| June 2007 |
|
Cell Mediated Immunity Assay "4 day" Training
Course
Sponsored by Client
Rockville, MD
Course Instructor |
| April 2007 |
|
The Williamsburg BioProcessing Foundation
12th Annual Meeting – The Waterside Conference
San Juan, Puerto Rico
“Product Characterization
of Recombinant Proteins and Monoclonals”
|
| February 2007 |
|
IBC’s 2nd International Technology Transfer
for Biopharmaceuticals
Carlsbad, CA
Speaker
“Worldwide Regulatory Expectations
for Technology Transfer”
|
| February 2007 |
|
ISPE Vendor Show
Boulder, CO
Speaker
“Recent Trends in FDA Inspections”
|
| November 2006 |
|
MSPDA Vendor Show and Dinner
Longmont, CO
Keynote Speaker
“Trends in FDA Inspections
and Implementation of Risk-Based QA Management”
|
| November 2006 |
|
9th Annual BioFlorida Statewide Conference –
Intersections: Converging Fields, Emerging Opportunities
Gainesville, FL
Panelist Chair
“Risk Benefit Analysis and
Clinical Trial Design”
|
| November 2006 |
|
IABs Emerging Diseases and Board Meeting
Lyon, France
Speaker
|
| November 2006 |
|
FDA Inspections Summit
FDA News
Rockville, MD
Speaker
“Development of Deviations, Investigations
and CAPA Systems to Support Product Quality and Inspections
|
| September 2006 |
|
Cell-Mediated Immunity Assays Training Course
Rockville, MD
Course Instructor with David Hines, Ph.D. |
| September 2006 |
|
BioPharma Operations Excellence Consortium
Tefen Executive Roundtable
Boston, MA
Keynote
“Visionary Quality and the Future
Regulatory Environment”
|
| June 2006 |
|
IVT FDA Inspections Conference
San Francisco, CA
Co-Speaker with Kevin Hennegan
“System-Based
Inspections: Controls, Labs Control Systems, & Handling
of OOT & OOS Results” |
| March 2006 |
|
Annual cGMP Course
Rockville, MD
Course Instructor |
| March 2006 |
|
World Vaccine 6th Annual Congress 2006
Four Seasons Hotel
Washington, DC
Chair, Speaker and Post-Congress Workshop Leader
"Clinical Plans, Practices and Procedures for
Vaccine Trials"
|
| February 2006 |
|
Williamsburg BioProcessing Foundation
Characterization and Comparability for Complex
Biological
Products 3rd Annual Meeting
Fairmont Hotel
San Francisco, California
Speaker-"How to Prepare a Successful Comparability
Protocol
for Process Changes"
|
| November 2005 |
|
BioWest 2005
Denver Convention Center
Denver, Colorado
Expert Panelist-"Regulatory Issues in Combination
Products"
|
| July 2005 |
|
IVT Validation adn cGXP Compliance Workshop
Wyndam El San Juan Hotel
San Juan, Puerto Rico
Speaker-"Validation Reports:Scientific, Compliance,
and Regulatory Aspects for Pharmaceutical Testing"
|
| June 2005 |
|
IBC's 1st International Vaccines Conference
Hotel Okura
Amsteram, Netherlands
Speaker-"Manufacturing, Therapeutics and Regulatory
Updates"
Conducted Full-Day workshop-"Comparability Issues
Within
Scale-up and Development"
|
| May 2005 |
|
Life Science Thursday
Radisson Conference Center
Longmont, Colorado
Speaker - "Investigational New Drug Applications,
FDA Trends
and Clincal Issues" |
| January 2005 |
|
Wilbio's 2nd Annual Meeting
Coronado, California
Speaker
"How to Prepare a Successful Comparability
Protocol for Process Changes" |
September 2004
|
|
ISPE Fall Conference
Durahm, North Carolina
Design of Recombinant DNA Biotechnology Facilities
Speaker
"Risk-based Compliance for Facility and Program
Development"
|
| June 2004 |
|
IBC Course
Washington, DC
Chair, Instuctor
"Use of PAT in Development
of Process Validation Protocols" |
| May 2004 |
|
CCE Course
Instructor for 3-day course
"US Regulations
of Biologics & Biophamaceuticals, FDA's
Policies and Expectations" |
| April 2004 |
|
IBC Course
San Diego, CA
Instructor for 3-day course
"Regulatory Concerns,
Future Challenges for Preclinical Development of Biotherapeutics" |
| February 2004 |
|
Comparability Protocols for Biologics
