|  ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
+++++Press Release++++++ Press Release ++++++
 |
150 Attend 2nd
European Conference
on Active
Pharmaceutical
Ingredients |
| 150 Delegates attended the 2nd
European Conference on Active Pharmaceutical Ingredients held in Brussels this September
(1999). The conference was arranged by the Active Pharmaceutical Ingredients Committee
of CEFIC (CEFIC/APIC), the conference organisers were Concept Heidelberg. |
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 |
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| from left to right: S. Higgins,
L. Hartmann, C. Pouget, N.C. Franklin, R. Gengenbach, W. Verhaegen, H. Leblanc, S.
Gangkofner, L. Le Doré, O. Schmidt, C. Oldenhof, E. Rivera Martinez, B. Fellows, K.
Metzger, J. Ruiz, P. Smith |
Comprehensive updates were given on recent
regulatory trends which will affect Good Manufacturing Practices for European Actives
manufacturers. Speakers attended from EDQM, FDA and the industry. The message was
brought firmly home to those who attended that the pace of change in the sector is rapid
and if companies are to remain competitive they must ensure that they have effective
quality management systems in place.
- The primary regulatory drivers discussed included
- The Starting Materials Directive - Henri Leblanc
CEFIC/APIC
- The Internationally Harmonised Guide on GMPs (ICH Q7a) -
Joyce Ramsbotham-Solvay/EFPIA
- The MRA Process - Matt Moran-CEFIC/APIC
- BACPAC/Variations - Chris Oldenhof-CEFIC/APIC
- Certificates of Suitability - Corinne Pouget-EDQM
Delegates received extensive up to the minute
presentations on recent inspection trends from John Ayling , previously an inspector
with the MCA , and Edwin Rivera Martinez of the US FDA.
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Edwin Rivera Martinez, US FDA |
Day 2 of the Conference comprised 8 parallel workshops
covering topics ranging from Computer Validation (David Selby) right the way through
Auditing (Lothar Hartmann) to Change Control (Chris Oldenhof).
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The podium |
Commenting at the end of the Conference CEFIC/APIC
President , Henri Leblanc of Rhodia Chimie said,
" Overall we are very pleased with the way the
event went. From a business perspective we feel that the European API sector is coming
under significant pressure from 3rd countries. We are concerned that there will
not be a level playing field for the industry here in Europe in terms of actual GMPs being
applied. We call on upon the regulatory authorities to ensure that common standards of GMP
are applied worldwide through frequent and rigorous inspections overseas. We welcome the
proposed GMP Guide developed by the International Conference on Harmonisation and urge
Europe to embrace the Mutual Recognition Agreement with The US FDA in any way that they
can."
For further information contact:
Matt Moran
CEFIC/APIC phone 087 2073919 / fax +35316381567
Loïc Le Dore
CEFIC/APIC phone 32 2 6767212 / fax 32 2 6767301/
E mail LLE@CEFIC.BE
Karl Metzger
CONCEPT phone 49 62 21 84440 / fax 49 62 218444 84 |
