CRTOnline - Workshop with the FDA

Welcome to the Workshop with the FDA Forum.

Workshop With The FDA
12/8/2008	Statistical View of “Reasonable Assurance of Safety and Efficacy” Industry Perspective, Roseann White
3/6/2008	What is Industry's Expectations from the New Guidance Document?, Susan Alpert, MD
3/6/2008	FDA View - Recap of the Last Circulatory Advisory Panel on Xience and Endeavor: Lessons to be Learned, Andrew Farb, MD
3/6/2008	Circulatory Panel View II: Recap of the Last Circulatory Advisory Panel on Xience and Endeavor: Lessons to be Learned, John C. Somberg, MD, PhD
3/6/2008	Circulatory Panel View I - Recap of the Last Circulatory Advisory Panel on Xience and Endeavor: Lessons to be Learned, Jeff A. Brinker, MD
3/6/2008	Industry View - Recap of the Last Circulatory Advisory Panel on Xience and Endeavor: Lessons to be Learned, LeRoy LeNarz, MD
3/6/2008	II: Update on FDA DES Requirements: Preclinical and Clinical, Ashley B. Boam, MSBE
3/6/2008	I: Update on FDA DES Requirements: Preclinical and Clinical, Elizabeth Hillebrenner, MSE
3/6/2008	Academic View - Devices: DES & DAP Therapy: Will we Ever Know the Answer?, George W. Vetrovec, MD
3/6/2008	Academic View - Drugs: DES & DAP Therapy: Will we Ever Know the Answer?, A. Michael Lincoff, MD
3/6/2008	FDA View: DES & DAP Therapy: Will we Ever Know the Answer?, Andrew Farb , MD
3/6/2008	FDA View - Drugs: DES & DAP Therapy: Will we Ever Know the Answer?, Shari L. Targum, MD
3/6/2008	ACC View: Real World Practice: How to Expand DES Indications?, David R. Holmes, Jr., MD
3/6/2008	Industry View: Real World Practice: How to Expand DES Indications?, LeRoy LeNarz, MD
3/6/2008	FDA View - Pre-Market: Real World Practice: How to Expand DES Indications?, Robert P. Fiorentino, MD
3/6/2008	FDA View - Post-Market: Real World Practice: How to Expand DES Indications?, Hesha Duggirala, PhD
3/6/2008	Industry View: Endpoints and Duration of Follow-Up for New DES Evaluation: What is Optimal?, Krishna Sudhir, MD, PhD
3/6/2008	Academic View: Endpoints and Duration of Follow-Up for New DES Evaluation: What is Optimal?, Roxana Mehran, MD
3/6/2008	FDA View: Endpoints and Duration of Follow-Up for New DES Evaluation: What is Optimal?, Ashley B. Boam, MSBE
3/6/2008	EU View: Endpoints and Duration of Follow-Up for New DES Evaluation: What is Optimal?, Isabelle Demade, PhD
3/6/2008	FDA View: Statistical Views of “Reasonable Assurance of Safety and Effectiveness”, Lilly Yue, PhD
3/6/2008	DSMC View: Statistical Views of “Reasonable Assurance of Safety and Effectiveness”, David L. DeMets, PhD
3/6/2008	Academic View: Post-market Evaluation: What is Optimal Information Distribution?, William H. Maisel, MD, MPH
3/6/2008	Industry View: Post-market Evaluation: What is Optimal Information Distribution?, Krishna Sudhir, MD, PhD
3/6/2008	FDA View: Post-market Evaluation: What is Optimal Information Distribution?, Bram D. Zuckerman, MD
2/25/2008	Post-market Evaluation: Reimbursement Considerations, Sean Tunis, MD, MSc
2/25/2008	Novel Strategies in Pre-Clinical Studies & Enhancement of Specimen Retrieval, Semih Oktay, PhD
3/22/2007	FDA Requirements for New DES: Surrogate Markers, Gregory Campbell, MD
3/22/2007	Challenges with Dual Drugs on DES Platforms, Hina M. Pinto
3/22/2007	Mechanism of Evaluation of New DES Platforms: Abbott Vascular Response, Krishna Sudhir, MD, PhD
3/22/2007	Mechanism of Evaluation of New DES Platforms: New Polymers, Mitchell W. Krucoff, MD
3/22/2007	FDA View: FDA Challenges to Determine Anti-platelet Durations, Norman L. Stockbridge, MD. PhD
3/22/2007	Why Should We Monitor Platelet Inhibition?, Robert S. Hillman, MD
3/22/2007	Adjunct Therapy for DES: sanofi-aventis Response, Carol A. Satler, MD, PhD
3/22/2007	Practical Issues Related to Pharmacology, Jeffrey A. Brinker, MD
3/22/2007	Trial Design for Dual Anti-platelet Therapy for DES, James Tcheng, MD
3/22/2007	Challenges of Pharmacology Trials, Robert M. Califf, MD
3/22/2007	Update on Duration Requirements of Anti-platelet Therapy for DES, Mitchell W. Krucoff, MD
