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Akelewicz, Frances
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Device Corrections and Removals
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Andrews, Judith
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Device Quality Systems
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Alschuler, Liora
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Product Labeling Production
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Avellanet, John
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Quality Systems Management
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Basile, Ed
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510(k)s
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Bentivoglio, John
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Pharmaceutical Promotion
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Bolsover, N.
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Clinical Research
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Bolter, Ruth
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Clinical Research
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Bonilla, Jackie Wright
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Patent Law
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Carsten, Douglas
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Patent Law
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Cavallaro, Sara
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Data Monitoring Committees
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Chamberlain, Richard
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Clinical Data Management
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Cobbold, Egan
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Device Regulations - Canada
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Corcoran, Julie
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Pharmaceutical Promotion
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DeRisio, Rick
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CAPA
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Dion, Denise
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Internal Audits
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Dolan, Alf
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Devices, ISO 14971
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Eden, Alison
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Informed Consent
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Elengold, Mark
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Internal FDA Documents
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Foltz, Bridget A.
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Clinical Research
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Friede, Arnie
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Online Advertising
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Frueh, Felix
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Pharmacogenomics
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Gelberg, Alan
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Adverse Event Inspections
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Goldmann, Bonnie
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Biomarkers in drug development
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Gottlieb, Scott
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FDA Legal
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Grezlak, Donna
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Informed Consent
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Gyovai, G.
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Clinical Research
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Hamrell, Michael
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Clinical Trials, Fraud, Detecting Clinical Misconduct
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Handzo, Jim
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Device Corrections and Removals
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Hanson, Karmen
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Pharmaceutical Promotion
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Helfgott, Jonathan
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Bioresearch Monitoring
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Hemeon-Heyer, Sheila
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Device Quality Systems
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Hirigoyenberry-Lanson, Fabienne
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EU & Medical Devices
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Hocker, Sue
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Clinical Research
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Horacek, Chris
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Device Advertising and Promotion
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Hornick, John
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Protecting Your Trade Secrets
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Isidor, John
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Central IRBs
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Jacobs, Sue
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Internal Audits
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Jarcho, Daniel
|
FDA Legal
|
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Kaars-Wiele, Petra
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Globally Harmonized Quality Systems
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Kaiser, Lisa
|
Device Corrections and Removals
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Kalter, Sandy C.
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Device Advertising and Promotion
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Kimmelman, Ed
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ISO 13485
|
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King & Spalding - a panel of experts
|
FDAAA 2007, Devices
|
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Klasmeier, Coleen
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FDA Legal, Device Advertising and Promotion
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Kun, Ildiko
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Clinical Research
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Leighton, Anton
|
Clinical Research
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Lesser, Carlen Lea
|
Online Advertising
|
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Ljubimir, V.
|
Clinical Research
|
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|
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Loh, Evangeline
|
European Medical Devices Directive
|
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Lovett, Linda
|
CAPA
|
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Ma, Janice
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Regulatory Approvals in China
|
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Macpherson, Marci
|
Bioresearch Monitoring
|
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Marcellari, Andrea
|
Central IRBs
|
|
|
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Mastrangelo, Stan
|
Devices, ISO 14971
|
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Mather, John
|
Central IRBs
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McCarthy, David
|
Drug Export
|
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Miles, Ken
|
FDA Inspections
|
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Morton, Michael
|
Informed Consent
|
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Murname, Joseph
|
Medical Devices, IEC 60601
|
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Niedelman, Steven
|
FDA Compliance Issues
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O'Flaherty, Neil
|
Device Advertising and Promotion
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Olivier, Dan
|
CAPA
|
|
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O'Reilly, James
|
FDA Practice and Procedure
|
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Palmer, Michael
|
Electronic NDAs, Structured Product Labels, CDISC
|
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Pellerite, Wally
|
CDRH
|
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Peltier, Louise
|
Central IRBs
|
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Perry, Virginia
|
Bioresearch Monitoring
|
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Petrin, Jurij
|
International Regulatory
|
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Peyser, Shoshana
|
Central IRBs
|
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Phillips, Phil
|
Device Evaluation
|
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Pozsonyi, Suzanne
|
Clinical Research
|
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Quinlan, Judith
|
Clinical Trial Design
|
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Rawlins, Andrew
|
Medical Devices
|
|
|
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Reeves, Nikki
|
Pharmaceutical Promotion, Device Advertising and Promotion
|
|
|
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Reilly, Susan
|
Internal Audits
|
|
|
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Richmond, Frances
|
Central IRBs
|
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|
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Riordan, Retta
|
Off-Label Promotion
|
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Rosen, David
|
FDA's Orange Book
|
|
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Rudolph, Harvey
|
Medical Device Risk Management
|
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Schiff, Kenneth
|
ICH/ISO
|
|
|
|
Scott, Jody
|
510(k)s
|
|
|
|
Seltzer, Jonathon
|
Data Monitoring Committees
|
|
|
|
Serge, Marian
|
Informed Consent
|
|
|
|
Seyedzadeh, Javad
|
Globally Harmonized Quality Systems
|
|
|
|
Shapiro, Jeff
|
Device Advertising and Promotion
|
|
|
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Sharlin, Joshua
|
SOPs, SAS, Part 11, Safety Reporting, Electronic NDAs, NDA Review, Statistics, Computerized Systems in Clinical Trials, FDA Legal, Online Advertising
|
|
|
|
Shelton, Deborah M.
|
Device Advertising and Promotion
|
|
|
|
Sheridan, Robert
|
510(k)s
|
|
|
|
Singer, Nancy
|
510(k)s, Devices, ISO 14971, Internal Audits, FDA Legal, Pharmaceutical Promotion, Device Advertising and Promotion, Device Corrections and Removals, CAPA, Informed Consent
|
|
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Sobczyk, Michael
|
Clinical Trials
|
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Spiller, Bob
|
Violative Inspection & FDA Actions
|
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|
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Sprinkle, Les
|
Informed Consent
|
|
|
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Stark, Nancy
|
Clinical Databases, Part 11; ICH/ISO
|
|
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Stephenson, Jenn
|
Central IRBs
|
|
|
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Taggart, Mike
|
Device Advertising and Promotion
|
|
|
|
Terman, Steve
|
510(k)s
|
|
|
|
Troy, Daniel E.
|
FDA Legal
|
|
|
|
Uldricks, Cap
|
Device Corrections and Removals
|
|
|
|
Usdin, Steve
|
FDA Legal
|
|
|
|
Walfish, Steven
|
ICH Guidelines
|
|
|
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Walters, Kris A.
|
Clinical Research
|
|
|
|
Warren, Ronald S.
|
Human Tissue-Based Combination Products
|
|
|
|
Welch, Jan
|
CAPA
|
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Zannetti, Simona
|
Clinical Research
|
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Zhang, Danyi
|
China
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|
