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A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

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.

Discover the secrets to a healing touch with this Massage Therapy Training for Nurses. The course will immerse you in the field, focusing on the knowledge, skills and attributes necessary for success as a qualified nurse! This course teaches fundamental massage skills such as hydrotherapy, palpation, remedial exercise, and patient assessment. Students learn different types of massage treatments, along with medical topics including anatomy, physiology, pharmacology, and pathology. Through the course you will not only learn the technical massage techniques and skills required for this career, you'll also walk away with knowledge on client relations and business best practices to get you working in Massage Therapy. Please note: This course only gives you the theoretical knowledge that you need to excel in this field. This Massage Therapy Training for Nurses doesn't entitle you to practise as a professional in this specific field. Why choose this course Earn an e-certificate upon successful completion. Accessible, informative modules taught by expert instructors Study in your own time, at your own pace, through your computer tablet or mobile device Benefit from instant feedback through mock exams and multiple-choice assessments Get 24/7 help or advice from our email and live chat teams Full Tutor Support on Weekdays Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Mock exams Multiple-choice assessment Certification After the successful completion of the final assessment, you will receive a CPD-accredited certificate of achievement. The PDF certificate is for £9.99, and it will be sent to you immediately after through e-mail. You can get the hard copy for £15.99, which will reach your doorsteps by post. Who is this course for? Massage Therapy Training for Nurses is suitable for anyone who want to gain extensive knowledge, potential experience and professional skills in the related field. This is a great opportunity for all student from any academic backgrounds to learn more on this subject. Course Content Module 01 Introduction to Massage Therapy 00:15:00 What is Physiotherapy? 00:30:00 What is Sports Physiotherapy? 00:15:00 Skeletal Muscle Structure 00:15:00 Neuromuscular System 00:15:00 Tissues, Organs, & Neuromuscular systems 01:00:00 General Benefits of Massage 00:15:00 Module 02 Injury Prevention 00:15:00 Osteoporosis 00:15:00 Back Pain & Critical Care 00:15:00 Aquatherapy & Hydrotherapy 00:15:00 Different Therapy Techniques 01:00:00 Treatment Method 01:00:00 Physiotherapy For MND Patient 01:00:00 Musculoskeletal Physiotherapy (MSK) 01:00:00 TENS Machines 00:30:00 What is Therapeutic Ultrasound? 00:15:00 Module 03 Indian Head Massage 00:15:00 Facial Massage 00:30:00 Neck Massage 00:30:00 Back Massage 00:30:00 Full Body Massage 00:15:00 Swedish Massage 00:15:00 Sports Massage 00:30:00 LomiLomi Massage 00:15:00 Module 04 Anti-Cellulite Massage 00:15:00 Hot Stone Massage 00:30:00 Thai Foot Massage 00:15:00 Prenatal Massage 00:15:00 Medical Massage 01:00:00 Baby Massage 01:00:00 Trigger Point Therapy 00:05:00 Thai Massage 01:00:00 Reflexology 01:00:00 Module 05 Acupressure 00:30:00 How Acupressure Works 00:30:00 Locating A Pressure Point 01:00:00 Acupressure Techniques 00:30:00 How To Apply Pressure 00:30:00 Mock Exam Mock Exam - Massage Therapy Training for Nurses 00:20:00 Final Exam Final Exam - Massage Therapy Training for Nurses 00:20:00 Order your Certificates & Transcripts Order your Certificates & Transcripts 00:00:00 Frequently Asked Questions Are there any prerequisites for taking the course? There are no specific prerequisites for this course, nor are there any formal entry requirements. All you need is an internet connection, a good understanding of English and a passion for learning for this course. Can I access the course at any time, or is there a set schedule? You have the flexibility to access the course at any time that suits your schedule. Our courses are self-paced, allowing you to study at your own pace and convenience. How long will I have access to the course? For this course, you will have access to the course materials for 1 year only. This means you can review the content as often as you like within the year, even after you've completed the course. However, if you buy Lifetime Access for the course, you will be able to access the course for a lifetime. Is there a certificate of completion provided after completing the course? Yes, upon successfully completing the course, you will receive a certificate of completion. This certificate can be a valuable addition to your professional portfolio and can be shared on your various social networks. Can I switch courses or get a refund if I'm not satisfied with the course? We want you to have a positive learning experience. If you're not satisfied with the course, you can request a course transfer or refund within 14 days of the initial purchase. How do I track my progress in the course? Our platform provides tracking tools and progress indicators for each course. You can monitor your progress, completed lessons, and assessments through your learner dashboard for the course. What if I have technical issues or difficulties with the course? If you encounter technical issues or content-related difficulties with the course, our support team is available to assist you. You can reach out to them for prompt resolution.

This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.

