About the RMM Working Group

The ECA RMM Working Group was founded on 7 June 2006 at the German Federal Agency for Sera and Vaccines by 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI).

During its inaugural meeting the working group reviewed the current situation of RMMs in Europe and defined a work plan.

One of the current issues the group identified is the lack of standardisation for the submission of RMMs. The group also considers the integration of certain methods into the European Pharmacopoeia chapter 5.1.6 as critical because it possibly sets a wrong focus on these tests only. In addition, the use of RMMs for marketed products is discouraged by the Type II Change effort. The group also voiced concerns about the inappropriate methods occasionally requested by the authorities -  like classical EP sterility tests for cell therapy products. In general it sees a clear forward path for using RMMs for new submissions.

To develop a work plan also representing the industry's point of view the group conducted a survey in one of ECA's Masterclasses and over the internet. The result representing close to 40 major European pharmaceutical companies and biotech start-ups across Europe showed that many companies plan on introducing RMMs in the next 1-3 years, and that most of them want to apply them for environmental monitoring and to focus on quantitative methods. Most companies also expressed that there is not enough regulatory support to drive a change quickly and that a clearer regulatory guidance would accelerate methods introduction. According to the survey companies also perceive the approval process as complex, thus delaying introduction. In that respect a clear expectation for adopting RMMs on the authorities' side would strongly influence many companies' thinking.

To help both authorities and industry get a better understanding of the requirements for the introduction of RMMs and to provide them with guidance based on case studies and available experience, the group will establish a Best Practice Guide. In two main chapters the guide will concentrate on traditional drugs and new drugs with their particular aspects and requirements. To share information from the guide with both sides the ECA will also organise webinars and courses. In addition the group plans on publishing articles in European pharmaceutical industry publications.

Advisory Board

The ECA RMM Working Group is lead by a Chairman and 10 Charter Members:

Chairman:

  • Dr Sven Deutschmann, Roche Diagnostics

Board Members:

  • Peter Ball, Pall Life Sciences
  • Barbara Gerten, Merck KGaA
  • Dr Klaus Haberer, Compliance Advice and Services in Microbiology
  • Dr Ulrich Herber, Accugenix
  • Dr Thomas Mikosch, Centocor
  • Dr Thomas Montag, German Federal Agency for Sera and Vaccines
  • Dr Paul Newby, GlaxoSmitKline
  • Dr Sébastien Ribault, MILLIPORE S.A.S.
  • Oliver Gordon, Novartis Pharma Stein AG

Learn more about this Working Group.