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Radha Nadimpalli

ICH QUALITY GUIDELINES

Health & Medicine

The document summarizes updates from New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) and manufacturing quality branch. It discusses the proposed Therapeutic Products Bill, which will modernize regulation of medicines, medical devices, and other therapies. It also covers GMP code updates, electronic submissions, and fees reviews. The COVID-19 pandemic has significantly impacted on-site GMP inspections internationally, requiring increased reliance on remote inspections and information sharing between regulatory authorities.

ARCS presentation_Radha.pptxRadha Nadimpalli

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The document discusses new regulations for medicinal cannabis in Australia. It outlines requirements for good manufacturing practices that products imported to Australia must meet to ensure quality. This includes being manufactured in countries that comply with specified GMP standards. It also discusses new labeling and packaging guidelines to promote safe use, as well as approval requirements for compounding medicinal cannabis products.

Presentation.pptxRadha Nadimpalli

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The document outlines the regulatory application process for pharmaceutical products in India. It describes the different types of applications including new drugs, variations, generics, and extensions. It lists the key application categories and types. The document also describes the dossier requirements including quality, safety and efficacy data. Finally, it outlines the 8 phases and milestones of the application review process from pre-submission to post-decision activities.

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The document outlines key SEO and content marketing trends for 2024, emphasizing the impact of AI, the importance of E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness), and a shift towards user-centric content strategies. It advises against focusing on outdated trends like voice search and stresses the need for creating value-driven, authoritative content. Additionally, it highlights the need to leverage AI as a supportive tool rather than relying solely on it for content creation.

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The document outlines a livestream presentation by Chiara Aliotta on integrating storytelling into web design to enhance user experiences. It covers the storytelling process for designers, emphasizing aspects such as understanding the audience, structuring narratives, and creating emotional connections. The presentation also includes case studies and practical examples to demonstrate effective storytelling in UX/UI design.

Artificial Intelligence, Data and Competition – SCHREPEL – June 2024 OECD dis...OECD Directorate for Financial and Enterprise Affairs

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This presentation by Thibault Schrepel, Associate Professor of Law at Vrije Universiteit Amsterdam University, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp. This presentation was uploaded with the author’s consent.

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The document discusses leveraging AI to enhance employee wellness through data analytics, automating tasks, and personalized wellness apps, emphasizing the shared responsibility of employee well-being between leaders and organizations. It outlines best practices for using AI in wellness strategies, including ensuring data privacy and security, understanding employee needs, and promoting inclusivity. Lydia Di Francesco, a wellness specialist, shares insights to optimize workplace wellness strategy using AI-driven data analytics and encourages collaboration and transparency.

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The State of Marketing 2024 report highlights the transformative impact of AI and automation, emphasizing the importance of personalization and engagement to drive growth in a competitive landscape. Marketers are focusing on optimizing budgets, leveraging social media for brand awareness, and utilizing AI tools to enhance efficiency across tasks. Key trends for 2024 include the rise of experiential marketing, content creation that meets user needs, and strengthened connections through personalized customer experiences.

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Chair, Allison Agwu, MD, ScM, FAAP, FIDSA, discusses HIV in this CME/MOC/NCPD/CPE/AAPA/IPCE activity titled “Unlocking the Potential of Long-Acting PrEP to Halt HIV Transmissions.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/40Mr2AC. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until June 12, 2026.

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An ancient System for holistic health (mental and physical) and wellbeing, is a scientific art of living with harmony (connecting) of mind and body. Although much more ancient than Patanjali, who documented yoga systematically about 2000 years ago, Patanjali is often referred to as the "father of modern yoga." Yoga postures are commonly depicted in ancient paintings, carvings, and sculptures in almost all civilizations and religions, thus Yoga can’t be described as an act of Hinduism. It originated long before any religion on Earth, with the emergence of life on the Planet. All yoga poses are natural, and what is not natural is not yoga; it is��Viyoga. Besides Vedic Yoga, Hatha, Vinyasa, Ashtanga, Iyengar, Yin, Restorative, Kundalini, Bikram, Sahaj, and Power yoga are some popular types. Vinyasa��Yoga is the closest form to Vedic Yoga; it is known for its flowing movements, not very rigorous, not too much straining, actions flow with the breath. Though all yoga may lead to meditation (Dhyan) for your inner upliftment, it is not the same as described in Hinduism for self-liberation. In Hinduism, different paths of life looking distinct but can be practiced all together, they are: Karma Yoga (selfless action and service), Bhakti Yoga (devotion and love for God or Godly power), Jnana (Gyan) Yoga (gaining knowledge for self-realization through wisdom), Dhyan Yoga (meditation) and Kriya Yoga (optimum utilization of your vital and muscular energy).��

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The Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC) collaborate closely to produce the globally recognized TNM Classification of Malignant Tumours. Therefore, when discussing the "9th edition of UICC head and neck staging," it's largely in alignment with the updates introduced by the AJCC's Version 9. The UICC's TNM Core Committee finalized the 9th edition of the TNM Classification, with publication anticipated in August 2025. The key updates for head and neck cancers in the 9th edition (or Version 9) reflect an ongoing effort to improve prognostic accuracy and align staging with contemporary clinical understanding and treatment outcomes. Here are the significant changes, particularly those relevant to head and neck: * Emphasis on Personalized Care and Prognostic Refinements: The 9th edition reflects a greater focus on personalized care, incorporating refinements that aim to better predict patient outcomes. * Revised Criteria for Specific Head and Neck Cancers: * Nasopharyngeal Carcinoma (NPC): This site has seen substantial revisions, as highlighted in the previous response on AJCC updates. Key changes include: * More precise definition of T3 disease (unequivocal evidence of bone involvement). * Introduction of advanced radiologic extranodal extension (ENE) as an N3 criterion. This acknowledges the prognostic impact of ENE seen on imaging. * Subclassification of M1 disease into M1a (3 or fewer metastatic lesions) and M1b (more than 3 lesions) to better stratify prognosis in metastatic settings. * Redefined Stage Groups for NPC, with T1-2N0-1 now often falling into Stage I, and Stage IV being exclusively for metastatic disease, further subdivided by the M1a/M1b categories. * Salivary Gland Cancers: Revised criteria based on updated imaging and anatomical features are being incorporated. * HPV-Related Oropharyngeal Cancers: New staging is introduced for HPV-associated oropharyngeal cancers to better reflect their distinct biological behavior and prognosis, which is generally more favorable than HPV-negative oropharyngeal cancers. This often involves specific considerations for nodal burden. * Integration of Imaging and Anatomical Features: The updates are grounded in recent evidence, incorporating insights from advanced imaging techniques and a deeper understanding of anatomical spread. * International Collaboration: These updates are the result of collaborative efforts between the AJCC and UICC, involving input from cancer registries, clinical outcomes data, and disease-specific experts worldwide. The goal is to provide a unified and globally applicable staging system. * Dynamic Update Process: Similar to the AJCC's shift from "Editions" to "Versions" for specific sites, the UICC is also exploring more flexible ways to share future TNM updates. In essence, the 9th edition of the UICC staging system for head and neck cancers, particularly in areas like NPC and HPV

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