TOPICS - Information on submitting and managing DMFs, fee payments, and facility identification
- How to maximize communication tools offered by the agency to get answers to your questions
- What to consider for development of a complex API
- Process validation and ICH Q7
- How to select an appropriate regulatory starting material (ICH Q11 and Q11 Q&A)
- Expectations for impurity assessment ((Q)SAR & pharm-tox) and control (ICH Q3A, Q3C, Q3D, and M7)
- How to develop a robust chromatographic method for API release
- Expectations for Lifecycle Management of DMFs and the Draft Post-Approval Change Guidance
- Common mistakes and how to avoid them-: case study examples
- Posters covering topics of interest
Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, and panel discussions. The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency. | | AUDIENCE - Manufacturers of active pharmaceutical ingredients in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA)
- Regulatory affairs professional or agents
- Outside testing facilities that provide data to support the safety (AMES Studies, (Q)SAR predictions, nitrosamine testing to support risk assessment) or quality (release or stability testers) of the active pharmaceutical ingredient in a DMF
- Outside manufacturing facilities that provide intermediates to be used in the manufacture of active pharmaceutical ingredients.
- Foreign regulatory bodies
- Compendia
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I Like to add one more important thing here, The global Active Pharmaceutical Ingredient/ API market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Active Pharmaceutical Ingredient/ API market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.
ReplyDeleteI Like to add one more important thing here, The Active Pharmaceutical Ingredients Market is expected to be around US$ 238.5 Billion by 2025 at a CAGR of 6% in the given forecast period.
ReplyDeleteI Like to add one more important thing here, The Global Active Pharmaceutical Ingredient (API) Market is expected to be around US$ 246 Billion by 2025 at a CAGR of 6% in the given forecast period.
ReplyDelete