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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 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.

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.

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.

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Level-5 QLS Endorsed | 19-in-1 Diploma Bundle | Free CPD PDF Certificate | Lifetime Access

We offer comprehensive training for UKMLA/PLAB 1 that would enable our doctors to pass the exam in the first go. A combination of self-study, live online classes, individual tutoring, and face-to-face sessions make our programme more practical and successful. We are proud to declare that our passing rate in the first attempt is outstanding.

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>>24 Hours Left! Don't Let the Winter Deals Slip Away - Enrol Now!<< Welcome to our outstanding Sports (Therapy, First Aid, and Nutrition) Bundle at QLS Level 5! This power-packed bundle includes eight comprehensive courses to propel your knowledge and understanding of sports therapy, first aid, nutrition, coaching, medicine, and much more. Three of these courses are QLS-endorsed, offering exclusive insights into Sports Therapy, Sports First Aid, and Sports Nutrition. After completion, you'll receive a hardcopy certificate to showcase your theoretical knowledge and dedication. Additionally, you're given access to five CPD QS accredited courses. These cover Sports Coaching & Fitness Training, Sports Medicine Fundamentals, Thai Massage Therapy for Pain Management, Hydrotherapy, and Sports Agent. Every course in this bundle offers a deep dive into their respective subjects, providing you with an enriched theoretical understanding of the sports field. Discover a world of sports learning today! Key Features of the Sports (Therapy, First Aid and Nutrition) at QLS Level 5 Bundle: 3 QLS-Endorsed Courses: We proudly offer 3 QLS-endorsed courses within our Sports (Therapy, First Aid and Nutrition) at QLS Level 5 bundle, providing you with industry-recognized qualifications. Plus, you'll receive a free hardcopy certificate for each of these courses. QLS Course 01: Sports Therapy QLS Course 02: Sports First Aid - Level 5 QLS Course 03: Sports Nutrition 5 CPD QS Accredited Courses: Additionally, our bundle includes 5 relevant CPD QS accredited courses, ensuring that you stay up-to-date with the latest industry standards and practices. Course 01: Sports Coaching & Fitness Training Course 02: Sports Medicine Fundamentals Course 03: Thai Massage Therapy for Pain Management - Online Diploma Course 04: Hydrotherapy Course 05: Sports Agent In Addition, you'll get Five Career Boosting Courses absolutely FREE with this Bundle. Course 01: Professional CV Writing Course 02: Job Search Skills Course 03: Self Esteem & Confidence Building Course 04: Professional Diploma in Stress Management Course 05: Complete Communication Skills Master Class Convenient Online Learning: Our Sports (Therapy, First Aid and Nutrition) at QLS Level 5 courses are accessible online, allowing you to learn at your own pace and from the comfort of your own home. Learning Outcomes of the Sports (Therapy, First Aid and Nutrition) at QLS Level 5 Bundle: Gain a thorough understanding of Sports Therapy and First Aid procedures. Understand the principles of Sports Nutrition for athletic performance. Learn the fundamentals of Sports Coaching and Fitness Training. Understand the basics of Sports Medicine. Learn about the Thai Massage Therapy for Pain Management Start your learning journey straightaway! This Sports's curriculum has been designed by Sports experts with years of experience behind them. This course is extremely dynamic and well-paced to help you understand Sports with ease. You'll discover how to master the skill while exploring relevant and essential topics. CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This bundle is ideal for: Students seeking mastery in this field Professionals seeking to enhance their skills Anyone who is passionate about this topic Career path Sports Medicine Specialist: Salary Range - £32,000 - £102,000 Sports Coaching and Fitness Trainer: Salary Range - £20,000 - £35,000 Thai Massage Therapist: Salary Range - £18,000 - £30,000 Certificates Digital certificate Digital certificate - Included Hard copy certificate Hard copy certificate - Included