17 February, 1997 |
| 18:27 |
Welcome to the Discussion Group |
RegAffairs |
19 February, 1997 |
| 07:50 |
joining the group |
RegAffairs |
| 07:51 |
Field Alerts - Significance? |
RegAffairs |
25 February, 1997 |
| 08:41 |
Pharmaceutical Excipient Information |
RegAffairs |
| 15:22 |
Re: Pharmaceutical Excipient Information |
RegAffairs |
26 February, 1997 |
| 08:57 |
Re: Pharmaceutical Excipient Information |
RegAffairs |
09 March, 1997 |
| 13:45 |
FDA/ drug compliance and life rsik (table ?) |
RegAffairs |
14 March, 1997 |
| 08:03 |
advice |
RegAffairs |
| 09:57 |
Re: advice |
RegAffairs |
| 15:14 |
Re: advice |
RegAffairs |
18 March, 1997 |
| 06:49 |
Re: Pharmaceutical Excipient Information |
RegAffairs |
| 18:14 |
GMPs World-Wide |
RegAffairs |
20 March, 1997 |
| 08:15 |
Re: GMPs World-Wide |
RegAffairs |
| 11:03 |
Re: GMPs World-Wide |
RegAffairs |
| 14:12 |
Re: GMPs World-Wide |
RegAffairs |
21 March, 1997 |
| 16:22 |
Re: GMPs World-Wide |
RegAffairs |
05 April, 1997 |
| 20:35 |
reconstituion with Sterile WFI vs bacteriostatic water |
RegAffairs |
06 April, 1997 |
| 21:35 |
International Pharmaceutical Excipients Council (Europe) |
RegAffairs |
08 April, 1997 |
| 19:18 |
Clinical Stability |
RegAffairs |
11 April, 1997 |
| 05:36 |
Good Manufacturing Practices for Bulk Pharmaceutical Excipients |
RegAffairs |
| 05:36 |
Clinical Stability |
RegAffairs |
24 May, 1997 |
| 13:13 |
EU regulatory issues |
RegAffairs |
| 20:34 |
Re: EU regulatory issues |
RegAffairs |
26 May, 1997 |
| 17:15 |
Re: EU regulatory issues |
RegAffairs |
27 May, 1997 |
| 11:19 |
Re: EU regulatory issues |
RegAffairs |
12 June, 1997 |
| 10:33 |
Methanesulfonic acid |
RegAffairs |
20 June, 1997 |
| 08:04 |
NOTE 06/19/97 11:20:34 |
RegAffairs |
| 09:26 |
Re: NOTE 06/19/97 11:20:34 |
RegAffairs |
| 23:02 |
NDA Submission |
RegAffairs |
21 June, 1997 |
| 09:05 |
Re: NDA Submission |
RegAffairs |
23 June, 1997 |
| 17:57 |
Re: NOTE 06/19/97 11:20:34 |
RegAffairs |
26 June, 1997 |
| 22:04 |
Procedures for Handling of OOS Results |
RegAffairs |
02 July, 1997 |
| 08:00 |
ICH GCP Consolidated Guidelines - Record Retention |
RegAffairs |
| 12:39 |
Re: ICH GCP Consolidated Guidelines - Record Retention |
RegAffairs |
03 July, 1997 |
| 08:11 |
IPEC (Auditing) Guidelines Good Manufacturing Practices for Excipients |
RegAffairs |
10 July, 1997 |
| 08:09 |
Switzerland - "named patient supply" of unlicenced medicine |
RegAffairs |
14 July, 1997 |
| 08:03 |
calibration method |
RegAffairs |
15 July, 1997 |
| 08:02 |
Re: calibration method |
RegAffairs |
17 July, 1997 |
| 09:25 |
FW: Exporting without Process/Product Va |
RegAffairs |
18 July, 1997 |
| 08:08 |
When to validate? |
RegAffairs |
21 July, 1997 |
| 17:27 |
RE: When to validate? |
RegAffairs |
22 July, 1997 |
| 14:34 |
RE: When to validate? |
RegAffairs |
| 16:02 |
scale up question |
RegAffairs |
23 July, 1997 |
| 08:14 |
RE: scale up question |
RegAffairs |
28 July, 1997 |
| 13:33 |
Re[2]: When to validate? |
RegAffairs |
05 August, 1997 |
| 08:45 |
Certificates of Analysis |
RegAffairs |
| 12:59 |
Re: Certificates of Analysis |
RegAffairs |
| 13:01 |
Re: Certificates of Analysis |
RegAffairs |
12 August, 1997 |
| 22:19 |
questions |
RegAffairs |
17 August, 1997 |
| 12:47 |
Re: questions |
RegAffairs |
18 August, 1997 |
| 05:14 |
Re: questions |
RegAffairs |
| 05:17 |
Re: Certificates of Analysis |
RegAffairs |
10 September, 1997 |
| 08:56 |
SOP List for Manufacturer of Pharmaceutical Solutions for Humanand Veterinary Use |
RegAffairs |
12 September, 1997 |
| 22:37 |
Re: SOP List for Manufacturer of Pharmaceutical Solutions for Human and Veterinary Use |
RegAffairs |
26 September, 1997 |
| 16:54 |
Procedure or Guide for Handling of OOS Results |
RegAffairs |
28 September, 1997 |
| 19:46 |
Thalidomide -- What really happened? |
RegAffairs |
29 September, 1997 |
| 09:21 |
Re: Procedure or Guide for Handling of OOS Results |
RegAffairs |
| 13:31 |
Re: Thalidomide -- What really happened? |
RegAffairs |
08 October, 1997 |
| 13:50 |
Tradename issues |
RegAffairs |
13 October, 1997 |
| 12:07 |
Re: clinical trial initiation procedures |
RegAffairs |
14 November, 1997 |
| 20:50 |
regulation in Brazil |
RegAffairs |
| 22:18 |
Re: regulation in Brazil |
RegAffairs |
| 22:28 |
Re: regulation in Brazil |
RegAffairs |
28 November, 1997 |
| 11:05 |
International Standards for the Packaging and Labelling ofMedicinal Products |
RegAffairs |
| 17:48 |
Re: International Standards for the Packaging and Labelling of |
RegAffairs |
| 17:48 |
Re: International Standards for the Packaging and Labelling of Medicinal Products |
RegAffairs |
09 December, 1997 |
| 11:15 |
pglickma@student.med.harvard.edu |
RegAffairs |
| 18:51 |
Product Liner Interactions |
RegAffairs |
| 22:37 |
Re: pglickma@student.med.harvard.edu |
RegAffairs |
10 December, 1997 |
| 04:31 |
Re: pglickma@student.med.harvard.edu |
RegAffairs |
| 13:29 |
repackaging of active ingredients |
RegAffairs |
11 December, 1997 |
| 08:30 |
Re: repackaging of active ingredients |
RegAffairs |
26 December, 1997 |
| 19:33 |
Publications* |
RegAffairs |
