FDA Centers
FDA Los Angeles District Office
And
Orange County Regulatory Affairs
Discussion Group
Present
The 14th Annual
FDA-OCRA Educational Conference
New Regulatory Challenges
June 8-9, 2011
A 2-Day Conference for Regulatory, Quality and Technical
Professionals inMedical Device, Drug, Biologics, Over the Counter, Generics and Dietary Supplements Regulated Companies.
Online Registration (Please Log On First):
Location:
Irvine Marriott
18000 Von Karman Avenue, Irvine, CA 92612
(949) 553-0100
Conference Chairs:
Alonza E. Cruse, B.S., District Director
U.S. Food & Drug Administration, Los Angeles District
Jocelyn Humphrey, Manager RA CMC, Gilead Sciences
The 14th Annual
FDA-OCRA Educational Conference
New Regulatory Challenges
June 8-9, 2011
The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA affording you maximum interaction with both Los Angeles District and Washington-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have brought FDA and Industry staff together for this Educational Conference.
Who Should Attend
• Regulatory Affairs/Compliance • Clinical Affairs/Auditors
• Legal • Quality Affairs/Quality Control
• Marketing & Advertising • Product Development
• Consultants & Analysts• Operations & Management
Why Should You Attend
Keynote Presentation by Dr. Margaret Hamburg, FDA Commissioner
Plenary topics:
- Enforcement, Inspections, Top 483s and Warning Letters
- Understanding FDA’s Product Safety and Risk Tolerance in the Pre-Approval/Approval Process
- Integrating Risk Management Throughout Product Life Cycle
- Challenges of Imports and Exports
- Global Clinical Trial Operations, Foreign Clinical Trials and Data for U.S. Applications
- Q&A Panel Sessions with all Speakers
Three Separate Breakout Sessions:
- Medical Devices & IVDs: Changes in 510(k) Review Process;Understanding how to Comply with
the Amendments to the EU Medical Device Directive Clinical Evaluations and Technical Files;
and Preparing, Performing and Managing Usability Reports
- Drugs/Biologics/OTC/Generics: Evaluating Safety Data Using Meta-Analysis;
FDA Expectations for CMC Data; and Biosimilars
- Dietary Supplements: FDA Update;Lessons from the Field; Quality Assurance Under the FDA
GMPs;,and Issues and Best Practices in Quality Assurance and GMP Compliance
Network with your colleagues in the industry and government
SCHEDULE
Wednesday, June 8, 2011
7:00 – 8:00 amRegistration and Continental Breakfast
8:00 -8:30 amOpening Remarks
Jocelyn Humphrey, Manager, RA CMC, Gilead Sciences
Alonza E. Cruse, BS, District Director, U.S. Food & Drug Administration, Los Angeles District
8:30 – 9:30 am
Keynote Address
Speakers:
Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration(via pre-recorded video)
Mary K. Lee, Office of Pharmaceutical Sciences/Office of Biotechnology Products
Division of Therapeutic Proteins, CDER, U.S. Food and Drug Administration
Synopsis:
Dr. Hamburgappears in a prepared video presentation for the conference. Attendees will not have the chance to ask questions. Dr. Hamburg’s keynote will be followed up by a second keynote presentation from Mary K. Lee from the Division of Therapeutic Proteins at the FDA.
9:30 – 9:45 amBREAK
9:45 – 11:15 am
Enforcement, Inspections, Top 483s and Warning Letters
Speakers:
Steve Silverman, Director, CDRH Office of Compliance, U.S. Food & Drug Administration
(via live video conference)
Jeff Yuen, President and CEO, Jeff Yuen & Associates (Former FDA Consumer Safety Officer/Investigator)
Synopsis:
In August 2009, FDA Commissioner Hamburg initiated a revived commitment by the Agency to enhance enforcement. This session will review the Agency’s performance towards this commitment with emphasis on enforcement efforts in the pharmaceutical and medical device arena as well as FDA’s techniques and methods for achieving compliance.
11:15 am – 12:30 pm
Understanding FDA’s Product Safety and Risk Tolerance in the Pre-Approval and Approval Process
Speakers:
Ann Ferriter, Senior Policy Analyst, CDRH, U.S. Food & Drug Administration
Daniel Schultz, Sr. Vice President, Medical Devices and Combination Products, Greenleaf Health, LLC
(former Director CDRH, FDA)
Synopsis:
FDA has heightened its attention on product safety through their strategic planning. The speakers will present FDA’s current and future activities for improving product safety with risk tolerance, while addressing the benefits of patient care. This session will provide attendees with much neededcurrent information regarding product safety.
