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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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    New Drug Development and Clinical Trials

    An essential overview of the drug development process, guiding learners through the stages from initial research to regulatory approval. This module covers the intricate path of new drug discovery, nonclinical studies, clinical trials, and regulatory requirements. It emphasizes the critical roles of safety, efficacy, and quality in developing new drugs and provides insight into the regulatory framework designed to protect patient health. Learners will explore each stage of development in depth, from lab-based research to Phase I-IV clinical trials and understand the importance of compliance and data integrity throughout.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins
    Grade: Core Library

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    SKU: CTM-1100-SPL01-EN Category: Tag:

    Description

    Learning Objectives:

    • Give an overview-level explanation of the drug development process and the various phases of clinical trials
    • Explain why the development and testing of new drug products must be regulated
    • Explain the term: Good Clinical Practice (GCP)
    • Describe the most important characteristics of a drug product

    Learner Benefits:

    • Comprehensive Understanding of Drug Development: Gain a clear understanding of the entire drug development process, including research, nonclinical studies, clinical trials, and regulatory approval, equipping you with the knowledge needed to navigate the complexities of the pharmaceutical industry.
    • In-depth Knowledge of Safety, Efficacy, and Quality: Learn the importance of ensuring the safety, efficacy, and quality of drugs, and how regulatory agencies enforce these standards to protect public health.
    • Awareness of Regulatory Compliance: Understand the critical role of regulatory bodies like the FDA and EMA in drug approval and how pharmaceutical companies must comply with stringent guidelines to bring new drugs to market.
    • Insights into Clinical Trial Phases: Explore the details of Phase I-IV clinical trials, including their objectives, methodologies, and how each phase contributes to determining a drug’s safety and effectiveness.
    		 Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    • ADME (Absorption, Distribution, Metabolism, Excretion)
    • Clinical Trials
    • Drug Discovery
    • EMA
    • FDA
    • New Drug Development
    • Pharmacology
    • Toxicology

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