|
Akelewicz, Frances
|
Risk Management, Device Corrections and Removals
|
|
|
|
Andrews, Judith
|
Device Quality Systems
|
|
|
|
Alschuler, Liora
|
Product Labeling Production
|
|
Basile, Ed
|
510(k)s
|
|
|
|
Bills, Edwin
|
Risk Management
|
|
|
|
Bentivoglio, John
|
Pharmaceutical Promotion
|
|
|
|
Bonforte, Link
|
Risk Management
|
|
|
|
Chamberlain, Richard
|
Clinical Data Management
|
|
|
|
Cobbold, Egan
|
Device Regulations - Canada
|
|
|
|
Corcoran, Julie
|
Pharmaceutical Promotion
|
|
|
|
DeRisio, Rick
|
CAPA
|
|
|
|
Dion, Denise
|
Internal Audits
|
|
|
|
Dolan, Alf
|
Devices, ISO 14971
|
|
|
|
Eden, Alison
|
Informed Consent
|
|
|
|
Elengold, Mark
|
Internal FDA Documents
|
|
|
|
Frueh, Felix
|
Pharmacogenomics
|
|
|
|
Garris, Cindy
|
Small Business Certification
|
|
|
|
Gelberg, Alan
|
Adverse Event Inspections
|
|
|
|
Goldmann, Bonnie
|
Biomarkers in drug development
|
|
|
|
Gollinger, Jerry
|
Risk Management
|
|
|
|
Gottlieb, Scott
|
FDA Legal
|
|
|
|
Grezlak, Donna
|
Informed Consent
|
|
|
|
Hamrell, Michael
|
Clinical Trials, Fraud, Detecting Clinical Misconduct
|
|
|
|
Handzo, Jim
|
Device Corrections and Removals
|
|
|
|
Hanson, Karmen
|
Pharmaceutical Promotion
|
|
|
|
Hemeon-Heyer, Sheila
|
Device Quality Systems
|
|
|
|
Horacek, Chris
|
Device Advertising and Promotion
|
|
|
|
Hornick, John
|
Protecting Your Trade Secrets
|
|
|
|
Hirigoyenberry-Lanson, Fabienne
|
EU & Medical Devices
|
|
|
|
Hocker, Sue
|
Informed Consent
|
|
|
|
Howard, Lindsey
|
Risk Management
|
|
|
|
Jacobs, Sue
|
Internal Audits
|
|
|
|
Jarcho, Daniel
|
FDA Legal
|
|
|
|
Kaiser, Lisa
|
Device Corrections and Removals
|
|
|
|
Kalter, Sandy C.
|
Device Advertising and Promotion
|
|
|
|
Kimmelman, Ed
|
ISO 13485
|
|
|
|
King & Spalding - a panel of experts
|
FDAAA 2007, Devices
|
|
|
|
Klasmeier, Coleen
|
FDA Legal, Device Advertising and Promotion
|
|
|
|
Lovett, Linda
|
CAPA
|
|
|
|
Mastrangelo, Stan
|
Devices, ISO 14971
|
|
|
|
McCarthy, David
|
Drug Export
|
|
|
|
Miles, Ken
|
FDA Inspections
|
|
|
|
Morton, Michael
|
Informed Consent
|
|
|
|
Niedelman, Steven
|
FDA Compliance Issues
|
|
|
|
O'Flaherty, Neil
|
Device Advertising and Promotion
|
|
|
|
Olivier, Dan
|
CAPA
|
|
|
|
O'Reilly, James
|
FDA Practice and Procedure
|
|
|
|
Palmer, Michael
|
Electronic NDAs, Structured Product Labels, CDISC
|
|
|
|
Pellerite, Wally
|
CDRH
|
|
|
|
Petrin, Jurij
|
International Regulatory
|
|
|
|
Phillips, Phil
|
Device Evaluation
|
|
|
|
|
|
Rawlins, Andrew
|
Medical Devices
|
|
Reeves, Nikki
|
Pharmaceutical Promotion, Device Advertising and Promotion
|
|
|
|
Reilly, Susan
|
Internal Audits
|
|
|
|
Rosen, David
|
FDA's Orange Book
|
|
|
|
Rudolph, Harvey
|
Medical Device Risk Management
|
|
|
|
Schiff, Kenneth
|
ICH/ISO
|
|
|
|
Scott, Jody
|
510(k)s
|
|
|
|
Serge, Marian
|
Informed Consent
|
|
|
|
Shapiro, Jeff
|
Device Advertising and Promotion
|
|
|
|
Sharlin, Joshua
|
SOPs, SAS, Part 11, Safety Reporting, Electronic NDAs, NDA Review, Reviewers, and Submissions, Statistics, Computerized Systems in Clinical Trials, FDA Legal
|
|
|
|
Shelton, Deborah M.
|
Device Advertising and Promotion
|
|
|
|
Sheridan, Robert
|
510(k)s
|
|
|
|
Singer, Nancy
|
510(k)s, Devices, ISO 14971, Internal Audits, Risk Management, FDA Legal, Pharmaceutical Promotion, Device Advertising and Promotion, Device Corrections and Removals, CAPA, Informed Consent
|
|
|
|
Spiller, Bob
|
Violative Inspection & FDA Actions
|
|
|
|
Sprinkle, Les
|
Informed Consent
|
|
|
|
Stark, Nancy
|
Clinical Databases, Part 11; ICH/ISO
|
|
|
|
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
|
|
|
|
Warren, Ronald S.
|
Human Tissue-Based Combination Products
|
|
|
|
Weagraff, Pam
|
Risk Management
|
|
|
|
Welch, Jan
|
CAPA
|
|
|
