Ref Id: S95439-T57800
Item Description: Customized Regulatory Affairs Training
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Major Modules:
FDA Regulations
CTD Structures
GCC Regulation for Pharmaceuticals
Medical Devices General Regulation followed by Middle East Regulation
CE – Marking
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Duration: 1 Month
Course Content and Deliverables:
1. FDA regulations – We will cover entire USFDA regulation. Where all aspect of drug discovery development to commercialization process will be discussed in details
– Tentative Days to Cover – 4-7 days
– Deliverables – 2 PDF Books (Downloadable) + E-Learning to attend the lecture
2. CTD Structures – Next step we can move to CTD and related guidelines. Practical Training on Dossier Preparation. Comparison of guideline of various regulatory zones with respect to key points to consider while preparaing dossier.
NOTE: DOSSIER PREPARATION TECHNIQUES REMAIN SAME. ONLY LITTLE CHANGE IN SPECIFIC STRUCTIRE REQUIRE FOR THE EACH DIFFERENT REGULATORY BODY
– Tentative Days to Cover – 3-4 Days
– Deliverables – 1 PDF Book (Downloadable) + Online lecture + 1 Open format Dossier (Word Document)*
*This is provided so that you can customize and do changes in dossier as per your need.
3. GCC Regulation for Pharmaceuticals – It will cover major part of Middle East Countries Regulation.
– Tentative Days to Cover – 3-4 Days
– Deliverables – 2 PDF Book (Downloadable) + online lectures
4. Medical Devices General Regulation followed by Middle East Regulation
– Tentative Days to Cover – 6-7
– Deliverables – 2 PDF Book (Downloadable) + online lectures
5. CE – Marking – Last Phase it can be added is CE-MARKING in totality. It will help you to get the comprehensive idea how CE certification process works.
– Tentative Days to Cover – 2-3 Days
– Deliverables – 1 PDF Book (Downloadable) + online lectures
Section 1FDA regulations
Lecture 1Drug Discovery - Introduction
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Fundamental of Generic Drugs
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Generic Drug User Fees Act (GDUFA)
Lecture 7Prescription Drug User Fees Act (PDUFA)
Lecture 8Handling of orange book
Lecture 9Priority Accelerated Review
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Practical Training on preparing DMF and SMF
Section 2CTD Structures
Lecture 14Introduction to Common Technical Document (CTD)
Lecture 15Electronic Common Technical Document (ECTD)
Lecture 16Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 17Modules on Stability Study 1
Lecture 18Stability Study Test
Lecture 19Module on Interchangeability
Lecture 20Stability Testing of API
Lecture 21Stability Testing of Finished Pharmaceutical Products
Lecture 22Review Test on Stability Testing
Section 3GCC Regulation for Pharmaceuticals
Lecture 23GCC Pharmaceutical Market
Lecture 24GCC Vs. Other Region - Regulatory point of view
Lecture 25Drug Registration Procedure in GCC countries
Lecture 26CTD
Lecture 27Drug Registration in Saudi Arabia
Lecture 28Documentation Required for the GCC countries
Lecture 29Drug Registration in UAE
Lecture 30Drug Registration in GCC countries
Lecture 31Requirements of the Drug Registration in the UAE
Lecture 32Drug Registration Requirement - Qatar
Lecture 33Stepwise Procedure for Export
Lecture 34Comparison of Registration Requirement of Different Regulatory Bodies
Lecture 35ASSESSMENT OF APPLICATIONS FOR NEW MARKETING AUTHORIZATIONS
Lecture 36Decision Chart for MA using WHO-Type of Product Certificate
Lecture 37Some Important Points Regarding GCC Exports
Section 4Medical Devices Regulation
Lecture 38Overall Understanding of Medical Devices Market
Lecture 39510(k) Regulation
Lecture 40510k VS. PMA
Lecture 41De Novo Petition - Medical Devices Regulation
Lecture 42Device Clinical Research
Lecture 43Humanitarian Device Exemption (HDE)
Lecture 44Labeling Requirement for Medical Devices
Lecture 45Marketing, Advertising and Promotion of Medical Devices
Lecture 46Unapproved use of Medical Devices
Lecture 47EU regulation of Medical Devices
Lecture 48Quality Management System (QMS) for medical devices company
Lecture 49c-GMP Requirement for Medical Devices
Lecture 50Medical Device Registration in GCC countries
