Your Local Conference Co-Sponsored by the

FDA Los Angeles District

Learn Regulatory Best Practices in FDA Regulated Industries

from Industry Experts and Regulators

Medical Devices/IVDs

Drugs and Biologics

Dietary Supplements

Clinical Trials

It only happens once a year!

Early Bird Pricing Until March 31st.

We hope to see you in May.

19th Annual

The Emerging Regulatory Landscape

Orange County Regulatory Affairs and FDA Los Angeles District

FDA-OCRA Educational ConferenceMay 5-6, 2016 NEW LOCATION Westin South Coast Plaza

http://www.ocra-dg.org/

REQUESTED SPEAKERS MODERATOR SYNOPSIS (if received)

7:00-8:00 AM Registration and Continental Breakfast

8:00-8:15 AM Opening Remarks

Evelyn De La Vega,Interim Head /Sr. Manager, Regulatory Affairs, Bausch + Lomb

Steven Porter, Acting Director, FDA Los Angeles District

Kimberly Ricks, Manager, Health Science Information, Herbalife

8:15-9:30 AM

1st Keynote Presentation: FDA's 2016 Strategic Plans and Overview of 2015

2nd Keynote Presentation: Industry Speaker Invited

William Maisel, MD, MPH, Deputy Director of Science and Chief CDRH Scientist, FDA (remote presentation)

Industry Speaker Invited

Ray Brullo, DPM, Compliance Officer, FDA Los Angeles District

9:30-9:45 AM Break

9:45-10:45 AM Fast Track Approvals for Drugs and Devices

Michael Swit, Senior Director, Legal and Regulatory, Illumina

FDA Speaker Invited

Trudy Papson, President, Regulatory Consultants Group (former FDA Investigator)

Hear from the FDA and an industry attorney about the Fast Track process.

10:45-11:45 AM

Due Diligence: The Regulatory, Quality, and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies

Speakers InvitedMichael Swit, Senior Director, Legal and Regulatory, Illumina

How to handle the difficult scientific and legal issues underlying the regulatory clinical and quality aspects of due diligence involving biotech products and companies.

Transactions involving FDA-regulated firms or products present unique challenges for professionals less familiar with the intricate regulatory, quality, and clinical considerations generated by the deal. This session will explore how to prepare and execute due diligence efforts , including how to separate the essential from the “nice-to-know” in conducting such reviews often with limited resources and subject to tight time lines. Attendees also will hear about other key issues involved in due diligence and learn how to organize internal teams so as to maximize efforts to help management decide if a deal is “GO!” or “no go.”

11:45 AM-12:30 PM

FDA Compliance Panel Discussion Panelists Invited

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

FDA Speakers will participate in a Compliance Panel discussion. Prior to the conference, OCRA will be reaching out to attendees for questions to the panel.

12:30-1:30 PM Lunch

FIRST DAY - Thursday, May 5, 2016Conference Chair: Kimberly Ricks, Herbalife)

May 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 9262619th Annual FDA-OCRA Educational Conference: The Emerging Regulatory Landscape

Plenary Sessions

1:30-2:30 PMNext Generation of Trial Design and FDA Regulations on Personalized Medicine

Razelle Kurzrock, MD, Senior Deputy Center Director, Clinical Science, UC San Diego Moores Cancer Center

You Li, PhD, Scientific Reviewer, FDA/CDRH/OIR/DMGP

Lei Zhang, PhD, Global Executive Director, Clinical Development, Zensun USA, Inc.

Dr. Kurrzrock will discuss Precision Medicine: Implications of Biomarkers for Predicting Response and Toxicity on Next Generation Trial Design

Dr. Li's presentation will focus on Regulation of Molecular Dx Devices for Personalized Medicine

2:30 - 2:45 PM Break

2:45-4:00 PM Clinical Trials and Data Integrity

Larry Shen, PhD, President, Pharmapace, Inc.

2nd Speaker Invited

Ginger Clasby, VP - Clinical & Regulatory Affairs/Quality Assurance, Transcend Medical, Inc.

Clinical Quality System and Its Utility for Clinical Trial Management (speaker TBD)

Dr. Shen's presentation is Practical Considerations on Data Quality and Statistic Analyses for Regulatory Submissions

4:00-5:15 PMEU Clinical Trials:New Regulations and Operations

Karen Hill, SVP, Global Therapeutic Leader, Cardiovascular & Late Phase, Worldwide Clinical Trials

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

How to Execute Clinical Trials in Europe to Support Regulatory Submission in the US vs. the EU?

1:30-2:45 PM

FDA Update followed by Dietary Supplement Panel Discussion with Industry Experts

FDA Invited Cameron Smith, Senior Director, Counsel, Herbalife

The FDA will provide an update for current dietary supplement regulations. Following will be a panel discussion with industry experts.