3/22/2007	Synopsis of the March 2nd Circulatory Panel Meeting on PFO, William H. Maisel, MD, PhD
3/22/2007	Cardiac Surgery: Appropriate Endpoints: FDA Expectations, Wolf Sapirstein, MD
3/22/2007	Cardiac Surgery: Appropriate Endpoints: Premarketing Challenges, Ferolyn Powell
3/22/2007	Clinical Trial Design Challenges: Percutaneous vs. Surgical Trials, Laura Mauri, MD
3/22/2007	What is the Appropriate Patient Follow-up Time?, Donald D. Glower, MD
3/22/2007	Mitral Surgical Repair vs. Percutaneous Valve Repair, Niv Ad, MD
3/22/2007	Study Population for Coronary Sinus Approaches, Raoul Bonan, MD
3/22/2007	Study Population for Edge to Edge Repair, Peter S. Block, MD
3/22/2007	Indications for Percutaneous Approach, Igor F. Palacios, MD
3/22/2007	OUS vs. US Development: FDA Challenges, Julie Swain, MD
3/22/2007	OUS vs. US Development: Industry View: Postmarketing Challenges, Rob Michiels
3/22/2007	OUS vs. US Development: Industry View: Premarketing Challenges, Stanton Rowe
3/22/2007	Clinical Trial Design for a New Technology: Limitations of Historical Controls, Sharon-Lise T. Normand, PhD
3/22/2007	Selection of a Balloon Valvuloplasty Group, Igor F. Palacios, MD
3/22/2007	Selection of a Surgical Control Group, Maurice Buchbinder, MD
3/22/2007	Lessons from the OUS Experience, Eberhard Grube, MD
3/22/2007	What is a High Surgical Risk?, Michael J. Mack, MD
3/22/2007	Introduction to the Workshop with the FDA, Carlos E. Ruiz, MD, PhD
3/20/2007	Guideline Modifications for DES Use, Bonnie H. Weiner, MD
3/20/2007	The SCAAR Study and its Implications, Stefan James, MD, PhD
3/20/2007	Harmonization of the European and the US Experience with the New Requirements, William Wijns, MD
3/13/2007	Response to the New Requirements of the FDA I, Jeffrey J. Popma, MD
3/9/2007	Response to the New Requirements of the FDA II, Ron Waksman, MD
3/9/2007	Synopsis of the Last Circulatory Panel on DES, William H. Maisel, MD, MPH
3/9/2007	Drug Eluting Stent Development Post December 2006 FDA Panel: Where Do We Stand?, Mitchell W. Krucoff MD, FACC
3/9/2007	Current FDA Expectations for DES Post-Panel, Ashley B. Boam, MSBE, Andrew Farb, MD
4/3/2006	PFO Closure/Migraine - FDA View, Andrew Farb, MD
4/3/2006	Historical Controls, Julie Swain, MD
4/3/2006	Historical Controls, Lilly Yue, PhD
4/3/2006	Historical Controls, Sharon-Lise T. Normand, PhD
4/3/2006	In Vulnerable Plaque Studies - FDA View, Takahiro Uchida, MD
4/3/2006	In Vulnerable Plaque Studies - FDA Statistical View, Ning Li, PhD
4/3/2006	In Vulnerable Plaque Studies - Industry View, David Snead, PhD
4/3/2006	In Vulnerable Plaque Studies - Academic View, Shein-Chung Chow, PhD
4/3/2006	Acute STEMI Studies - Industry View, Griff Tully, MD
4/3/2006	Acute STEMI Studies - FDA Statistical View, Heng Li, PhD
4/3/2006	Acute STEMI Studies - FDA View, Steven Kurtzman, MD
4/3/2006	DES Studies - Industry View, Sara Toyloy
4/3/2006	DES Studies - Statistical View, David DeMets, PhD
4/3/2006	DES Studies - FDA View, Andrew Farb, MD
4/3/2006	Acute STEMI Studies - Academic View, Alexandra Lansky. MD
4/3/2006	Report from the Standardization of Clinical Endpoints for Drug Eluting Stents Trials: Is it Time for a Change?, Laura Mauri, MD
4/3/2006	What is a “Good” Surrogate Marker? Statistical View, Gregory Campbell, PhD
4/3/2006	What is a “Good” Surrogate Marker? FDA View, Owen Faris, PhD
4/3/2006	What is a “Good” Surrogate Marker? Academic View, Mitchell Krucoff, MD
4/3/2006	Peripheral Intervention - FDA View, Chandeysson & Goode
4/3/2006	Peripheral Intervention - Academic View, David Allie, MD
4/3/2006	Percutaneous Valves - FDA View, Carolyn Vaughn
4/3/2006	Percutaneous Valves - FDA View, Julie Swain, MD
4/3/2006	Bioabsorbable Stents - FDA View, Jonette Foy, PhD
4/3/2006	Bioabsorbable Stents - FDA View, Robert Fiorentino, MD
4/3/2006	Bioabsorbable Stents - Academic View, Ron Waksman, MD
4/3/2006	PFO Closure/Migraine - Academic View, Bernard Meier, MD
4/3/2006	Japan-US Regulatory Harmonization: Vision or Pipe Dream? Update: Comparing, Contrasting, Converging Japan-U.S. Device Evaluation: Academic View, Mitchell W. Krucoff, MD

