees the opportunity to present their thinking on the questions raised and engage with the presenters on ways to ensure a smooth regulatory premarket path and avoid post-market surprises for their products. 14:15 14:30 Break & Networking 14:30 15:30 Hot Topics There are always a host of issues and activities relating to combination products. This session will address those that are hottest at the moment whether in premarket or post-market, offering insights into what FDA is working on now, and where the agency is planning to head. It will also offer an opportunity for the audience to raise topics and questions not addressed in other sessions. 15:15 15:30 Adjourn ** FDA speakers may be limited by knowledge/expertise in their ability to respond to all questions. 15:30 17:00 One-on-one sessions with FDA officials (15 min. each) * Program can be subject to changes 5
Speakers Thinh Nguyen Director Office of Combination Products Office of the Commissioner Thinh Nguyen has been Director of the Office of Combination Products (OCP) since January 2008. Prior to joining OCP, Mr. Nguyen spent 7 years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. Dr. Patricia Love Deputy Director Office of Combination Products Office of the Commissioner As Deputy Director of the Office of Combination Products since 2003, Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from 1993-2003, Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products John B. Weiner Associate Director for Policy Office of Combination Products Office of the Commissioner John Weiner is the Associate Director for Policy in the Food and Drug Administration s Office of Combination Products (OCP). Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and crosscutting topics including the regulation of products that use nanotechnology. Shannon Hoste Senior Staff Fellow Office of Device Evaluation Center for Devices and Radiological Health Shannon Hoste is a Human Factors Engineer in the Human Factors Pre-Market Evaluation Team of FDA s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), where she reviews Human Factors data for ODE, OIR and pre-market submissions which cross centers. 6
Registration deadline April 12, 2016 Return completed form to Justin Origen at jusori@um.dk FDA Seminar on Combination Products // Registration Form Yes, I want to attend the FDA Seminar on Combination Products on at the Ministry of Foreign Affairs, Eigtveds Pakhus, Asiatisk Plads 2G, Copenhagen, Denmark. DKK 7.500 per person (mark required). The registration fee includes two-day seminar participation, materials, lunches/refreshments, and individual consultation with FDA officials. Registration is considered agreement to pay, unless cancellation received by April 12. Name: Title/Department: Company Name & EAN Number: Address: Your Phone: Your Email: Name/Initials of person to be sent invoice: Their email address: My interest(s) in the seminar are: Consultations I would like to reserve a consultation of 15 minutes with the speakers. Participants from the same company may reserve as group. Please identify the general topic(s) you wish to address (e.g., premarket review, postmarket regulation, classification/assignment) here: My preference for consultation is: Wednesday, April 27 Thursday, April 28 (Consultations will be assigned on a first-come, first-served basis) Signature Date Please only scan the completed registration form and send to Justin Origen at jusori@um.dk by April 12 7