2. Weiss Pharmacy Symposium

Unterföhring

Already for the second time, Weiss Klimatechnik GmbH hosted its successful Pharmacy Symposium on November 8th and 9th – this time under the auspices of the "Fourth Ordinance amending the Pharmacy Operating Regulations" which came into force in the middle of the year. A key goal of the revised regulation is improved drug safety, especially in pharmaceutical manufacturing by pharmacies.

The two-day, free event took place in Munich and was again aimed at pharmacists as well as operators and decision-makers of hospital pharmacies, retail pharmacies, or compounding centers. They could gain an overview of economic and political as well as legal and technical aspects of cleanroom-compliant manufacturing according to GMP in pharmacies.

Recognized experts and representatives of approval authorities presented practical solutions for a field characterized by market consolidation, increasing price pressure, and complex regulations. The broad range of topics included issues of health policy relevance, economic efficiency, legal certainty, and the legal foundations – including international standards – for cytostatics and sterile production, as well as equipment and monitoring, microbiology, and GMP qualification.

For this purpose, Weiss Klimatechnik invited renowned experts, including the distinguished lawyer and physician Prof. Dr. iur. Dr. med. Alexander Ehlers from the law firm Ehlers, Ehlers & Partner, who introduced the health policy dimension of the issue. This was followed by a contribution from Dr. Rainer Gnibl from the Oberbayern Regional Council on the legal foundations according to the current state, as well as three short presentations within the framework of a "Speed-Dating": Participants could visit three thematic islands – each with approximately half-hour short presentations and live exhibits: Thomas Hinrichs from Berner International discussed safety cabinets and isolators in pharmacies, Thomas Christen from Vali.sys GmbH covered monitoring systems for cleanrooms. Anja Monning from Fresenius Kabi Germany and Kerstin Glöser from Weiss Klimatechnik discussed the topic "Qualification and Documentation".

An insight into the requirements for aseptic preparations was provided by Dr. Uli Löscher from the University Hospital Basel – and Dr. Luzian Baumann from the Wetzlar Lahn-Dill Clinics spoke on "GMP and its microbiological validation". Prof. Dr. Weißsieker from TÜV Süd and Karl-Heinz Lotz, head of cleanroom technology at Weiss Klimatechnik, moderated the event as well as a panel discussion and concluded the event with a summary of the results.

ADKA and BLAK as well as GSASA each recognize continuing education points for the event. Karl-Heinz Lotz gives an extremely positive review: "Our guests and we were again able to use the symposium for very qualitative or high-quality and interesting discussions. I am especially pleased with the very positive feedback from the participants: The stimulating atmosphere, the highly current expert contributions, and the intensive speed-datings did not come across as dry frontal teaching, but offered a real forum for scientific exchange." On the second day of the event, interested participants had the opportunity to experience a cleanroom facility planned and implemented by Weiss Klimatechnik for compounding at Fresenius Kabi in Neufahrn near Munich live. On this day, discussions and questions about operational procedures and the efficient operation of a new cleanroom building were the main focus.

Due to overwhelming response, not all interested parties could participate in this 2nd Weiss Pharmacy Symposium. This prompted Weiss Klimatechnik to offer a follow-up event already in spring 2013. The date will be announced soon.