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DIA Global Center

Sep 11, 2017 8:15 AM - Sep 12, 2017 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

Back to Agenda

Sessions 2, 3, and 4

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Session 2: Types of Submissions Affected by CMC

FDA Briefing Package
Investigational New Drug Application (IND)
Investigational Medicinal Product Dossier (IMPD)
New Drug Application (NDA/CTD)
Biologics License Application (BLA)
Common Technical Document (CTD)
Drug Master Files (DMFs)
Abbreviated New Drug Application (ANDA)
Amendments to an IND
Supplements to an Approved NDA/ANDA
IND/NDA Annual Reports

Session 3: Pre-formulation & Formulation Development

CMC Steps Leading to an IND
Key Active Pharmaceutical Ingredient (API) Characteristics
Development of Analytical Assay
Preformulation Testing
Solubility/Stability
Forced Degradation Studies
Formulation Development and Challenges
cGMP Manufacturing
Requisites for Clinical Trial Materials (CTM) Manufacture
Stability Testing and Storage

Session 4: FDA Briefing Process

The meeting package

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