Presentations
FDA Approval Process for medical Devices, September 2019
Drug/Device and Device/Drug Combinations in the EU and USA, September 2019
St. Cloud State University's Combination Products Course, Spring 2019
GMP by the Sea, August 2017
What's New in the US? MDUFA IV and Other New Developments (DIA 2017), June 2017
FDA Approval Process for Medical Devices, April 2017
Drug/Device and Device/Drug Combinations in the EU and USA, April 2017
Current Good Manufacturing Practice and Postmarket Safety Reporting Requirements for Combination Products, February 2017
St. Cloud State University's Combination Products Course, Spring 2017
Postmarket Safety Reporting for Combination Products, January 2017
Drug/Device and Device/Drug Combinations in the EU and USA, April 2016
FDA Approval Process for Medical Devices, April 2016
FDA-USP WCDG & AOAC-SCS Joint Regulatory & Compliance Conference, December 2015
FDA Approval Process for Medical Devices, September 2015
Drug/Device and Device/Drug Combinations in the EU and USA, October 2015
Paths to US Markets for Medical Devices, June 2015
Drug/Device and Device/Drug Combinations in the EU and USA, April 2015
St. Cloud State University Combination Products Course, Spring 2015
Best Practices for Communicating and Interacting with FDA, October 2014
GMP Requirements for Combination Products, May 2014
Pre-Submission Meetings for Drugs and Devices, May 2014
St. Cloud State University Combination Products Course, Spring 2014
Drug/Device and Device/Drug Combinations in the EU and USA, January 2014
AOAC-SCS-FDA Conference, December 2013
Regulatory Strategy Forum for Medical Devices, September 2013
Regulatory Affairs Certification (RAC) Preparation for Medical Devices, July 2013
Combination Product GMP Inspections Will Change Under the Final GMP Requirements, May 2013
Drug/Device and Device/Drug Combinations in the EU and USA, February 2013
St. Cloud State University Combination Products Course, February 2013
Developing an Effective Regulatory Strategy, December 2012
Medical Device User Fee Act (MDUFA) 2012, October 2012
Combination Product Regulation for the US Market, October 2012
Regulatory Affairs Certification (RAC) Exam Preparation for Medical Devices, August 2012
FOI Services Combination Products Teleconference, April 2012
Life Science Alley: Advanced Topics in Combination Product Regulation, February 2012
St. Cloud State University Combination Products Course, Spring 2012
Drug/Device and Device/Drug Combinations, January 2012
Combination Product Regulation in the US Market, October 2011
Fundamentals of US Regulatory Affairs Webcast Series, August 2011
Regulatory Strategy Forum for Medical Devices, March 201
Updates to the 510(k) Clearance Process, February 2011
RAPS Pre-Conference Workshop on Combination Products, October 2010
Drug/Device and Device/Drug Combinations, October 2010
Keynote Speaker: Advances in Therapeutic Discovery and Drug Development: Combination Products, October 2010
Combination Products, September 2010
Medical College of Wisconsin/Marquette University Health Technology Management Course, 2010-2014
Biologics Clinical and Regulatory Conference, February 2010
Regulatory Strategy Forum for Medical Devices, November 2009
Drug/Device and Device/Drug Combinations, September 2009
OCP Executive Staff Briefing, September 2009
US and EU Requirements for Combination Products, September 2009