Interview ISPE First Europe Annual Conference Raises a flag for More Europe in the ISPE
Dr. Thomas Zimmer was named ISPE Vice-President of European Operations in November 2013 and this year he will shoulder responsibility for the first ISPE Europe Annual Conference. In an interview with PROCESS Worldwide, he explained why ISPE will develop its network with european regulators and how the conference will contribute to a new quality awareness.
Dr. Zimmer, ISPE is perceived to be heavily dominated by America. Is this first ISPE Europe Annual Conference an indication that Europe is starting to play a more significant role in the organization?
Zimmer: It is true that the ISPE is still seen as being very US-centric. However there is growing recognition for the need to pay more attention to Europe and to listen more. If that were not the case, the ISPE would not have a Vice-President for European Operations. ISPE now understands that solutions which work well in America cannot simply be transferred to Europe on a 1:1 basis. If you take a look at the EC GMP Guide, you see that many chapters are currently being revised. We have a lot of work ahead of us.
Compared to the FDA, the EMA is much more active and above all much more specific. The basic GMP principles are the same, but there are definitely differences in the details. Despite all of the harmonization efforts, there is a tendency for the differences to become bigger rather than smaller. As EMA now sets the tone, the Europeans have clearly emancipated themselves from the Americans. That fact that the Australians and Chinese are heavily influenced by the EC GMP Guide is a clear indication of this. As a result, the FDA is not automatically seen as the world standard when solutions are being developed. Europe now plays a crucial role.
What are the essential differences between Europe and the US?
Zimmer: To start with, the regulatory system in Europe is completely different. To cite two examples, most production registration in Europe is organized at the national level. Around 80 %–85 % of all drugs are approved at the national level and only 15 %–20 % by the EMA.
In addition, EMA does not conduct any audits in Europe. The EU countries have audit responsibility, and the audits are usually administered by regional commissions or public health bodies. Outside the EU, the authorities of EU member states carry out audits on behalf of the EMA.
The key issue to be discussed at the conference is how to reconcile increased effectiveness with a quality culture? Where is the industry struggling at the moment?
Zimmer: Many international pharmaceutical companies are currently trying to manage quality problems. The audit authorities are more critical. Many deficiencies are being identified at the plants and as a result the plants are not GMP compliant. The work is not being carried out in accordance with the regulations as interpreted by the authorities.
The FDA in particular does not hesitate to take drastic measures. This can create shortages, and the population does not always have access to adequate supplies of drugs. The effects are felt by the segment of the pharmaceutical industry which conducts research as well as by generics manufacturers and OTC drug makers.
How does the conference intend to contribute to an improvement of the quality situation?
Zimmer: We have a clear message. Quality problems cannot be solved by the Quality Assurance Department alone. Everything is inter-related at a pharmaceutical plant. All of the functions which operate at the technical level including Production, Quality Assurance, Quality Control, Logistics and Engineering acting in unison must engage in an interdisciplinary dialogue and work to improve quality. Quality must be built into the process right from the start. It cannot be inspected in after the fact. We want to address all of the functions at the plants.
The Executive Forum on the first day and the keynote sessions on the following morning will be the conference highlights. What topics are on the agenda?
Zimmer: The Executive Forum and keynote speeches will zero in on the really big challenges in pharmaceutical production. They will be looking at market realization, supply chain integrity and how to prevent non-compliance from causing drug shortages. Experts from Mc Kinsey will be addressing the compliance-shortages issue based on their 10 years of experience with the Pobos database. This is a very important issue.
We need to understand how to resolve the apparent conflict between lean production and compliance. Keynote speaker Dr. Wolfram Carius from Sanofi Frankfurt will be sharing information on the challenges facing the biopharmaceutical industry. The talk by John Pinion from Roche will be another highlight. Roche currently has a reputation in the community for being highly innovative. It is seen as a company which has succeeded in completely revamping its Quality Assurance systems.
What will be going on in the parallel sessions?
Zimmer: The three tracks are Quality by Design, Quality Risk Management and Facilities of the Future. The use of disposables in production will be addressed in the Quality Risk Management and Facility of the Future tracks. Using practical examples, we will explain how to make the transition from conventional technology to single-use items, in other words how to set up Post-Approval Change Management and what the costing might look like. If this type of approach can simplify revalidation, companies may be able to save a lot of money. The list of other topics includes new strategies for continuous production, especially in the biotech industry. We place great emphasis on providing information that is of particular interest to Production Engineers, Production Managers, Production Foremen and other technical personnel who work at the practical level.
Your target audience is front-line staff as well as management. What will the various participants take away with them?
Zimmer: The conference as a whole spans a spectrum ranging from regulatory requirements and their importance in practical application continuing right through to the potential consequences of non-compliance for companies and the supply of drugs to the market. In this way, we are able to promote a dialogue between management and front-line staff. Management learns that lean production and compliance are not necessarily conflicting goals. Based on best-practice, the people who work on the front-line learn how implementation can be carried out in the plant. ●