This course describes the requirements that must be met by, and options available to, the sponsor during the conduct of an authorised clinical trial. It identifies the various interactions with MSCs that occur via the Clinical Trials Information System (CTIS), and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT11 sets out the European legal and regulatory context for clinical trials and describes how to apply via the CTIS for authorisation to conduct trials. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

***Don't Spend More; Spend Smart*** Boost Your Career with Apex Learning and Get Noticed By Recruiters in this Hiring Season! **Nursing Exclusive Bundle | 14 Exclusive Courses, PDF + Hard Copy Certificate, Transcript, Student ID | Nurse Training Level 4 | Nurse Prescribing | Public Health | Phlebotomy |Catheterisation | Wound Care | GDPR in Healthcare | Consent in Healthcare & Much More!** It's hard to imagine a more dynamic, fast-changing sector than nursing and healthcare in the UK. Whether you're seeking entry into the health and social care professions or looking to progress your career and want to learn the fundamentals, then our Nursing Training in Hygiene and Infection Control has much to offer you. Nurses who further their education and improve their knowledge can provide a higher level of care for patients and begin to climb the career ladder. Experienced nurses who have completed the relevant qualifications can enhance their chances of becoming specialist nurses or consultant nurses. Specialist and consultant nurses earn a significantly higher salary and have increased responsibility for patients in their remit. The Nursing Training in Hygiene and Infection Control Diploma has been meticulously created with the assistance of industry professionals and will assist you in your journey for a rewarding career as a Healthcare specialist. You will be shown the duties you must master, including Pharmacology, Neurological Treatments, Cardiac Recovery Techniques, Genitourinary Procedures, and much more. You will even be taught basic Nursing maths to aid with medicinal dispensing. Along with this Nursing Training in Hygiene and Infection Control Diploma, you will get 10 premium courses specially designed for Nurses. Also, you will get an original hardcopy certificate, transcript and a student ID card, which will allow you to get discounts on things like music, food, travel and clothes etc. Courses are included with this Nursing Training in Hygiene and Infection Control Complete Bundle: Course 01: Nursing Training Level 4 Course 02: Nurse Prescribing Diploma Course 03: Public Health Course 04: Phlebotomy Course 05: Clinical Training for Nurses and Carers - Catheterisation Course 06: Wound Care Level 2 Course 07: Clinical Observations Skills Course 08: Verification of Death Training for Nurses Course 09: Consent in Healthcare Course 10: Medical Law Course 11: Medication Administration Level 4 Course 12: Medical Transcription Course 13: Diabetes Care Diploma Course 14: Health and Social Care UK The Nursing Training in Hygiene and Infection Control will help you develop your skills, confidence and knowledge of this sector, helping to add real value to your CV and personal development. Learning Outcomes of Nursing Training in Hygiene and Infection Control: Learn the requirements for every healthcare setting and the nursing staff therein Understand all the legal and ethical responsibilities of a Nursing Assistant Know how to communicate efficiently with patients and staff Become fully aware of all the necessary health and safety protocols for nursing Acquire the ability to perform valuable infection control in an emergency Be able to practise rest and sleep management on patients Gain an acute understanding of nutrition and fluid requirements for patients Show the ability to perform essential medical practises like Oxygenation and suchlike Gain the knowledge, skill and guideline to work as a healthcare technician specialising in phlebotomy. Grasp the primary job responsibilities for a certified phlebotomist and get a firm understanding of Venepuncture techniques. Get a comprehensive knowledge of Medical Terminologies of phlebotomy that involves drawing blood and preparing it for lab testing. Understand the legislation and guidance of medication management and much more... Benefits you'll get choosing Apex Learning for this Nursing: One payment, but lifetime access to 11 CPD courses Certificates, student ID for the title course included in a one-time fee Full tutor support available from Monday to Friday Free up your time - don't waste time and money travelling for classes Study the course from your computer, tablet or mobile device CPD accredited course- improve the chance of gaining professional skills Gain valuable knowledge without leaving your home How will I get my Certificate? After successfully completing the course you will be able to order your CPD Accredited Certificates (PDF + Hard Copy) as proof of your achievement. PDF Certificate: Free (For The Title Course) Hard Copy Certificate: Free (For The Title Course) Course Curriculum of Nurse Training Level 4 Course 01: Nurse Training Level 4 Introduction Working in Different Healthcare Settings Understanding legal, professional standards of practice and ethical aspects of health care- Part 1 Understanding legal, professional standards of practice and ethical aspects of health care- Part 2 Effective Communication Health and Safety Hygiene Infection Control Asepsis Medication Administration Adult Care in Different Life Stages Understanding Immune System Rest and Sleep Management Mobility and Immobility