|
No. |
Topic |
Summary |
Pages |
7670
| Background and History of APIs in Europe
The level Playing Field | - | 15 |
7671
| Is there am API Crisis Europe? | - | 30 |
7672
| Continuous Improvement /Change Control / Inspection
Supplement submissions: Under a Modern Quality System | - | 37 |
7673
| Industry´s View on /role in the FDA´s 21th Century Initiative | - | 21 |
7674
| The new Pharmaceutical Legislation in Europe and implementing measures | - | 22 |
7675
| Current and future programme of the QWP | 1 | 39 |
7676
| Pharmaceutical Quality Assessment for 21st Century | - | 45 |
7677
| ICH Q10 on Quality Systems - It´s possible implications from Industry Perspective | - | 37 |
7678
| Globalisation of regulatory requirements | - | 30 |
7679
| Active Substance Master File Procedure: Variation Application | - | 39 |
7680
| Experience with the new CEP Change Submission System | - | 47 |
7681
| New EMEA procedure to develop regulatory documents | - | 15 |
7682
| An industry view on transparency and cooperation in developing regulatory documents | - | 20 |
7684
| Parallel Session 1: PAT | - | 45 |
7685
| Parallel Session 2: APIC Audit Programme | - | 46 |
7686
| Parallel Session 3: Counterfeit in the API Supply Chain | - | 18 |
7687
| Parallel Session 5: APIs from recombinant cell lines | - | 55 |
8368
| Parallel Session 4: SAP and Validation | - | 68 |
8369
| Parallel Session 6: Vendor Qualification | - | 29 |
8370
| Parallel Session 7: Impurities (RA) | - | 52 |
8371
| Parallel Session 8: Clinical Trials Directive Implications | - | 20 |
