Invitation from the Chair of IPEC Europe

Dear Colleagues,

With the implementation of the EU Directive 2001/83/EC into national law, all active pharmaceutical ingredients and the yet-to be-defined Certain Excipients used in pharmaceutical manufacturing, must be produced in compliance with current Good Manufacturing Practice (cGMP). However a series of incidents with major public health problems showed excipients of substandard quality or counterfeited excipients to be involved. Often the supply chain has many traders and brokers and is of considerable complexity. Currently regulation of excipients is limited and legal enforceability is difficult. This situation has raised a debate about setting GMP, GDP and traceability requirements that are appropriate to excipients and do not simply mirror those developed for active pharmaceutical ingredients.

Our task at IPEC Europe and its sister organisations in America and Japan, is to continue to advocate better quality standards, appropriate regulation, and encourage innovation by protecting knowledge.

The IPEC Conference on Good Manufacturing Practices for Pharmaceutical Excipients provides an international forum for discussing new developments and recent initiatives of the major stakeholders.

We have invited speakers from EU, FDA and national authorities who will present updates on their recent and upcoming activities.

The conference provides time for networking with other colleagues and to benefit from exchanging information with industry and authority representatives.

I would like to invite you to this unique opportunity.

On behalf of IPEC Europe board,
Patricia Rafidison
Chair to IPEC Europe