Academic Perspective
9/28/2009	Non-US Physician - Scientist Perspectives: Device Regulation and Approvals, Prof. Dr. Sigmund Silber FACC, FESC

Academic Perspective
3/28/2005	International Post-Market Evaluation – Professional Society US, Michael J. Cowley, MD
3/28/2005	Global Regulatory Harmonization: Future or Fantasy?, Mitchell W. Krucoff, MD

Academic Perspective
3/28/2005	Distal Protection Devices: Academic Perspective, Laura Mauri, MD

Academic Perspective
	Talks From: How to Become a Cardiovascular Investigator, acc.org

FDA Perspective DES, BMS, DEB
9/6/2007	The EUROASPIRE Surveys, David A Wood, MD

FDA Perspective DES, BMS, DEB
3/28/2005	Distal Protection Devices Clinical Trials and Regulatory Pathways, Ron Waksman, MD
3/28/2005	Distal Embolic Protection Devices: The FDA Perspective, Neal I. Muni, M.D.,
3/28/2005	Hot Issues: Active Control Arms for DES Trials, Victor Hasselblad, PhD

FDA Perspective Pecutaneous Valves
3/28/2005	Percutaneous Valve Trials: the FDA Perspective, Julie Swain M.D.

FDA Perspective Vascular Intervention
3/28/2005	Impact of the Critical Path Initiative: Percutaneous Valves: Academic Viewpoint, Michael J. Mack, MD

Guidance Documents
10/5/2009	European vs. USA Guidelines:Similarities and Differences, Prof. Dr. Sigmund Silber FACC, FESC
1/29/2009	Carotid Guidelines BCBS 2008, The Journal of the College of American Cardiology
10/15/2008	The Necessity of Surgical Backup for PCI, Sigmund Silber, MD, PhD, FACC, FESC
10/15/2008	DES and DAP: How do the EU and US Guidelines Differ?, Sigmund Silber, MD, PhD, FACC, FESC
4/22/2008	II - Cases - Cardiology Update, Mohit Rastogi, MD
4/22/2008	Risk Factors for Increased Mortality with Heart Failure, Peter E. Carson, MD
4/22/2008	Treatment of Acute Decompensated Heart Failure, George Ruiz, MD
4/22/2008	The Case for Pharmacological Therapy of Atrial Fibrillation: Are the Drugs of Today and the Future the Answer?, Steven N. Singh, MD
4/22/2008	The Case for Catheter Ablation Therapy for Atrial Fibrillation, Zayd A. Eldadah, MD, PhD
4/22/2008	ICD and Pacemaker Update 2008, Susan O’Donoghue, MD
4/22/2008	The Big Picture: The Epidemic of Sudden Cardiac Death, Gordon F. Tomaselli, MD
4/22/2008	Is there still room for PCI after COURAGE?, Lowell Satler, MD
4/22/2008	Why Intensive Medical Therapy Should Be the Initial Approach to Stable CAD Management, William E. Boden, MD
4/22/2008	Place for CABG in Coronary Artery Disease, Paul J. Corso, MD
4/22/2008	Should We Operate on Asymptomatic Severe Aortic Stenosis?, Rick A. Nishimura, MD
9/7/2007	Risk Stratification in Acute Heart Failure, Aldo P Maggioni, MD
9/6/2007	The New ESC Guidelines on Valve Disease, Alec Vahanian, FESC, FRCP

Guidance Documents
3/28/2005	An FDA Perspective on Medical Device Pre-Market Development, Bram D. Zuckerman, MD
3/28/2005	Implications of Critical Path and Devices Approval: An Overview, Daniel G. Schultz, MD

Industry
3/28/2005	Distal Embolic Protection Devices: Industry Perspective, Matthew F. Ogle, MS

Industry Perspective
10/5/2009	JP Morgan Survey: What the Docs are Saying Post TCT, JP Morgan
1/28/2009	Simulation in Cardiology: “From Conception to Reality”, William O. Suddath, M. D.

Industry Perspective
3/28/2005	From Harmonization by Talking to Harmonization by Doing: Reflections, Dan Schultz, MD
3/28/2005	Post-Market Evaluation - From a Viewpoint of Academics in Japan, Kazuhiro Sase, MD, PhD
3/28/2005	International Post-Market Evaluation: FDA, William H. Maisel, MD
3/28/2005	International Post-Market Evaluation – Industry US, Susan Alpert, Ph.D., M.D.
3/28/2005	Pre-Market Evaluation: Academics - US, Ron Waksman, MD
3/28/2005	Pre-Market Evaluation: Academics - Japan, Shigeru Saito, MD
3/28/2005	Pre-Market Device Evaluation: Industry - Europe, Michael Gropp