Eric Sheinin, Ph.D. - Specialist in CMC Sections of NDA, ANDA, DMF Filings

 

Qualifications

Thirty years experience at FDA: 15 years in Drug Chemistry Laboratory, 15 years in increasingly significant managerial positions focusing on Chemistry, Manufacturing and Controls review. Six years at USP as Vice President and Chief Science Officer focusing on monograph and general chapter development/revision, stakeholder interactions, international scientific activities and launch of USP’s Pharmaceutical Ingredient Verification Program. Extensive FDA and USP liaisons with international regulatory agencies. Author/co-author of approximately 40 scientific publications; over 200 presentations. Rapporteur for ICH Q6A Guideline, member ICH Q2A and Q3B Expert Working Groups, USP lead to the Pharmacopeial Discussion Group (EP, JP, USP), Board of Directors, Parenteral Drug Association. Charter member, American Association of Pharmaceutical Scientists. Fellow, 2010.

Work History

	2007 - Present	Senior Consultant, Specialist in CMC Sections of NDA, ANDA, DMF Filings	D.H. Gold Associates, Inc.
		Specializing in chemistry, manufacturing and controls documentation for filing submissions.
	2005 - 2007	Vice President	United States Pharmacopeia, Rockville, MD
		Pharmaceutical Ingredient Verification Program
	2005 - 2005	Chief Science Officer	United States Pharmacopeia, Rockville, MD
	2001 - 2005	Vice President	United States Pharmacopeia, Rockville, MD
		Standards Develpoment
	1999 - 2001	Deputy Director, Office of Pharmaceutical Science	FDA, Rockville, MD
		Center for Drug Evaluation and Research, FDA, Rockville, MD
	1996 - 1999	Director, Office of New Drug Chemistry	FDA, Rockville, MD
		Office of Pharmaceutical Science, Center for Drug Evaluation and Research
	1995 - 1996	Director, Division of New Drug Chemistry III	FDA, Gaithersburg, MD
		Office of New Drug Chemistry, Office of Pharmaceutical Science, Center for Drug Evaluation and Research.
	1989 - 1995	Supervisory Chemist, Division of Medical Imaging, Surgical and Dental Drug Products	FDA, Rockville, MD
		Center for Drug Evaluation and Research
	1985 - 1989	Supervisory Chemist, Division of Oncology and Radiopharmaceutical Drug Products	FDA, Rockville, MD
		Center for Drug Evaluation and Research
	1978 - 1985	Chief, Drug Standards Research Branch	FDA, Washginton DC
		Division of Drug Chemistry, Bureau of Drugs
	1971 - 1978	Research Scientist	FDA, Washington DC
		Division of Drug Chemistry, Bureau of Drugs

 

Education

	1967 - 1970	Ph.D. (Organic Chemistry) (1970) Public Health Service Fellowship, 1967 - 1969 University of Illinois Graduate School Fellowship, 1969 - 1970	University of Illinois at the Medical Center, Chicago, IL
	1965 - 1966	High Honors	University of Illinois, College of Pharmacy, Chicago, IL
	1961 - 1965	B.S. (Zoology) (1965) Illinois State Scholarship, 1961 – 1965 B.S. with Honors in Liberal Arts and Sciences and distinction in Zoology	University of Illinois, Urbana, IL

Publications

• Extractables and Leachables-Compendial and Regulatory Perspectives, Eric B. Sheinin, American Pharmaceutical Review, April 2008
• Equivalence Studies for Complex Active Ingredients and Dosage Forms, Lokesh Bhattacharyya, Roger Dabbah, Walter Hauck, Eric Sheinin, Lynn Yeoman, and Roger Williams, The AAPS Journal, 7(4), Article 77 (2005)
• Oral Dosage Form Performance Tests: New Dissolution Approaches, Walter W. Hauck, Thomas Foster, Eric Sheinin, Todd Cecil, William Brown, Margareth Marques, and Roger Williams, Pharmaceutical Research, 22(2) (2005)
• The Value of USP Public Standards for Therapeutic Products, L. Bhattacharyya, T. Cecil, R. Dabbah, D. Roll, S. Schuber, E.B. Sheinin, R.L. Williams, and the USP Council of Experts Executive Committee, Pharmaceutical Research, 21(10), 1725-1731 (2004)
• Chemistry, Manufacturing, and Controls Information in NDAs and ANDAs, Supplements, Annual Reports, and Other Regulatory Filings, Eric Sheinin and Roger Williams, Pharmaceutical Research, 19(3), 217-226 (2002)
• Trends in the Analysis of Marketed Pharmaceuticals: A Regulatory View, E.B. Sheinin in The Aster Introduction of Applications of Liquid Chromatography to the Development of Pharmaceuticals, Irving W. Wainer, Edit., pages 419-455, Aster Publ. Corp., New York, October 1985

Memberships in Professional Societies

• American Chemical Society – 1967 to Present
• Chemical Society of Washington, 1971 to Present
  • Board of Managers, 1972 – 1976
  • Treasurer, 1977
  • Treasurer, “The Capital Chemist,” 1978 – 1986
• AOAC International, 1971 – 1998      Secretary, Committee B, 1981 – 1986
  • Chair, Committee B, 1986 – 1989
  • Fellow of the AOAC, 1979
• American Association of Pharmaceutical Scientists, 1986 to Present
  • Charter Member
  • Fellow of AAPS – 2010
• RAPS – 2008 - Present

  
  

 

 

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