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The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

Medical Secretary: Medical Secretary Training Online A medical secretary: medical secretary is responsible for ensuring that a doctor's office runs smoothly so that patients receive the best possible care. A medical secretary: medical secretary must understand office organisation and standard procedures to provide this secretarial support. They should also be able to use medical terminologies fluently. This Medical Secretary: Medical Secretary course will teach you about the medical secretarial profession and the skills needed to do the job successfully. This Medical Secretary: Medical Secretary Training course will teach you about the roles and responsibilities of a medical secretary. You will also learn various medical secretary skills, including an effective filing system, medical transcription, medical writing, maintaining medical records, an appointment system, and more. Furthermore, this comprehensive Medical Secretary: Medical Secretary Training course will teach you the critical concepts of patient confidentiality and other legal aspects of the healthcare industry. Special Offers of this Medical Secretary Course This Medical Secretary Course includes 5 FREE PDF Certificates. Lifetime access to this Medical Secretary Course Instant access to this Medical Secretary: Medical Secretary Course Get FREE Tutor Support from Monday to Friday in this Medical Secretary: Medical Secretary Course Courses are included in this Medical Secretary: Medical Secretary Training course Course 01: Diploma in Medical Receptionist and Secretary Course 02: Medical Terminology Course 03: Executive Secretary & PA Training Course 04: Office Management and Administration Course 05: Level 2 Customer Service Medical Secretary & Terminology with Executive Secretary & PA Training Industry Experts Designed this Medical Secretary: Medical Secretary Training course into 13 detailed modules. Detailed course curriculum of the Diploma in Medical Receptionist & Secretary: Module 1: The National Health Service Module 2: Patient (Customer) Care Module 3: Communication Module 4: Law, Ethics and Medicine Module 5: Health & Safety in a Clinical Environment Module 6: Practical Reception Skills in General Practice Module 7: The Hospital Service Module 8: Private Medicine Module 9: Forms, Fees and Finances in General Practises Module 10: Using Information Technology Module 11: Medical Terminology and Clinical Aspects Module 12: Audit, Health Economics and Ensuring Quality for the Medical Receptionist and Secretary Module 13: Complementary Medicine Detailed course curriculum of the Medical Terminology: Module 01: Introduction to Medical Terminology Module 02: Body Systems Terminology Module 03: Medical Specialties and Procedures Module 04: Common Medical Conditions and Diseases Module 05: Medical Documentation and Communication Module 06: Pharmacology Module 07: You Have to Know Other Topics Detailed course curriculum of the Executive Secretary & PA Training: Module 1: Personal Assistant Fundamentals Module 2: Business Telephone Approaches Module 3: Information regarding shipping and mail services Module 4: An Overview of Travel Arrangements Module 5: Outline setting up conferences and meetings Module 6: Management of time Module 7: Systems for Record Keeping and Filing Module 8: Business Writing Techniques Module 9: Communication Skills Module 10: Customer Service Module 11: Basics of Microsoft Office Skills Detailed course curriculum of the Office Management and Administration: Module 01: Fundamentals of Office Administration Module 02:Qualities of an Effective Administrator Module 03: Information regarding shipping and mail services Module 04: Ways to create effective plans and schedule Module 05: Outline setting up conferences and meetings Module 06: Business Writing Techniques Module 07: Management of time Module 08: An Overview of Stress Management Module 09: Telephone Business Proficiency Module 10: Communication Techniques Module 11: Strategies to manage conflicts Module 12: Business etiquette guidelines Module 13:Basics of Microsoft Office Skills Detailed course curriculum of the Level 2 Customer Service: Module 1: Introduction to Customer Service Module 2: Understanding the Organisation Module 3: Prepare to Deliver Excellent Customer Service Module 4: Communication in the Customer Service Role Module 5: Understand Customers Who is this course for? Medical Secretary & Terminology with Executive Secretary & PA Training This Medical Secretary: Medical Secretary Training Course is ideal for Health Care Professionals who work and will be working in healthcare settings such as hospitals, clinics, and healthcare facilities.