25th GMP Conference in Dresden

The 25th GMP conference was held in the old part of town in Dresden, making it impossible for delegates to reach the venue without stumbling across the popular Christmas market and enjoying the pre-Christmas atmosphere. In fact, many delegates paid a visit to the Christmas market to met up with friends and fellow delegates on the evening before the event.

Reinhard Schnettler, Prof Dr Christa Schröder and Dr Nadine Frankenberg welcomed the delegates and gave an introduction to the conference.

Dr Landwehr opened the presentations with “GMP, QM and soft skills”, offering an extended view regarding regulatory compliance.

However, Rico Schulze quickly brought delegates back to reality. He informed the audience about current developments in the GxP world. Serialization, the Mutual Recognition Agreements (MRA) between the EU and the USA as well as the supply bottlenecks in the pharmaceutical market were just some of the topics that were met with great interest among delegates. This as well as other presentations showed the faults that resulted from the Lunapharm affair.

This was followed by five interactive group discussions on topics such as digitalisation, data integrity, MRA and considerations of the supply chain.

Recently retired Karl-Heinz Menges then said goodbye by taking a look at data management / data integrity and sharing a few personal reflections on his work in the expert group on computer-aided systems (EFG 11).

Dr Gabriele Wanninger also offered insights into the monitoring of drug manufacturers from the perspective of an inspector. Key words such as “audit tourism” caused heated discussions and debates.

This anniversary of GMP conference was a welcome occasion to look back over the past 25 years. Messrs Schnettler and Nedvidek recalled the historical developments and points of conversation of previous GMP conferences. It was interesting and a little frightening to notice the recurring themes, eg MRA, that seem to have established over the years.

The evening event took place in the German Hygiene Museum, which provided an informative framework for the lively discussions among the delegates.

Thomas Brückner from the Federal Association of the Pharmaceutical Industry opened the second day of the event. His descriptions of developments at European level were very particularly informative and revealing. Some of the topics he touched on were the use of titanium dioxide, aide-mémoire for GMP and GDP inspections, as well as his experience of the first months of serialization practice.

Afterwards, depending on their interests, participants were able to receive information and contribute to a number of round table discussions One of these was led by Thescon on the topic of “Artificial Intelligence and GxP”, where both fundamental questions and application-specific subtleties were explained. It turned out that this exciting topic offers potential for further discussions and will be picked up again during the seminar organised by PTS, to be held in Wiesbaden on 31st March 2020.

https://www.pts.eu/angebote/trainings/kuenstliche-intelligenz-ki-in-der-pharmaindustrie_3523.html

Delegates agreed that our industry needs to continue to engage on areas such as the Lunapharm affair, the rapidly increasing number of identified drug contaminants, delivery bottlenecks. We aslo need to take into consideration and embrace the challenges with regard to sustainability and negative effects of medication, including critical view points and crisis management.

In that respect, Mr Zimmermann gave insights into the mechanisms and “rules” of good corporate communication. Above all, the power of social networks ensures that tried-and-tested ways of providing targeted information reach their limits and that one has to face up to technical and social developments in this environment.

In the afternoon, many delegates took the opportunity to visit various companies in and around Dresden. In doing so, the diverse programme of this anniversary event came to a successful conclusion.