Just founded: Special Interest Group (SIG)“Regulatory & Guidelines

Regulatory Affairs is one of the most important disciplines accompanying drug development from tube to market. Regulations governing research, development and marketing of medicinal products are nowaday developed in close co-operation between authorities and pharmaceutical industry.

Methods and technology in pharmaceutical biotechnology are advancing much faster than the respective regulations. In the EU as well as elsewhere – and also at ICH (International Conference on Harmonisation of the technical requirements for drug registrations) – we must take into account, that the development of guidances, directives and regulations takes a long time before they come into force.
In the mean biotechnology based companies which develop their new drugs with new technologies, have a regulatory “black box” concerning the design of their development program.

This is why EAPB has the mission to 

-  develop a regulatory competence within the association to support their members in designing their regulatory strategies and development programs
-  identify regulatory issues of our members which are not clearly covered by existing legislation and recognise the need for the development of new guidances and laws
-  discuss a recognised need in case studies within the association, with other relevant organisations and the authorities
-  discuss and comment draft regulations ( eg. from ICH step 2) 
-  establish close relations to the European Union authorities, the ICH and others and exchange experience on a regular base
-  become acknowledged by these authorities as an “interested party” which will be invited to comment the development of new regulations before they come into force
This will be realised by a highly competent and efficient Special Interest Group of Regulatory Affairs Professionals together with experienced and interested EAPB members of senior level, especially from our corporate members as well as from academia. The group should
-  become knowledgeable concerning existing biotech related legislation,
-  analyse weak points in existing legislation and 
-  bring case studies and subjects for discussion,
-  start co-operating contacts to EC DG Enterprise, EMEA as the major European authorities re Biotechnology as well as to ICH,
-  represent EAPB and biotech Regulatory Affairs in the public in presentations and publications.

Expected benefits for members:

1.  support to solution of own Regulatory Affairs issues
2.  platform for professional discussions
3.  direct contacts to superior authorities
In case you are interested to participate in this SIG, please contact Dr. Axel F. Wenzel. For the last four years Dr. Wenzel was President of MEGRA (Mid-European Group of Regulatory Affairs) and simultaneously of PEFRAS (Pan-European Group of Regulatory Affairs Societies). His e-mail address is:
axel.wenzel@p-ss-t.de