Combination Products: Regulations, Guidances, Proposed Rules, Strategies, and Practical Challenges

Monday, November 16 – Tuesday, November 17, 2009

Washington, DC Metro Area | Offices of Morgan Lewis


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

COURSE DESCRIPTION
Join us for AdvaMed MTLI’s annual workshop on Combination Products, as key presenters and former FDA staff and industry experts discuss important regulatory and practical issues, including the new proposed rules on GMPs and postmarket safety reporting for combination products.  Sessions will cover Primary Mode of Action and Request for Designation, the effect of different submission routes on the premarket regulatory process, cross-labeling, the relationship between GMP and QSR, issues with combination product marketing claims, current and anticipated adverse event reporting, and logistical challenges of coordinating timelines and efforts for drugs and devices.

 

Click here for the Full Agenda


Who Should Attend
Those involved with Premarket regulatory sffairs, Postmarket RA/QA,  Device, drug, and biologics for combination products, Manufacturing/GMP experts for combination products and operations.

Registration
AdvaMed Member $1295 Register Now
Non-Member $1915
AdvaMed EGCC Member $1095
Government $495

Agenda Overview
View Full Agenda
Combination Products: Past, Present, and Future
Primary Mode of Action (PMOA) and Request for Designation (RFD)
PMAs, 510(k)s, 513(g)s, and Combination Products
Proposed Rule on cGMPs for Combination Products - Presentations and Discussion
Comprehensive Development Strategies with Case Studies
Labeling and Cross-labeling of Combination Products
Adverse Event Reporting and the Proposed Rule
Pre and Post-Approval Inspections of Combination Products
Post-Approval Changes


Click here for the Full Agenda


Speakers
Anastacia Bilek, Branch Chief, OPMD Division of Enforcement, FDA
Thinh Nguyen, Director, Office of Combination Products, FDA
Christy Foreman, Deputy Director for Engineering and Science Review, FDA/CDRH
John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products (invited)
Jim Cohen, Partner, Buchanan Ingersoll & Rooney, formerly with the Office of Combination Products, FDA
Winifred Wu, Vice President, Regulatory Affairs, Medtronic
Suzzane O'Shea, Counsel, Baker & Daniels, former Product Classification Officer, Office of Combination Products, FDA
Leighton Hansel, Director, Regulatory Affairs, Abbott Laboratories
Janet Trunzo, Executive Vice President, Technology and Regulatory Affairs, AdvaMed
Alberto Velez, Director, Quality and Compliance Worldwide, Johnson & Johnson
Phoebe Mounts, Partner, FDA/Healthcare Regulation Practice, Morgan Lewis

Click here for the Full Agenda

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General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.

For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Friday October 23rd will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

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Location Information

This seminar will take place at the Law Offices of Morgan Lewis, Washington, DC located at:

1111 Pensylvania Ave., NW
Washington, DC  20004
202.739.3000

Please be advised that there are no hotel room blocks associated with this seminar.  For your convenience we have listed hotels close to Morgan Lewis offices:


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Frequently Asked Questions

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