The podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)/Q14 for analytical validation, Q5(R2) for viral safety evaluation, and Q9(R1) for quality risk management. The text also examines the ICH's efforts to address emerging technologies in cell and gene therapy and real-world data utilization for safety assessments. Finally, the text discusses the impact of the ICH Biannual Assembly held in June 2024, including progress updates on current guidelines, the introduction of new proposals, and the harmonization of regulatory requirements across different regions.

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The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pharmaceutical industry, emphasizing reducing subjectivity and integrating knowledge into risk-based decision-making. The update encourages the use of digital tools and emerging technologies to control risks, and it aims to improve industry consistency and regulatory oversight. The updated guidelines promote a shift to more objective risk assessments, ultimately contributing to a safer and more reliable pharmaceutical industry by reducing quality defects and improving patient outcomes.

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This Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the importance of these documents for demonstrating a product's quality, navigating the regulatory review process, and achieving global market access. They also provides best practices for authoring these documents, common pitfalls to avoid, and strategic advice for optimizing their use. The discussion emphasizes the QOS as a critical component for communicating with regulatory authorities and justifying deviations from standard guidelines, thus streamlining the review process.

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This podcast covers the common regulatory challenges faced by professionals working in the pharmaceutical and biotechnology industries. The authors provide seven scenarios, ranging from an unexpected clinical hold to difficulty obtaining budget approval for regulatory activities, and present solutions for each. These solutions include strategies for effective communication with regulatory agencies, proactive planning, and utilizing readily available resources. The document emphasizes the importance of preparation and a proactive approach to navigating the complex regulatory landscape.

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The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It emphasizes aligning stability protocols with regulatory guidelines from bodies like the FDA and EMA, focusing on key aspects like study design, storage conditions, analytical method validation, quality control, and forced degradation studies. The episode also highlights the need for data integrity, clear scope definition, and container compatibility, underscoring how a strong stability protocol ensures drug quality, safety, and efficacy throughout its shelf-life, supporting successful NDA/BLA submissions.

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The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-IND, Post-IND but pre-clinical trials, and late development before submission—each with its own advantages and challenges. Early-stage definitions offer flexibility but limited regulatory guidance, mid-stage definitions align with initial regulatory interactions but reduce flexibility, while late-stage definitions are data-backed but difficult to adjust. The episode emphasizes balancing flexibility and regulatory alignment, advocating for a collaborative, data-driven approach to ensure efficient development and compliance.

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The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, and marketing comply with regulatory standards. The source details the key functions of CMC RA, such as regulatory strategy development, submission management, and compliance monitoring, and highlights the importance of collaboration with various departments, such as research and development, manufacturing, and quality assurance. Additionally, it provides insights into the day-to-day work of CMC RA professionals, emphasizing the need for clear communication, detailed documentation, and a deep understanding of regulatory guidelines. Finally, it emphasizes the human side of CMC RA, encouraging professionalism, courtesy, and cooperation amongst teams.

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This article argues that strategic outsourcing, particularly for Small Molecule APIs, is a key component of successful drug development. It outlines the benefits of outsourcing for pharmaceutical companies, including cost reduction, increased focus on R&D, and faster time-to-market. The article also emphasizes the importance of regulatory strategy and highlights how Enkrisi, a company specializing in drug development consulting, can help pharmaceutical companies navigate complex regulatory requirements. The article concludes by presenting case studies demonstrating the successful implementation of outsourcing strategies for various pharmaceutical companies.

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