In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.
In this course we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.
The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.
The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.
Description Substance Misuse Awareness Diploma Drug use is ingesting any chemical substance into the body, especially the ones that have physiological effects when introduced into the body. When drug use poses a problem it becomes drug abuse. Drug abuse is also defined as excessive consumption of drugs especially the ones which are illegal. There are a variety of drugs both legal and forbidden and the effects of different drugs on the human body are different. The physiological effects of the drug do not only depend on the drug as previously thought but also on the person who consumes it as well as the setting where the drug is taken. Drug addiction is a major problem faced by almost every culture in every country. But every society does not condemn the self-same drugs. Some drugs may be condoned in one society but condemned in another. Therefore, drug use and abuse depend greatly on the sociocultural beliefs and assumptions of a particular society. The history of drugs is not always invaded by a negative attitude. Drugs have been known to have had medicinal uses and cultural and religious value since time immemorial. Only when drug use becomes habitual and addictive will it become drug abuse and that is when it needs to be addressed with great seriousness. Substance Misuse Awareness Diploma is an introductory course that traces the history of drugs and discusses the basics of drug use and abuse including the needed terminology. It also touches upon the field of pharmacology and psychopharmacology which is concerned with drug use. Popular drugs like cocaine, nicotine and alcohol are discussed in separate units. Substance Misuse Awareness Diploma ends with treatment and prevention of substance use disorders. What you will learn 1: Drug Use and Abuse 2: The History of Drug Use 3: Drugs and the Nervous System 4: Pharmacology 5: Psychopharmacology 6: Cocaine 7: Nicotine 8: Alcohol 9: Treatment of Substance Use Disorders 10: Prevention of Substance Abuse Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.
This course is aimed at managers and staff in all industries who play a role in reducing drug, alcohol and substance misuse in the UK. The course starts with official statistics to illustrate the scale of drug and alcohol abuse in the UK. You'll learn in detail about commonly used drugs, including cannabis, cocaine, heroin, LSD, ecstasy and some new designer drugs. Turning to alcohol abuse, the course will show you how to introduce a 4-stage plan to deal with any problems - including how to write an effective Drug and Alcohol Policy. Beyond this the course will explore best business practice in terms of HR, legislation, spotting signs of drug misuse and the implementation of workplace solutions. The course also explains how the Advisory, Conciliation and Arbitration Service (ACAS) can help with effective alcohol and drugs policies and the development of related management skills. Finally, it looks at current drug treatments and the options for outside support available to individuals and organisations.
Description Pharmacology Diploma Clinics, pharmacies, and other healthcare facilities need to run smoothly, and this need has grown in necessity. You can be of great significance in this sector by receiving the appropriate training to offer your abilities to its development. Sign up for our Pharmacology Diploma course and join the healthcare sector to use your skills to help people in need and offer them relief. Elearncollege brings you a chance to hone your pharmaceutical skills through the diploma course in Pharmacology. In this Pharmacology Diploma course, you will learn the necessity of the healthcare and pharmaceutical industry. A course endorsed by Elearncollege, the Pharmacology Diploma, will teach you new skills to develop your profession. The Pharmacology Diploma course is comprehensive and detailed. The course will teach you all the basics of Pharmacology required by an employee in the pharmaceutical industry and healthcare. The Pharmacology Diploma course will help you become a skilled practitioner capable of dispensing the correct medication. The Pharmacology Diploma course from Elearncollege will help you progress in your pharmaceutical and healthcare career. Learn about the ideas and regulating organisations that help guarantee pharmacology is safe. You'll learn about drug administration methods, how medicines interact with the body, pharmacokinetics, how to measure pharmaceuticals safely, and drug action processes on the body's many receptors. What you will learn 1:The basics of pharmacology 2:Drugs for the nervous system 3: Medical terminologies 4:Cardiovascular and respiratory drugs 5:Drugs for GI and GU disorders 6:Hematologic and endocrine drugs 7:Psychotropic drugs 8:Drugs and the immune system and infection 9:Antineoplastic drugs 10:Drugs to balance fluids and electrolytes Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.
This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.
