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