Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
The Changing Landscape of Clinical Research Regulations: Updates and Implicat...ClinosolIndia
The landscape of clinical research regulations is constantly evolving to adapt to the changing needs of the research community, advancements in scientific understanding, and the protection of research participants. Here are some key updates and implications that have shaped the current state of clinical research regulations
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
The Changing Landscape of Clinical Research Regulations: Updates and Implicat...ClinosolIndia
The landscape of clinical research regulations is constantly evolving to adapt to the changing needs of the research community, advancements in scientific understanding, and the protection of research participants. Here are some key updates and implications that have shaped the current state of clinical research regulations
Role of Drug Regulatory agencies in Clinical Research.ClinosolIndia
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Drug regulatory agencies play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products, including drugs, biologics, and medical devices. These agencies are responsible for establishing and enforcing regulations and guidelines that govern the development, testing, approval, manufacturing, labeling, marketing, and post-market surveillance of these products.
Regulatory Update Panel
An overview of all Health Canada policies supporting access to Drugs for Rare Diseases, including regulatory pathways and support for innovation, patient engagement, Special Access Programs, aligned HC/CADTH/INESSS, international harmonization, post-market monitoring, support for patient registries, current status and relevance of biosimilars for rare disease patients
Rare Disease Day Conference 2020 March 9-10
Role of drug regulatory agencies in Clinical ResearchClinosolIndia
Drug regulatory agencies play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. These agencies are responsible for regulating and overseeing the development, approval, manufacturing, labeling, and post-marketing surveillance of drugs. Their primary objectives include safeguarding public health and facilitating access to safe and effective medications. Here are key roles and responsibilities of drug regulatory agencies
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
The Impact of Real-World Data in Pharmacovigilance and Regulatory Decision-Ma...ClinosolIndia
Real-world data (RWD) has gained significant importance in pharmacovigilance and regulatory decision-making processes. Real-world data refers to data collected from routine clinical practice, including electronic health records (EHRs), claims databases, registries, and other sources, outside the controlled environment of clinical trials. Here are some key impacts of real-world data in pharmacovigilance and regulatory decision-making
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
Data Standards and Interoperability in Clinical Research and Data ManagementClinosolIndia
Data standards and interoperability play a crucial role in clinical research and data management. They ensure that data collected from various sources can be effectively shared, integrated, and analyzed across different systems and organizations. Here's an overview of data standards and interoperability in the context of clinical research and data management
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
Canada’s regulatory approach to drugs for rare diseases - Fiona Frappier, Health Canada
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
Data Privacy and consent management .. .ClinosolIndia
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
Clinical data security and Integrity in Clinical ResearchClinosolIndia
Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation.
Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.
Pharmacovigilance in Patriatics and GeriatricsClinosolIndia
Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.
Presenting- Signal mining in PharmacovigilanceClinosolIndia
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa NizamiClinosolIndia
Blogs, presentations, and review articles stand as dynamic mediums, each with its unique power to engage, inform, and influence. Blogs, the conversational storytellers; presentations, the visual orchestrators; and review articles, the comprehensive knowledge curators, collectively play pivotal roles in shaping how we share, learn, and explore diverse subjects. This exploration delves into the distinct characteristics and purposes of these forms of communication, unveiling the art of effective expression and knowledge sharing in the digital age.
Patient-Centric Approaches in Precision Medicine Trials: Strategies for SuccessClinosolIndia
Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...ClinosolIndia
Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...ClinosolIndia
The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
Regulatory Considerations in Precision Medicine: Navigating the Approval ProcessClinosolIndia
Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
Emerging Technologies and Tools in Precision Medicine ResearchClinosolIndia
Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success StoriesClinosolIndia
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...ClinosolIndia
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Integration of Clinical Trial Systems: Enhancing Collaboration and EfficiencyClinosolIndia
Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...ClinosolIndia
Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision MedicineClinosolIndia
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical TrialClinosolIndia
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision MedicineClinosolIndia
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
Innovations in Liquid Biopsies for Precision Cancer DiagnosisClinosolIndia
Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.
Machine Learning Algorithms for Predictive Analytics in Precision MedicineClinosolIndia
The integration of machine learning algorithms for predictive analytics in precision medicine represents a powerful tool for extracting meaningful insights from diverse and complex datasets. As the field continues to evolve, these algorithms play a crucial role in advancing our understanding of individualized treatment strategies, improving patient outcomes, and ultimately shaping the future of personalized healthcare.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Pharynx and Clinical Correlations BY Dr.Rabia Inam Gandapore.pptx
Introduction to Clinical Research Regulations
1. Welcome
Introduction to clinical Research Regulations: Understanding
Regulatory landscapes
P.HEMALATHA
PHRM.D 6yr
ID N0:093/052023
10/18/2022
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1
2. Index
• Introduction
• Regulatory bodies in India
• Regulatory frame work in India
• The world wide Regulations
• Understanding Regulatory Landscapes.
