US FDA and EU Regulatory Requirements Training for Combination Products
Prefilled syringes. Infusion pumps. Drug eluting stents. Inhalers. Surgical kits. These are all products that combine a medical device with a drug and / or biologic. This course provides an overview of combination products and explores the unique challenges of FDA and EU compliance for these products. Using exercises and case studies, we will explore US and EU regulatory pathways for combination devices and learn how to apply Good Manufacturing Practices (GMPs). You'll also walk away with a solid understanding of best practices for managing the product life cycle, from premarket through postmarket activities.