“Today and Tomorrow of the Polish Generic Medicines Industry in the Enlarged EU”

The seminar, which focussed on the present and future regulatory and legal environment for generic manufacturers, took place in Warsaw, Poland on 9-10 June 2005.

The seminar was organised by POLFARMED with particiaption from the EGA. It brought together around 70 delegates and guests for the two-day event. During nine sessions 16 speakers from regulatory bodies and industry discussed the latest tendencies in market development (IMS Health Poland) as well as challenges and opportunities for the generic industry.

The first day of the seminar was dedicated to Pharma Review implementation and new European regulatory procedures. During the second day, the new provisions for biosimilar medicinal products and herbal medicinal products, requirements in GMP for API and Pharmacovigilance as well as some legal issues were presented by speakers from EMEA (Dr S. Brosch) and the EGA (S. Kox and B. Stepniewska). Also presenting on these issues were speakers from the Polish authorities (Chief Pharmaceutical Inspectorate), legal advisors and representatives from the pharmaceutical industry.

The seminar also presented a good opportunity to discuss the drafting of provisions for implementing the new EU legislation from the Pharma Review into Polish law, with the Polish health authorities, officially presented by the Ministry of Health, just three days before the meeting took place.