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2
3. Introduction to clinical Research
• Clinical research is a branch of healthcare science that determines the safety
and effectiveness (efficacy) of medications, devices, diagnostic products
and treatment regimens intended for human use.
• Interventions include but or not restricted to drug, cells and other biological
products, surgical procedures, Radiological procedures, Devices, behavioral
treatment, Process-of-care changes, preventive care, etc.
• Synthetic study of new drugs in human subjects to generate data for
discover and/ or verifying.
• The clinical pharmacological(including pharmacodynamics and
pharmacokinetics) effux.
• And/or adverse effects, if the objective of determination safety and/or
efficacy.
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3
4. Clinical Research Regulations
Why are Regulation important to clinical Research?
• Regulations has been set to Ensure integrity of data collected from clinical
trials which assure the safety, right and welfare of the subject.
• Clinical trials are the only way of establishing the safety and efficacy of any
new drug before its introduction in the market for human use. Clinical trials
(with safeguards) are necessary for introduction of new drugs for a country
like India, considering its disease burden and emergence of new variants of
disease.
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4
5. • The regulatory bodies need to frame guidelines and regulatory approval
processes on a par with international standards. Many of the new laws, guidance
documents, notifications and initiatives for regulating pharmaceutical industry
were in the charts for quite a long time. Indian regulatory authorities have
started looking into speedy implementation and providing support in terms of
necessary infrastructure and investment.
• CDSCO which comes under the Ministry of health and family welfare Is the
main body which works On development of regulatory Procedures And
standard for drugs, cosmetics, diagnostics and devices. It lays down regulatory
guidence by amending acts and rules; and regulate new drugs approvals. Its
main objective is to standardize clinical research and bring safer drugs to
market.
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6. Clinical Research Regulations in India
• Schedule y allows Clinical trials to be carried out in India.
• India has appropriate provisions to ensure the human subjects used
for the trails are informed Well and their participation is voluntary.
• CDSCOs priorities to enhance the current mechanism
• Establish single window clearance for approvals.
• Fix timelines for each application(2-6 weeks).
• Subject experts-reviewers – internal/external.
• Staff and infrastructure at one site.
• Continuous training for the officers.
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7. Regulatory bodies in India
• Central Drugs Regulatory body Standard Control controlled and Organization
governed by
•
• (CDSCO) drug directorate General of Health Services of Ministry of Health
and Family Welfare which regulates drugs in India
• Drugs Controller Regulatory agency General India (DCGI):
Under the government of India whose function is to assess the quality, safety and
efficacy of a drug.
• Indian Council of Medical Research (ICMR);
Apex body in India that formulates, co-ordinates and promotes biomedical
research
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8. • Drugs consultative committee (DCC);
Provides technical guidance to the central drug standard control organization
• Central Drugs Laboratory (CDL);
National statutory laboratory of the Indian government for quality control of drugs.
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• Drugs Technical Advisory Board (DTAB)
Provides technical guidance to the CDSCO
9. Regulatory frame work in India
• (Text here)
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10. The world wide Regulations
• USA : United States food and drug administration(USFDA)
• INDIA : Central drug standard control organization(CDSCO)
• CANADA : Health Canada – sante canada
• AUSTRALIA : Therapeutic goods administration( TDA)
• UK : Medicine and health care products and regulatory
Agencies (MHRA).
• EUROPE : European medicines agency(EMEA)
• SWITZERLAND : Swissmedic
• JAPAN : Ministry of health and labour welfare(MHLW)
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11. • Regulators desire good proof-of-concept studies, leading to representative clinical trials
that can then, in turn, result in appropriate clinical practice guidelines and performance
measures.
• Regulators are also increasingly focused on sustainability, which may be achievable by
simplifying trials and enrolling representative populations and through the use of real-
world data or drug-product monitoring registries.
Another way to help sustainability is early health technology assessment (HTA)
evaluation.
• Integrating clinical research networks is one way to ensure more efficient trails.
• The patient's voice in particular has become increasingly important to regulators in
defining the value of a medicine, yet incorporating patients' viewpoints into clinical trials
may further increase the complexity of those trials.
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Regulatory landscapes
12. • Regulators have been pushing for increased data sharing to promote efficiency and
ensure continued progress.
• There is a need for new regulatory approaches for combining passive and
experimental data that would meet the needs of the 21st century.
• Drug-product monitoring registries enable tracking of longitudinal outcomes and
adverse effects.
• Randomization with a registry enables real-world testing of hypotheses.
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13. Thank You!
www.clinosol.com
(India | Canada)
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info@clinosol.com
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