Drug regulatory authority - PowerPoint PPT Presentation


Age-Friendly App: Managing Drug-Drug Interactions Between Prescriptions and OTC Analgesics

The Age-Friendly app addresses the crucial issue of drug-drug interactions between current prescriptions and over-the-counter analgesics in the geriatric population. With a significant percentage of OTC sales attributed to older adults, there is an increased risk of adverse drug events due to polyph

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Understanding Delegation of Authority and Management by Objectives

The lesson on delegation of authority and management by objectives covers the process of delegating authority, implementing authorities, management by objectives, and the importance of preparedness plans and agreements. It discusses the authority having jurisdiction, scope of authority, and the dele

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Five Dimensions to Our Spiritual Authority

Explore the five dimensions of spiritual authority - Redemptive, Inherited, Positional, Delegated, and Empowered authority - outlined in the context of Christ's triumph and our identity as children and heirs of God. Scriptures from Romans 8:16-17 and Galatians 4:6-7 emphasize our position as joint h

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Understanding Regulatory Requirements of Drugs and Pharmaceuticals

Drug regulation involves controlling drug use through international agreement authorities like the FDA, EMA, and PMDA. The FDA plays a crucial role in drug evaluation and research, biologic evaluation, devices, and food safety. There are various types of applications for drug approval, along with a

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Understanding Delegation of Authority in Management

Delegation of authority in management is a crucial process where managers assign tasks to subordinates, allowing them to exercise authority on their behalf. Louis A. Allen defined authority as the rights entrusted to a position holder to enable task performance. Effective delegation involves element

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Understanding the NDA and ANDA Regulatory Approval Process

The New Drug Application (NDA) submission process to the FDA involves extensive documentation of non-clinical, clinical, and drug chemistry data to support the product's labeling. Key decisions during the FDA review include evaluating the drug's safety, effectiveness, labeling, manufacturing methods

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Developing an Effective Regulatory Experience Feedback Program for Safety: A Guide for Regulatory Bodies

This Safety Guide aims to assist regulatory bodies in managing regulatory experience by identifying sources, establishing means for information exchange, and implementing record-keeping processes. It addresses the need for cooperation and knowledge sharing among regulatory bodies to enhance safety s

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Polymeric Controlled Drug Delivery Systems

Polymeric controlled drug delivery systems play a crucial role in regulating drug release through diffusion, solvent penetration, and chemical mechanisms. These systems include diffusion-controlled, solvent-controlled, and chemically-controlled devices, each operating based on specific principles. S

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Renal Pharmacology: Drug Excretion and Renal Clearance Questions

This comprehensive set of questions and answers covers topics related to drug excretion and renal pharmacology. It includes information on glomerular filtration, drug excretion mechanisms, dosage adjustments in renal impairment, factors influencing drug excretion, and the effects of long-term NSAID

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Understanding Nasopulmonary Drug Delivery System

Nasopulmonary drug delivery system, utilizing the nasal route for drug administration, offers advantages such as hepatic first-pass metabolism avoidance and rapid drug absorption. This system is beneficial for pharmacologically active compounds with poor stability in gastrointestinal fluids. While i

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Dimensions of Spiritual Authority: Five Empowering Realms in Christ

Explore the five dimensions of spiritual authority rooted in Christ's triumph, our identity as sons and daughters of God, our authority in Christ, the delegated authority as Christ's representatives, and the empowered authority through the anointing. Delve into how Jesus ministered under the anointi

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Presentation on Central Drug Authority's 2021/2022 Annual Report

This presentation focuses on briefing the Select Committee on Health and Social Services regarding the Central Drug Authority's (CDA) annual report for 2021/2022. It highlights the progress made in implementing the National Drug Master Plan and emphasizes the CDA's role in coordinating efforts again

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Understanding Physicochemical Properties of Drugs

The physicochemical properties of drugs play a crucial role in their pharmacological effects. These properties include physical and chemical characteristics that influence interactions with biomolecules. Solubility, partition coefficient, and dissociation constant are key factors affecting drug beha

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Understanding Formulary Systems in Healthcare