2:45-3:00 PM Break

3:00-4:15 PM Interactive Workshop Industry Leaders Invited Cameron Smith, Senior Director, Counsel, Herbalife

Industry leaders will discuss industry best practices in this workshop designed to include interactive participation with the audience.

4:15-5:15 PM Alternative Pathways for Regulation Speakers Invited Cameron Smith, Senior

Director, Counsel, Herbalife Stay tuned for more information.

5:30-8:00 PM Attendees Invited to a separate event, OCRA's Member Appreciation Night with OCRA Members serving Appetizers and Drinks

CLINICAL BREAKOUT SESSIONS (Manager: Lei Zhang, PhD)

DIETARY SUPPLEMENT BREAKOUT SESSIONS (Manager: Cameron Smith, Herbalife)

7:00-8:00 AM Continental Breakfast

8:00-9:15 AMChanges in EU Medical Device Regulation: The Notified Body Perspective

Peter Havel, PhD, Senior Vice President, MHS Global and Regional Director MHS, TUV SUD America Inc.

Tammy Vu, RAC, Senior Regulatory Affairs Specialist, Abbott Medical Optics (AMO)

Regulatory experts need to be prepared as early as possible for the upcoming regulation changes in Europe. The message was clear - change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. Learn about the status of the current discussions and the remaining regulatory options in the EU Commission, Parliament and Council in anticipation of a possible final decision in 2016. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. Contribute to discussions on the status of preparations in the industry and within Notified Bodies, the impact of these changes and how to make relevant decisions.

9:15-10:30 AM 2016 Changes to ISO 13485

Johnathan Bis, VP Healthcare Solutions, BSI

2nd Speaker Invited

James R. Lusk, RAC, Principal, Quality Systems International (QSI)

Do you know that major changes are coming to ISO 13485? Should we also expect subsequent adoption by the European Union (EN ISO…). For instance, no Quality Manual! What about no procedures? How many of us use the Quality Manual as the pointer document to the entire Quality System. There are more. This session will provide you with the current status of the changes, the major changes, how to revise the Quality System to support the changes, and with a lot of hope, help you to revise your Quality System two minutes before it must be done.

10:30-10:45 AM Break

10:45-Noon Cybersecurity Threats in the Medical Device World

Marcel Hill, Global Director, IoT Services, Intertek

Seth Carmody, PhD, Staff Fellow, CDRH, FDA (remote presentation)

Shep Bentley, RAC, President, Bentley Biomedical Consulting, LLC

Eri Hirumi, Auditor, TÜV SÜD and Paul Kramsky, President, Rockin' Regulatory, Inc.

With the increased use of wireless technology and software, medical devices that are connected to the Internet, hospital networks, and to other medical devices are becoming more vulnerable to cybersecurity breaches, potentially impacting the safety and effectiveness of these devices. The threat is real, as evidenced by a number of recent instances, such as the hacking of implantable insulin pumps reported in 2011, the temporary closure of a Veteran’s Administration Catheter Lab in 2014 caused by malware infected computers used in cardiac procedures, and more recently, confirmation of the potential for remote access of Hospira infusion systems through a hospital’s network.

Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them, and this can be especially challenging. As part of its ongoing efforts to protect the public health from cybersecurity vulnerabilities and maintain a balance of protecting patient safety while using innovative technologies, the FDA held a public workshop in October 2014 to seek input from the health care and public health sector on medical device and health care cybersecurity. Very shortly after this workshop, FDA held a webinar and issued two guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. This program, featuring experts from both FDA and industry, will report on the latest developments in the cybersecurity of medical devices and provide manufacturers with steps they can take to proactively support the safety and effectiveness of their medical devices in this bold new cyber world.

The FDA speaker will speak on Goals and Current Status of the Collaborative Efforts of the FDA.

MEDICAL DEVICE BREAKOUT SESSIONS (Manager: Chris Posin)

19th Annual FDA-OCRA Educational ConferenceMay 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 92626SECOND DAY - Friday, May 6, 2016

8:00-9:15 AM Biologics and Quality by Design

FDA Speaker invited

Christopher Watts, Founding Partner, Volpal

Cindy Fisher, PhD, Director, Regulatory Affairs, Vical Incorporated

The first half of this session will examine the application of statistical quality control techniques to ensure the quality of biological products. The second half will cover the applicability and incorporation of quality by design concepts in the management of development and risk in biologics manufacture.

9:15-10:30 AM Quality Metrics in Pharmaceuticals

FDA Speaker Invited

Cylia Chen, Sr. Manager, Amgen

Amy Stanton, Quality Systems Specialist, Amgen

Quality metrics are widely used in the industry to monitor processes and quality control and many are collected and maintained as GMP documents. With the roll out of FDA’s new risk based inspection approach, the industry needs to implement a metrics program whereby data from FDA defined metrics will have to be reported to the agency. This session provides overview of the Quality Metrics draft guidance and industry’s comments submitted to FDA, including short term and long term challenges and benefits. The first half of this session will examine the application of statistical quality control techniques to ensure the quality of biological products. The second half will cover the applicability and incorporation of quality by design concepts in the management of development and risk in biologics manufacture.

