1.Product Development and Licensing Procedures Training (A. Fatih Türeli)
2.Production of Solid Pharmaceutical Forms (A. Fatih Türeli)
3.Production of Liquid and Semi-Solid Pharmaceutical Forms (A. Fatih Türeli)
4.CTD File Preparation & Licensing (Gülcan Benzer)
•What is Licensing? Prioritization Application, GMP Audit process for Imported Medicines.
•Module 1-2-3-4-5 Contents, SPC&KT Content, Readability Test.
5.DMF Review and Alternative Active Ingredient Supplier Evaluation Process (Gülcan Benzer)
•Deciding the Suitability/Quality of a DMF
•Critical Considerations When Searching for Alternative Suppliers
6.CMC & License Compliance Processes (Gulcan Benzer)
•CMC Responsibilities and Collaborations
•CTD Format
•License Compliance Project Planning
•Precautions to be taken in order not to receive a Missing Letter from TITCK
•Respond quickly and accurately to TITCK Missing Letters
•Localization Applications and Details
7.Stability Studies (Gülcan Benzer)
•Types, Procedures, Guidelines of Stability Studies
•History of World Climate Classification, ICH & WHO Guidelines
•Global Stability Study Planning
•Stability Program (from Protocol to Annual Product Evaluation Report)
•Sample Management in Stability Cabinets/Rooms
•Management of Stability Cabinets/Rooms Alarms and Logbooks
•Calculation of Stability Cab/Room Volumes to be Invested
•Management of Malfunctions and Deviations in Stability Cabins/Rooms
•Evaluation of Out-of-Trend and Out-of-Limit Data
•Preparations To Be Made Before Inspection, Precautions To Be Taken
8.Details of the Critical Global Guidelines (ICH & WHO) (Gülcan Benzer)
•Local & Global Guides
•Process Validation, Bioequivalence, Impurities, Acceptance Criteria,
•Guidance References on Analytical Method Validation and Stability
9.Analytical Method Development and Validation (Gülcan Benzer)
10.GMP Training (Gulcan Benzer)
11.Reimbursement Basic and Advanced Training (Ahmet Kemal Kardan)
12.Orphan Pharmaceuticals -Foreign Medicines and Alternative Payment System (Ahmet Kemal Kardan)