12:30 – 1:30 pm
NETWORKING LUNCH
1:30 – 3:00 pm
Integrating Risk Management Throughout Product Life Cycle – Post-Market
Speakers:
Ann Ferriter, Senior Policy Analyst, Division of Risk Management Operations, CDRH, U.S. Food & Drug Administration
Mary K. Lee, Office of Pharmaceutical Sciences/Office of Biotechnology Products, Division of Therapeutic Proteins, CDER, U.S. Food and Drug Administration
Synopsis:
Integrating risk management throughout the product life cycle of medical products presents unique challenges. Many decisions made during the design and development phase bear on the safety and effectiveness of the device. FDA has an interest in reviewing such design decisions and how those decisions are documented. Many pre-market submissions include a risk management report and the other related documents to demonstrate that the results of risk management activities were incorporated into the device design. However, risk management should not end once the pre-market submission is approved or cleared. Many post-market product compliance and quality issues are directly related to how well a manufacturer integrates risk management throughout the product life cycle. This session will review how a manufacturer should incorporate risk management through the post-market life cycle phase of their product and will attempt to answer the following questions:
-Which standards and guidance documents should be followed?
-How do you choose the right risk management process for your product and company?
-How do differences in risk perception impact post-market clinical study requirements, labeling, and marketing strategies for medical products throughout the product life cycle?
-How do risk management approaches vary amongst medical devices, in vitro diagnostics, pharmaceuticals, biologics, and combination products?
-What differences are there in the risk management approach for a product in the pre-market phase versus the post-market phase?
3:00 – 3:15 pm
BREAK
3:15 – 4:30 pm
Challenges of Imports and Exports
Speakers:
Domenic J. Veneziano, Director Division of Import Operations and Policy, U.S. Food & Drug Administration
Dan Solis, Director, Imports,U.S. Food & Drug Administration, Los Angeles District
Synopsis:
Regulatory requirements to ensure smooth product flow is not only dependent on proper product registrations. Import and export requirements to ensure the timely delivery of raw materials to our manufacturing sites and the smooth delivery of products to our customers is a critical logistical challenge. Within this stream of products, there are a myriad of details that can easily cause interruptions to the supply chain. This session will be geared towards learning what FDA is doing to help maintain a constant and predictable flow of products while ensuring product safety.
4:30 – 5:15 pm
End of Day Panel Session
Synopsis:
The speakers who presented on this first day will convene and discuss issues and answer questions related to presentations on this day.
5:15 – 8:00 pm
After Conference Reception
OCRA Member Appreciation Night
All Attendees invited at no additional cost
SCHEDULE
Thursday, June 9, 2011
8:00 – 9:00 am
Breakfast Session: High Level FDA Speaker Requested
NOTE: Dietary Supplement Breakouts Begin at 9:00 am
9:00 – 10:15 am
Global Clinical Trial Operations, Foreign Clinical Trials and Data for U.S. Applications
Speakers:
Dr. Cara Krulewitch, Branch Chief, Office of Surveillance and Biometrics, CDRH, U.S. Food & Drug Administration
Kathleen A. Marshall, President, MAXIS, LLC
Synopsis:
Planning ahead for global clinical studies becomes increasingly important for small or large companies. This session will provide a good understanding of how outside U.S. clinical data can be used in support of foreign product registrations, and U.S. applications including IDEs, PMAs, and NDAs.In addition, speakers will present on post-approval studies with an emphasis on FDA's goals, expectations and requirements for post-approval studies.
10:15 – 10:30 am BREAK
Breakout Sessions Follow for the Rest of the Day
Please see the following pages for individual breakout sessions.
Noon – 1:00 pm LUNCH
4:00 – 5:00 pmAll Sessions Convene for End of Day Q&A Panel with All Speakers
MEDICAL DEVICE & IVD BREAKOUT SESSIONS
10:30 am - Noon
Session 1: Changes in 510(k) Review Process
Speakers and Panelists:
Heather Rosecrans, Sr. Regulatory Advisor, Greenleaf Health LLC and VP, RA, MDMA (via live video conference)
Daniel Schultz, Sr. Vice President, Medical Devices and Combination Products, Greenleaf Health, LLC
(former Director CDRH, FDA)
Synopsis:
Significant changes to the 510(k) submissionprocess are on the horizon. Industry needs to understand what the changes are and the rationale for these changes. The common goal is for submissions to get cleared the first time.
