Drug product development plan
This webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US market.
Product ID: 702909
Training Level: Advanced
Why Should You Attend:
The unique market positioning opportunity of a Paragraph IV Application in the US Market allows global Generic Product Manufacturers to develop useful Drug Products (even those with high barriers to entry e.g. transdermals) to offer significant value to patients prior to Branded Patent Expiration on providing a Certification of Non-Infringement and an automatic 30 month stay prior to approval.
This 60-minute webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US Market. The mechanism of a Paragraph IV Filing will be discussed using case studies to demonstrate the creation of value prior to Patent Expiration as a unique opportunity exclusive to the US Market.
Areas Covered in the Webinar:
- Strategic Planning for an ANDA vs Paragraph IV
- Efficient Implementation and Communication with the FDA.
- Content and Format of ANDAâs
- Plan for FDA-Sponsor Meetings
- FDA Expectations and CMC Data including Bioavailability/Bioequivalence
- Outline of Paragraph IV Applications and Case Studies
Who will Benefit:
This topic applies to personnel/ companies in the pharma/biopharma industries. The employees who will benefit most include:
- Senior management
- Regulatory affairs
- Quality Assurance
- CMC and Clinical Development
- Scientists, R&D
- Product Development
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