This program delivers a complete, structured understanding of the drug development lifecycle, covering every critical stage - from early discovery and preclinical research to clinical trials, regulatory approval, and post-marketing surveillance.
You will explore how drugs are developed, tested, approved, and brought to market, with a strong focus on scientific principles, regulatory requirements, and industry best practices.
You will explore how drugs are developed, tested, approved, and brought to market, with a strong focus on scientific principles, regulatory requirements, and industry best practices.
Learning Objectives
- Drug discovery: target identification, lead optimization, and emerging technologies
- Preclinical development, toxicity studies & pharmacokinetics (ADME)
- Clinical trials (Phase I-III): design, execution & data integrity
- Regulatory pathways (FDA, EMA, global frameworks)
- Biologics vs small molecules: key differences
- Pharmacovigilance & post-marketing surveillance
- Commercialization and lifecycle management strategies
Speaker
Kelly ThomasWho Should Attend
- Medical and clinical investigators
- Investigation & expansion scientists
- Quality Assurance professionals
- Scientific Research professionals
- Auditors
- Strategic planners
- Senior sales managers
- Regulatory Affairs Professionals
- Non-scientific employees of pharmaceutical companies who would like to understand how drugs are developed
- Regulatory affairs professionals
- Project managers
- CMC/pharmaceutical research professionals
- Manufacturing Personnel
- Newly-appointed staff with no previous experience in the pharmaceutical industry
- Financial managers
- Brand team personnel
- Statisticians & data management professionals
- A pharmaceutical employee who wishes to better their knowledge of drug development