Issues of Patients Pain Management for Nurses Nutrition Fluid and Electrolyte Balance Assisting with Elimination Oxygenation Health and Social Care Training Introduction to Health and Social Care Communication and its Relevance Rights and Responsibilities as a Health and Social Care Worker Role as A Caregiver and Healthcare Professional Working in Health and Social Care; Promoting Equality, Diversity and Rights Important Principles and Policies in Health and Social Care Work Safeguarding Vulnerable Individuals Health and Safety Responsibilities Risk Management in Health and Social Care Course 02: Nurse Prescribing Diploma Introduction to Nurse Prescribing Legal and Ethical Aspects of Prescribin Medicine Management Anxiety Disorders in Adults Liver Diseases: Diagnosis & Prescribing Common Problems: Pharmacological Management Anti-Microbial Prescribing Cardiac Problems and Prescribing Neurological Problems and Prescribing Palliative Cares Prescribing in Pregnancy and Lactation Prescribing for Older People Prescribing Children's Common Medicines in Use Challenges and Future of Nurse Prescribing Course 03: Public Health Introduction to Public Health Principles of Public Health Understanding Epidemiology Disease Control Understanding Measures of Disease Frequency Maternity and Childbirth Health System and Policy Public Health and Ethics Course 04: Phlebotomy Introduction to Phlebotomy Blood Circulation, Function, and Composition Phlebotomy Equipment Routine Venipuncture Venipuncture Complications and Pre-Examination Variables Dermal Puncture Quality Assessment and Management in Phlebotomy Special Blood Collection Procedure Course 05: Clinical Training for Nurses and Carers - Catheterisation Introduction to Urinary Catheterisation The Urinary System Patients' Guide for Catheterisation Guidance for Nursing and Care Staff Protocol for Female Catheterisation Protocol for Male Catheterisation Course 06: Wound Care Level 2 The Wound Healing Process & Factors Delaying Wound Healing Types of Wounds and Their Treatment Dressing Wound Assessment Glossary Course 07: Clinical Observations Skills Introduction to Clinical Observation and Clinical Carer Legal Standards and Professional Aspects of Ethical Practice Patient's Condition Observation Clinical Management Observation Technical Clinical Method Observation Medicine and Dispensaries Observation Health Safety and Hygiene Course 08: Verification of Death Training for Nurses Introduction to Verification of Death Legal Considerations Expected Death Natural Cause of Death Verification of Unexpected Death Process for Verifying a Death Role of Forensic Nurse Course 09: Consent in Healthcare Covid-19 Awareness for General People and Healthcare Introduction to Covid-19 Understanding of Covid-19 as a Pandemic and How It Is Related to Zoonotic Diseases Like SARS and MERS The Strike of Pandemic Around the World and Great Britain Effects of Covid-19 on Human Life Consent Training in Healthcare Course An Introduction to Consent Information Regarding Consent Consent Training in Healthcare Course Best Interest Decision Making Assessing Capacity Providing Care or Treatment to People Who Lack Capacity Public Bodies and Services Created by MCA Act 2005 UK Acts in Relation to Consent Course 10: Medical Law An Introduction to Medical Law Legislation on Access to Health, Medical Report, Treatment Legislation on Adult Support Legislation on Public Health and Health Service Legislation on Coronavirus Legislation on Mental Health Legislation on Abortion Other Legislation Course 11: Medication Administration Level 4 Introduction to Safe Handling of Medicines Legislation and guidance of medication management Principles of Safe and Appropriate Handling of Medicines Medication Risk Assessment Guidance Handling Medicines in Social Care Settings Consent to Treatment …and many more Course 12: Medical Transcription Introduction to Medical Transcription The What, How, Who and Why of Medical Transcription Understanding Medical Reports Medical Language Boot Camp Formatting: The Basics Data Protection Course 13: Diabetes Care Diploma What is Diabetes The Diabetes Challenge The Cost of Diabetes in Social Care Type 1 Diabetes Type 2 Diabetes Type 2 Diabetes Treatments Prediabetes Gestational Diabetes Course 14: Health and Social Care UK Introduction to Advanced Health and Social Care Introduction to the UK Health System Essential Principles, Policies and Legislations in Health and Social Care Work Fundamental Aspects of Providing Quality Health CPD 145 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this Training Bundle. Please note: This course doesn't entitle you to practice as a professional in this specific field. Rather, this course will assist you in understanding the fundamentals so that you can improve your knowledge in the relevant field. Requirements This Training Course has been designed to be fully compatible with tablets and smartphones. Career path Having this expertise will increase the value of your CV and open you up to multiple job sectors. Certificates Certificate of completion Digital certificate - Included You will get the PDF Certificate for the title course (Nurse Training Level 4) absolutely Free! Certificate of completion Hard copy certificate - Included You will get the Hard Copy certificate for the title course (Nurse Training Level 4) absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost.

This module will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put.

A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.

Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.

Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice.