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.
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.
Duration 3 Days Validity 3 years Course Overview The Level 3 Award in First Aid at Work is a nationally recognized qualification designed for individuals who need to gain the skills and knowledge to respond effectively in a workplace first aid emergency. This course is suitable for those working in environments with a high risk of accidents or injuries, including industries such as construction, manufacturing, and hospitality. The qualification meets the standards set by the Health and Safety Executive (HSE) and ensures participants can competently manage emergency situations, from assessing casualties to providing essential life-saving interventions. Upon successful completion, learners will have the confidence and practical skills necessary to handle a range of injuries and illnesses in the workplace, making them a valuable asset to their employers. What’s Covered Understanding the roles and responsibilities of a First Aider Conducting initial assessments of incidents Performing adult, child, and infant CPR & AED usage Managing unconscious casualties Providing treatment for wounds and bleeding Administering first aid for shock Dealing with injuries to bones, muscles, and joints (including fractures) Handling burns and scalds Responding to eye injuries Managing cases of poisoning Dealing with anaphylaxis and other severe allergic reactions Addressing minor injuries (e.g., cuts, bruises, and small burns) Understanding the legal requirements and importance of accurate incident reporting Entry Requirements Participants must be at least 16 years old on the first day of training. There are no formal entry requirements; however, learners are encouraged to have a good level of literacy and numeracy to complete the written assessments. Course Information Venue: All our 'Open' courses are delivered from our dedicated training venue: Pulse South Coast Ltd, Bentley Wildfowl, Harveys Lane, Ringmer, BN8 5AF On occasion we may use a separate venue, this will be advised on the course booking. Facilities: On your course you will be provided with tea & coffee making facilities and biscuits. We are in a rural location so we recommend brining lunch with you on the day. There is a microwave & fridge on site for your use. There is a garage that is approximately a 10 minute drive from our venue. Parking: We have a dedicated car park that is approximately a 300m walk to the training venue. There is no additional cost to use this parking. We accept no responsibility for any personal loss or theft while you are on our training courses or premises. Please ensure to keep your personal belongings safe at all times. What is required from you: All courses are delivered in English, you must have a basic understanding of the English language to attend. There is a requirement for you to show that you are capable of performing the skills you are taught on the course, due to this you will need to be physically able to demonstrate all practical elements of the course. Dress: As a company we pride ourselves on running immersive & practical training courses. You will often be expected to kneel & work outdoors, please dress appropriately. Identification: As we deliver Ofqual accredited courses, there is a requirement for you to show a form of ID on the first day of the course. This could be; a driving license, passport or something that clearly shows who you are. Timings: All of our courses have a minimum training time of six hours a day, we will often advertise a course as seven hours to include break times. On occasion it is required to go over the scheduled times, however this will always be discussed with the group on the day. Trainer: During your course you will have a designated trainer for the duration. They are there not only to assess for the qualification, but to offer you guidance and support throughout. Security: We accept no responsibility for any personal loss or theft while you are on our training courses or premises. Please ensure to keep your personal belongings safe at all times.
The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.
Explore the intricate tapestry of Comparative Politics with our course on the UK and USA Comparative Systems. Uncover the foundations of government, analyze the US Constitution, dissect the roles of Congress, the President, and the Supreme Court. Dive into electoral processes and direct democracy while developing a keen understanding of comparative approaches. Gain valuable insights into the political landscapes of the United Kingdom and the United States, equipping yourself with the knowledge to critically assess and compare these dynamic systems. Enroll now to embark on a journey of political discovery and comparative analysis.