Presentations

2008

• Polymorphism- Interplay of Science and Risk-Based Regulation [PDF]
  Stephen Miller, Ph.D.
  SSCI - Pharmaceutical Solids, April 10, 2008

2007

• Points to Consider for the Submission of Chemistry, Manufacturing, and Controls (CMC) Information in Oligonucleotide-Based Therapeutic Drug Applications [PDF]
  Rao V.B. Kambhampati, Ph.D., DIA Industry and Health Authority Conference, Bethesda, MD, April 20, 2007
   
• Quality by Design (QbD) Approaches for Orally Inhaled and Nasal Drug Products (OINDPs) in the USA [PDF]
  Prasad Peri, Ph.D., RDD Europe 2007.

2006

• Scientific and Regulatory Aspects of Quality Control for Chiral Drugs [PDF]
  Stephen Miller, Ph.D., Chirality International Symposium, June 2006, Busan, S. Korea
• Drug Master Files [PDF]
  Arthur B. Shaw, Ph.D., AAPS Short Course, June 20, 2006

2005

• Implementation of Quality-by-Design Principles in CMC Review [PDF]
  Chi-Wan Chen, Ph.D., October 26, 2005, Advisory Committee for Pharmaceutical Science (ACPS)
   
• Quality Issues for Clinical Trial Materials - US FDA Perspectives [PDF]
  Stephen Miller, Ph.D.
  DIA 3rd Canadian Annual Meeting; Montreal, September, 2005
   
• Polymorphism - Interplay of Science and Regulation
  Presented at  [PDF]
  Stephen Miller, Ph.D.
  SSCI's short course on Pharmaceutical Solids, May 2005,
   
• Quality by Design in the New Pharmaceutical Quality Assessment System (PQAS) [PDF]
  Moheb M. Nasr, Ph.D., November 21, 2005, Quality-International 2005 Conference, London
   
• FDA Perspectives on Process Analytical Technology (PAT) [PDF]
  Moheb M. Nasr, Ph.D., November 21, 2005, Quality-International 2005 Conference, London
   
• Establishing Drug Release/Dissolution Specifications - QBD Approach [PDF]
  Moheb M. Nasr, Ph.D., October 25, 2005, Advisory Committee of Pharmaceutical Science (ACPS)
   
• A New Pharmaceutical Quality Assessment System (PQAS) for the 21st Century [PDF]
  Moheb M. Nasr, Ph.D., October 5, 2005, AAPS Workshop, North Bethesda, MD
   
• FDA Modern Regulatory System - Pharmaceutical Quality Assessment [PDF]
  Moheb M. Nasr, Ph.D., September 27-30, 2005, 2005 Pharmaceutical Manufacturing Workshop, Dublin, Ireland
   
• Pharmaceutical Quality Assessment -- The New Chemistry, Manufacturing, and Controls (CMC) Review Paradigm in the 21st Century [PDF]
  Moheb M. Nasr, Ph.D., September 3-8, 2005, FIP World Congress of Pharmacy and Pharmaceutical Sciences
   
• Pharmaceutical Quality Assessment -- The New CMC Review Paradigm [PDF]. Moheb M. Nasr, Ph.D., June 27, 2005, DIA Annual Meeting
   
• Pharmaceutical Quality Assessment for the 21st Century [PDF]
  Moheb M. Nasr, Ph.D., May 23, 2005, PDA 2005 Extractables and Leachable Forum
   
• Setting Specifications in the New Paradigm - Scientific and Regulatory Challenges [PDF]. Moheb M. Nasr, Ph.D., March 16, 2005, PQRI Workshop, North Bethesda, MD
   
• Pharmaceutical Quality for the 21st Century [PDF]
  Moheb M. Nasr, Ph.D., February 2, 2005, CAMP Annual Meeting, Gaithersburg, MD
   
• Chemistry, Manufacturing, and Control. (CMC) Initiatives -- FDA Perspective [PDF]
  Moheb M. Nasr, Ph.D., February 15, 2005, International Conference on Drug Develop (ICD), Austin, Texas

2004

• Update on Drug Substance and Drug Product Draft Guidances [PDF]
  DIA Annual Meeting; June, 2004; Washington DC,
  Stephen Miller, Ph.D.
   
• Comparability Protocols: FDA Perspective  [PPT].
  Stephen Moore, Ph.D.
  AAPS Annual Meeting, 2004

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