Do you want to provide expert care and support for a loved one who is suffering from drug addiction? Are you considering a career in addiction counselling or recovery work? This Addiction & Mental Health (Dual Diagnosis) Integrative 12hrs Course will benefit anyone who wants to broaden their understanding of drug addiction and learn how to deliver early intervention and treatment for those who are struggling with drug abuse. In this comprehensive course you will start by familiarising with different types of drugs and their effects, including the psychology behind drug addiction and the causes and stages of addiction. Later, you'll move onto harm reduction strategies and long-term health outcomes, before exploring the psychology behind substance abuse and neurophysiology. Lastly, you will look into the trauma model and early intervention treatments such as holistic addiction therapy. This course is ideal for anyone who wants to run family support groups or wants to update their career skills in this field. Enrol in this course today and make a difference to vulnerable people's lives by delivering a successful drug intervention for your loved ones or clients. What you'll learn Understand the psychology, causes and cycle of addiction Expand your knowledge of the effects of alcohol, tobacco, cannabis, and other substances Familiarise with the early intervention process and areas of development Broaden your understanding of pharmacotherapies and pharmaceutical drugs Explore the stages of change model of overcoming addiction Develop the skills to deliver a professional intervention for drug abusers or loved ones struggling with substance abuse Learn about the benefits and costs of drug use prevention Gain an understanding of holistic treatment and integrative therapies for treating addiction Requirements Only requirements is computer with sound Self paced training Who this course is for: Anyone who wants to learn how to deliver a brief intervention with loved ones using alcohol, ICE & other drugs Advanced practitioners who want to receive updated skills in evidence base best practice from an integrative holistic approach Clinicians and Counsellors that would like to earn 12 points of CPD (Continuing Professional Development) for their counselling peak body (APS, ACA, AASW, CPS, PACFA etc) Promotional Video Promotional 5 minute video FREE 00:06:00 SAMHI Dual Diagnosis Intro video SAMHI Dual Diagnosis Intro video and downloadable worksheet PowerPoint slides FREE 00:04:00 Module 1 - Drugs and Effects Module 1 - Drugs and Effects: VIDEO PART 1 (content part 1 - 4) 00:16:00 Module 1 - Drugs and Effects: VIDEO PART 2 (content part 5 - 6) 00:20:00 Module 1 - Drugs and Effects: VIDEO PART 3 (content part 7 - 8) 00:20:00 Module 1 - Drugs and Effects: VIDEO PART 4 (content part 9) 00:15:00 Module 1 - Drugs and Effects: VIDEO PART 5 (content part 10) 00:10:00 Module 1 - Drugs and Effects: VIDEO PART 6 (content 10 - 12) 00:18:00 Module 1 - Drugs and Effects: VIDEO PART 7 (content part 13) 00:13:00 Module 1 - Drugs and Effects: VIDEO PART 8 (content part 14) 00:20:00 Module 1 - Drugs and Effects: VIDEO PART 9 (content part 14) 00:20:00 Module 1 - Drugs and Effects: VIDEO PART 10 (content part 15 - 18) 00:19:00 Module 2 Addictions & Mental Health Module 2 Addictions & Mental Health: VIDEO PART 1 content part 1 - 2 00:16:00 Module 2 Addictions & Mental Health: VIDEO PART 2 content part 3 - 5 00:18:00 Module 2 Addictions & Mental Health: VIDEO PART 3 content part 6 - 7 00:14:00 Module 2 Addictions & Mental Health: VIDEO PART 4 content part 00:17:00 Module 2 Addictions & Mental Health: VIDEO PART 5 content part 00:18:00 Module 2 Addictions & Mental Health: VIDEO PART 6 content part 00:20:00 Module 2 Addictions & Mental Health: VIDEO PART 7 content part 00:14:00 Module 2 Addictions & Mental Health: VIDEO PART 8 content part 00:11:00 Module 2 Addictions & Mental Health: VIDEO PART 9 content part 00:20:00 Module 2 Addictions & Mental Health: VIDEO PART 10 content part 00:13:00 Module 3 Harm Minimisation & Optimal Health Module 3 Harm Minimisation & Optimal Health VIDEO PART 1 content part 00:23:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 2 content part 00:17:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 3 content part 00:09:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 4 content part 00:18:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 5 content part 00:17:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 1 content part 6 00:11:00 Module 3 Harm Minimisation & Optimal Health VIDEO PART 7 content part 7 00:12:00 Module 4 Brain Works - Neurophysiology Module 4 Brain Works - Neurophysiology 00:17:00 Module 4 Brain Works - Neurophysiology VIDEO PART 1 content part 00:10:00 Module 4 Brain Works - Neurophysiology VIDEO PART 2 content part 00:17:00 Module 4 Brain Works - Neurophysiology VIDEO PART 3 content part 00:19:00 Module 4 Brain Works - Neurophysiology VIDEO PART 4 content part 00:16:00 Module 4 Brain Works - Neurophysiology VIDEO PART 5 content part 00:11:00 Module 5 Trauma Model & Keys to Treatment Module 5 Trauma Model & Keys to Treatment VIDEO PART 1 content part 1 - 2a - 2f 00:20:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 2 content part 2g 00:15:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 3 content part 2h - 2i 00:15:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 4 content part 3 00:13:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 5 content part 4 00:12:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 6 content part 5 - 7 00:18:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 7 content part 8 00:17:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 7 content partVIDEO PART 8 00:16:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 9 content part 11 00:16:00 Module 5 Trauma Model & Keys to Treatment VIDEO PART 10 content part 12 00:18:00 Module 6 Brief & Early Intervention and Tripod of Support Module 6 Brief & Early Intervention and Tripod of Support VIDEO 1 content part 1 00:18:00 Module 6 Brief & Early Intervention and Tripod of Support VIDEO 2 content part 2 00:20:00 Resources - Addiction & Mental Health (Dual Diagnosis) Integrative 12hrs Resources - Addiction & Mental Health (Dual Diagnosis) Integrative 12hrs 00:00:00