281 Pharmacology courses delivered On Demand

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.

This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.

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.

Epilepsy and Buccal Midazolam Are you interested in learning about buccal midazolam for managing acute seizures in epilepsy patients? Then our epilepsy and buccal midazolam course will be your perfect guide. The principles of epilepsy, identifying various seizure types, and the pharmacology of midazolam are all covered in this course on epilepsy and buccal midazolam. This course on epilepsy and buccal midazolam also covers dose calculations and appropriate delivery methods. Additionally, safety procedures for buccal midazolam are explained in the Epilepsy and Buccal Midazolam course. This epilepsy and buccal midazolam course also explains documentation procedures, legal implications, and possible side effects. Without further delay, participate in our epilepsy and buccal midazolam course and enhance your knowledge in this field! Learning outcome of epilepsy and buccal midazolam This epilepsy and buccal midazolam course teaches: Comprehensive training on epilepsy and buccal midazolam. Handling epilepsy, emergency response, and first aid are included in this epilepsy and buccal midazolam course. This epilepsy and buccal midazolam course also explains the administration of medication. How to provide support and resources for this disorder is elaborated on in this epilepsy and buccal midazolam course. Throughout this epilepsy and buccal midazolam course, you can learn safety and lifestyle management techniques. Legal and ethical considerations are part of this epilepsy and buccal midazolam course. This epilepsy and buccal midazolam course provides simulation and case studies for practical knowledge of this field. Special Offers of this Epilepsy: Epilepsy Course This Epilepsy: Epilepsy Course includes a FREE PDF Certificate. Lifetime access to this Epilepsy: Epilepsy Course Instant access to this Epilepsy: Epilepsy Course Get FREE Tutor Support to this Epilepsy: Epilepsy Course Epilepsy and Buccal Midazolam Unlock your potential with our Epilepsy: Epilepsy and Buccal Midazolam course! Gain an in-depth understanding of Epilepsy: Epilepsy principles and learn to identify various seizure types with precision. This Epilepsy: Epilepsy course delves into the pharmacology of midazolam, ensuring accurate dose calculations and effective delivery methods. Master safety procedures for buccal midazolam in our comprehensive Epilepsy: Epilepsy training. Additionally, explore essential documentation procedures, legal implications, and potential side effects in this Epilepsy: Epilepsy course. Enroll now to enhance your expertise and provide exceptional care in the field of Epilepsy: Epilepsy management! Who is this course for? Epilepsy and Buccal Midazolam This epilepsy: epilepsy and buccal midazolam training is intended for those who work in the field of epilepsy: epilepsy care and may need to provide buccal midazolam to patients who are having seizures. Requirements Epilepsy and Buccal Midazolam To enrol in this Epilepsy: Epilepsy Course, students must fulfil the following requirements. To join in our Epilepsy: Epilepsy Course, you must have a strong command of the English language. To successfully complete our Epilepsy: Epilepsy Course, you must be vivacious and self driven. To complete our Epilepsy: Epilepsy Course, you must have a basic understanding of computers. A minimum age limit of 15 is required to enrol in this Epilepsy: Epilepsy Course. Career path Epilepsy and Buccal Midazolam With the epilepsy: epilepsy and buccal midazolam course qualification, you can work as a clinician educator, care coordinator, or epilepsy expert, with chances for research, leadership, and policy.

The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards. This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.