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2-day In-person seminar on Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace at Philadelphia

Event Details

2-day In-person seminar on Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace at Philadelphia

Time: July 17, 2014 at 9am to July 18, 2014 at 6pm
Location: DoubleTree by Hilton Hotel Philadelphia Center City
Street: Philadelphia
City/Town: Philadelphia
Website or Map: http://bit.ly/1lrZENK
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: May 9, 2014

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Event Description

Overview:

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

Participants will learn what a Combination Product is; learn about mode of action and primary mode of action, how to prepare a Request for Designation submission, Combination Product user fees, GMP for Combination Products and how to interact with the FDA Office of Combination products. They will also learn about submissions for post-approval modifications for a Combination product. This course provides the participant the ability to understand the entire FDA Combination Product Process and how to navigate through the FDA Combination Product Process to get your Combination Product onto the US marketplace.

Why should you attend?

A must course for those who have Combination Products or are anticipating that they will have Combination Products. This course explains the entire FDA Combination Product system and how to navigate the FDA Combination Product system. 

ABOUT SPEAKER –

Albert A. Ghignone

Chief Executive Officer and President, AAG Incorporated. 

 

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, and regulatory affairs, manufacturing and clinical. 

Location: Location: Philadelphia        Date: July 17th & 18th 2014        Time: 9 AM to 6 PM EDT 

Venue: DoubleTree by Hilton Hotel Philadelphia Center City  

Venue Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA

Price: $1,295.00 

Discount:

Register now and save $200. (Early Bird)

Until May 31, Early Bird Price: $1,295.00 
from June 01 to July 15, Regular Price: $1,495.00

Contact Information:
Event Coordinator

Toll free: 1800 447 9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php

Event Link: http://bit.ly/1lrZENK

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA  

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