Combination Products Handbook

Combination products allow the integration of drugs, devices, and/or biological components that provide new and innovative therapeutic approaches taking medicinal know how and combining it with modern technologies that can lead to improved outcomes, improved quality of life and effective treatment delivery.In simple terms a Combination product is two or more different medical products or constituent parts. The growth of combination products is dependent upon the collaboration of professionals with expertise in pharmaceuticals, medical devices, biologics and regulation to work together in an integrated fashion. Drug-eluting stents, pen injectors, inhalers are regulated as combination products that illustrate the prevalence of combination products in everyday treatments. -CHAPTER 1- Combination Products- An Introduction, CHAPTER 2- Skin Physiology & Needle Injection Systems and Transdermal Delivery, -CHAPTER 3- Risk Management for Combination Products, -CHAPTER 4- Design Controls -CHAPTER 5- Design & Development of Combination Products, -CHAPTER 6-Essential Performance Requirements -CHAPTER 7-Part I: Usability Engineering And Human Factors, -CHAPTER 8-Part II: Usability Engineering And Human Factors, -CHAPTER 9-Automation & Electronics for Combination Products, -CHAPTER 10- FMEA 1. Introduction to Combination Products , Non-Complex and Complex Drug-Device Combination Product?, FTechnical Considerations for Combination Products, Indications, Design Considerations for Combination Projects, Usability and Human Factors Design Considerations, Materials,Performance testing, Functional testing, Safety by Design, Biocompatibility, Shelf life, Sterility and Container Closure Integrity . 2. Skin Structure, Needle systems and Transdermal Delivery , Skin, The Epidermis Keratinocytes,.The Dermis, Skin Circulation, .Hypodermis, Basal Membrane How Needles Work, Physiological response to needles, Administration routes, Transdermal delivery systems 3. Risk Management for Combination Products, Drug Agnostic Risk Management, Risk management Planning, Risk analysis, . Establishing Hazards Hazardous situation, Identification of hazards and hazardous situations, Residual Risk, .Overall residual risk, Risk Management Report, Production and Post-Production Activities 4. Design Controls and Combination Products, Design Controls , Risk Management & Design controls, Design Changes, Design Planning , .Design Inputs,Design Inputs Design Outputs, Design verification, Design Validation,.Design Transfer, Design Reviews, Design History File 5. Design and Development Quality By Design, Performance Testing,Container Closure Systems, Resealability, Fragmentation Integrated Fluid Path, Device Development, Co-packaged syringes and Needles, Pen Injector, Device Development and Standards, Drug Development, Drug -Device Interaction, 7. Introduction to Usability Engineering and Human Factors , Identification of Use Errors, Usability Engineering Process, Identification of Known Use-Related Problems Task Analysis, User Interface, Post-Marketing Surveillance, Simple Use Related Risk Analysis for Insulin Pen Injector 8. PART II: Usability Engineering And Human Factors , Design and minimizing Medication Errors, Use Related Risk Analysis (URRAs), Formative Studies and Validation studies, Combination Product Design and Medication Errors , Combination Product Use Environment, Naming and Tall Man Lettering, 9. Automation & Electronics, Needle-based injection systems containing Electronics, 10. Risk Analysis Using Failure Modes and Effects Analysis (FMEA) 11. Appendix- ICH Guidelines Listing 12. Risk Analysis Techniques , 13. APPENDIX – Risk Management and (GSPR) 2017/745 (EU MDR)