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.
What is Emergency First Aid? Well it’s exactly that, the first aid to be offered if an incident occurs. Not many of us are confronted with scenes of blood and gore in our everyday lives – so usually first aid could be as simple as sticking a plaster on a small cut. But what if you did find yourself confronted with a more serious situation. This Emergency aid course will highlight some of the most common situations that you might come across and the actions that you can take to help. In the most serious situations a first aider's role will be to assess the scene so that accurate information can be passed to Emergency services and then to act appropriately to try and increase the patients odds of survival.
What is Emergency First Aid? Well it’s exactly that, the first aid to be offered if an incident occurs. Not many of us are confronted with scenes of blood and gore in our everyday lives – so usually first aid could be as simple as sticking a plaster on a small cut. But what if you did find yourself confronted with a more serious situation. This Emergency aid course will highlight some of the most common situations that you might come across and the actions that you can take to help. In the most serious situations a first aider's role will be to assess the scene so that accurate information can be passed to Emergency services and then to act appropriately to try and increase the patients odds of survival.
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction Welcome 00:03:00 Meet your trainers 00:04:00 Is this course for you? 00:04:00 Potential Emergencies for Venues Emergency Planning, identification and Analysis Plus Fire Emergen 00:03:00 Bomb Threats 00:04:00 Active Shooter and Terrorism 00:02:00 Crowd Related Emergencies 00:02:00 Emergency Control Organisation ECO Considerations 00:05:00 Emergency Response Procedures Notification, Communication, Control, Response, Evacuation 00:08:00 Human Behaviour and Children 00:05:00 Lifts and Escalators, Media, People with Disabilities 00:03:00 Personal Effects, Emergency Colour Codes, Recovery 00:01:00 Warden Skills Leadership and Communication in Emergencies 00:04:00 Being Calm Under Pressure and Situational Awareness 00:01:00 Tactical Decision Games, Drills and Exercises 00:08:00 Wrap Up Wrap Up 00:01:00 Certificate of Achievement Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Creating a gold leaf surface Welcome From Your Instructor 00:01:00 Introduction to Gold Leaf 00:07:00 All About Your Supplies 00:05:00 Preparing Your Surface for Leafing 00:08:00 Applying Leaf Adhesive 00:05:00 Leafing and Burnishing 00:09:00 Cleaning Excess Leaf 00:03:00 Sealing the Leaf 00:07:00 Acrylic Painting on Gold Leaf Introduction to Acrylic Painting on Gold Leaf 00:05:00 Key Concepts About Painting on Leaf 00:03:00 Subtle Colored Glazes 00:14:00 Intense Colored Glazes 00:04:00 Translucent Layering 00:07:00 Cool Technique Using Glass Bead Gel 00:06:00 Opaque Paint Color 00:03:00 Sanding Techniques on Leaf 00:03:00 Special Effects with Pastes 00:06:00 Finishing Varnish Topcoat 00:01:00 Certificate of Achievement Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction Introduction 00:01:00 The Fundamentals Of Process Improvement The fundamentals of Process Improvement 00:15:00 Types Of Process In Process Improvement Types of Process in Process Improvement 00:05:00 The Process Delivering Process Improvement Process Overview 00:01:00 Step 1: Identify the Process 00:02:00 Step 2: Map the as-is Process 00:02:00 Step 3: Identify the Value-add and Non Value-add Steps 00:02:00 Step 4: Map the to-be Process 00:01:00 Step 5: Gap Analysis 00:02:00 Step 6: Map the Realised Process 00:02:00 Step 7: Test the New Process 00:02:00 Step 8: Provide Wider Updates 00:03:00 LIVE Demonstration of a Process Improvement LIVE demonstration of a process improvement 00:18:00 Close Out Close Out 00:06:00 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
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction to The Course Introduction 00:02:00 Downloading Audacity 00:01:00 Creating a New Project 00:02:00 Getting Familiar With Audacity Playback And Transport 00:07:00 Zooming And Navegation 00:06:00 Managing Tracks 00:09:00 Showing Waveform And Spectogram 00:06:00 Mono And Stereo Tracks 00:05:00 Tools and Techniques for Recording and Mixing Editing Tracks 00:09:00 Using Labels to Identify Sections 00:06:00 Recording Audio with your Smart Phone and Good Acoustics 00:09:00 Recording Audio Inside Audacity 00:05:00 Cleaning and Improving the Recorded Audio 00:10:00 Compressing to Improve Audio Levels 00:16:00 Editing Audio with the different tools in Audacity 00:12:00 Mixing a Scene - Music and Sound Effects 00:18:00 Adding Dialogue to Finishing off the Scene 00:19:00 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
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum An Introduction to Speech Therapy An Introduction to Speech Therapy 00:30:00 Decoding Speech Science Decoding Speech Science 00:30:00 Characteristics of Speech Characteristics of Speech 00:27:00 Mock Assessment 1 Assessment Mock-1- Speech and Language Therapy Diploma 00:10:00 Language Acquisition And Literacy Development Language Acquisition And Literacy Development 00:27:00 Speech and Communication Disorders Speech and Communication Disorders 00:28:00 Child Speech and Language Disorders Child Speech and Language Disorders 00:26:00 Mock Assessment 2 Assessment Mock-2-Speech and Language Therapy Diploma 00:10:00 SLTs role in helping a child with Speech and Language Disorders SLTs role in helping a child with Speech and Language Disorders 00:26:00 Adult Speech and Language Disorders Adult Speech and Language Disorders 00:27:00 Conclusion Conclusion 00:25:00 Final Assessment Assessment - Speech and Language Therapy Diploma 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
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. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. What is CPD? Employers, professional organisations, and academic institutions all recognise CPD, therefore a credential from CPD Certification Service adds value to your professional goals and achievements. Benefits of CPD Improve your employment prospects Boost your job satisfaction Promotes career advancement Enhances your CV Provides you with a competitive edge in the job market Demonstrate your dedication Showcases your professional capabilities What is IPHM? The IPHM is an Accreditation Board that provides Training Providers with international and global accreditation. The Practitioners of Holistic Medicine (IPHM) accreditation is a guarantee of quality and skill. Benefits of IPHM It will help you establish a positive reputation in your chosen field You can join a network and community of successful therapists that are dedicated to providing excellent care to their client You can flaunt this accreditation in your CV It is a worldwide recognised accreditation What is Quality Licence Scheme? This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. Benefits of Quality License Scheme Certificate is valuable Provides a competitive edge in your career It will make your CV stand out Course Curriculum Introduction Introduction l 00:03:00 Statistical Process Control (SPC) Statistical Process Control (SPC) 00:03:00 Data Analysis in SPC 00:07:00 Control Charts 00:07:00 Types & Detailed Description of Control Charts 00:11:00 Design of Experiment (DOE) Introduction to DOE 00:06:00 Why Implement DOE 00:01:00 Approaches to Implementing DOE 00:01:00 Setting up DOE 00:11:00 When to Use DOE 00:01:00 Taguchi Methods & Robust Design Taguchi Methods & Robust Design 00:05:00 Why Robust Design 00:01:00 Robustness Strategy 00:05:00 Quality Loss Function (QLF), (S/N) Ratio and Benchmarking Robust Parameter Design 00:02:00 Quality Loss Function (QLF) 00:03:00 Signal to Noise (S/N) Ratio 00:04:00 Six Sigma & Benchmarking 00:08:00 Certificate of Achievement Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00
20-in-1 Diploma Bundle | Gifts: ! Free CPD PDF + Transcript | Lifetime Access