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. If your concern is getting your Combination Product on the US marketplace this course is a must attend for you.
Areas Covered in the Session:
• Learn about the FDA Office of Combination products
• Learn what a Combination Product is
• Learn the FDA Combination Product Process
• How to navigate the FDA Combination Product system
• Mode of action and primary mode of action
• How to prepare a Request for Designation
• User Fees for Combination products
• GMPs for Combination products
• Post-Approval Modifications
Day 1 – Agenda
Lecture 1: Introduction to FDA: Laws and Regulations involved
Lecture 2: Definitions
Lecture 3: FDA Office of Combination Products
Lecture 4: What is a Combination Product
Lecture 5: Examples of Combination products
Lecture 6: Mode of Action and Primary mode of Action
Day 2 – Agenda
Lecture 7: Preparation of Request for Designation submission
Lecture 8: User Fees for Combination products
Lecture 9: GMPs for Combination Products
Lecture 10: Frequently Asked Questions about Combination products
Lecture 11: Lead Center
Lecture 12: Post - Approval Modifications
Who Will Benefit:
• Regulatory Affairs Personnel
• Research Personnel
• Quality Personnel
• Clinical Personnel
• Manufacturing Personnel
• Personnel who require an understanding of the FDA Combination Product Process
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. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.
He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group.
Location: Location: Philadelphia Date: July 17th & 18th 2014 Time: 9 AM to 6 PM EDT
Venue: WILL BE ANNOUNCED SOON
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
Toll free: 1800 447 9407
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