Global Registration and Life Cycle Management of APIs
Art-No.: A-1169
Date: 12-14 March 2019
Price: EUR 380,-
The Conference folder includes the following topics:
| No. | Topic | Summary | Pages |
| 14210 | Dossier Requirements for the Drug Substance | 0 | 38 |
| 14211 | Requirements for the certificate of Suitability | 0 | 44 |
| 14212 | Pharmaceutical Impurities: REsidual solvents, synthesis-derived and genotoxis impurities | 0 | 26 |
| 14213 | Stability data | 0 | 32 |
| 14214 | Workshop: Stability studies and estabilishing the restest-date | 0 | 14 |
| 14215 | Workshop: Description of the manufacturing process | 0 | 30 |
| 14216 | Workshop: The CEP prodecure - do´s and dont´s | 0 | 61 |
| 14218 | APIs Regulatory staring materials | 0 | 35 |
| 14219 | Comparison od the CEP and DMF Procedure | 0 | 29 |
| 14220 | Variations/Changes and life cycle management in the EU, US and rest of the world | 0 | 41 |
| 14221 | Registration requirements for APIs in emerging countries | 0 | 33 |
| 14652 | How to read and use a CEP | 0 | 53 |
| 14653 | Pharmaceutical Impurities | 0 | 41 |
| 14654 | Registration procedures in the US and Japan | 0 | 42 |
| 14655 | The EDQM inspection program | 0 | 25 |
| 14656 | ICH Q3D - how to do in practice for APIs | 0 | 40 |
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