April 11-12, 2011 WHO prequalification workshop for Ukrainian manufacturers of anti-tuberculosis second-line drugs, 12 Melnikova str.

On April 11-12, 2011 on the basis of National University of Pharmacy (12 Melnikova str.) a WHO prequalification workshop was held for Ukrainiansecond-line anti-tuberculosis drugs manufacturers.

The event was organized bythe Promoting the Quality of Medicines (PQM) program of The United States Pharmacopoeial Convention (USP), the World Health Organization (WHO) and Global Drug Facility (GDF) in cooperation withthe State Service of Ukraine for medications and drug control, National Pharmaceutical University, and the Ukraine Scientific Pharmacopoeial Centre for the Quality of Medicines.

The workshop was held with financial support from The United States Agency for International Development (USAID).

The purpose of the workshop was to provide Ukrainian drug manufacturers with necessary information on the WHO prequalification program, conditions of providing technical aid in prequalification to the members of PQM program, prospects of global anti-tuberculosis drugs market as well as to increase the number of manufacturers which follow the WHO recommendations on Good Manufacturing Practice(GMP) and which can apply for WHO prequalification status and thus obtain access to high quality second-line anti-tuberculosis drugs worldwide.

The facilitators of the workshop were Dr. Kennedy Chibwe, senior PQM program advisor; Lynda Paleshnuik, WHO advisor; Deusdedit Mubangizi, WHO advisor (GMP department); Paloma Marroqun Lerga, Global Drug Facility technical officer.

Co-speakers at the workshop were Elena Perezhogina (“Sintez” OJSC, Kurgan) and Maddina Sottaeva (“Pharm Center” holding company).

The representative of the international organization for the purchase of drugs against HIV/AIDS, Malaria and Tuberculosis (UNITAID) Lorenzo Witherspoon was also present at the workshop.

Among the attendees there were the representatives ofthe State Service of Ukraine for medications and drug control, National Pharmaceutical University, The Ukrainian Scientific Pharmacopoeial Centre for the Quality of Medicines, and representatives of pharmaceutical enterprises of Ukraine, which are the current or prospective second-line anti-tuberculosis drugs manufacturers: “Lekhim-Kharkiv” CJSC (Kharkiv); “Pharmaceutical firm “Darnitsa” CJSC (Kyiv); CJSCSPC “Borshchahivskiy Chemical-pharmaceutical plant” (Kyiv);  “Kievmedpreparat” JSC (Kyiv); “Pharmex Group” LLC (Kyiv); “Stoma” JSC (Kharkiv); “Pharmaceutical company “Zdorovie” LTD ; “Yuria-Pharm” LTD  (Kyiv); The Chemical – Pharmaceutical plant “Chervona Zirka” JSC (Kharkiv);  “Avant” LTD (Kyiv).

The workshop was carried out in a warm and friendly atmosphere. All the parties involved have reached the established goals.