Conference/Seminar Attendance

2007

RAPS Horizons 2007, San Francisco, CA. Moderated panel on “Electronic Submissions Update and Case Study,” March 2007.
San Diego Regulatory Affairs Network (SDRAN), “Inspections, 483s, and Warning Letters,” program committee, La Jolla, CA, February 14, 2007.
DIA EDM Conference, Philadelphia, PA, February 2007.
FOI Teleconferences, “Electronic Submissions: Will FDA Require eSubs & Outsource eSub Infrastructure,” guest speaker assisting featured presenter, Joshua Sharlin, Ph.D., January 18, 2006.

2006

FOI Teleconferences, “Electronic Submissions: Will FDA Require eSubs & Outsource eSub Infrastructure,” guest speaker assisting featured presenter, Joshua Sharlin, Ph.D., December 21, 2006.
“Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing,” [Docket No. 2006N-0464], December 18, 2006.
DIA “eCTDs: Entering the Mainstream,” San Diego, CA, November 2006.

LORENZ User Group Meeting, Berlin, Germany, September 2006, featured speaker, "Preparing to Submit an eCTD - Key Steps to Take Before Submission to Authority."

DIA Annual Meeting, Philadelphia, PA, June 2006.
Bay Area Biotechnology Consultants Network. Guest Speaker, “Nightmare or Blessing (or both)? - Electronic Document Systems and Submission Publishing Management.” El Rancho Hotel, Millbrae, CA, May 2006.
San Diego State University Center for Distance Learning Interwork Institute. Guest Speaker for Week 9 of RA774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices on the topic of Electronic Submissions, May 2006.
DIA EDM Conference, Philadelphia, PA, February 2006.

2005

LORENZ User Group Meeting, Vienna, Austria, September 2005.
DIA SPL Workshop, Washington, DC, August 2005.
ISI eCTDXpress training, Whippany, NJ, August 2005.
QUMAS e-DOC Compliance Training, Florham Park, NH, August 2005.
Lorenz docuBridge training, Philadelphia, PA, June 2005.

San Diego State University Center for Distance Learning Interwork Institute. Guest Speaker for Week 9 of RA774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices on the topic of Electronic Submissions, May 2005

DIA Regulatory Affairs I & II, West Chester University, West Chester, PA, May 2005.
RAPS West Coast Conference, San Francisco, CA. Moderated panel on “CTD/eCTD Submissions,” March 2005
Liquent West Coast User Group, Emeryville, CA. Delivered presentation “Challenges Leading up to CTD/eCTD Publishing,” March 2005
FDA public meeting on CDISC and Study Data Tabulation Model (SDTM), Rockville, MD, February 2005
DIA EDM Conference, Philadelphia, PA, February 2005.

2004

DIA EDM Conference, Philadelphia, PA

San Diego Regulatory Affairs Network, San Diego, CA.  Delivered presentation "Tools for Electronic Submissions Publishing and Electronic Record Keeping."

University of California at San Diego, Extension, San Diego, CA.  Guest lecturer on IT Requirements in FDA-Regulated Industries, addressing electronic document management and electronic submission publishing.

2003

DIA EDM Conference, Philadelphia, PA.

San Diego Regulatory Affairs Network, Del Mar, CA. “What you need to know about the IND Process 2002,” moderated a panel on electronic INDs and the FDA CBER electronic review process.

Barnett International, Philadelphia, PA.  “Electronic Regulatory Submissions,” presented on the topic of Explore Accepted Technologies for Electronic Submissions.

San Diego State University Center for Distance Learning Interwork Institute.  Guest Instructor for Week 9 of RA774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices on the topic of Electronic Submissions.

DIA eCTD Conferences (May, October, December).

2002

DIA EDMS Conference, Philadelphia, PA. Speaker on panel concerning implementation timelines for electronic submission publishing.

DIA Workshop on CBER Electronic Investigatory New Drug Application Guidance, Irvine, CA.

DIA Workshop on CBER Electronic Submissions Review, La Jolla, CA.

CALBIOsummit2002, San Diego, CA.  Speaker on panel concerning implementation of electronic document and data collection technologies from patient bedside to regulatory submission.

DIA Annual Meeting, Chicago, IL.

San Diego Regulatory Affairs Network. Moderator for panel presentation on preparing for electronic submissions.

2001

BIO2001, San Diego, CA.

DIA Annual Meeting, Denver, CO.

DIA EDMS Conference, Philadelphia, PA. Speaker on panel concerning options for publishing and document management solutions for regulatory submissions.

DIA European Regulatory Affairs, Boston, MA.

DIA Workshop on CDER Electronic Submissions Review, Philadelphia, PA.

RAPS seminar on electronic submissions, San Diego, CA.

2000

BIOCOM 2000, San Diego, CA.

DIA Annual Meeting, San Diego, CA.

DIA CBER Seminar on eBLA and electronic submissions, Washington, DC.

ICH5, San Diego, CA.

IIR Conference on Common Technical Document (CTD).

PhRMA Conference on Biostatistics.  Speaker on panel concerning electronic submissions standards, Baltimore, MD.

San Diego Regulatory Affairs Network Seminar on QSIT, Carlsbad, CA.

1999

BIO1999, Seattle, WA.

BIOCOM 1999, San Diego, CA.

DIA Annual Meeting, Baltimore, MD.  Speaker on panel concerning electronic submissions standards.

DIA Seminar on CDER Electronic Submissions, Baltimore, MD.

1998

DIA Annual Meeting, Boston, MA.

DIA Seminar on CDER Electronic Submissions, Washington, DC.

BIO1995, San Francisco, CA.