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Pharmaceutical Regulatory Affairs

 

Karlton CMC Consulting 


Pharmaceutical CMC and Developing World Regulatory Affairs

Experience - Knowledge - Global Strategy

 

 

Karlton CMC Consulting
1008 Capuchino Avenue
Burlingame, CA 94010
United States

ph: (650) 430-8329
fax: (650) 393-5781

Peter Karlton's Publications and Presentations

 

 

Karlton, P. “Regulatory Issues in the Development of Topical Microbicides for the Prevention of HIV”: UNAIDS WHO-ICMR-CONRAD-IPM Meeting on Regulatory Issues in Microbicide Research, October 28-31, 2007.  New Delhi, India.

Karlton, P. “Advancing Therapeutics and Improving Lives.” American Association for the Advancement of Science February Annual Meeting - 2007.  Invited panelist: Institute for OneWorld Health Global Health Seminar.

Karlton, P. “AIDS in the Developing World – A Regulatory Perspective.”  AAPS Newsmagazine (April 2005).

Karlton, P. “International Product Registration Strategies in Sub-Saharan Africa and PEPFAR Funded Countries.” Presented at the American Association of Pharmaceutical Scientist’ November 2005 Annual Meeting.

Karlton, P. “Position Paper for US FDA on Inadequacies of ICH Q1F Guideline on Stability Data Package for Registration in Climatic Zones III and IV." Submitted to FDA in 2005.

Karlton, P. “Registration of ARV Drugs in Africa.” Presented at the Drug Information Association Conference on CM&C/Regulatory and Technical Strategies: Compressing the Time To Global Marketing on March 1-3, 2004 in Bethesda, MD.

Karlton, P. “CMC Post Approval Changes.” Presented at the International Institute for Research conference on Chemistry, Manufacturing, and Controls on April 29-30, 2002 in Alexandria, VA.

Karlton, P. and Gray, J. “Risk Assessment in CMC Regulatory Filings”. Presented at the DIA workshop on Active Pharmaceutical Ingredients - Issues at the Development, Production, Regulatory Interface, Baltimore, November 8-11, 1998.

Karlton, P. and Johnston, D. “An Integrated Approach to the Preparation of Global CMC Dossiers”, Drug Information Journal, Vol. 31 Number 1(1997): 237. Presented at the DIA workshop on International Issues and Perspectives on Medical and Technical Writing and Document Preparation for the Pharmaceutical Industry and Regulatory Agencies, Philadelphia, October 30-3 1, 1995.

Karlton, P. “Meeting the Challenge of FDA’s CMC Initiatives”, Journal of Pharmaceutical Technology, Vol. 20 (October 1996).  Also presented at the AAPS Eastern Regional Meeting, New Brunswick, NJ, June 1996.

Karlton, P. and Isherwood, C. “Quality Issues In International Harmonization”, Regulatory Affairs, Vol. 7 (Spring 1995).

Karlton, P. ‘Quality Issues in the Preparation of Chemistry, Manufacturing, and Control Documents”, Regulatory Affairs, Vol. 4 (Winter 1992): 389.

Karlton, P. and Gallagher, C. “Is There An Ideal Stability Data Base?” Proceedings Fall 1990, Journal of Pharmaceutical Technology. Presented at the International Institute for Research conference on Chemistry, Manufacturing, and Controls on April 29-30, 2002 in Alexandria, VA.

 

 

 

 

 

 

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Karlton CMC Consulting
1008 Capuchino Avenue
Burlingame, CA 94010
United States

ph: (650) 430-8329
fax: (650) 393-5781