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THE PATH TO COMMERCIALIZATION: Past Events
Thursday
Sept. 3 |
Design Controls for the Medical
Device
Start Up.
A must attend for small medical device companies, new inventors, PIs and engineers. Gain an imperative understanding of when to stop “R” and start “D” and what it entails.
PROGRAM
7.15-7.50 AM
Networking Continental Breakfast
8.00-10.45 AM
Essentials of Design Control
GLP - Applicability & Key Requirements
Premarket Regulatory Compliance:
Current FDA Perspective
The Importance of Quality & Compliance in an
Exit Strategy
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SPEAKERS AND PANELISTS:
- Teresa Thompson
FDA District Director, Cincinnati
- Georgia Layloff
Independent consultant, ex FDA Investigator
- Michael H. Southworth
RAC / Principal, Southworth & Associates, LLC
- Christian Haller
Director of Technology
MPR
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Thursday
July 23 |
Regulation of Biologics: Biotechnology drugs, Stem cells and Engineered Tissues.
Be ahead of the game by being aware of the regulations guiding regenerative medicine products. Engage in a panel discussion with ex-FDA officers, leading clinicians and company executives.
PROGRAM
7.15-7.45 AM
Networking Continental Breakfast
7.45-10.30 AM
FDA Regulation of your Regenerative Medicine Product
- Data Elements & Rationale for First in Man studies
Darin Weber
Regulation on Recombinant Proteins:
Case Study of Thrombolytics
Ed Korwek
Standardization of Clinical Trials for Biologic Products
Stan Gerson
Quick Insights into Allogenic Cell Manufacturing
Bob Deans
Panel Discussion and Q&A
Cost:
$35 ($25 for early bird registrations)
Venue:
 Map/Directions
Lerner Research Institute; Rm NA1-138;
Cleveland Clinic Foundation
Corner of 100th Street and Carnegie Avenue
Cleveland, OH 44195 USA
Lerner Research Institute is located opposite the Intercontinental Hotel on Carnegie Avenue. For convenience, we suggest you use the Parking Garage on 100th Street and take the skyway into Lerner.
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SPEAKERS AND PANELISTS:
- Darin J Weber
Senior Consultant, Biologics Consultant Group
- Ed Korwek
Partner, Hogan & Hartson
- Robert Perry
Director, Athersys Inc.
- Stanton L Gerson
Director, National Center for Regenerative Medicine
Director, Case Comprehensive Cancer Center
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Thursday
June 25 |
Regulation of Medical Devices
A forum to learn the basic guidelines that govern medical device regulation by the FDA. Learn from the experience of experts in the field and engage in a candid panel discussion.
PROGRAM
7.15-7.45 AM
Networking Continental Breakfast
7.45-10.30 AM
FDA Regulation of Medical Devices :
Mike Southworth
- Overview of FDA & Medical Device Regulation
- Key Definitions
- Device Classifications & Regulatory Controls
- Premarket Notification (510(k))
- Premarket Approval (PMA)
- Humanitarian Device Exemption (HDE)
- Investigational Device Exemption (IDE)
- In Vitro Diagnostic (IVD) Requirements
- Postmarket Requirements
- Comparison with Other Major Regulatory Authorities
The Right Regulatory Strategy is Half the Battle Won: Howard Holstein
Panel Discussion and Q &A
Cost:
$35 ($25 for early bird registrations)
Venue:
Map/Directions
Lerner Research Institute; Rm NA1-138;
Cleveland Clinic Foundation
Corner of 100th Street and Carnegie Avenue
Cleveland, OH 44195 USA
Lerner Research Institute is located opposite the Intercontinental Hotel on Carnegie Avenue. For convenience, we suggest you use the Parking Garage on 100th Street and take the skyway into Lerner.
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SPEAKERS AND PANELISTS:
- Michael H. Southworth
RAC / Principal, Southworth & Associates, LLC
- Howard Holstein
Partner, Hogan & Hartson
- Stephanie Harrington
VP, Frantz Medical
- Raymond Ursick
Principal, REU Associates
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© 2009 Global Cardiovascular Innovation Center 