Training Workshop: Assessment of the Quality Part of the Dossier –– WHO Prequalification of Medicines Programme

Agency for International Development (USAID), is the successor of the Drug Quality and Information (DQI) program implemented by the United States Pharmacopeia (USP). PQM is USAID's response to the growing challenge posed by the proliferation of counterfeit and substandard medicines. By providing technical assistance to developing countries, PQM helps build local capacity in medicine quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally. PQM staff, Dr. Souly Phanouvong and Mr. David Vanscoy, traveled to Copenhagen, Denmark, at the invitation of the World Health Organization (WHO) Prequalification Team, to participate in the Training Workshop: Assessment of the Quality Part of the Dossier. The workshop aimed to increase PQM's knowledge of key dossier requirements, commonly encountered deficiencies, and how to provide better technical assistance to manufacturers interested in pursuing WHO prequalification for second-line tuberculosis (TB) medicines. The workshop was attended by 37 participants representing regulatory agencies and programs from several countries. Senior assessors of the WHO PQ led the training based on their respective areas of expertise. The training covered the background of prequalification to drug development and final medicinal products. Participants were given an opportunity to review and provide solutions to different case study scenarios, and one-on-one meetings with the trainers were held on the last day of the workshop. Key benefits the PQM staff received from this training workshop include the latest updates on WHO PQ guidelines, familiarization with the new dossier format and presentation (CTD), especially the QIS/QOS formats and templates, clarifications on many practical issues PQM staff have encountered while providing technical assistance to manufacturers, and interaction with assessors of WHO PQ for specific questions and improved communications. The PQM program is providing technical assistance to interested companies to prepare their product dossiers for submission to the WHO prequalification program in a manner that fulfills the requirements. This includes facilitating discussions with WHO to remedy incomplete dossiers or to respond to WHO comments, and guiding manufacturers onsite to comply with the principles and guidelines of WHO Good Manufacturing Practices (GMP) and the requirements of the prequalification program. The workshop materials, including workshop slide presentations, can be obtained online at http://apps.who.int/prequal/ or upon request from PQM staff ([email protected]). The PQM program is working to increase the availability of good quality second-line ATBs and to expedite the prequalification process, thereby expanding the pool of viable manufacturers. The PQM program is also assisting in efforts to increase the availability of good quality second-line ATBs. To expedite the prequalification process and thereby expand the pool of viable manufacturers, PQM is providing technical assistance to interested companies to prepare their product dossiers for submission to the WHO prequalification program in a manner that fulfills the requirements. The PQM program is working to address the inadequate supply of products to treat patients with multi-drug resistant TB (MDR-TB). The program is providing technical assistance to manufacturers to prepare their product dossiers for submission to the WHO prequalification program in a manner that fulfills the requirements. This includes facilitating discussions with WHO to remedy incomplete dossiers or to respond to WHO comments, and guiding manufacturers onsite to comply with the principles and guidelines of WHO Good Manufacturing Practices (GMP) and the requirements of the prequalification program.