Noon – 1:00 pm LUNCH
1:00 – 2:15 pm
Session 2: Understanding how to Comply with the Amendments to the EU Medical Device Directive Clinical Evaluations and Technical Files
Speaker:
Mindy McCann, Healthcare Director, SGS Notified Body
Synopsis:
The European Union‘s Medical Device Directive has been amended. These changes affect the essential requirements. Our expert speaker will explain the significant changes and provide guidance on how to comply with these changes, including the requirements for conducting clinical evaluations.
2:15 – 2:30 pm BREAK
2:30 – 4:00 pm
Session 3: Preparing, Performing and Managing Usability Reports
Speakers:
Daniel Schultz, Sr. Vice President, Medical Devices and Combination Products, Greenleaf Health, LLC
(former Director CDRH, FDA)
Robert North, PhD, Chief Scientist, Human Centered Strategies
Synopsis:
The session will cover both U.S. and EU Requirements. The most recent version of the Medical Device Directive (M5) includes the requirement to address Use Errors. As well, FDA is concerned with Use Errors. There are several hundred deaths per day attributable to Use Errors, and this topic is important to the FDA.
(From 93/42/EEC (M5 dated 21.9.2007) Annex I, Essential Requirements, General Requirements, Paragraph 1:
This shallinclude:
-reducing, asfar as possible, the risk of use error due to the ergonomic features of thedevice and the environment in which the device is intended tobe used (designfor patient safety), and
-consideration of the technical knowledge,experience, education and training and where applicable the medical andphysical conditions of intended users (designfor lay, professional, disabledor other users)."
This session will provide the attendee with a better understanding of what the expectations are for address “Use Errors” by the FDA and the Notified Body and reduce the confusion associated with this new requirement.
DRUGS, BIOLOGICS, OTC, GENERICS BREAKOUT SESSIONS
10:30 am - Noon
Session 1: Evaluating Safety Data Using Meta-Analysis
Speaker:
Ingram Olkin, Professor of Statistics and Education, Emeritus, CHP/PCOR Fellow, Stanford University
Synopsis:
Publication of meta-analyses that identify potential safety problems have lead to urgent calls for immediate regulatory action without acknowledgment of potential pitfalls in the interpretation of data.In this session the benefits and challenges of using meta-analysis to support regulatory decisions will be examined.
Noon – 1:00 pm LUNCH
1:00 – 2:30 pm
Session 2: FDA Expectations for CMC Data
Speaker: Nallaperumal Chidambaram,Office of New Drug Quality Assessment, Post Marketing CMC Lead, U.S. Food & Drug Administration
Synopsis:
Part 1: This session will cover FDA CMC expectations in INDs, NDAs, and postmarketing, and will review recent CMC guidances.
Speaker: Mike Havert, PhD, Biologist, Office of Cellular, Tissue and Gene Therapies, CBER, U.S. Food & Drug Administration
Part 2: This session will cover FDA expectations regarding master files and provide useful information for both master file holders and sponsors who cross-reference them.
2:30 – 2:45 pm BREAK
2:45 – 4:00 pm
Session 3: Biosimilars
Speakers:
Michael Swit, Esq., Vice President, The Weinberg Group Inc.
Robert Church, Partner, Hogan Lovells US LLP
Louis C. Cullman, Partner, K&L Gates
Synopsis:
This year we saw the enactment of the Biologics Price Competition & Innovation Act, giving FDA clear authority to approve biosimilar versions of innovative biologics. In this session,our expert speakers will help you understand how the new U.S. regulatory pathway will likely work, and the challenges facing companies developing and marketing biosimilars,as well as innovative firms that will seek to maintain market share in the face of a new era of competition.
DIETARY SUPPLEMENTS BREAKOUT SESSIONS
9:00 – 10:15 amSession 1: FDA Update
Speakers:
Alonza E. Cruse, BS, District Director, U.S. Food & Drug Administration, Los Angeles District
Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and
Dietary Supplements, Center for Food Safety and Applied Nutrition, U.S. Food & Drug Administration
Synopsis:
The speakers will discuss current FDA activities related to the dietary supplement industry including current Agency priorities, recent industry related activities and enforcement actions related to product and ingredient contamination.
