Last updated 6/2022 MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz Language: English | Size: 294.74 MB | Duration: 0h 51m Chemistry, Manufacturing and Controls. From RA History to Submission.
What you'll learn Identify the CMC information required for submissions to support clinical studies and marketing applications Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section Identify CMC changes that require agency notification Be an expert in the main CMC-guidances Requirements Previous regulatory affairs, quality, clinical, R&D experience is a plus, but not strictly required Description This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC changes that are required for amendments, and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC for IMPD. The best choice for future certification and career promotion. In general, despite regional differences, most health authorities expect an increasing amount of information and a depth of technical knowledge to be provided in clinical trial applications, CTD/eCTD dossiers. Regulatory requirements for CMC information, history of CMC, guidance, and tips are provided within the scope of this course. Creator of this course - D. Ladanovska (RA Consultant, Head of RA)Speaker of this course - Liyonish (US singer, actress, speaker) Upon completion of this course, you will be able to:Identify the CMC information required for submissions to support clinical studies and marketing applications;Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section;Identify CMC changes that require agency notification;Explain different types of postapproval submissions;Describe the use of Drug Master Files (DMFs);Use tips for the IMPD Quality part;Be an expert in the main CMC-guidances. With a calm invited narrator's voice in this course, be ready to expand your knowledge and be prepared for future career challenges and winnings. Let's go! Overview Section 1: Introduction Lecture 1 Greetings Lecture 2 Introduction Section 2: What is CMC? Lecture 3 What is CMC? Lecture 4 Application Section 3: Regulatory History of CMC Lecture 5 Regulatory History of CMC (1862) Lecture 6 1883 - 1906 Lecture 7 1938 Section 4: EU Legislation Lecture 8 EU Legislation Section 5: ICH Lecture 9 ICH Section 6: Pharmacopeial Standards Lecture 10 EU Lecture 11 USA and Japan Section 7: CMC Within A Drug Application Lecture 12 CMC Within A Drug Application Section 8: CMC Module 3 Lecture 13 CMC Module 3 Lecture 14 Dossier and Quality Lecture 15 GMP guidelines Lecture 16 QMS Section 9: Up-to-date CMC Lecture 17 Up-to-date CMC Section 10: Procedure of Changes Lecture 18 Procedure of Changes Section 11: CMC-Guidances Lecture 19 CMC-Guidances Lecture 20 25 Tips for IMPD Lecture 21 CMC planning for biologics application Section 12: Summary of the course Lecture 22 Importance Lecture 23 Planning Strategies Regulatory Affairs Officer,Regulatory Affairs Associate,Regulatory Affairs Specialist,Regulatory Affairs Manager,Quality Control Manager,Head of Regulatory Affairs,Regulatory Writer
