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To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

24 Hour Flash Deal **25-in-1 Advanced Medical Writing Diploma Mega Bundle** Advanced Medical Writing Diploma Enrolment Gifts **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter ** Take the initial steps toward a successful long-term career by studying the Advanced Medical Writing Diploma package online with Studyhub through our online learning platform. The Advanced Medical Writing Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Advanced Medical Writing Diploma course provides complete 360-degree training on Advanced Medical Writing Diploma. You'll get not one, not two, not three, but twenty-five Advanced Medical Writing Diploma courses included in this course. Plus Studyhub's signature Forever Access is given as always, meaning these Advanced Medical Writing Diploma courses are yours for as long as you want them once you enrol in this course This Advanced Medical Writing Diploma Bundle consists the following career oriented courses: Course 01: Medical Writing Course 02: Medical Transcription Diploma Course 03: Medical Law Course 04: Medical & Clinical Administrator Course 05: Medical coding Training Course 06: Medical Receptionist Course 07: Medical Teaching Course 08: Clinical Research Administration: Navigating the Healthcare Landscape Course 09: Nurse Prescribing and Medicine Management Course 10: Research in Adult Care Course 11: Anatomy and Physiology of Human Body Course 12: Human Anatomy, Physiology and Medical Terminology Diploma Course 13: Pharmacology Diploma Course 14: Clinical Pharmacy Certificate Program and Professional Standards Course 15: Biochemistry Course 16: Molecular Genetics: Unraveling the Secrets of DNA Course 17: Neurology, Neurological Assessments & Medication Course 18: Understanding the Immune System Course 19: Radiography Course 20: Mental Health and Psychiatry Training Course 21: Infection Control & Medicine Handling Course 22: Health Economics and Health Technology Assessment Course 23: Public Health Course 24: International Healthcare Policy Course 25: Effective Communication Skills Diploma The Advanced Medical Writing Diploma course has been prepared by focusing largely on Advanced Medical Writing Diploma career readiness. It has been designed by our Advanced Medical Writing Diploma specialists in a manner that you will be likely to find yourself head and shoulders above the others. For better learning, one to one assistance will also be provided if it's required by any learners. The Advanced Medical Writing Diploma Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Advanced Medical Writing Diploma bundle course has been created with twenty-five premium courses to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Advanced Medical Writing Diploma Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Advanced Medical Writing Diploma Elementary modules, allowing our students to grasp each lesson quickly. The Advanced Medical Writing Diploma course is self-paced and can be taken from the comfort of your home, office, or on the go! With our Student ID card you will get discounts on things like music, food, travel and clothes etc. In this exclusive Advanced Medical Writing Diploma bundle, you really hit the jackpot. Here's what you get: Step by step Advanced Medical Writing Diploma lessons One to one assistance from Advanced Medical Writing Diplomaprofessionals if you need it Innovative exams to test your knowledge after the Advanced Medical Writing Diplomacourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Advanced Medical Writing Diploma courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Advanced Medical Writing Diploma certificate and transcript on the next working day Easily learn the Advanced Medical Writing Diploma skills and knowledge you want from the comfort of your home CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Advanced Medical Writing Diploma training is suitable for - Students Recent graduates Job Seekers Individuals who are already employed in the relevant sectors and wish to enhance their knowledge and expertise in Advanced Medical Writing Diploma Requirements To participate in this Advanced Medical Writing Diploma course, all you need is - A smart device A secure internet connection And a keen interest in Advanced Medical Writing Diploma Career path You will be able to kickstart your Advanced Medical Writing Diploma career because this course includes various courses as a bonus. This Advanced Medical Writing Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Advanced Medical Writing Diploma career opportunities. Certificates CPD Accredited Certificate Digital certificate - Included CPD Accredited e-Certificate - Free CPD Accredited Hardcopy Certificate - Free Enrolment Letter - Free Student ID Card - Free

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + QLS Endorsement | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

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