10:30-10:45 AM Break

10:45-Noon Smart Scale-Up Strategies FDA Speaker InvitedRuchika Raval, President, Global Biopharm Regulations Inc.

During the Drug Development Process, variations typically exist between early-phase clinical trial material and materials used in Phase III and subsequent market launch. Without a carefully developed scale-up plan, the materials may be so different from one another that the Agency asks the Sponsor to conduct a comparability study before launch, which adds delay and cost to the program. How can Regulatory and Development groups collaborate to reduce the burden? What are some key principals, methodologies, and best practices to minimize the risk?

Noon End of ConferenceOCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612. Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046

DRUGS & BIOLOGICS BREAKOUT SESSIONS (Manager: Cindy Fisher, PhD)

Step 1: Click on this link: http://www.ocra-dg.org/

Step 2: From the Home Page, enter your user name and password in the two empty fields to the right of the ocean graphic if you have an exist-ing account on our site. If you do not yet have an account, select “sign up” to create a new account. Immediately log in with your user name and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

If you do not know your user name or password, click on “Forgot login?” and follow the steps.

Step 3: Once you have logged on (and paid for membership) select the meeting you would like to attend (See Home Page near the bottom right side of the ocean graphic. Once on the page for the event, scroll to the bottom and click “Register Now!”. Complete the registration process by filling in the appropriate fields.

NON MEMBERSIf you are not an OCRA Member, we require you to join OCRA before registering for this meeting. To join OCRA go to this link: http://www.ocra-dg.org/. Once you have paid for membership, follow the instructions above to register.

MULTIPLE REGISTRATIONS:Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address. Supply a credit card number and expiration date or let us know that a check will be mailed (checks should be received prior to the event). If you need a receipt, please let us know to whom it should be emailed.

To Register With Company or Personal Check: Please submit the online registration form. Mail your check made payable to OCRA to the following address:

Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Tel: 949-387-9046 Fax: 949-266-8461 Email: ksyre@cox.netOCRA’s non-profit Federal Tax ID# 33-0630455

Cancellation Deadline:For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 22, 2016.

NOTE: If you have reserved a space but do not attend, your payment MUST be remitted. We will ask for a credit card pay-ment for any checks not received by the meeting date.

Group Registrations: This conference is priced to break even, as such, we do not offer discounts for group registrations. Please com-plete the registration form for each attendee.

We also accept faxed registrations. See registration form on the next page.

Venue: The Westin South Coast Plaza686 Anton Blvd., Costa Mesa, CA 92626Free shuttle from John Wayne Airport (SNA)http://www.westinsouthcoastplaza.com/Special OCRA Rate $189 single/double occupancy: https://www.starwoodmeeting.com/Book/FDAOCRAEducationalConferenceDirections:From Los Angeles: Take 405 South, Exit at Bristol. Turn Left on Bristol, Right on Anton, Left on Park Center Dr. Hotel on the Left.From San Diego: Take 5 North to 405 North. Exit at Anton Blvd. Turn Left on Anton. Turn Right on Park Center Dr. Hotel on the Left.

RegistRation instRuctions

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

Please Provide Complete Contact Information for Each Attendee:

FIRST NAME: LAST NAME:

COMPANY: TITLE:

ADDRESS:

CITY/STATE/ZIP:

PHONE: __________________________________________E-MAIL: _________________________________________________

Vegetarian Meal Requested or List Other Dietary Restrictions:

Please Select Your Breakout Sessions (you can switch sessions at the conference if needed):

May 5 _______Clinical Trial Breakout Sessions _______Dietary Supplements Breakout Sessions

May 6 _______Medical Device/IVD Breakout Sessions _______Drugs and Biologics Breakout Sessions

Registration Fee includes the following: Access to available speaker presentations to download prior to the conference (some will be sent after the conference, breakfast, lunch on first day, breaks and parking.

Please check type of card: ______Visa ______ Master Card ______ American Express

Card #: Exp 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.

Early Bird Registration Rate (If Paid by March 31st)_______$ 725 - OCRA Members_______$ 775 - Non-members (includes OCRA membership for one year)_______$ 475 – FDA/Government/Students*_______$ 475 - Thursday Only - For Dietary Supplement Industry Attendees Only

Regular Registration Rate (After March 31st)_______$ 775 - OCRA Members_______$ 825 - Non-members (includes OCRA membership for one year)_______$ 475 – FDA/Government/Students*_______$ 475 - Thursday - For Dietary Supplement Industry Attendees Only

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA. We do not offer online registration at this rate as it requires approval. Please fax this form with payment and items described above (if applicable).

**The one day rate is available for those attending the Dietary Supplements breakout.

RegistRation FoRm

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

OCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046