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.
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 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.
Recognised Accreditation This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. Course Curriculum How does it work? How Does It Work 00:04:00 Going to the restaurant Going To The Restaurant 00:04:00 Hobbies and family Hobbies And Family 00:04:00 Travelling by plane Welcome Video 00:04:00 Travelling By Plane 00:04:00 Going shopping Going Shopping 00:04:00 In the morning In the morning 00:04:00 Going to a hotel Going To a Hotel 00:04:00 Doing the chores Doing The Chores 00:04:00 At the beach At The Beach 00:04:00 Numbers Numbers 00:04:00 Colours Colours 00:04:00 Animals Animals 00:04:00 Going to school Going To School 00:04:00 Fruits and vegetables Fruits And Vegetables 00:04:00 Adjectives Adjectives 00:04:00 Going to the doctor Going To The Doctor 00:04:00 The weather and countries The Weather And Countries 00:04:00 Questions and answers Questions And Answers 00:04:00 Going out Going Out 00:04:00 Food and drinks Food And Drinks 00:04:00 Home stuff and prepositions Home Stuff And Prepositions 00:04:00 Assessment Assessment - Learn French - Video Animated Course 00:10:00 Obtain Your Certificate Order Your Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00
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