Program Overview
Participants will gain comprehensive insights into the regulatory framework governing New Drug Applications (NDAs) and Supplemental New Drug Applications (SNDAs), including submission types, data requirements, and the review process. The program also delves into various regulatory impact assessments, data analysis techniques, and the latest developments in assessment methodologies.
Features
- Interactive Lectures
- Case Studies
- Hands-on Exercises
- Group Discussion
Target audiences
- Professionals in the pharmaceutical industry involved in clinical trial management, regulatory affairs, quality assurance, and drug development.
Curriculum
- 6 Sections
- 15 Lessons
- 1 Day
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- Overview of Regulatory Framework3
- Data Collection and Analysis3
- Impact Identification and Assessment3
- 3.1Overview of regulatory impact assessments to evaluate the potential effects of regulatory changes on drug development and marketing
- 3.2Techniques for identifying and assessing regulatory impacts on timelines, costs, and market access.
- 3.3Case studies: impact assessments on hypothetical regulatory scenarios
- Different Types of Analysis and Assessments2
- Communication of Findings2
- Review Process and Latest Developments2
Instructor
