Online Training Courses for Human Drug Approval in the US
Introduction and Course Overview
This online course provides a deep dive into the strategy, preparation, and execution for new drug marketing applications (NDA: new drug applications or BLA: biologics license applications) in the US with real case experiences, lessons learned, and best practices.
Regulatory Strategy Part -1
Learn the building blocks of developing a global marketing application strategy starting with the US. Gain valuable insight into the pre-NDA/BLA requirements, expedited drug approval programs, and the procedures for meetings with FDA with real-case examples. Best practices for communications with FDA will also be discussed.
Course Price: $60
Course Run Time: 45:41 min
Course Level: Day 1 – Part 1
Access Period: 2 months
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Regulatory Strategy Part -2
This session will discuss the application review process and industry communication associated with the application review. It will also provide exposure to the composition of FDA review teams, the assessment of risks related to the content of the NDA/BLA, and the establishment of defense strategies during the review process.
Course Price: $60
Course Run Time: 30:45 min
Course Level: Day 1 – Part 2
Access Period: 2 months
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Regulatory Execution
In addition to the NDA/BLA review process, this session will describe the content and format of a typical NDA/BLA application. It will discuss briefly the documentation required for these applications, with keys for successful filing. It also covers points to consider when preparing your eCTD dossier and making electronic submissions to the FDA.
Course Price: $60
Course Run Time: 01:10:13
Course Level: Day 1 – Part 3
Access Period: 2 months
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Nonclinical Considerations
This session provides insight into key nonclinical requirements and the relevant ICH and FDA guidelines for the preparation of an NDA/BLA. It will discuss the similarities and differences in nonclinical information required for an NDA vs. BLA with relevant case studies. You will also learn the differences in the requirements for accelerated vs. standard approval.
Course Price: $60
Course Run Time: 01:02:52
Course Level: Day 2 – Part 1
Access Period: 2 months
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Getting Ready for Pre-Approval Inspection
This session provides an overview of the FDA Pre-License or Pre-Approval inspections for BLA products including cell therapy products regulated under PHS ACT section 351. It also covers the Quality System Approach to inspections (BLA), the timing of inspections, inspection readiness, and response strategy in case of receipt of FDA Form 483.
Course Price: $60
Course Run Time: 01:07:45
Course Level: Day 2 – Part 2
Access Period: 2 months
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CMC Considerations
This session will dive into the key CMC data requirements for filing an NDA/BLA along with the review of relevant FDA guidances with real-case examples. You will also learn the key differences in CMC requirements between an IND and an NDA/BLA and CMC requirements for accelerated vs. standard approval pathways.
Course Price: $60
Course Run Time: 01:11:53
Course Level: Day 2 – Part 3
Access Period: 2 months
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Clinical pharmacology considerations
In this session, gain insight into key clinical pharmacology (CP) requirements and the relevant FDA guidelines for the preparation of an NDA/BLA. It also discusses CP information in labeling and provides case studies of approval/rejection of applications based on CP.
Course Price: $60
Course Run Time: 56:33
Course Level: Day 3 – Part 1
Access Period: 2 months
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Preparing Clinical Section of NDA/BLA Part 2.1
In this session, learn the approaches to clinical development, including critical study design decisions, analysis plans for individual studies, and pooling strategies for the preparation of the clinical sections of the marketing application. Case studies and recommendations from previous experience will also be discussed.
Course Price: $60
Course Run Time: 01:05:24
Course Level: Day 3 – Part 2.1
Access Period: 2 months
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Preparing Clinical Section of NDA/BLA Part 2.2
Clinical Part II focuses on requirements of safety information supporting NDA/BLA including accelerated approval, REMS criteria, and post-marketing clinical requirements/commitments with relevant case studies.
Course Price: $60
Course Run Time: 49:18
Course Level: Day 3 – Part 2.2
Access Period: 2 months
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Statistical Practice in Regulatory Submission of NDA/BLA
This session provides an overview of the statistician’s role and the general statistical information required for an NDA/BLA. It provides recommendations on good statistical practice for the preparation of clinical and integrated summaries, and electronic study data submission, with examples. A case study of statistical and measurement issues for a successful NDA/BLA is also discussed.
Course Price: $60
Course Run Time: 01:03:59
Course Level: Day 4 – Part 1
Access Period: 2 months
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Developing New Drug Labeling
This session provides an overview of patient labeling, the different types, and the FDA review process of the labeling, including recommendations for negotiation. You will learn about developing draft USPI for NDAs and BLAs with specific considerations for clinical sections and potential scenarios for post-approval labeling amendments.
Course Price: $60
Course Run Time: 54:40
Course Level: Day 4 – Part 2
Access Period: 2 months
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Regulatory Defense and Post-approval Activities
In this session, gain insight into the type of FDA communications that can be expected during NDA/BLA review and the recommended response strategies with a special focus on the Complete Response (CR) Letter. It will provide an overview of the regulatory implications of PMCs and PMRs, the post-marketing safety reporting requirements, and the US market access routes of innovative drugs post-approval.
Course Price: $60
Course Run Time: 52:47
Course Level: Day 4 – Part 3
Access Period: 2 months
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