Course ID: C-13314

Members of LabOps Unite, please register here.

Members of Bio CT, please register here.

• Member: $850

• Non-Member: $1,025

Interested in offering the training exclusively to a group of your employees? Email courses@massbioed.org to learn more.

Description

In this interactive, hands-on workshop, participants will learn the basics of drug development. Starting with identifying a target or indication in the discovery phase, the de-risking necessary before entering the manufacturing and regulatory environment, the pre-clinical and clinical phases leading to regulatory approval. You will learn these different phases, why it is important to mitigate risk therefore minimize spend allowing companies to progress and the regulatory landscape necessary for approval. Included in the discussions will be the variety of vendors and roles necessary and their interdependent relationships and the need for teamwork. The post-approval and marketing process will be discussed especially as it relates to study design, regulations, and alliances. The course will provide you the history of US FDA regulations providing a framework as to why certain guidance’s were implemented.

Schedule

1. Monday, September 15, 2025, 10:00 AM – 12:30 PM  

2. Tuesday, September 16, 2025, 10:00 AM – 12:30 PM  

3. Thursday, September 18, 2025, 10:00 AM – 12:30 PM  

Agenda

Session 1: Strategy and Early Development

• The history of regulation and how to navigate
• Discovery phase to selecting a candidate
• Developing the strategy and lead indication
• Building quality into your plans

Session 2: The Regulatory Process and Pre-Clinical/Clinical Development

• IND and alternative strategies to First in Human/Patient
• Pre-clinical plans
• The phases of clinical trials
• Pharmacovigilance

Session 3: The Approval Process and Post-Marketing

• Business considerations
• Regulatory submissions and meetings with authorities
• Marketing authorities and post-approval commitments
• Wrap up and Q&A