Is it a Drug, a Medical Device or both? Determine Product Classification with Precision and Risk

This course offers comprehensive training on classifying medical products as drugs, medical devices, or combination products, emphasizing precision and risk assessment. Participants will gain a deep understanding of regulatory frameworks, including FDA and EMA regulations, and learn to apply key classification criteria such as primary mode of action, intended use, and structural characteristics. Through interactive exercises, case studies, and real-world examples, participants will develop practical skills in accurately classifying products and conducting effective risk assessments. By mastering these essential concepts, participants will enhance regulatory compliance, streamline product development processes, and mitigate risks, ultimately contributing to the safe and successful commercialization of medical products.

WHY YOU SHOULD ATTEND:

This course is essential for professionals involved in the development, regulatory compliance, and commercialization of medical products. By attending this training, participants will gain a comprehensive understanding of regulatory frameworks, classification criteria, and risk assessment principles crucial for navigating the complex regulatory landscape effectively. Understanding the distinctions between drugs, medical devices, and combination products is vital for determining the appropriate regulatory pathway and ensuring compliance with regulatory requirements set forth by agencies such as the FDA and EMA. Additionally, precise classification and thorough risk assessment are paramount for ensuring the safety, efficacy, and quality of medical products, ultimately safeguarding patient health and minimizing regulatory risks. By mastering these key concepts and skills, participants can contribute to the successful development, approval, and commercialization of medical products, while also enhancing regulatory compliance and mitigating potential risks associated with product development and marketing. Attendees will benefit from practical insights, interactive exercises, and real-world case studies, enabling them to apply learned principles effectively in their roles and organizations.

SEMINAR AGENDA:

• Regulatory Frameworks: Participants will gain an understanding of FDA and EMA regulations governing the classification of medical products as drugs, medical devices, or combination products.
• Classification Criteria: Key factors such as primary mode of action, intended use, and structural characteristics will be explored in detail to facilitate accurate product classification.
• Regulatory Pathways: Participants will learn about the different regulatory pathways for drug approval, medical device clearance/approval, and combination product pathways, including the differences in requirements and documentation.
• Precision in Classification: Strategies for precise classification will be discussed, including utilizing regulatory guidance documents, collaborating with experts, and identifying borderline cases.
• Risk Assessment: Principles of risk assessment will be covered, including identifying potential risks, assessing safety and efficacy, and implementing risk mitigation strategies.
• Interactive Exercises and Case Studies: Participants will engage in hands-on activities, group discussions, and analysis of real-world case studies to reinforce learning and practical application of classification and risk assessment concepts.
• Regulatory Compliance and Documentation: The importance of proper documentation and regulatory compliance throughout the product lifecycle will be emphasized, along with post-market surveillance and reporting obligations.
• Real-world Applications and Best Practices: Success stories, lessons learned, and best practices for effective classification and risk management will be shared to provide practical insights and guidance.

Overall, the training provides a comprehensive overview of product classification and risk assessment, equipping participants with the knowledge and skills necessary for regulatory compliance and successful product development.

WHO SHOULD ATTEND:

• Regulatory Affairs Departments
• Product Development Teams
• Quality Assurance Departments
• Clinical Research Professionals
• Compliance Officers
• Engineering Departments
• Manufacturing Departments
• Production Departments
• Operations Departments
• Scientists
• Consultants and Contractors

Course Director: MEREDITH CRABTREE

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.