Q&A Document to European NfG [Regulatives / Guidelines]
Hi Helmut,
after browsing through the document, I'm a little bit confused...
Are the rumors of a nostalgic 'Habsburgian' conspiracy with some Hungarian/Spanish/Dutch touch true?
What makes me wonder is the fact that it took nine drafted versions to proceed from one adopted NfG on BA/BE (1992) to the last one (2001): endless discussions, presentations at international conferences, etc.
The MR-NfG obviously remains 'stuck' at Draft #15 from 1999, and now we have a Q&A document which was (secretly?) prepared by an anonymous 'Therapeutic Subgroup on Pharmacokinetics (EWP-PK)': no drafted versions, no public discussion, etc.
I'm asking myself whether the EWP-PK (with its eight members, again according to rumors...) is representative of the European Regulatority Authorities?
But possibly preparing such a document is just a displacement activity for the real important stuff: two separate guidances for BA and BE!
after browsing through the document, I'm a little bit confused...
Are the rumors of a nostalgic 'Habsburgian' conspiracy with some Hungarian/Spanish/Dutch touch true?
What makes me wonder is the fact that it took nine drafted versions to proceed from one adopted NfG on BA/BE (1992) to the last one (2001): endless discussions, presentations at international conferences, etc.
The MR-NfG obviously remains 'stuck' at Draft #15 from 1999, and now we have a Q&A document which was (secretly?) prepared by an anonymous 'Therapeutic Subgroup on Pharmacokinetics (EWP-PK)': no drafted versions, no public discussion, etc.
I'm asking myself whether the EWP-PK (with its eight members, again according to rumors...) is representative of the European Regulatority Authorities?
But possibly preparing such a document is just a displacement activity for the real important stuff: two separate guidances for BA and BE!
—
Regards, Jaime
Regards, Jaime
Complete thread:
- European NfG Update? Helmut 2005-09-20 14:58 [Regulatives / Guidelines]
- Concept Paper for Addendum to NfG: HVDs Helmut 2006-05-25 12:15
- Q&A Document to European NfG Helmut 2006-08-16 19:18
- Q&A Document to European NfGJaime_R 2006-08-18 15:54