10:15 – 10:30 am BREAK
10:30 am – NoonSession 2: Lessons from the Field
Speakers:
Bradford Williams, Manager, Dietary Supplement Programs, Center for Food Safety and Applied Nutrition
U.S. Food & Drug Administration
Industry Speaker Invited
Synopsis:
The FDA GMPs for dietary supplements have been in force for close to four years and FDA has conducted over 100 GMP inspections. During this session we will hear from FDA on their current inspection priorities and get feedback from GMP inspections. The industry speaker will discuss how to handle visits from the FDA and will discuss appropriate follow-up to 483s and strategies to avoid potential warning letters and other enforcement action.
Noon – 1:00 pm LUNCH
1:00 – 2:30 pmSession 3: Quality Assurance Under the FDA GMPs
Speakers:
Carl Reynolds, Contractor to FDA, DSP, Office of Nutrition, Labeling and Dietary Supplements
U.S. Food & Drug Administration
Cindy Beehner, President, QSD Consulting
Synopsis:
This session will feature a FDA presentation on quality assurance /quality control responsibilities under the GMP rule and an industry presentation on the challenges associated with QA/QC and laboratory GMP compliance. The discussion will cover topics such as developing and using valid scientific methods, verifying specifications,contaminant testing, qualifying COAs and discussion of the various initiatives related to these issues.
2:30 – 2:45 pm BREAK
2:45 – 4:00 pmSession 4: Issues & Best Practices in Quality Assurance/GMP Compliance
Industry Panel
Synopsis:
This session will feature an interactive panel discussion of current industry issues and best practices related to quality assurance and GMP operations. There will be a discussion among the panelists, followed by an open discussion to include Q&A from the audience.
REGISTRATION INSTRUCTIONS
The 14th Annual FDA-OCRA Educational Conference
June 8-9, 2011
Online Registration (Be Sure To Log On First):
Follow the steps below to register online.
Use the Online system to receive an immediate receipt and immediate confirmation.
Register Online
Log On to the OCRA website:
Once logged on, select “Register for a Meeting”. Select the applicable payment button, which will take you to Authorize.net, a secure website to process your card.
When your payment has been processed, you will receive an email with the subject "Order Confirmation". This email is also sent to OCRA, so we know that your payment has been processed.
Payment can also be made via PayPal, and company or personal checks can also be mailed.
To Register With Company or Personal Check:
Please complete the online registration form, then mail checks made payable to OCRA to the address below:
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461 or 949-387-9047
Email:
OCRA's non-profit Federal Tax ID# 33-0630455
If paying by check, please mail your check at least one week prior to ensure that it is received in time.
Register via Fax or Mail
Please use the registration form on the following pages.
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OCRA REGISTRATION FORM
PAGE 1 of 3 (please supply all 3 pages)
The 14th Annual FDA-OCRA Educational Conference
June 8-9, 2011
Please register online for an immediate receipt and confirmation:
This document can also be used as a registration form.
Fax This Registration Form With Credit Card Information To: (949) 266-8461 or (949) 387-9047
NAME of REGISTRANT: ______
Submit one copy for each person attending. Registration Fee includes the following: Access to speaker presentations to download prior to the conference, CD with speaker presentations after the conference, breakfast, lunch, breaks and parking.
Please check type of card:
______VISA ______MASTERCARD ______AMERICAN EXPRESS
Card #:______Expiration Date:______
Name on Card:______Signature:______
Name badges and receipts will be provided at the on-site registration desk. If you would like a receipt prior to the event, please use the On-Line or Pay Pal payment option. Submit one copy for each person attending.
REGISTRATION RATE
______$ 725 – OCRA Members
______$ 775 - Non-members (includes 2011 OCRA membership)
______$ 475 – FDA/Government/Students*
*OCRA Student Rate applies to those individuals enrolled in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment required.
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OCRA REGISTRATION FORM
PAGE 2 of 3 (please supply all 3 pages)
The 14th Annual FDA-OCRA Educational Conference
June 8-9, 2011
Please register online for an immediate receipt and confirmation:
To Register With Company or Personal Check:
Please complete the registration form and fax it to (949) 266-8461 or (949) 387-9047.If you are paying by check less than one week prior to the conference, please bring the check with you. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received. Make your check payable to: “OCRA” 5319 University Dr., Suite 641, Irvine, CA 92612. Phone: (949) 387-9046. OCRA’s non-profit Federal Tax ID# 33-06304553.