Recent OCP Presentations
- Current Good Manufacturing Practice for Combination Products
Practical Issues in Combination Products, May 25, 2006
AdvaMed's Medical Technology Learning Institute
James Cohen
Senior Advisor
- Primary Mode of Action & Request for Designation
Practical Issues in Combination Products, May 25, 2006
AdvaMed's Medical Technology Learning Institute
Suzanne O'Shea
Product Classification Officer
- Cross Labeling
Practical Issues in Combination Products, May 25, 2006
AdvaMed's Medical Technology Learning Institute
Suzanne O'Shea
Product Classification Officer
- Regulation of Biologics and Biotechnology Products in the United States and Europe, May 9, 2006
University of Rhode Island College of Pharmacy
Suzanne O'Shea, Esq.
Product Classification Officer
- ACRP 2006 Global Conference, April 30, 2006
Mark Kramer, OCP Director
Office of Combination Products
- BioWest Keynote Denver,
November 9, 2005
Mark Kramer, OCP Director
Office of Combination Products
- BioWest Regulation of Combination Products,
November 9, 2005
Mark Kramer, OCP Director
Office of Combination Products
- ACT Annual Meeting , November 7, 2005
Patricia Y. Love, MD, MBA,
Assoc. Director OCP
Office of Combination Products
- BIO Annual
Meeting, June 21, 2005
Mark Kramer, OCP Director
Office of Combination Products
- Society
of Toxicologic Pathology Annual Meeting - June 20, 2005
Patricia Love, Associate Director
Office of Combination Products
- FDA/DIA Workshop:
Combination Products and Mutually Conforming Labeling -- May 10, 2005
- Regulation
of Combination Products: Progress Report -- DIA
Webinar on Combination Products -- January 19, 2005
Mark Kramer, Director
Patricia Love, Associate Director
Office of Combination Products
- Presentations by Mark Kramer, OCP Director,
at RAPS Consensus Summit on Regulatory Issues Involving Combination - January
11-12, 2005
- Challenges of Regulating Combination Products – January
11, 2005 [PDF 269KB]
- Office of Combination Products: Roles and Progress – January
12, 2005 [PDF 163KB]
- Presentation by Suzanne O’Shea,
OCP Product Classification Officer,
Surfaces in Biomaterials Foundation Annual Symposium, October
27, 2004 [PDF 690KB
]
- Presentation by Mark Kramer, OCP Director,
Society of Biomaterials Combination
Products Workshop,
October 17, 2004 [PDF 352KB]
- Presentation by Leigh Hayes, OCP Product Assignment Officer,
Regulatory
Affairs Professional Society Annual Meeting,
October 12, 2004 [PDF 265KB]
- Presentation by Mark Kramer, OCP Director,
Medical Device Manufacturers
Association’s 510(k) Workshop,
September 30, 2004 [PDF 279KB]
- Presentation by Patricia Love, OCP Associate Director,
Parenteral Drug
Association/FDA Joint Regulatory Conference,
September 22, 2004 [PDF 137KB]