A formulary is a dynamic list of medications curated by healthcare professionals to guide drug selection based on efficacy, safety, cost, and patient acceptability. It plays a vital role in promoting evidence-based and cost-effective drug therapy, improving communication between prescribers and phar

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Overview of Central and State Drug Regulatory Bodies in India

Drug Regulatory Authority plays a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products in India. Governed by both Central and State Governments, key bodies such as CDSCO and DCGI regulate the importation, distribution, and promotion of drugs. Ministry of Health & Fam

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Ways to Stay Drug Free: Lessons for Teens and Families

Understanding the reasons behind drug usage among teens, this lesson provides valuable resources and strategies to stay drug-free. It emphasizes the importance of making healthy decisions and offers alternatives to drug use. Additionally, it highlights the significance of saying no to drugs, provide

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Hepatitis B Vaccines: Genuine vs Counterfeit - Insights from Uganda National Drug Authority

Explore the difference between genuine and counterfeit Hepatitis B vaccines in Uganda, as detailed by the National Drug Authority. Learn about the authorized vaccine on the market, counterfeit batch numbers, fake addresses on invoices/receipts, and the availability of vaccines in private sectors. St

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Understanding the Hatch-Waxman Act: Promoting Affordable Generic Drugs

The Hatch-Waxman Act, also known as The Drug Price Competition and Patent Term Restoration Act, was enacted in 1984 to amend patent laws and the Federal Food, Drug, and Cosmetic Act. It aims to reduce costs associated with generic drug approval, allow early experimental use, compensate branded drug

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Safety Considerations and Regulatory Definitions in Drug Evaluation

This presentation by Ramy Abdelrahman, MD, delves into safety considerations, regulatory definitions, and practical responsibilities in drug evaluation. It covers adverse events, suspected adverse reactions, and reporting responsibilities for investigators and sponsors. The content emphasizes making

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Understanding Biopharmaceutics: pH Partition Theory and Drug Absorption

Biopharmaceutics explores how drug properties and administration methods impact drug absorption. Factors affecting oral absorption include membrane physiology and drug partitioning based on pH levels. The pH partition theory, explained by Brodie et al., highlights the role of drug lipid solubility a

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Importance of In-Vitro Dissolution Testing in Drug Assessment

In drug development, in-vitro dissolution testing plays a crucial role in evaluating drug release from tablets when in-vivo bioavailability studies are limited. By ensuring drug release is close to 100% and uniform batch to batch, these tests help assess drug availability and effectiveness. Regulato

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Understanding Pharmacodynamics: Potency and Efficacy

Pharmacodynamics explores how drugs interact with receptors in the body, affecting the magnitude of drug effects based on concentration. Graded dose-response relationships, potency, and efficacy play key roles in determining drug efficiency. Potency reflects the amount of drug needed for a specific

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Understanding Drug Absorption, Excretion, and Bioavailability in Humans

Delve into the complex processes of drug absorption, excretion, and bioavailability in the human body. Learn about the various factors affecting drug absorption from the gastrointestinal tract, including biological, physiochemical, and pharmaceutical factors. Explore the mechanisms of drug transport

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Understanding Quantitative Aspects of Drug Action

Explore the quantitative aspects of drug action, including drug receptor binding, concentration binding curves, dose-response curves, and types of antagonism. Learn to relate drug concentration to receptor binding capacity and response produced. Discover how concentration binding curves and dose-res

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Review of DRE School and Drug Evaluation Techniques

Explore key topics such as the definition of drugs for DRE purposes, basic drug statistics, review of symptomatology, and vital signs assessment in the context of Drug Recognition Expert (DRE) training. Learn about CNS depressants, stimulants, hallucinogens, and analogs, as well as vital signs like

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Study on Juvenile Drug Crime Prevention in Taiwan: Insights from ACS Conference 2020

This presentation at the Asian Criminological Society Conference 2020 delves into the current situation, dilemmas, and responses regarding juvenile drug crime prevention in Taiwan. The presenter, Zeng Li-Wen, a PhD student at Central Police University in Taiwan, provides valuable insights based on t

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Understanding Drug Abuse: Definitions, Effects, and Stages

Drug abuse is a serious issue involving various substances like prescription drugs, alcohol, and illegal drugs. This includes terms and definitions, effects on the body and mind, stages of addiction, and withdrawal symptoms. Factors influencing drug action and reasons for drug use are also explored.