San Diego, CA
Speaker: Michael Schick, Ph.D. on behalf of Dr. Jeanne
Novak
"Comparability Protocols for Biologicals:
Strategies for Post-
Approval Changes" |
| November 2003 |
|
Well Characterized Biologicals
Vienna, VA
Chair/Speaker
"Process and Analytical Validation
in the Demonstration of
Comparability ", "Clear Guidance for Comparability:Template
for Writing a Comparability Protocol " |
| October 2003 |
|
Rocky Mountain ISPE
Boulder, Colorado
Speaker
"Designing for Compliance:
The (Former) Inpsectors's Perspective" |
| October 2003 |
|
Biowest 2003
Auroro, Colorado
Speaker - Conference Sponsor
"Program Development
Strategies for Executives" |
| October 2003 |
|
Institute for International
Research
Amsterdam,The Netherlands
"Immunogenicity of Protein-based Therapeutics"
Chair |
| July 2003 |
|
Center for Pharmaceutical Training
Philadelphia, PA
Speaker “Designing a Successful Validation Master
Plan" |
| June 2003 |
|
DIA 39th Annual Meeting
San Antonio, TX
Immunogenicity |
| May 2003 |
|
IBC Life Sciences
Bethesda, MD
Speaker
“Process and Analytical Validation
in the Demonstration of Comparability” |
| March 2003 |
|
Institute for International Research
San Francisco, CA
Chair and Keynote Speaker |
| March 2003 |
|
Plant Made Pharmaceuticals
Quebec, Canada
Speaker “Compliance, Validation and Downstream
Processing" |
| March 2003 |
|
IBC Life Sciences
LaJolla, CA
Speaker “Role of Process Validation in
Demonstration of Comparability” |
| October 2002 |
|
RAPS
Lakewood, CO
Speaker |
| October 2002 |
|
RAPS
Washington, DC
Speaker “Developing a Biologic:
Nuts and Bolts of IND Applications" |
| September 2002 |
|
Immunogenicity
Boston, MA
Keynote Speaker, Facilitator, Chair |
| June 2002 |
|
cGMP Course
Sponsored by Client
Boston, MA.
Facilitator and Speaker |
| January 2002 |
|
University of Colorado School of Medicine
Denver, CO.
Speaker, “Clinical Trial Outcome Measures for
FDA” |
| November 2001 |
|
Biological Deviation Reporting
DIA/FDA
Bethesda, MD.
Co-Chair |
| October 2001 |
|
University of Colorado Biotechnology Course
Boulder, CO.
Speaker, “Introduction to FDA Regulations” |
| October 2001 |
|
Mountain States RAPS Meeting
Lakewood, CO.
Speaker, “Current Trends in Biologic and Drug
Relations” |
| October 2001 |
|
GCP Course for Physicians
Sponsored by Client
Los Angeles, CA.
Instructor |
| July 2001 |
|
Technology Transfer for the Pharmaceutical and Biotech
Industries
Institute for International Research (IIR)
San Francisco, CA
Speaker, “Demonstration of Comparability of Biological
Products During Development”
Speaker, “Writing a Tech Transfer Task Agreement
to Meet
Specifications” |
| June 2001 |
|
U.S. Regulations of Biologics
Center for Continuous Education (CCE)
San Diego, CA
Instructor |
| May 2001 |
|
Process Validation for Pharmaceutical and Biotech
Companies
Institute for International Research (IIR)
San Diego, CA
Speaker, “Defining, Qualifying and Validating
Critical Process Steps for Biologics” |
| April 2001 |
|
Mountain States PDA Round Table Dinner
Longmont, CO
Keynote Speaker |
| March 2001 |
|
Research Ethics in Pediatrics
The Children’s Hospital
Denver, CO
Keynote Speaker, “Federal Guidelines and Regulations”
Speaker, “Clinical Trials in Children: the FDA
Perspective” |
| February 2001 |
|
Tech Transfer Conference
Institute for International Research (IIR) |
| August 2000 |
|
U.S. Regulations of Biologics
Center for Continuous Education (CCE)
Denmark
Instructor |
| March 2000 |
|
Biotechnology Case Studies
University of Colorado
Boulder, CO.
“cGMP and Regulatory Affairs”
1999 Biotechnology Case Studies Course
University of Colorado
Boulder, CO.
“Good Manufacturing Practices
(cGMP)” |
| November 1999 |
|
GCP Training for Principal Investigators
Sponsored by Client
Los Angeles, CA.
