Exploring FDA Regulations Series

Exploring FDA Regulations Workshop One

Exploring FDA Regulations Workshop One

Wednesdays, April 3, April 10, and April 17, 2024
11:00 AM–1:00 PM ET

This introductory workshop is an essential resource for professionals engaged in the study or oversight of FDA-regulated drugs, biologics, and medical devices.

By employing a multifaceted educational approach that includes pre-learning modules, hands-on exercises, and real-world case studies, will equip you with the skills necessary to navigate the complex landscape of FDA human subjects research regulations effectively. 

This workshop will address a range of critical aspects of FDA regulations, from legal frameworks and compliance protocols to specific challenges associated with emerging technologies.

Offered in three 2-hour sessions, through pre-learning modules and interactive exercises you will gain proficiency in applying the FDA regulations.  

You Will Learn To:

  • Analyze the intricate relationship between FDA regulations and ethical considerations in research involving drugs, biologics, and medical devices, proposing solutions for compliance and ethical integrity.
  • Evaluate FDA regulations in various research scenarios, making informed decisions to ensure compliance and address ethical dilemmas within the context of drugs, biologics, and medical devices.
  • Construct strategies for implementing FDA regulations, integrating legal, ethical, and practical aspects to promote compliance and participant welfare across the spectrum of drugs, biologics, and medical devices.

Cost 
Members: $350
Nonmembers: $595

Navigating the Nuances of FDA-Regulated Research Workshop Two

Navigating the Nuances of FDA-Regulated Research Workshop Two

Tuesdays, June 18, June 25, and July 2, 2024 
1:00–3:00 PM ET

This advanced-level, three-session workshop is designed for research compliance professionals, regulatory affairs professionals, clinical research coordinators, and others involved in the study, oversight, and regulation of drugs, biologics, and devices.

Through interactive exercises, immersive case studies, and expert-led presentations, you will gain proficiency applying the FDA regulatory framework to advanced scenarios.

Explore real-life examples of research with FDA-regulated products and test articles, including emerging technologies; use existing resources to support regulatory determinations; and consider ongoing oversight with an emphasis on protecting human subjects. 

A prerequisite for this workshop is a foundational knowledge of FDA research regulations governing human subjects protection and the conduct of clinical trials. You should be familiar with common definitions; history and organization of the FDA; criteria for exemption from IND and IDE requirements; and sponsor, investigator, and IRB responsibilities in the conduct and oversight of FDA-regulated clinical trials. 

This workshop, "Navigating the Nuances of FDA-Regulated Research" provides opportunities for you to apply inductive reasoning and resourcefulness to real-world scenarios you may encounter in the future. 

What Will I Learn?

After attending the workshop, attendees will be able to: 

  • Identify and use resources to interpret and apply FDA-regulations to unique products or study design scenarios.  

  • Employ analytical frameworks to chart a course for compliance with FDA research regulations.  

  • Formulate requisite determinations, document rationales, and obtain useful agency input where needed.   

Cost 
Members: $350
Nonmembers: $595