Mark D. Kramer

Consulting


REgulator​y Strategies, Inc.
Presentations



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