Introduction to an Evidence-Based Review System

Learning Objective: Understand the regulatory landscape and frameworks that guide the evidence-based review process for health claims.

Description: Introduce the principles and frameworks of evidence-based review systems, focusing on regulatory guidelines and standards.

Skills Required:

1. Navigating Complex Regulatory Documents and Guidelines: Participants will learn how to effectively read and understand complex regulatory documents such as FDA guidelines, European Food Safety Authority (EFSA) opinions, and other regulatory bodies’ documents.
2. Interpreting Legal and Scientific Standards Affecting Product Claims: This skill involves deciphering the legal language and scientific requirements that must be met for health claims. Participants will learn how to interpret these standards to ensure that product claims are both compliant and scientifically substantiated.

Week 1 Wrap-up:

The week will conclude with a quiz covering key regulatory terms and concepts introduced during the week. This assessment aims to reinforce the participants’ understanding and ensure they are well-prepared to apply these insights in subsequent modules. This foundational knowledge sets the stage for deeper dives into specific aspects of evidence-based review and claim substantiation in the weeks to follow.

Takeaway: Participants will learn how to navigate and apply the foundational regulatory frameworks, including the Federal Food, Drug, and Cosmetic Act.

Surrogate Endpoints for Disease Risk

Learning Objective: Identify and justify the use of surrogate endpoints in clinical trials and health claim substantiation.

Description: Surrogate endpoints are essential for substantiating health claims without the need for long-term clinical outcomes. Detailed exploration of surrogate biomarkers and their role in predicting and measuring disease outcomes.

Skills Required

1. Selecting Appropriate Surrogate Endpoints: Participants will learn how to choose surrogate endpoints that are scientifically valid and accepted by regulatory agencies for specific conditions.
2. Understanding the Validation Process: This includes understanding how surrogate endpoints are validated through clinical research and statistical analysis to predict or correlate with clinical outcomes.
3. Impact on Regulatory Approval: Insight into how the use of validated surrogate endpoints can accelerate the regulatory review process and support the approval of health claims.

Application in Product Development:

Participants will engage in exercises where they select an appropriate surrogate endpoint for a hypothetical health product intended to manage or treat a specific condition. They will justify their selection based on current scientific understanding and regulatory guidelines, preparing them to handle similar tasks in real-world scenarios efficiently. This week’s learning will culminate in drafting a proposal for a health claim based on the surrogate endpoint they have selected, which will be critiqued and refined with feedback from the instructor and peers. This approach ensures that participants not only understand the theory behind surrogate endpoints but also gain hands-on experience in applying this knowledge in a practical setting.

Takeaway: Gain expertise in selecting and justifying appropriate surrogate markers for health claim substantiation in product development.

Understanding Human Study Designs

Learning Objective: Evaluate the strengths and limitations of various human study designs used in clinical research.

Description:Proper study design is crucial for generating robust, reproducible data that can withstand regulatory scrutiny. Examination of various experimental and observational study designs, including randomized controlled trials (RCTs), cohort studies, and case-control studies.

Skills Required

Designing and critiquing experimental and observational studies; enhancing study reliability and validity.

Takeaway: Learn to design, critique, and optimize study designs to ensure they effectively address research hypotheses and meet regulatory standards.

Evidence-based Review Methodology: PRISMA/MOOSE

Learning Objective:Apply PRISMA and MOOSE guidelines to conduct systematic reviews and meta-analyses.

Description: Adherence to these guidelines ensures transparency, reproducibility, and reliability of literature reviews. In-depth training on PRISMA and MOOSE guidelines for conducting and reporting systematic reviews and meta-analyses.

Skills Required

Structuring and conducting comprehensive literature reviews; critical analysis of existing research; documenting reviews to meet international standards.

Takeaway:Master the skills necessary to perform and document systematic reviews and meta-analyses that contribute to evidence-based practice.

Evaluating the Evidence: Rigor of Evidence

Importance:Critical evaluation of evidence quality underpins the credibility of health claims and recommendations.

Description: Techniques for assessing the quality and rigor of research evidence using tools like the GRADE system.

Takeaway:Develop proficiency in critically appraising study reliability, bias, and validity to ensure robust conclusions.

Claim Languages for Qualified Health Claims

Learning Objective: Assess the methodological quality of research and the rigor of the evidence using established tools.

Description: Accurate claim language is vital for legal compliance and consumer trust, avoiding misrepresentation of product benefits. Strategies for crafting precise and compliant language for health claims that reflect the strength of the scientific evidence.

Skills Required

Grading the quality of evidence; identifying biases and evaluating the impact on study conclusions.

Takeaway:Learn to develop clear, scientifically justified health claims that align with regulatory guidelines and consumer expectations.

Capstone: Development of Functional Product – Theoretical

Learning Objective: Develop accurate and legally compliant health claim language based on scientific evidence.

Description: This synthesis of prior learning simulates the process of functional product development from concept to market strategy. Application of theoretical knowledge to formulate a functional product concept, incorporating bioactive components and health claims.

Skills Required

Crafting clear and effective health claims; understanding regulatory requirements for claim wording.

Takeaway:Create a comprehensive product development plan, including target market analysis, product formulation, and health claim integration.

Developing a Product with Defined Dose as per the FDA – Practical

Learning Objective:Formulate a theoretical functional product incorporating bioactive ingredients and health claims.

Description:Ensures that the final product is safe, effective, and compliant with all necessary regulations for market entry. Practical implementation of a developed product, focusing on dosage calculations, stability testing, and regulatory compliance.

Takeaway:Execute a full-scale development process, from dosage formulation to preparing for clinical trials and regulatory submission.