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Webinar: Drug Development Overview
February 20 @ 4:00 pm - 5:00 pm
From Discovery to Market: Decoding Drug Development’s Journey
What are the Key Milestones, Challenges, and Innovations in the intricate development process?
This webinar provides an insightful view of the intricate process involved in developing pharmaceutical drugs and delves into the multifaceted stages shaping the landscape of modern medicine. From initial discovery to market launch, this presentation will take you on a journey through key milestones, challenges, and innovations that define the pharmaceutical industry today.
Date: Tue, Feb 20, 2024
Time: 4:00 PM- 5:00 PM PT
Location: Zoom
Registration: Free for OCRA members, $20 for nonmembers
This presentation will use the real-world case scenario approach to provide a look at the drug development process, covering:
- Drug Discovery Milestones: Understand the critical importance of milestones in drug discovery.
- Nonclinical Testing: How nonclinical testing lays the groundwork for successful drug development, ensuring safety and efficacy are at the forefront.
- Chemistry, Manufacturing, and Controls (CMC): Gain insights into the necessity of a clear understanding of CMC, a foundational element in the development process that ensures the quality and consistency of pharmaceutical products.
- Regulatory Path for IND Application Submission: Explore innovative approaches to identifying the most successful regulatory path for Investigational New Drug (IND) Application.
- Phases of Clinical Trials: Navigate through the phases of clinical trials, from initiation to completion, understanding the challenges and triumphs that accompany each stage.
- New Drug Application (NDA) and FDA Inspections: Understanding the crucial steps that determine a drug’s eligibility for market launch.
- Post Marketing Requirements: Uncover the ongoing responsibilities that pharmaceutical companies face after a drug is introduced to the market.
Who Should Attend:
- Regulatory professionals
- Pharmaceutical researchers and scientists
- Healthcare professionals
- Students and academics
About the speaker:
Bani Tchekanova, PhD
SVP of Global Regulatory Affairs
ClinReg Partners
Member of FDA Advisory Committee
Dr. Tchekanova has over 25 years of extensive industry expertise spanning diverse therapeutic areas, including oncology, dermatology, infectious disease, ophthalmology, cardiovascular, and neuroscience. A seasoned Strategic Global Regulatory Affairs Professional, Dr. Tchekanova’s proficiency extends to various pharmaceutical domains such as IND, NDA, BLA, and MAA encompassing CMC, nonclinical, clinical, biologics (BLA), medical devices (510k), OTC, and cosmetics.
Thank you to our platinum Sponsor!
