THIRD EUROPEAN GMP CONFERENCE - A UNIQUE FORUM
It is well accepted in the US, in Asia and Europe that GMP Conferences have been established as meeting places and platform to exchange information for the pharmaceutical industry. Early on, the University of Heidelberg and ECA recognized this need and set up the first European GMP Conference in June 2005, focusing on harmonisation, ICH Q8 and ICH Q9. Two years later, in June 2007, the 2nd European GMP Conference concentrated on GMP Harmonisation. Participants from 30 countries registered for this event.
Now, another two years later, the 3rd European GMP Conference will be held on 23-24 June 2009, again in Heidelberg, Germany. This year, the focus will be on GMP Initiatives to meet globalisation, as the Heparin case and other incidents caused a number of initiatives in Europe and the US.
One of the sessions will highlight the fight against counterfeit and unsafe medicinal products. For many years the fight against counterfeit products was considered to be a non-GMP topic. Today, after an increasing number of incidents, it is obvious that this effort is highly linked with the GMP world. In addition, many other formally not GMP-related topics became a challenge for industry, like the US bioterrorism initiative, Sarbanes Oxley Act, etc. Pharmaceutical companies have to implement a system that fulfils the needs of an increasing number of requirements. Daniel Scheidegger, Chairman of the ECA and Vice President Operations at Genzyme in Switzerland will discuss the idea of a management system that implants an increasing number of regulatory requirements. These systems have to deal with the various regulations to manage these requirements in an effective way. Dr Stephan Schwarze, member of the EFPIA Task Force and Head of Counterfeit Protection Management at Bayer Schering Pharma, will present the EFPIA proposal for coding and identification. The current project on 2D Matrix Codes as a coding solution will be discussed.
Auditing in third countries outside Europe and the US will be discussed in a further session. The auditing systems within industry as well as the GMP inspection system by authorities have been designed for auditing of domestic manufacturers. Very few adjustments have been made to face the different environments. But can audits/ inspections be the same in e.g. Europe and the US as in non-EU and non-US countries? And how to face the problem of counterfeit in countries where high counterfeiting is expected? Industry and authority have developed risk-based audit schedules. Audits and inspections need to address the potential risks to mitigate the probability of occurrence of GMP deviations and counterfeiting. Possible strategies will be discussed with the delegates.
Recommendation
7/8 May 2024
KPIs and Quality Metrics - Live Online Training
The Conference provides a meeting place for GMP professionals every other year. The unique concept with a total of five sessions allows a maximum of interactive involvement of the participants. The details of the programme can be found at www.gmp-conference.org.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
