Presentations

  • Presented "Preparing the CMC Section for NDAs/INDs/CTDs", Center for Professional Innovation and Education, 2003-ongoing
  • Presented "FDA Container-Closure System Guidances," Private client, 2002
  • Presented "IND Requirements for Drug Substances and Drug Products," Private client, 2001
  • Presented "Stability Guidances," Private client, 2000
  • Presented "CMC Analytical Requirements," Private client, 1999
  • Presented "CMC Filings -- The Fine Points," Private client, 1998
  • Presented "Drug Master Files -- When and How to Use Them," Private client, 1998
  • Presented "QA/QC Challenges for Multinational Corporations," Drug Information Association CMC Conference, September 1996
  • Presented "Need for Common CMC Format -- US Industry Perspective," AAPS, September 1995
  • Organized Various Symposia and Discussion Groups, AAPS Annual Meetings, 1993-1994
  • Presented "FDA Foreign Inspection Program," Janssen International, Belgium, December 1992
  • Presented "FDA Registration Process," Janssen International, Belgium, June 1992
  • Organized and Chaired Workshop "International Pharm/Chem Regulatory Requirements," AAPS, April 1992
  • Organized and Chaired Course "Regulatory Requirements for EEC Submissions," AAPS Annual Meeting, 1990
  • First President Regulatory Affairs Focus Group, American Association Pharmaceutical Scientists (AAPS), 1989-1991
  • Presented "Regulatory Requirements for Polylactic/Polyglycolic Acid Systems," Controlled Release Society Workshop, August 1989
  • Presented (in Spanish) "Pharmaceutical and Chemical Regulatory Requirements," Syntex Mexico, June 1988