6th APIC 2003

The 6th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients took place from 5-7 November 2003 in the Hilton Hotel Budapest in Budapest/Hungary on the Castle Hill in Buda, the medieval heart of the Hungarian capital.

Nearly 200 participants from all over Europe participated in theconference that meanwhile has become the key event for the API industry in Europe. Speakers from API and Pharmaceutical Industry as well as from organisations and authorities from Europe, the US and Canada (among them Dr. Moheb Nasr and Dr. Stephen P. Miller from CDER/FDA, Ms Corinne Pougetfrom EDQM, Dr. Mike Morris from Irish Medicines Boards, IMB, Mr Jean Lambert from the Canadian Health Products and Food Branch Inspectorate, Dr. Peter Bachmann from the German Federal Institute for Drugs and Medical Devices) presented actual GMP and RA topics.

As in the last years, the conference consisted of a GMP-part, a joint day and a Regulatory Affairs Part. The first and the third conference day focused on worldwide news in the GMP and the RA field related to the API industry. A new feature of the 6th APIC/CEFIC Conference on APIs were different parallel sessions on 'How to do ICH Q7a' together with a final Round Table 'How to do' discussion with members of different authorities worldwide.

Dr. Henri Leblanc, President of the APIC (Active Pharmaceutical Ingredients Committee) opened the conference on Wednesday, 5 November2005, followed by Mrs Gabriella Détari, Hungary, who gave the keynote address and focused on the impact of the EU in largement for the Hungarian pharmaceutical and API industry.

The GMP Part of the conference focused on worldwide GMP newsrelated to the API industry. Special attention was given on recent FDA/CDER initiatives (Risk based approach for GMP and CMC Review – PAT and product characteristics for the 21st century; Dr. Moheb Nasr, CDER/FDA) as well as the answer of the API industry to the changing authority environment. In particular the 6 Sigma Approach (Mr Rolf Staal, Aventis Pharma GmbH) as a vision and the Quality Management Systems (Dr. Lothar Hartmann, F. Hoffmann-La Roche AG) as a way to fulfil the authorities' expectations were discussed. Furthermore, the current situation worldwide and trends in audits and inspections were presented,e.g. the IMI-PIC/S Inititative for ensuring API compliance (Mr Jean Lambert, Health and Products and Food Branch Inspectorate, Canada) as well as first experiences with the APIC Audit Programme (Dr. Barbara Jentges, Concept Heidelberg GmbH). Experiences and practical hints on how to prepare authority inspections and customer audits were presented (Dr. Reiner Kirrstetter, Aventis Pharma GmbH).

In the Joint Day, the new practical part of the conference, different parallel sessions for biotechnology (Dr. Harald Wiedner, QuaSyCon GmbH), computer related issues (Mr Willy Vervest, Omnichem NV/SA and Dr. Ralf Otte, ABB), cleaning validation (Ms Claudia Toobe,AstraZeneca, and Mr Stefan Gangkofner, Chemie Uetikon) and laboratory equipment (including raw data handling; Dr. Peter Kammerer, Merckle GmbH and Dr. Uwe Plankert, F. Hoffmann-La Roche AG) with special focus on 'How to do ICH Q7a' took place. Each participant had the opportunity to participate in two out of of 4 parallel sessions where specific topics were presented and discussed in smaller groups together with specialists from the API industry. A highlight of this part of the conference was the Questions & Answers Section at the end of the day with a Round Table Discussion with all authority members that participated in the conference as speakers.

The RA Part of the conference discussed worldwide RA news related to the API Industry. The status of the CMC risk-based review project, of BACPAC II and of the revision of the 1987 FDA Drug Substance Guidance (Dr. Stephen P. Miller, CDER/FDA) were presented. The reactions of the pharmaceutical and the API industry to these initiatives were discussed by members of the industry organisations PhRMA (Ms WendyMavroudakis, Johnson&Johnson, USA) and APIC (Ms Charlotte Hemmingsen, Alpharma Aps).

Furthermore, API related activities in 2003 and a forecast of 2004 activities of CPMP/CVMP Quality Working Party (Dr. Mike Morris, IMB) were explained, special focus was given on the impact of the new EU Variations Regulations on API manufacturers (Dr. Peter Bachmann, Federal Institute of Drugs and Medical Devices, Germany) and their API aspects and interpretations (Dr. Jan Smeets, DSM Anti-Infectives), on frequent deficiencies in CEP applications (Ms Corinne Pouget, EDQM) and experiences with CTD/eCTD related to APIs (Dr. Mike Morris, MBA). The RA part was highlighted by a presentation of Professor Dr. Holzgrabe (UniversityWürzburg, Germany), who presented her results of a research of different Gentamicin products to give an impression of the different API qualities available on the market.

The conference was marked very good by the participants, who enjoyed the presentations and the discussions in the parallel sessions on the one hand and the opportunity to discuss special items with the authority speakers and the API Industry specialists personally.

Another highlight of the conference was the social event that meanwhile has become a tradition and was well received. Participants and speakers were invited to an entertaining evening outside the hotel followed by adinner in a typical Hungarian restaurant.


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