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Understanding Drug Targets and Mechanisms of Action

Explore the intricate world of pharmacokinetics and pharmacodynamics, from drug absorption to their interaction with biological molecules. Learn about different drug targets, such as proteins and ions, and how drugs alter their biochemical and biophysical activities. Dive into molecular mechanisms o

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International Day Against Drug Abuse and Illicit Trafficking 2022 Initiatives and Awareness

The United Nations observes 26th June as the International Day Against Drug Abuse and Illicit Trafficking to combat substance abuse worldwide. Various initiatives like the National Drug Master Plan, Nasha Mukt Bharat Abhiyaan, and the National Action Plan for Drug Demand Reduction aim to raise aware

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Comprehensive Review of Drugs, Categories, and Drug Influence Evaluation

This mid-course review covers key aspects such as defining drugs, naming drug categories and subcategories, identifying drug categories for specific drugs, components of drug influence evaluation, and examinations conducted as part of the evaluation process. The content also includes identifying dru

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Impact of Socioeconomic Conditions on Drug Use Disorders: Insights from World Drug Report 2020

The World Drug Report 2020 highlights the strong correlation between socioeconomic factors and drug use disorders. Studies reveal that communities facing poverty, violence, and social inequality are at a higher risk of drug overdoses and addiction. Factors like income inequality, lack of social capi

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CITES Tasks and Methods in the Netherlands - Scientific Authority Overview

The Netherlands has a Scientific Authority for CITES tasks and methods, playing a crucial role in the Convention on International Trade in Endangered Species of Wild Fauna and Flora. This independent body advises the Management Authority and assists in preventing extinction due to international trad

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Understanding Targeted Clinical Investigation in Pharmacovigilance

Targeted clinical investigation plays a crucial role in pharmacovigilance by further evaluating significant risks identified in pre-approval clinical trials. This involves conducting pharmacokinetic and pharmacodynamic studies, genetic testing, interaction studies, and large simplified trials to ass

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Awakening to Spiritual Authority in Christ

Christians often overlook their true identity and authority in Christ, hindering their ability to wield spiritual authority effectively. The ignorance within the Church has allowed Satan to thrive. It is crucial for believers to awaken to the reality of spiritual warfare, comprehend the disparity be

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Airports Economic Regulatory Authority of India - Regulatory Overview

The Airports Economic Regulatory Authority of India (AERA), established in 2009, regulates major airports to facilitate aviation sector growth, protect user interests, and promote investment. AERA sets tariffs, development fees, and monitors service quality to ensure efficient airport operations. Th

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Advances in Ophthalmic Drug Delivery Systems

This content explores various advanced ophthalmic drug delivery systems including erodible ophthalmic inserts, soluble ocular drug inserts, new ophthalmic drug delivery systems, and bioadhesive ophthalmic drug inserts. These innovative systems aim to provide accurate dosing, prolonged drug release,

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State Responsible Inmates with Marijuana Convictions Research Report

Research conducted by VADOC indicates a total of 570 state responsible inmates incarcerated for marijuana-related offenses as of August 31, 2021. Among them, 229 inmates had non-drug-related Most Serious Offenses, 331 were convicted for Drug Sales MSO, and 10 were convicted for Drug Possession MSO.

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Innovative Online Learning for Drug Court Professionals

Center for Court Innovation has introduced a new National Drug Court Online Learning System aimed at assisting drug court professionals. This system offers free access to web-based training, expert video lessons, virtual site visits to drug treatment courts, practitioner interviews, and a resource l

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Understanding Drug Testing Policies in the Workplace

The Drug-Free Workplace Act of 1988 mandates federal grant recipients to implement zero-tolerance drug policies to maintain a drug-free environment. Employers must establish clear policies, conduct awareness programs, offer counseling and rehabilitation services, and impose penalties for violations.

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Insights on Authority and Wisdom in Life

Exploring the concepts of wisdom, authority, and righteousness through a biblical lens, this collection of images and verses prompts reflection on one's approach to authority and decision-making. It emphasizes listening to the right voices, leveraging authority for just actions, and the importance o

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