Speaker |
| November 1999 |
|
Introductory GCP Course
Sponsored by Client
Los Angeles, CA.
Speaker |
| November 1999 |
|
Advanced GCP Course
Sponsored by Client
Los Angeles, CA.
Speaker |
| October 1999 |
|
Launching Quality into the Next Millennium
Society of Quality Assurance (SQA)
Chicago, IL.
“Quality Assurance: Good Practice,
Regulation, and Law” |
| October 1999 |
|
RAPS Annual Conference
Regulatory Affairs Professional Society (RAPS)
Washington, D.C.
Moderator of Session
“Managing Late Stage
Development to Meet Targets”
“Managing
Late Stage Development” |
| October 1999 |
|
RAPS Annual Conference
Regulatory Affairs Professional Society (RAPS)
Washington, D.C.
“Contract Manufacturing in
the New Millennium”
“Contract Manufacturing
and Technology Transfer” |
| July 1999 |
|
Vaccine Summit: Gene Therapy and Vaccine Production:
New Strategies for Efficient Scale-up of Adenovirus
and Adenoviral Vectors
International Business Communications (IBC)
Arlington, VA.
Conference Chair
“Interfacing Production Science
and Regulatory Science” |
| July 1999 |
|
Vaccine Summit: Vaccine Clinical Trials
International Business Communications (IBC)
Arlington, VA.
Conference Chair
“Clinical Assay Validation
and Clinical Trials Support for Phase III Studies” |
| March 1999 |
|
U.S. Regulations of Biologics:
Center for Continuous Education (CCE)
San Diego, CA.
Instructor |
| February 1999 |
|
Biotechnology: Product Development for the New Millennium
DIA
Dana Point, CA.
“Regulatory Policy Update-CBER:
Interpretation and Implementation” |
| April 1998 |
|
Biologics Approval & Compliance Workshops
Regulatory Affairs Professional Society (RAPS)
Reston, VA.
“Advisory Panels/IRB”
“The Data Safety Monitoring Board (DSMB) and The
Institutional Review Board (IRB)” |
| April 1998 |
|
Biologics Approval & Compliance Workshops
Regulatory Affairs Professional Society (RAPS)
Reston, VA.
“Advisory Panels/IRB”
“Advisory Panels: The FDA Advisory Committee” |
| March 1998 |
|
Regulatory Strategies for Vaccines
Barnett International Conference Group
Arlington, VA.
“Combination Vaccines: Issues
for Development of Future Combinations” |
| March 1998 |
|
Regulatory Strategies for Vaccines
Barnett International Conference Group
Arlington, VA.
“FDA Address: The IND Process-From
pre-IND to Phase III” |
| March 1998 |
|
Drugs, Devices, Biologics: Testing for Safety and
Effectiveness
Regulatory Affairs Professional Society (RAPS)
Baltimore, MD.
“Sessions Specifically for
Biological Clinical Trials”
“Phase 3:
Proof of Safety & Effectiveness, Pivotal Studies
& Animal Efficacy Studies” |
| November 1997 |
|
Vaccine Regulatory Summit-Strategies and Solutions
for Product Approval
International Business Communications (IBC)
Washington, D.C.
Co-Speaker, “Successful Registration of Combination
and DNA-based Vaccines” |
| April 1997 |
|
IIR Meeting
Institute for International Research (IIR)
Washington, D.C.
Conference Chair
“The Evaluation of Combination
Vaccines” |
| December 1996 |
|
Oncologic Drugs Advisory Committee 52nd Meeting
Rockville, MD.
“TICE®BCG for Intravesical
Use for Superficial Transitional Cell Carcinoma of the
Bladder” |
| October 1996 |
|
Chemical/Biological Warfare Defense Conference
Alexandria, VA.
“Vaccine Approval Within the
Office of Vaccines Research and Review”
Co-Speaker, “Vaccine Approval Process” |
| September 1996 |
|
RAPS 20th Annual Conference
Regulatory Affairs Professional Society (RAPS)
Washington D.C.
“Emerging Issues for Products
and Technologies Regulated Within the Office of Vaccines
Research and Review”
“Regulatory Update:
New Policies, Rules and Procedures” |
| February 1996 |
|
IBC’s 3rd Annual Vaccines New Advances in Technologies
and Applications
International Business Communications (IBC)
Rockville, MD.
“Regulatory and Clinical Issues
for Vaccine Development”
“Advances in
Vaccine Technologies Regulatory Perspective” |
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